Trial Outcomes & Findings for Family Diabetes Prevention Program Pilot Study (NCT NCT05358444)

NCT ID: NCT05358444

Last Updated: 2025-07-08

Results Overview

The average total number of required core period program sessions attended by the adult participant (inclusive of make-up sessions) including all DPP (and, if in Family DPP, additional Family DPP sessions); for Family DPP adult participants this will also be examined for the subset of DPP sessions and additional Family DPP sessions.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

34 participants

Primary outcome timeframe

6 months

Results posted on

2025-07-08

Participant Flow

This study enrolled adult participants only in the DPP arm, and adult-child dyads in the Family DPP arm. 10 adult participants were enrolled in the DPP arm, and 12 adult-child dyads were enrolled in the Family DPP arm (12 adults and 12 children).

Participant milestones

Participant milestones
Measure
Diabetes Prevention Program (DPP)
Adult participants who are engaged in the Centers for Disease Control and Prevention's (CDC) National Diabetes Prevention Program lifestyle intervention (DPP) as delivered by the Johns Hopkins Brancati Center; this is a 12-month long, group-based lifestyle intervention, delivered by a certified lifestyle coach using a CDC-approved curriculum. This "concurrent control" group will consist of adults who are enrolled in the Brancati Center's DPP within 6 months of the intervention group start dates, who have children less than 18 years of age living in their households. National Diabetes Prevention Program Lifestyle Intervention (DPP): The National Diabetes Prevention Program lifestyle intervention (DPP) is a 12-month long, group-based lifestyle intervention for adults at high-risk for type 2 diabetes. The DPP will be delivered by certified coaches from the Johns Hopkins Brancati Center. The program uses the CDC's Prevent T2 curriculum, with a total of 32-34 sessions delivered over a 12-month period. In the initial "core" period (first 6 months), there are at least 16 sessions delivered on a weekly basis. In the "post-core" period, additional (at least 6) sessions are offered over a 6 month period. Sessions are delivered either in-person or via a virtual synchronous platform (Zoom).
Family Diabetes Prevention Program (Family DPP)
Adult participants will engage in the family-oriented Diabetes Prevention Program lifestyle intervention (Family DPP); this is an augmented version of the DPP lifestyle intervention. This 12-month, group-based lifestyle intervention will include all elements of the DPP lifestyle intervention as delivered by the Johns Hopkins Brancati Center using a CDC-approved curriculum, with additional child-focused sessions in which adult participants will learn about children's health-related behaviors. Children will be present at the child-focused sessions and family activities, and will be engaged in data collection. Groups will be "mixed," in that non-study participants (adults who are eligible for the DPP), may also participate. Family DPP: The Family DPP has been developed as an augmented version of the National Diabetes Prevention Program Lifestyle Intervention (DPP). It includes all elements of the 12-month, group-based DPP lifestyle intervention, led by a CDC certified-coach using a CDC-approved curriculum (involving around 32-34 sessions). The augmentations of the Family DPP include 2 additional sessions that address barriers to adults' own lifestyle change efforts related to being a caregiver of children and child-focused sessions to introduce basic concepts regarding healthy child lifestyle habits. The additional sessions that will be delivered to the adult DPP participant, and in which children, ages 5 through 12, can also be engaged.
Overall Study
STARTED
10
12
Overall Study
COMPLETED
10
8
Overall Study
NOT COMPLETED
0
4

Reasons for withdrawal

Reasons for withdrawal
Measure
Diabetes Prevention Program (DPP)
Adult participants who are engaged in the Centers for Disease Control and Prevention's (CDC) National Diabetes Prevention Program lifestyle intervention (DPP) as delivered by the Johns Hopkins Brancati Center; this is a 12-month long, group-based lifestyle intervention, delivered by a certified lifestyle coach using a CDC-approved curriculum. This "concurrent control" group will consist of adults who are enrolled in the Brancati Center's DPP within 6 months of the intervention group start dates, who have children less than 18 years of age living in their households. National Diabetes Prevention Program Lifestyle Intervention (DPP): The National Diabetes Prevention Program lifestyle intervention (DPP) is a 12-month long, group-based lifestyle intervention for adults at high-risk for type 2 diabetes. The DPP will be delivered by certified coaches from the Johns Hopkins Brancati Center. The program uses the CDC's Prevent T2 curriculum, with a total of 32-34 sessions delivered over a 12-month period. In the initial "core" period (first 6 months), there are at least 16 sessions delivered on a weekly basis. In the "post-core" period, additional (at least 6) sessions are offered over a 6 month period. Sessions are delivered either in-person or via a virtual synchronous platform (Zoom).
Family Diabetes Prevention Program (Family DPP)
Adult participants will engage in the family-oriented Diabetes Prevention Program lifestyle intervention (Family DPP); this is an augmented version of the DPP lifestyle intervention. This 12-month, group-based lifestyle intervention will include all elements of the DPP lifestyle intervention as delivered by the Johns Hopkins Brancati Center using a CDC-approved curriculum, with additional child-focused sessions in which adult participants will learn about children's health-related behaviors. Children will be present at the child-focused sessions and family activities, and will be engaged in data collection. Groups will be "mixed," in that non-study participants (adults who are eligible for the DPP), may also participate. Family DPP: The Family DPP has been developed as an augmented version of the National Diabetes Prevention Program Lifestyle Intervention (DPP). It includes all elements of the 12-month, group-based DPP lifestyle intervention, led by a CDC certified-coach using a CDC-approved curriculum (involving around 32-34 sessions). The augmentations of the Family DPP include 2 additional sessions that address barriers to adults' own lifestyle change efforts related to being a caregiver of children and child-focused sessions to introduce basic concepts regarding healthy child lifestyle habits. The additional sessions that will be delivered to the adult DPP participant, and in which children, ages 5 through 12, can also be engaged.
Overall Study
Withdrawal by Subject
0
1
Overall Study
Lost to Follow-up
0
3

Baseline Characteristics

Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Diabetes Prevention Program (DPP)
n=10 Participants
Adult participants who are engaged in the Centers for Disease Control and Prevention's (CDC) National Diabetes Prevention Program lifestyle intervention (DPP) as delivered by the Johns Hopkins Brancati Center; this is a 12-month long, group-based lifestyle intervention, delivered by a certified lifestyle coach using a CDC-approved curriculum. This "concurrent control" group will consist of adults who are enrolled in the Brancati Center's DPP within 6 months of the intervention group start dates, who have children less than 18 years of age living in their households. National Diabetes Prevention Program Lifestyle Intervention (DPP): The National Diabetes Prevention Program lifestyle intervention (DPP) is a 12-month long, group-based lifestyle intervention for adults at high-risk for type 2 diabetes. The DPP will be delivered by certified coaches from the Johns Hopkins Brancati Center. The program uses the CDC's Prevent T2 curriculum, with a total of 32-34 sessions delivered over a 12-month period. In the initial "core" period (first 6 months), there are at least 16 sessions delivered on a weekly basis. In the "post-core" period, additional (at least 6) sessions are offered over a 6 month period. Sessions are delivered either in-person or via a virtual synchronous platform (Zoom).
Family Diabetes Prevention Program (Family DPP)
n=24 Participants
Adult participants will engage in the family-oriented Diabetes Prevention Program lifestyle intervention (Family DPP); this is an augmented version of the DPP lifestyle intervention. This 12-month, group-based lifestyle intervention will include all elements of the DPP lifestyle intervention as delivered by the Johns Hopkins Brancati Center using a CDC-approved curriculum, with additional child-focused sessions in which adult participants will learn about children's health-related behaviors. Children will be present at the child-focused sessions and family activities, and will be engaged in data collection. Groups will be "mixed," in that non-study participants (adults who are eligible for the DPP), may also participate. Family DPP: The Family DPP has been developed as an augmented version of the National Diabetes Prevention Program Lifestyle Intervention (DPP). It includes all elements of the 12-month, group-based DPP lifestyle intervention, led by a CDC certified-coach using a CDC-approved curriculum (involving around 32-34 sessions). The augmentations of the Family DPP include 2 additional sessions that address barriers to adults' own lifestyle change efforts related to being a caregiver of children and child-focused sessions to introduce basic concepts regarding healthy child lifestyle habits. The additional sessions that will be delivered to the adult DPP participant, and in which children, ages 5 through 12, can also be engaged.
Total
n=34 Participants
Total of all reporting groups
Age, Categorical
Adult participants · <=18 years
0 Participants
n=10 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
0 Participants
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
0 Participants
n=22 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
Age, Categorical
Adult participants · Between 18 and 65 years
9 Participants
n=10 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
11 Participants
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
20 Participants
n=22 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
Age, Categorical
Adult participants · >=65 years
1 Participants
n=10 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
1 Participants
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
2 Participants
n=22 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
Age, Categorical
Child participants · <=18 years
12 Participants
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
12 Participants
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
Age, Categorical
Child participants · Between 18 and 65 years
0 Participants
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
0 Participants
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
Age, Categorical
Child participants · >=65 years
0 Participants
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
0 Participants
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
Age, Continuous
Adult participants
48.2 years
n=10 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
46.4 years
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
47.2 years
n=22 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
Age, Continuous
Child participants
9.85 years
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
9.85 years
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
Sex: Female, Male
Adult participants · Female
8 Participants
n=10 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
10 Participants
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
18 Participants
n=22 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
Sex: Female, Male
Adult participants · Male
2 Participants
n=10 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
2 Participants
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
4 Participants
n=22 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
Sex: Female, Male
Child participants · Female
9 Participants
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
9 Participants
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
Sex: Female, Male
Child participants · Male
3 Participants
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
3 Participants
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
Ethnicity (NIH/OMB)
Adult participants · Hispanic or Latino
0 Participants
n=10 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
0 Participants
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
0 Participants
n=22 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
Ethnicity (NIH/OMB)
Adult participants · Not Hispanic or Latino
9 Participants
n=10 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
11 Participants
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
20 Participants
n=22 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
Ethnicity (NIH/OMB)
Adult participants · Unknown or Not Reported
1 Participants
n=10 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
1 Participants
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
2 Participants
n=22 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
Ethnicity (NIH/OMB)
Child participants · Hispanic or Latino
0 Participants
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
0 Participants
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
Ethnicity (NIH/OMB)
Child participants · Not Hispanic or Latino
8 Participants
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
8 Participants
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
Ethnicity (NIH/OMB)
Child participants · Unknown or Not Reported
4 Participants
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
4 Participants
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
Race (NIH/OMB)
Adult participants · American Indian or Alaska Native
0 Participants
n=10 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
0 Participants
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
0 Participants
n=22 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
Race (NIH/OMB)
Adult participants · Asian
0 Participants
n=10 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
0 Participants
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
0 Participants
n=22 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
Race (NIH/OMB)
Adult participants · Native Hawaiian or Other Pacific Islander
0 Participants
n=10 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
0 Participants
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
0 Participants
n=22 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
Race (NIH/OMB)
Adult participants · Black or African American
7 Participants
n=10 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
9 Participants
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
16 Participants
n=22 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
Race (NIH/OMB)
Adult participants · White
2 Participants
n=10 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
3 Participants
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
5 Participants
n=22 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
Race (NIH/OMB)
Adult participants · More than one race
1 Participants
n=10 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
0 Participants
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
1 Participants
n=22 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
Race (NIH/OMB)
Adult participants · Unknown or Not Reported
0 Participants
n=10 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
0 Participants
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
0 Participants
n=22 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
Race (NIH/OMB)
Child Participants · American Indian or Alaska Native
0 Participants
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
0 Participants
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
Race (NIH/OMB)
Child Participants · Asian
0 Participants
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
0 Participants
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
Race (NIH/OMB)
Child Participants · Native Hawaiian or Other Pacific Islander
0 Participants
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
0 Participants
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
Race (NIH/OMB)
Child Participants · Black or African American
6 Participants
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
6 Participants
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
Race (NIH/OMB)
Child Participants · White
2 Participants
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
2 Participants
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
Race (NIH/OMB)
Child Participants · More than one race
0 Participants
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
0 Participants
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
Race (NIH/OMB)
Child Participants · Unknown or Not Reported
4 Participants
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
4 Participants
n=12 Participants • Adult participants only were enrolled in the DPP arm. Child participants and adult participants (as adult-child dyads) were enrolled in the Family DPP arm.
Region of Enrollment
United States
10 Participants
n=10 Participants
24 Participants
n=24 Participants
34 Participants
n=34 Participants
Adult participant/caregiver relation to child
Parent
9 Participants
n=10 Participants • This is a characteristic unique to adult participants only.
10 Participants
n=12 Participants • This is a characteristic unique to adult participants only.
19 Participants
n=22 Participants • This is a characteristic unique to adult participants only.
Adult participant/caregiver relation to child
Grandparent
1 Participants
n=10 Participants • This is a characteristic unique to adult participants only.
2 Participants
n=12 Participants • This is a characteristic unique to adult participants only.
3 Participants
n=22 Participants • This is a characteristic unique to adult participants only.
Adult participant/caregiver employment status
Employed/Works Outside the Home
8 Participants
n=10 Participants • This is a characteristic unique to adult participants only.
9 Participants
n=12 Participants • This is a characteristic unique to adult participants only.
17 Participants
n=22 Participants • This is a characteristic unique to adult participants only.
Adult participant/caregiver employment status
Not Employed
2 Participants
n=10 Participants • This is a characteristic unique to adult participants only.
3 Participants
n=12 Participants • This is a characteristic unique to adult participants only.
5 Participants
n=22 Participants • This is a characteristic unique to adult participants only.
Household annual income, category
Less than $10,000
0 Participants
n=10 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
1 Participants
n=12 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
1 Participants
n=22 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
Household annual income, category
Between $10,001 and $20,000
0 Participants
n=10 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
0 Participants
n=12 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
0 Participants
n=22 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
Household annual income, category
Between $20,001 and $40,000
1 Participants
n=10 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
1 Participants
n=12 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
2 Participants
n=22 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
Household annual income, category
Between $40,001 and $60,000
0 Participants
n=10 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
1 Participants
n=12 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
1 Participants
n=22 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
Household annual income, category
Between $60,001 and $70,000
1 Participants
n=10 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
0 Participants
n=12 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
1 Participants
n=22 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
Household annual income, category
Above $70,001
8 Participants
n=10 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
9 Participants
n=12 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
17 Participants
n=22 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
Household annual income, category
Decline to answer
0 Participants
n=10 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
0 Participants
n=12 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
0 Participants
n=22 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
Household receipt of benefits in past year
None
6 household
n=10 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
9 household
n=12 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
15 household
n=22 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
Household receipt of benefits in past year
Special Supplemental Nutrition Program for Women, Infants and Children
0 household
n=10 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
1 household
n=12 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
1 household
n=22 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
Household receipt of benefits in past year
Supplemental Nutrition Assistance Program
1 household
n=10 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
3 household
n=12 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
4 household
n=22 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
Household receipt of benefits in past year
Temporary Cash Assistance/TANF
0 household
n=10 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
1 household
n=12 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
1 household
n=22 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
Household receipt of benefits in past year
Temporary Disability Assistance
0 household
n=10 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
0 household
n=12 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
0 household
n=22 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
Household receipt of benefits in past year
Energy Assistance
0 household
n=10 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
0 household
n=12 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
0 household
n=22 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
Household receipt of benefits in past year
Medicaid
3 household
n=10 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
3 household
n=12 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
6 household
n=22 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
Household receipt of benefits in past year
Reduced cost or free school lunch
3 household
n=10 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
2 household
n=12 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
5 household
n=22 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
Household receipt of benefits in past year
Other
1 household
n=10 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
1 household
n=12 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
2 household
n=22 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
Household receipt of benefits in past year
Decline to answer
1 household
n=10 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
0 household
n=12 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).
1 household
n=22 Participants • This is a household level characteristic (1 household per adult in the control arm, 1 household per adult-child dyad in the intervention arm).

PRIMARY outcome

Timeframe: 6 months

Population: Adult participants in the DPP group and Family DPP group, who did not formally withdraw from the study.

The average total number of required core period program sessions attended by the adult participant (inclusive of make-up sessions) including all DPP (and, if in Family DPP, additional Family DPP sessions); for Family DPP adult participants this will also be examined for the subset of DPP sessions and additional Family DPP sessions.

Outcome measures

Outcome measures
Measure
Diabetes Prevention Program (DPP)
n=10 Participants
Adult participants who are engaged in the Centers for Disease Control and Prevention's (CDC) National Diabetes Prevention Program lifestyle intervention (DPP) as delivered by the Johns Hopkins Brancati Center; this is a 12-month long, group-based lifestyle intervention, delivered by a certified lifestyle coach using a CDC-approved curriculum. This "concurrent control" group will consist of adults who are enrolled in the Brancati Center's DPP within 6 months of the intervention group start dates, who have children less than 18 years of age living in their households. National Diabetes Prevention Program Lifestyle Intervention (DPP): The National Diabetes Prevention Program lifestyle intervention (DPP) is a 12-month long, group-based lifestyle intervention for adults at high-risk for type 2 diabetes. The DPP will be delivered by certified coaches from the Johns Hopkins Brancati Center. The program uses the CDC's Prevent T2 curriculum, with a total of 32-34 sessions delivered over a 12-month period. In the initial "core" period (first 6 months), there are at least 16 sessions delivered on a weekly basis. In the "post-core" period, additional (at least 6) sessions are offered over a 6 month period. Sessions are delivered either in-person or via a virtual synchronous platform (Zoom).
Family Diabetes Prevention Program (Family DPP)
n=11 Participants
Adult participants will engage in the family-oriented Diabetes Prevention Program lifestyle intervention (Family DPP); this is an augmented version of the DPP lifestyle intervention. This 12-month, group-based lifestyle intervention will include all elements of the DPP lifestyle intervention as delivered by the Johns Hopkins Brancati Center using a CDC-approved curriculum, with additional child-focused sessions in which adult participants will learn about children's health-related behaviors. Children will be present at the child-focused sessions and family activities, and will be engaged in data collection. Groups will be "mixed," in that non-study participants (adults who are eligible for the DPP), may also participate. Family DPP: The Family DPP has been developed as an augmented version of the National Diabetes Prevention Program Lifestyle Intervention (DPP). It includes all elements of the 12-month, group-based DPP lifestyle intervention, led by a CDC certified-coach using a CDC-approved curriculum (involving around 32-34 sessions). The augmentations of the Family DPP include 2 additional sessions that address barriers to adults' own lifestyle change efforts related to being a caregiver of children and child-focused sessions to introduce basic concepts regarding healthy child lifestyle habits. The additional sessions that will be delivered to the adult DPP participant, and in which children, ages 5 through 12, can also be engaged.
Adult Participant Attendance in Program as Assessed by Total Number of Required Program Sessions Attended, Core
All Core Sessions
17.6 sessions
Standard Error 0.22
14.8 sessions
Standard Error 1.8
Adult Participant Attendance in Program as Assessed by Total Number of Required Program Sessions Attended, Core
DPP only core sessions
13.5 sessions
Standard Error 1.6
Adult Participant Attendance in Program as Assessed by Total Number of Required Program Sessions Attended, Core
Family DPP child-focused sessions
1.4 sessions
Standard Error 0.24

PRIMARY outcome

Timeframe: 12 months

Population: Adult participants in the DPP group and Family DPP group, who did not formally withdraw from the study.

The average total number of all required sessions attended by the adult participant (inclusive of make-up sessions); for Family DPP adult participants this will also be examined for the subset of DPP sessions only, and additional required Family DPP sessions only (of which there were 10), and didactic/required child-focused sessions only (of which there were 8).

Outcome measures

Outcome measures
Measure
Diabetes Prevention Program (DPP)
n=10 Participants
Adult participants who are engaged in the Centers for Disease Control and Prevention's (CDC) National Diabetes Prevention Program lifestyle intervention (DPP) as delivered by the Johns Hopkins Brancati Center; this is a 12-month long, group-based lifestyle intervention, delivered by a certified lifestyle coach using a CDC-approved curriculum. This "concurrent control" group will consist of adults who are enrolled in the Brancati Center's DPP within 6 months of the intervention group start dates, who have children less than 18 years of age living in their households. National Diabetes Prevention Program Lifestyle Intervention (DPP): The National Diabetes Prevention Program lifestyle intervention (DPP) is a 12-month long, group-based lifestyle intervention for adults at high-risk for type 2 diabetes. The DPP will be delivered by certified coaches from the Johns Hopkins Brancati Center. The program uses the CDC's Prevent T2 curriculum, with a total of 32-34 sessions delivered over a 12-month period. In the initial "core" period (first 6 months), there are at least 16 sessions delivered on a weekly basis. In the "post-core" period, additional (at least 6) sessions are offered over a 6 month period. Sessions are delivered either in-person or via a virtual synchronous platform (Zoom).
Family Diabetes Prevention Program (Family DPP)
n=11 Participants
Adult participants will engage in the family-oriented Diabetes Prevention Program lifestyle intervention (Family DPP); this is an augmented version of the DPP lifestyle intervention. This 12-month, group-based lifestyle intervention will include all elements of the DPP lifestyle intervention as delivered by the Johns Hopkins Brancati Center using a CDC-approved curriculum, with additional child-focused sessions in which adult participants will learn about children's health-related behaviors. Children will be present at the child-focused sessions and family activities, and will be engaged in data collection. Groups will be "mixed," in that non-study participants (adults who are eligible for the DPP), may also participate. Family DPP: The Family DPP has been developed as an augmented version of the National Diabetes Prevention Program Lifestyle Intervention (DPP). It includes all elements of the 12-month, group-based DPP lifestyle intervention, led by a CDC certified-coach using a CDC-approved curriculum (involving around 32-34 sessions). The augmentations of the Family DPP include 2 additional sessions that address barriers to adults' own lifestyle change efforts related to being a caregiver of children and child-focused sessions to introduce basic concepts regarding healthy child lifestyle habits. The additional sessions that will be delivered to the adult DPP participant, and in which children, ages 5 through 12, can also be engaged.
Adult Participant Attendance in Program as Assessed by Total Number of Program Sessions Attended, Full Program
All required sessions
25.2 sessions
Standard Error 0.99
25.1 sessions
Standard Error 3.9
Adult Participant Attendance in Program as Assessed by Total Number of Program Sessions Attended, Full Program
All required DPP sessions
18.8 sessions
Standard Error 2.8
Adult Participant Attendance in Program as Assessed by Total Number of Program Sessions Attended, Full Program
All required Family DPP sessions
6.3 sessions
Standard Error 1.2
Adult Participant Attendance in Program as Assessed by Total Number of Program Sessions Attended, Full Program
All required child-focused Family DPP sessions
4.9 sessions
Standard Error 1.0

PRIMARY outcome

Timeframe: 6 months

Population: Adult participants in the DPP group and Family DPP group, who did not formally withdraw from the study.

The average percentage of required core period program sessions attended by the adult participant (inclusive of make-up sessions) in each arm (denomiator of 18 for DPP, and 20 for Family DPP); for Family DPP adult participants this will also be examined for the subset of required DPP sessions only (denominator is 18) and additional Family DPP sessions only (of which there were 2).

Outcome measures

Outcome measures
Measure
Diabetes Prevention Program (DPP)
n=10 Participants
Adult participants who are engaged in the Centers for Disease Control and Prevention's (CDC) National Diabetes Prevention Program lifestyle intervention (DPP) as delivered by the Johns Hopkins Brancati Center; this is a 12-month long, group-based lifestyle intervention, delivered by a certified lifestyle coach using a CDC-approved curriculum. This "concurrent control" group will consist of adults who are enrolled in the Brancati Center's DPP within 6 months of the intervention group start dates, who have children less than 18 years of age living in their households. National Diabetes Prevention Program Lifestyle Intervention (DPP): The National Diabetes Prevention Program lifestyle intervention (DPP) is a 12-month long, group-based lifestyle intervention for adults at high-risk for type 2 diabetes. The DPP will be delivered by certified coaches from the Johns Hopkins Brancati Center. The program uses the CDC's Prevent T2 curriculum, with a total of 32-34 sessions delivered over a 12-month period. In the initial "core" period (first 6 months), there are at least 16 sessions delivered on a weekly basis. In the "post-core" period, additional (at least 6) sessions are offered over a 6 month period. Sessions are delivered either in-person or via a virtual synchronous platform (Zoom).
Family Diabetes Prevention Program (Family DPP)
n=11 Participants
Adult participants will engage in the family-oriented Diabetes Prevention Program lifestyle intervention (Family DPP); this is an augmented version of the DPP lifestyle intervention. This 12-month, group-based lifestyle intervention will include all elements of the DPP lifestyle intervention as delivered by the Johns Hopkins Brancati Center using a CDC-approved curriculum, with additional child-focused sessions in which adult participants will learn about children's health-related behaviors. Children will be present at the child-focused sessions and family activities, and will be engaged in data collection. Groups will be "mixed," in that non-study participants (adults who are eligible for the DPP), may also participate. Family DPP: The Family DPP has been developed as an augmented version of the National Diabetes Prevention Program Lifestyle Intervention (DPP). It includes all elements of the 12-month, group-based DPP lifestyle intervention, led by a CDC certified-coach using a CDC-approved curriculum (involving around 32-34 sessions). The augmentations of the Family DPP include 2 additional sessions that address barriers to adults' own lifestyle change efforts related to being a caregiver of children and child-focused sessions to introduce basic concepts regarding healthy child lifestyle habits. The additional sessions that will be delivered to the adult DPP participant, and in which children, ages 5 through 12, can also be engaged.
Adult Participant Attendance in Program as Assessed by Percentage of Program Sessions Attended, Core
Percentage of required core Family DPP sessions
68.2 percentage of sessions
Interval 41.0 to 95.4
Adult Participant Attendance in Program as Assessed by Percentage of Program Sessions Attended, Core
Percentage of all required core sessions
97.8 percentage of sessions
Interval 95.0 to 100.0
74.1 percentage of sessions
Interval 53.6 to 94.6
Adult Participant Attendance in Program as Assessed by Percentage of Program Sessions Attended, Core
Percentage of all required core DPP sessions
74.7 percentage of sessions
Interval 54.5 to 95.0

PRIMARY outcome

Timeframe: 12 months

Population: Adult participants in the DPP group and Family DPP group, who did not formally withdraw from the study.

The percentage of all required program sessions attended by the adult participant (inclusive of make-up sessions); for Family DPP adult participants this will also be examined for the subset of DPP sessions only, all additional Family DPP sessions only (of which there were 10), and child-focused DPP sessions only (of which there were 8).

Outcome measures

Outcome measures
Measure
Diabetes Prevention Program (DPP)
n=10 Participants
Adult participants who are engaged in the Centers for Disease Control and Prevention's (CDC) National Diabetes Prevention Program lifestyle intervention (DPP) as delivered by the Johns Hopkins Brancati Center; this is a 12-month long, group-based lifestyle intervention, delivered by a certified lifestyle coach using a CDC-approved curriculum. This "concurrent control" group will consist of adults who are enrolled in the Brancati Center's DPP within 6 months of the intervention group start dates, who have children less than 18 years of age living in their households. National Diabetes Prevention Program Lifestyle Intervention (DPP): The National Diabetes Prevention Program lifestyle intervention (DPP) is a 12-month long, group-based lifestyle intervention for adults at high-risk for type 2 diabetes. The DPP will be delivered by certified coaches from the Johns Hopkins Brancati Center. The program uses the CDC's Prevent T2 curriculum, with a total of 32-34 sessions delivered over a 12-month period. In the initial "core" period (first 6 months), there are at least 16 sessions delivered on a weekly basis. In the "post-core" period, additional (at least 6) sessions are offered over a 6 month period. Sessions are delivered either in-person or via a virtual synchronous platform (Zoom).
Family Diabetes Prevention Program (Family DPP)
n=11 Participants
Adult participants will engage in the family-oriented Diabetes Prevention Program lifestyle intervention (Family DPP); this is an augmented version of the DPP lifestyle intervention. This 12-month, group-based lifestyle intervention will include all elements of the DPP lifestyle intervention as delivered by the Johns Hopkins Brancati Center using a CDC-approved curriculum, with additional child-focused sessions in which adult participants will learn about children's health-related behaviors. Children will be present at the child-focused sessions and family activities, and will be engaged in data collection. Groups will be "mixed," in that non-study participants (adults who are eligible for the DPP), may also participate. Family DPP: The Family DPP has been developed as an augmented version of the National Diabetes Prevention Program Lifestyle Intervention (DPP). It includes all elements of the 12-month, group-based DPP lifestyle intervention, led by a CDC certified-coach using a CDC-approved curriculum (involving around 32-34 sessions). The augmentations of the Family DPP include 2 additional sessions that address barriers to adults' own lifestyle change efforts related to being a caregiver of children and child-focused sessions to introduce basic concepts regarding healthy child lifestyle habits. The additional sessions that will be delivered to the adult DPP participant, and in which children, ages 5 through 12, can also be engaged.
Adult Participant Attendance in Program as Assessed by Percentage of Program Sessions Attended, Full Program
Percentage of all required sessions
87.8 percentage of sessions
Interval 80.2 to 95.4
64.3 percentage of sessions
Interval 42.1 to 86.6
Adult Participant Attendance in Program as Assessed by Percentage of Program Sessions Attended, Full Program
Percentage of all required DPP sessions
64.8 percentage of sessions
Interval 43.4 to 86.4
Adult Participant Attendance in Program as Assessed by Percentage of Program Sessions Attended, Full Program
Percentage of all required FDPP sessions
62.8 percentage of sessions
Interval 35.2 to 90.3
Adult Participant Attendance in Program as Assessed by Percentage of Program Sessions Attended, Full Program
Percentage of all child-focused required FDPP sessions
61.4 percentage of sessions
Interval 32.4 to 90.3

PRIMARY outcome

Timeframe: 12 months

Population: Child participants (who were enrolled in the Family DPP only), who did not formally withdraw from the study

The percentage of required child-focused sessions (N=8) attended by the child participant will be examined for child participants in the Family DPP arm only.

Outcome measures

Outcome measures
Measure
Diabetes Prevention Program (DPP)
Adult participants who are engaged in the Centers for Disease Control and Prevention's (CDC) National Diabetes Prevention Program lifestyle intervention (DPP) as delivered by the Johns Hopkins Brancati Center; this is a 12-month long, group-based lifestyle intervention, delivered by a certified lifestyle coach using a CDC-approved curriculum. This "concurrent control" group will consist of adults who are enrolled in the Brancati Center's DPP within 6 months of the intervention group start dates, who have children less than 18 years of age living in their households. National Diabetes Prevention Program Lifestyle Intervention (DPP): The National Diabetes Prevention Program lifestyle intervention (DPP) is a 12-month long, group-based lifestyle intervention for adults at high-risk for type 2 diabetes. The DPP will be delivered by certified coaches from the Johns Hopkins Brancati Center. The program uses the CDC's Prevent T2 curriculum, with a total of 32-34 sessions delivered over a 12-month period. In the initial "core" period (first 6 months), there are at least 16 sessions delivered on a weekly basis. In the "post-core" period, additional (at least 6) sessions are offered over a 6 month period. Sessions are delivered either in-person or via a virtual synchronous platform (Zoom).
Family Diabetes Prevention Program (Family DPP)
n=11 Participants
Adult participants will engage in the family-oriented Diabetes Prevention Program lifestyle intervention (Family DPP); this is an augmented version of the DPP lifestyle intervention. This 12-month, group-based lifestyle intervention will include all elements of the DPP lifestyle intervention as delivered by the Johns Hopkins Brancati Center using a CDC-approved curriculum, with additional child-focused sessions in which adult participants will learn about children's health-related behaviors. Children will be present at the child-focused sessions and family activities, and will be engaged in data collection. Groups will be "mixed," in that non-study participants (adults who are eligible for the DPP), may also participate. Family DPP: The Family DPP has been developed as an augmented version of the National Diabetes Prevention Program Lifestyle Intervention (DPP). It includes all elements of the 12-month, group-based DPP lifestyle intervention, led by a CDC certified-coach using a CDC-approved curriculum (involving around 32-34 sessions). The augmentations of the Family DPP include 2 additional sessions that address barriers to adults' own lifestyle change efforts related to being a caregiver of children and child-focused sessions to introduce basic concepts regarding healthy child lifestyle habits. The additional sessions that will be delivered to the adult DPP participant, and in which children, ages 5 through 12, can also be engaged.
Child Participant Attendance in Family Diabetes Prevention Program
44.3 percentage of child-focused sessions
Interval 20.5 to 68.2

PRIMARY outcome

Timeframe: Baseline

Population: Enrolled child participants in the Family DPP arm.

The percentage of total enrolled child participants (in the intervention arm) for whom BMI data and also child-health behavior data are collected will be examined for at baseline data collection point.

Outcome measures

Outcome measures
Measure
Diabetes Prevention Program (DPP)
Adult participants who are engaged in the Centers for Disease Control and Prevention's (CDC) National Diabetes Prevention Program lifestyle intervention (DPP) as delivered by the Johns Hopkins Brancati Center; this is a 12-month long, group-based lifestyle intervention, delivered by a certified lifestyle coach using a CDC-approved curriculum. This "concurrent control" group will consist of adults who are enrolled in the Brancati Center's DPP within 6 months of the intervention group start dates, who have children less than 18 years of age living in their households. National Diabetes Prevention Program Lifestyle Intervention (DPP): The National Diabetes Prevention Program lifestyle intervention (DPP) is a 12-month long, group-based lifestyle intervention for adults at high-risk for type 2 diabetes. The DPP will be delivered by certified coaches from the Johns Hopkins Brancati Center. The program uses the CDC's Prevent T2 curriculum, with a total of 32-34 sessions delivered over a 12-month period. In the initial "core" period (first 6 months), there are at least 16 sessions delivered on a weekly basis. In the "post-core" period, additional (at least 6) sessions are offered over a 6 month period. Sessions are delivered either in-person or via a virtual synchronous platform (Zoom).
Family Diabetes Prevention Program (Family DPP)
n=12 Participants
Adult participants will engage in the family-oriented Diabetes Prevention Program lifestyle intervention (Family DPP); this is an augmented version of the DPP lifestyle intervention. This 12-month, group-based lifestyle intervention will include all elements of the DPP lifestyle intervention as delivered by the Johns Hopkins Brancati Center using a CDC-approved curriculum, with additional child-focused sessions in which adult participants will learn about children's health-related behaviors. Children will be present at the child-focused sessions and family activities, and will be engaged in data collection. Groups will be "mixed," in that non-study participants (adults who are eligible for the DPP), may also participate. Family DPP: The Family DPP has been developed as an augmented version of the National Diabetes Prevention Program Lifestyle Intervention (DPP). It includes all elements of the 12-month, group-based DPP lifestyle intervention, led by a CDC certified-coach using a CDC-approved curriculum (involving around 32-34 sessions). The augmentations of the Family DPP include 2 additional sessions that address barriers to adults' own lifestyle change efforts related to being a caregiver of children and child-focused sessions to introduce basic concepts regarding healthy child lifestyle habits. The additional sessions that will be delivered to the adult DPP participant, and in which children, ages 5 through 12, can also be engaged.
Feasibility of Measurement of Child-related Outcomes as Assessed by the Percentage of Total Child Participants for Whom Data Are Collected
100 percentage of children

PRIMARY outcome

Timeframe: 6 months

Population: Enrolled child participants in the Family DPP Arm, who had not formally withdrawn from the study.

The percentage of total enrolled child participants (in the Family DPP interventionarm) for whom BMI data and also child-health behavior data are collected will be examined for the 6 month data point.

Outcome measures

Outcome measures
Measure
Diabetes Prevention Program (DPP)
Adult participants who are engaged in the Centers for Disease Control and Prevention's (CDC) National Diabetes Prevention Program lifestyle intervention (DPP) as delivered by the Johns Hopkins Brancati Center; this is a 12-month long, group-based lifestyle intervention, delivered by a certified lifestyle coach using a CDC-approved curriculum. This "concurrent control" group will consist of adults who are enrolled in the Brancati Center's DPP within 6 months of the intervention group start dates, who have children less than 18 years of age living in their households. National Diabetes Prevention Program Lifestyle Intervention (DPP): The National Diabetes Prevention Program lifestyle intervention (DPP) is a 12-month long, group-based lifestyle intervention for adults at high-risk for type 2 diabetes. The DPP will be delivered by certified coaches from the Johns Hopkins Brancati Center. The program uses the CDC's Prevent T2 curriculum, with a total of 32-34 sessions delivered over a 12-month period. In the initial "core" period (first 6 months), there are at least 16 sessions delivered on a weekly basis. In the "post-core" period, additional (at least 6) sessions are offered over a 6 month period. Sessions are delivered either in-person or via a virtual synchronous platform (Zoom).
Family Diabetes Prevention Program (Family DPP)
n=11 Participants
Adult participants will engage in the family-oriented Diabetes Prevention Program lifestyle intervention (Family DPP); this is an augmented version of the DPP lifestyle intervention. This 12-month, group-based lifestyle intervention will include all elements of the DPP lifestyle intervention as delivered by the Johns Hopkins Brancati Center using a CDC-approved curriculum, with additional child-focused sessions in which adult participants will learn about children's health-related behaviors. Children will be present at the child-focused sessions and family activities, and will be engaged in data collection. Groups will be "mixed," in that non-study participants (adults who are eligible for the DPP), may also participate. Family DPP: The Family DPP has been developed as an augmented version of the National Diabetes Prevention Program Lifestyle Intervention (DPP). It includes all elements of the 12-month, group-based DPP lifestyle intervention, led by a CDC certified-coach using a CDC-approved curriculum (involving around 32-34 sessions). The augmentations of the Family DPP include 2 additional sessions that address barriers to adults' own lifestyle change efforts related to being a caregiver of children and child-focused sessions to introduce basic concepts regarding healthy child lifestyle habits. The additional sessions that will be delivered to the adult DPP participant, and in which children, ages 5 through 12, can also be engaged.
Feasibility of Measurement of Child-related Outcomes as Assessed by the Percentage of Total Child Participants for Whom Data Are Collected
81.2 percentage of children

PRIMARY outcome

Timeframe: 12 months

Population: There are no child participants in the DPP arm.

The percentage of total enrolled child participants (in the Family DPP intervention arm) for whom BMI data and child-health behavior data are collected will be examined for the 12 month data point.

Outcome measures

Outcome measures
Measure
Diabetes Prevention Program (DPP)
Adult participants who are engaged in the Centers for Disease Control and Prevention's (CDC) National Diabetes Prevention Program lifestyle intervention (DPP) as delivered by the Johns Hopkins Brancati Center; this is a 12-month long, group-based lifestyle intervention, delivered by a certified lifestyle coach using a CDC-approved curriculum. This "concurrent control" group will consist of adults who are enrolled in the Brancati Center's DPP within 6 months of the intervention group start dates, who have children less than 18 years of age living in their households. National Diabetes Prevention Program Lifestyle Intervention (DPP): The National Diabetes Prevention Program lifestyle intervention (DPP) is a 12-month long, group-based lifestyle intervention for adults at high-risk for type 2 diabetes. The DPP will be delivered by certified coaches from the Johns Hopkins Brancati Center. The program uses the CDC's Prevent T2 curriculum, with a total of 32-34 sessions delivered over a 12-month period. In the initial "core" period (first 6 months), there are at least 16 sessions delivered on a weekly basis. In the "post-core" period, additional (at least 6) sessions are offered over a 6 month period. Sessions are delivered either in-person or via a virtual synchronous platform (Zoom).
Family Diabetes Prevention Program (Family DPP)
n=11 Participants
Adult participants will engage in the family-oriented Diabetes Prevention Program lifestyle intervention (Family DPP); this is an augmented version of the DPP lifestyle intervention. This 12-month, group-based lifestyle intervention will include all elements of the DPP lifestyle intervention as delivered by the Johns Hopkins Brancati Center using a CDC-approved curriculum, with additional child-focused sessions in which adult participants will learn about children's health-related behaviors. Children will be present at the child-focused sessions and family activities, and will be engaged in data collection. Groups will be "mixed," in that non-study participants (adults who are eligible for the DPP), may also participate. Family DPP: The Family DPP has been developed as an augmented version of the National Diabetes Prevention Program Lifestyle Intervention (DPP). It includes all elements of the 12-month, group-based DPP lifestyle intervention, led by a CDC certified-coach using a CDC-approved curriculum (involving around 32-34 sessions). The augmentations of the Family DPP include 2 additional sessions that address barriers to adults' own lifestyle change efforts related to being a caregiver of children and child-focused sessions to introduce basic concepts regarding healthy child lifestyle habits. The additional sessions that will be delivered to the adult DPP participant, and in which children, ages 5 through 12, can also be engaged.
Feasibility of Measurement of Child-related Outcomes as Assessed by the Percentage of Total Child Participants for Whom Data Are Collected
72.7 percentage of children

PRIMARY outcome

Timeframe: 12 months (end of intervention)

Population: Adult participants in the Family DPP (intervention arm) only who completed the FDPP satisfaction survey.

Mean Likert-scale score (for most items, Likert scale on a range of 1 to 4; from strongly disagree (1) to strongly agree (4)), exploring satisfaction with Family DPP content and structure). Mean of participant choice is reported.

Outcome measures

Outcome measures
Measure
Diabetes Prevention Program (DPP)
Adult participants who are engaged in the Centers for Disease Control and Prevention's (CDC) National Diabetes Prevention Program lifestyle intervention (DPP) as delivered by the Johns Hopkins Brancati Center; this is a 12-month long, group-based lifestyle intervention, delivered by a certified lifestyle coach using a CDC-approved curriculum. This "concurrent control" group will consist of adults who are enrolled in the Brancati Center's DPP within 6 months of the intervention group start dates, who have children less than 18 years of age living in their households. National Diabetes Prevention Program Lifestyle Intervention (DPP): The National Diabetes Prevention Program lifestyle intervention (DPP) is a 12-month long, group-based lifestyle intervention for adults at high-risk for type 2 diabetes. The DPP will be delivered by certified coaches from the Johns Hopkins Brancati Center. The program uses the CDC's Prevent T2 curriculum, with a total of 32-34 sessions delivered over a 12-month period. In the initial "core" period (first 6 months), there are at least 16 sessions delivered on a weekly basis. In the "post-core" period, additional (at least 6) sessions are offered over a 6 month period. Sessions are delivered either in-person or via a virtual synchronous platform (Zoom).
Family Diabetes Prevention Program (Family DPP)
n=8 Participants
Adult participants will engage in the family-oriented Diabetes Prevention Program lifestyle intervention (Family DPP); this is an augmented version of the DPP lifestyle intervention. This 12-month, group-based lifestyle intervention will include all elements of the DPP lifestyle intervention as delivered by the Johns Hopkins Brancati Center using a CDC-approved curriculum, with additional child-focused sessions in which adult participants will learn about children's health-related behaviors. Children will be present at the child-focused sessions and family activities, and will be engaged in data collection. Groups will be "mixed," in that non-study participants (adults who are eligible for the DPP), may also participate. Family DPP: The Family DPP has been developed as an augmented version of the National Diabetes Prevention Program Lifestyle Intervention (DPP). It includes all elements of the 12-month, group-based DPP lifestyle intervention, led by a CDC certified-coach using a CDC-approved curriculum (involving around 32-34 sessions). The augmentations of the Family DPP include 2 additional sessions that address barriers to adults' own lifestyle change efforts related to being a caregiver of children and child-focused sessions to introduce basic concepts regarding healthy child lifestyle habits. The additional sessions that will be delivered to the adult DPP participant, and in which children, ages 5 through 12, can also be engaged.
Satisfaction With Family Diabetes Prevention Program as Assessed by Study Team Designed Questionnaire
"I would recommend the Family DPP to others"
3.88 score on Likert scale (range 1 to 4)
Standard Error 0.13
Satisfaction With Family Diabetes Prevention Program as Assessed by Study Team Designed Questionnaire
"I believe the Family DPP sessions were helpful in helping me address children's health behaviors"
3.75 score on Likert scale (range 1 to 4)
Standard Error 0.16
Satisfaction With Family Diabetes Prevention Program as Assessed by Study Team Designed Questionnaire
"I believe the Family DPP sessions were helpful in helping me address my own health behaviors"
3.75 score on Likert scale (range 1 to 4)
Standard Error 0.16

PRIMARY outcome

Timeframe: Up to 12 months

Population: The units analyzed are FDPP sessions.

Using an adapted DPP fidelity checklist, this will examine fidelity of delivery of Family DPP specific sessions; percentage of content delivered by coach during session is reported.

Outcome measures

Outcome measures
Measure
Diabetes Prevention Program (DPP)
Adult participants who are engaged in the Centers for Disease Control and Prevention's (CDC) National Diabetes Prevention Program lifestyle intervention (DPP) as delivered by the Johns Hopkins Brancati Center; this is a 12-month long, group-based lifestyle intervention, delivered by a certified lifestyle coach using a CDC-approved curriculum. This "concurrent control" group will consist of adults who are enrolled in the Brancati Center's DPP within 6 months of the intervention group start dates, who have children less than 18 years of age living in their households. National Diabetes Prevention Program Lifestyle Intervention (DPP): The National Diabetes Prevention Program lifestyle intervention (DPP) is a 12-month long, group-based lifestyle intervention for adults at high-risk for type 2 diabetes. The DPP will be delivered by certified coaches from the Johns Hopkins Brancati Center. The program uses the CDC's Prevent T2 curriculum, with a total of 32-34 sessions delivered over a 12-month period. In the initial "core" period (first 6 months), there are at least 16 sessions delivered on a weekly basis. In the "post-core" period, additional (at least 6) sessions are offered over a 6 month period. Sessions are delivered either in-person or via a virtual synchronous platform (Zoom).
Family Diabetes Prevention Program (Family DPP)
n=14 Family DPP specific sessions
Adult participants will engage in the family-oriented Diabetes Prevention Program lifestyle intervention (Family DPP); this is an augmented version of the DPP lifestyle intervention. This 12-month, group-based lifestyle intervention will include all elements of the DPP lifestyle intervention as delivered by the Johns Hopkins Brancati Center using a CDC-approved curriculum, with additional child-focused sessions in which adult participants will learn about children's health-related behaviors. Children will be present at the child-focused sessions and family activities, and will be engaged in data collection. Groups will be "mixed," in that non-study participants (adults who are eligible for the DPP), may also participate. Family DPP: The Family DPP has been developed as an augmented version of the National Diabetes Prevention Program Lifestyle Intervention (DPP). It includes all elements of the 12-month, group-based DPP lifestyle intervention, led by a CDC certified-coach using a CDC-approved curriculum (involving around 32-34 sessions). The augmentations of the Family DPP include 2 additional sessions that address barriers to adults' own lifestyle change efforts related to being a caregiver of children and child-focused sessions to introduce basic concepts regarding healthy child lifestyle habits. The additional sessions that will be delivered to the adult DPP participant, and in which children, ages 5 through 12, can also be engaged.
Intervention Fidelity as Assessed by a Fidelity Checklist
91.4 percentage of session content
Interval 86.9 to 95.8

PRIMARY outcome

Timeframe: 12 months (end of intervention)

Cost of program delivery (including staffing, materials, wrap-around support) per participant (or for FDPP, per dyad). Calculated separately for DPP and Family DPP (intervention) arm. Total delivery cost of DPP incurred by the delivering center was used for DPP cost/participant- this is calculated as a total cost for a set number of cohorts/participants, divided by number of participants. There is a single value (no variation) for each category of cost that was used to calculate this number, and thus no measure of precision or dispersion can be calculated due to nature of calculating a total cost. For FDPP dyads, additional costs related to FDPP intervention and delivery were included in this calculation.

Outcome measures

Outcome measures
Measure
Diabetes Prevention Program (DPP)
n=10 Participants
Adult participants who are engaged in the Centers for Disease Control and Prevention's (CDC) National Diabetes Prevention Program lifestyle intervention (DPP) as delivered by the Johns Hopkins Brancati Center; this is a 12-month long, group-based lifestyle intervention, delivered by a certified lifestyle coach using a CDC-approved curriculum. This "concurrent control" group will consist of adults who are enrolled in the Brancati Center's DPP within 6 months of the intervention group start dates, who have children less than 18 years of age living in their households. National Diabetes Prevention Program Lifestyle Intervention (DPP): The National Diabetes Prevention Program lifestyle intervention (DPP) is a 12-month long, group-based lifestyle intervention for adults at high-risk for type 2 diabetes. The DPP will be delivered by certified coaches from the Johns Hopkins Brancati Center. The program uses the CDC's Prevent T2 curriculum, with a total of 32-34 sessions delivered over a 12-month period. In the initial "core" period (first 6 months), there are at least 16 sessions delivered on a weekly basis. In the "post-core" period, additional (at least 6) sessions are offered over a 6 month period. Sessions are delivered either in-person or via a virtual synchronous platform (Zoom).
Family Diabetes Prevention Program (Family DPP)
n=12 Participants
Adult participants will engage in the family-oriented Diabetes Prevention Program lifestyle intervention (Family DPP); this is an augmented version of the DPP lifestyle intervention. This 12-month, group-based lifestyle intervention will include all elements of the DPP lifestyle intervention as delivered by the Johns Hopkins Brancati Center using a CDC-approved curriculum, with additional child-focused sessions in which adult participants will learn about children's health-related behaviors. Children will be present at the child-focused sessions and family activities, and will be engaged in data collection. Groups will be "mixed," in that non-study participants (adults who are eligible for the DPP), may also participate. Family DPP: The Family DPP has been developed as an augmented version of the National Diabetes Prevention Program Lifestyle Intervention (DPP). It includes all elements of the 12-month, group-based DPP lifestyle intervention, led by a CDC certified-coach using a CDC-approved curriculum (involving around 32-34 sessions). The augmentations of the Family DPP include 2 additional sessions that address barriers to adults' own lifestyle change efforts related to being a caregiver of children and child-focused sessions to introduce basic concepts regarding healthy child lifestyle habits. The additional sessions that will be delivered to the adult DPP participant, and in which children, ages 5 through 12, can also be engaged.
Total Cost of Program Delivery
1022.95 dollar cost per participant
1288.97 dollar cost per participant

PRIMARY outcome

Timeframe: During recruitment period up to 22 weeks

Recruitment rate is calculated as the number of eligible participants (adult controls or adult-child dyad intervention arm) consenting and completing enrollment and participating in the trial, divided by period of recruitment (in weeks). This value is calculated separately for intervention arm and concurrent control group. The measure is calculated as # of participants recruited (total)/total number of weeks of recruitment. (For intervention arm, 12 adult-child dyads/22 weeks; for control arm adults: 10 adults/9.5 weeks).

Outcome measures

Outcome measures
Measure
Diabetes Prevention Program (DPP)
n=10 Participants
Adult participants who are engaged in the Centers for Disease Control and Prevention's (CDC) National Diabetes Prevention Program lifestyle intervention (DPP) as delivered by the Johns Hopkins Brancati Center; this is a 12-month long, group-based lifestyle intervention, delivered by a certified lifestyle coach using a CDC-approved curriculum. This "concurrent control" group will consist of adults who are enrolled in the Brancati Center's DPP within 6 months of the intervention group start dates, who have children less than 18 years of age living in their households. National Diabetes Prevention Program Lifestyle Intervention (DPP): The National Diabetes Prevention Program lifestyle intervention (DPP) is a 12-month long, group-based lifestyle intervention for adults at high-risk for type 2 diabetes. The DPP will be delivered by certified coaches from the Johns Hopkins Brancati Center. The program uses the CDC's Prevent T2 curriculum, with a total of 32-34 sessions delivered over a 12-month period. In the initial "core" period (first 6 months), there are at least 16 sessions delivered on a weekly basis. In the "post-core" period, additional (at least 6) sessions are offered over a 6 month period. Sessions are delivered either in-person or via a virtual synchronous platform (Zoom).
Family Diabetes Prevention Program (Family DPP)
n=12 Participants
Adult participants will engage in the family-oriented Diabetes Prevention Program lifestyle intervention (Family DPP); this is an augmented version of the DPP lifestyle intervention. This 12-month, group-based lifestyle intervention will include all elements of the DPP lifestyle intervention as delivered by the Johns Hopkins Brancati Center using a CDC-approved curriculum, with additional child-focused sessions in which adult participants will learn about children's health-related behaviors. Children will be present at the child-focused sessions and family activities, and will be engaged in data collection. Groups will be "mixed," in that non-study participants (adults who are eligible for the DPP), may also participate. Family DPP: The Family DPP has been developed as an augmented version of the National Diabetes Prevention Program Lifestyle Intervention (DPP). It includes all elements of the 12-month, group-based DPP lifestyle intervention, led by a CDC certified-coach using a CDC-approved curriculum (involving around 32-34 sessions). The augmentations of the Family DPP include 2 additional sessions that address barriers to adults' own lifestyle change efforts related to being a caregiver of children and child-focused sessions to introduce basic concepts regarding healthy child lifestyle habits. The additional sessions that will be delivered to the adult DPP participant, and in which children, ages 5 through 12, can also be engaged.
Recruitment Rate as Assessed by the Rate of Enrollment Per Week
1.05 adults enrolled per week
0.55 adults enrolled per week

PRIMARY outcome

Timeframe: Baseline

Population: Data was not able to be collected, as measurement of time required for administration was unable to be assessed by study team member while simultaneously administering surveys.

Mean time (minutes) for administration of baseline surveys to adult participant and child participant in the Family DPP (intervention) arm.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Population: Data was not able to be collected, as measurement of time required for administration was unable to be assessed by study team member while simultaneously administering surveys.

Mean time (minutes) for administration of surveys to adult participant and child participant at 6 month time point in the Family DPP (intervention) arm.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 12 months

Population: Data was not able to be collected, as measurement of time required for administration was unable to be assessed by study team member while simultaneously administering surveys.

Mean time (minutes) for administration of surveys to adult participant and child participant in the Family DPP (intervention) arm.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 12 months (end of intervention)

Population: Adults who are considered "DPP completers" (requires having been in DPP at least 9 months and also attending at least 8 sessions in core period) as per the DPP specific definition.

Percentage change in weight (kilograms) from baseline to end of program (Self-report from home weight may be used depending on program delivery modality). Calculated for adults who are considered "DPP completers" (requires having been in DPP at least 9 months and also attending at least 8 sessions in core period) per the DPP specific definition.

Outcome measures

Outcome measures
Measure
Diabetes Prevention Program (DPP)
n=9 Participants
Adult participants who are engaged in the Centers for Disease Control and Prevention's (CDC) National Diabetes Prevention Program lifestyle intervention (DPP) as delivered by the Johns Hopkins Brancati Center; this is a 12-month long, group-based lifestyle intervention, delivered by a certified lifestyle coach using a CDC-approved curriculum. This "concurrent control" group will consist of adults who are enrolled in the Brancati Center's DPP within 6 months of the intervention group start dates, who have children less than 18 years of age living in their households. National Diabetes Prevention Program Lifestyle Intervention (DPP): The National Diabetes Prevention Program lifestyle intervention (DPP) is a 12-month long, group-based lifestyle intervention for adults at high-risk for type 2 diabetes. The DPP will be delivered by certified coaches from the Johns Hopkins Brancati Center. The program uses the CDC's Prevent T2 curriculum, with a total of 32-34 sessions delivered over a 12-month period. In the initial "core" period (first 6 months), there are at least 16 sessions delivered on a weekly basis. In the "post-core" period, additional (at least 6) sessions are offered over a 6 month period. Sessions are delivered either in-person or via a virtual synchronous platform (Zoom).
Family Diabetes Prevention Program (Family DPP)
n=7 Participants
Adult participants will engage in the family-oriented Diabetes Prevention Program lifestyle intervention (Family DPP); this is an augmented version of the DPP lifestyle intervention. This 12-month, group-based lifestyle intervention will include all elements of the DPP lifestyle intervention as delivered by the Johns Hopkins Brancati Center using a CDC-approved curriculum, with additional child-focused sessions in which adult participants will learn about children's health-related behaviors. Children will be present at the child-focused sessions and family activities, and will be engaged in data collection. Groups will be "mixed," in that non-study participants (adults who are eligible for the DPP), may also participate. Family DPP: The Family DPP has been developed as an augmented version of the National Diabetes Prevention Program Lifestyle Intervention (DPP). It includes all elements of the 12-month, group-based DPP lifestyle intervention, led by a CDC certified-coach using a CDC-approved curriculum (involving around 32-34 sessions). The augmentations of the Family DPP include 2 additional sessions that address barriers to adults' own lifestyle change efforts related to being a caregiver of children and child-focused sessions to introduce basic concepts regarding healthy child lifestyle habits. The additional sessions that will be delivered to the adult DPP participant, and in which children, ages 5 through 12, can also be engaged.
Percentage Change in Adult Participant Weight (Kilograms)
-8.19 percentage change in weight (kilograms)
Standard Deviation 1.97
-3.83 percentage change in weight (kilograms)
Standard Deviation 3.18

SECONDARY outcome

Timeframe: Baseline, 6 months and 12 months (end of intervention)

Population: Children in the Family DPP (intervention) arm only who did not formally withdraw from the study and for whom data was collected at relevant time points; there were no children enrolled in the DPP (control) arm.

Change in Centers for Disease Control and Prevention's extended Body Mass Index (BMI) z-score at end of program (12 months) compared to baseline and 6 months, from BMI calculated from weight and height measurements during program in the Family DPP (intervention) arm. (Z-score of 0 indicates population mean value). Calculated for all children and among subgroup of children with overweight or obese weight status at baseline.

Outcome measures

Outcome measures
Measure
Diabetes Prevention Program (DPP)
Adult participants who are engaged in the Centers for Disease Control and Prevention's (CDC) National Diabetes Prevention Program lifestyle intervention (DPP) as delivered by the Johns Hopkins Brancati Center; this is a 12-month long, group-based lifestyle intervention, delivered by a certified lifestyle coach using a CDC-approved curriculum. This "concurrent control" group will consist of adults who are enrolled in the Brancati Center's DPP within 6 months of the intervention group start dates, who have children less than 18 years of age living in their households. National Diabetes Prevention Program Lifestyle Intervention (DPP): The National Diabetes Prevention Program lifestyle intervention (DPP) is a 12-month long, group-based lifestyle intervention for adults at high-risk for type 2 diabetes. The DPP will be delivered by certified coaches from the Johns Hopkins Brancati Center. The program uses the CDC's Prevent T2 curriculum, with a total of 32-34 sessions delivered over a 12-month period. In the initial "core" period (first 6 months), there are at least 16 sessions delivered on a weekly basis. In the "post-core" period, additional (at least 6) sessions are offered over a 6 month period. Sessions are delivered either in-person or via a virtual synchronous platform (Zoom).
Family Diabetes Prevention Program (Family DPP)
n=11 Participants
Adult participants will engage in the family-oriented Diabetes Prevention Program lifestyle intervention (Family DPP); this is an augmented version of the DPP lifestyle intervention. This 12-month, group-based lifestyle intervention will include all elements of the DPP lifestyle intervention as delivered by the Johns Hopkins Brancati Center using a CDC-approved curriculum, with additional child-focused sessions in which adult participants will learn about children's health-related behaviors. Children will be present at the child-focused sessions and family activities, and will be engaged in data collection. Groups will be "mixed," in that non-study participants (adults who are eligible for the DPP), may also participate. Family DPP: The Family DPP has been developed as an augmented version of the National Diabetes Prevention Program Lifestyle Intervention (DPP). It includes all elements of the 12-month, group-based DPP lifestyle intervention, led by a CDC certified-coach using a CDC-approved curriculum (involving around 32-34 sessions). The augmentations of the Family DPP include 2 additional sessions that address barriers to adults' own lifestyle change efforts related to being a caregiver of children and child-focused sessions to introduce basic concepts regarding healthy child lifestyle habits. The additional sessions that will be delivered to the adult DPP participant, and in which children, ages 5 through 12, can also be engaged.
Change in Child Body Mass Index (BMI) Z-score
Change in BMI extended Z-score of all child participants, baseline to 12 months
0.02 z-score
Standard Deviation 0.31
Change in Child Body Mass Index (BMI) Z-score
Change in BMI extended Z-score of all child participants, 6 months to 12 months
-0.017 z-score
Standard Deviation 0.25
Change in Child Body Mass Index (BMI) Z-score
Change in BMI extended Z-score of child participants with overweight /obesity, baseline to 12 months
0.06 z-score
Standard Deviation 0.32
Change in Child Body Mass Index (BMI) Z-score
Change in BMI extended Z-score of child participants with overweight /obesity, 6 months to 12 months
-0.019 z-score
Standard Deviation 0.18

SECONDARY outcome

Timeframe: Baseline

Population: This outcome was assessed among adult study participants in either the control or intervention arm for whom data was collected at the baseline time point AND who did not formally withdraw from the study.

Average number of minutes/week of moderate-vigorous physical activity by self report, at baseline.

Outcome measures

Outcome measures
Measure
Diabetes Prevention Program (DPP)
n=10 Participants
Adult participants who are engaged in the Centers for Disease Control and Prevention's (CDC) National Diabetes Prevention Program lifestyle intervention (DPP) as delivered by the Johns Hopkins Brancati Center; this is a 12-month long, group-based lifestyle intervention, delivered by a certified lifestyle coach using a CDC-approved curriculum. This "concurrent control" group will consist of adults who are enrolled in the Brancati Center's DPP within 6 months of the intervention group start dates, who have children less than 18 years of age living in their households. National Diabetes Prevention Program Lifestyle Intervention (DPP): The National Diabetes Prevention Program lifestyle intervention (DPP) is a 12-month long, group-based lifestyle intervention for adults at high-risk for type 2 diabetes. The DPP will be delivered by certified coaches from the Johns Hopkins Brancati Center. The program uses the CDC's Prevent T2 curriculum, with a total of 32-34 sessions delivered over a 12-month period. In the initial "core" period (first 6 months), there are at least 16 sessions delivered on a weekly basis. In the "post-core" period, additional (at least 6) sessions are offered over a 6 month period. Sessions are delivered either in-person or via a virtual synchronous platform (Zoom).
Family Diabetes Prevention Program (Family DPP)
n=11 Participants
Adult participants will engage in the family-oriented Diabetes Prevention Program lifestyle intervention (Family DPP); this is an augmented version of the DPP lifestyle intervention. This 12-month, group-based lifestyle intervention will include all elements of the DPP lifestyle intervention as delivered by the Johns Hopkins Brancati Center using a CDC-approved curriculum, with additional child-focused sessions in which adult participants will learn about children's health-related behaviors. Children will be present at the child-focused sessions and family activities, and will be engaged in data collection. Groups will be "mixed," in that non-study participants (adults who are eligible for the DPP), may also participate. Family DPP: The Family DPP has been developed as an augmented version of the National Diabetes Prevention Program Lifestyle Intervention (DPP). It includes all elements of the 12-month, group-based DPP lifestyle intervention, led by a CDC certified-coach using a CDC-approved curriculum (involving around 32-34 sessions). The augmentations of the Family DPP include 2 additional sessions that address barriers to adults' own lifestyle change efforts related to being a caregiver of children and child-focused sessions to introduce basic concepts regarding healthy child lifestyle habits. The additional sessions that will be delivered to the adult DPP participant, and in which children, ages 5 through 12, can also be engaged.
Adult Participant Physical Activity as Assessed by Average Duration of Activity Per Week
147.4 minutes of physical activity, per week
Standard Deviation 139.8
106.82 minutes of physical activity, per week
Standard Deviation 126.22

SECONDARY outcome

Timeframe: 6 months

Population: Among adult study participants for whom data was collected through the time point as described (and who did not formally withdraw from the study)

Average number of minutes/week of moderate-vigorous physical activity by self report, at 6 months (during core period) among adults for whom data was collected through this time point (this reflects average of values reported Sessions 2 through 18).

Outcome measures

Outcome measures
Measure
Diabetes Prevention Program (DPP)
n=10 Participants
Adult participants who are engaged in the Centers for Disease Control and Prevention's (CDC) National Diabetes Prevention Program lifestyle intervention (DPP) as delivered by the Johns Hopkins Brancati Center; this is a 12-month long, group-based lifestyle intervention, delivered by a certified lifestyle coach using a CDC-approved curriculum. This "concurrent control" group will consist of adults who are enrolled in the Brancati Center's DPP within 6 months of the intervention group start dates, who have children less than 18 years of age living in their households. National Diabetes Prevention Program Lifestyle Intervention (DPP): The National Diabetes Prevention Program lifestyle intervention (DPP) is a 12-month long, group-based lifestyle intervention for adults at high-risk for type 2 diabetes. The DPP will be delivered by certified coaches from the Johns Hopkins Brancati Center. The program uses the CDC's Prevent T2 curriculum, with a total of 32-34 sessions delivered over a 12-month period. In the initial "core" period (first 6 months), there are at least 16 sessions delivered on a weekly basis. In the "post-core" period, additional (at least 6) sessions are offered over a 6 month period. Sessions are delivered either in-person or via a virtual synchronous platform (Zoom).
Family Diabetes Prevention Program (Family DPP)
n=8 Participants
Adult participants will engage in the family-oriented Diabetes Prevention Program lifestyle intervention (Family DPP); this is an augmented version of the DPP lifestyle intervention. This 12-month, group-based lifestyle intervention will include all elements of the DPP lifestyle intervention as delivered by the Johns Hopkins Brancati Center using a CDC-approved curriculum, with additional child-focused sessions in which adult participants will learn about children's health-related behaviors. Children will be present at the child-focused sessions and family activities, and will be engaged in data collection. Groups will be "mixed," in that non-study participants (adults who are eligible for the DPP), may also participate. Family DPP: The Family DPP has been developed as an augmented version of the National Diabetes Prevention Program Lifestyle Intervention (DPP). It includes all elements of the 12-month, group-based DPP lifestyle intervention, led by a CDC certified-coach using a CDC-approved curriculum (involving around 32-34 sessions). The augmentations of the Family DPP include 2 additional sessions that address barriers to adults' own lifestyle change efforts related to being a caregiver of children and child-focused sessions to introduce basic concepts regarding healthy child lifestyle habits. The additional sessions that will be delivered to the adult DPP participant, and in which children, ages 5 through 12, can also be engaged.
Adult Participant Physical Activity as Assessed by Average Duration of Activity Per Week
192.72 minutes of physical activity per week
Standard Deviation 110.27
137.11 minutes of physical activity per week
Standard Deviation 92.41

SECONDARY outcome

Timeframe: 12 months

Population: Among adult study participants considered as per specific Diabetes Prevention Program definition to have been completers in the DPP.

Average number of minutes/week of moderate-vigorous physical activity by self report, by 12 months/end of program, among adults considered DPP completers (this reflects average of values reported Sessions 2 through 29).

Outcome measures

Outcome measures
Measure
Diabetes Prevention Program (DPP)
n=9 Participants
Adult participants who are engaged in the Centers for Disease Control and Prevention's (CDC) National Diabetes Prevention Program lifestyle intervention (DPP) as delivered by the Johns Hopkins Brancati Center; this is a 12-month long, group-based lifestyle intervention, delivered by a certified lifestyle coach using a CDC-approved curriculum. This "concurrent control" group will consist of adults who are enrolled in the Brancati Center's DPP within 6 months of the intervention group start dates, who have children less than 18 years of age living in their households. National Diabetes Prevention Program Lifestyle Intervention (DPP): The National Diabetes Prevention Program lifestyle intervention (DPP) is a 12-month long, group-based lifestyle intervention for adults at high-risk for type 2 diabetes. The DPP will be delivered by certified coaches from the Johns Hopkins Brancati Center. The program uses the CDC's Prevent T2 curriculum, with a total of 32-34 sessions delivered over a 12-month period. In the initial "core" period (first 6 months), there are at least 16 sessions delivered on a weekly basis. In the "post-core" period, additional (at least 6) sessions are offered over a 6 month period. Sessions are delivered either in-person or via a virtual synchronous platform (Zoom).
Family Diabetes Prevention Program (Family DPP)
n=7 Participants
Adult participants will engage in the family-oriented Diabetes Prevention Program lifestyle intervention (Family DPP); this is an augmented version of the DPP lifestyle intervention. This 12-month, group-based lifestyle intervention will include all elements of the DPP lifestyle intervention as delivered by the Johns Hopkins Brancati Center using a CDC-approved curriculum, with additional child-focused sessions in which adult participants will learn about children's health-related behaviors. Children will be present at the child-focused sessions and family activities, and will be engaged in data collection. Groups will be "mixed," in that non-study participants (adults who are eligible for the DPP), may also participate. Family DPP: The Family DPP has been developed as an augmented version of the National Diabetes Prevention Program Lifestyle Intervention (DPP). It includes all elements of the 12-month, group-based DPP lifestyle intervention, led by a CDC certified-coach using a CDC-approved curriculum (involving around 32-34 sessions). The augmentations of the Family DPP include 2 additional sessions that address barriers to adults' own lifestyle change efforts related to being a caregiver of children and child-focused sessions to introduce basic concepts regarding healthy child lifestyle habits. The additional sessions that will be delivered to the adult DPP participant, and in which children, ages 5 through 12, can also be engaged.
Adult Participant Physical Activity as Assessed by Average Duration of Activity Per Week
188.97 minutes of physical activity per week
Standard Deviation 99.69
113.78 minutes of physical activity per week
Standard Deviation 67.38

SECONDARY outcome

Timeframe: 12 months

Population: Adult participants considered DPP completers.

Whether or not the adult participant met the program goal of an average 150 minutes/week of moderate-vigorous physical activity.

Outcome measures

Outcome measures
Measure
Diabetes Prevention Program (DPP)
n=9 Participants
Adult participants who are engaged in the Centers for Disease Control and Prevention's (CDC) National Diabetes Prevention Program lifestyle intervention (DPP) as delivered by the Johns Hopkins Brancati Center; this is a 12-month long, group-based lifestyle intervention, delivered by a certified lifestyle coach using a CDC-approved curriculum. This "concurrent control" group will consist of adults who are enrolled in the Brancati Center's DPP within 6 months of the intervention group start dates, who have children less than 18 years of age living in their households. National Diabetes Prevention Program Lifestyle Intervention (DPP): The National Diabetes Prevention Program lifestyle intervention (DPP) is a 12-month long, group-based lifestyle intervention for adults at high-risk for type 2 diabetes. The DPP will be delivered by certified coaches from the Johns Hopkins Brancati Center. The program uses the CDC's Prevent T2 curriculum, with a total of 32-34 sessions delivered over a 12-month period. In the initial "core" period (first 6 months), there are at least 16 sessions delivered on a weekly basis. In the "post-core" period, additional (at least 6) sessions are offered over a 6 month period. Sessions are delivered either in-person or via a virtual synchronous platform (Zoom).
Family Diabetes Prevention Program (Family DPP)
n=7 Participants
Adult participants will engage in the family-oriented Diabetes Prevention Program lifestyle intervention (Family DPP); this is an augmented version of the DPP lifestyle intervention. This 12-month, group-based lifestyle intervention will include all elements of the DPP lifestyle intervention as delivered by the Johns Hopkins Brancati Center using a CDC-approved curriculum, with additional child-focused sessions in which adult participants will learn about children's health-related behaviors. Children will be present at the child-focused sessions and family activities, and will be engaged in data collection. Groups will be "mixed," in that non-study participants (adults who are eligible for the DPP), may also participate. Family DPP: The Family DPP has been developed as an augmented version of the National Diabetes Prevention Program Lifestyle Intervention (DPP). It includes all elements of the 12-month, group-based DPP lifestyle intervention, led by a CDC certified-coach using a CDC-approved curriculum (involving around 32-34 sessions). The augmentations of the Family DPP include 2 additional sessions that address barriers to adults' own lifestyle change efforts related to being a caregiver of children and child-focused sessions to introduce basic concepts regarding healthy child lifestyle habits. The additional sessions that will be delivered to the adult DPP participant, and in which children, ages 5 through 12, can also be engaged.
Percentage of Adult Participants Who Met Physical Activity Achievement
55.6 percentage of participants
14.29 percentage of participants

SECONDARY outcome

Timeframe: Baseline, 6 months and 12 months (end of intervention)

Population: This outcome was assessed among adult study participants in the intervention arm only; outcome was calculated for adult participants for whom data was collected at referenced time points (e.g., baseline and 6 months, and baseline and 12 months) AND who did not formally withdraw from the study. (This data was not collected in the control arm).

Questions from the Behavioral Risk Factor Surveillance System (BRFSS) 2017 modules on fruit, vegetable and fruit juice intake as assessed by participant recall (for 1 week period), which quantify frequency of intake of these food items over 1 week-recall period; changes in intake patterns from baseline, at 6 and 12 months, will be assessed for adults in the Family DPP (intervention) arm.

Outcome measures

Outcome measures
Measure
Diabetes Prevention Program (DPP)
Adult participants who are engaged in the Centers for Disease Control and Prevention's (CDC) National Diabetes Prevention Program lifestyle intervention (DPP) as delivered by the Johns Hopkins Brancati Center; this is a 12-month long, group-based lifestyle intervention, delivered by a certified lifestyle coach using a CDC-approved curriculum. This "concurrent control" group will consist of adults who are enrolled in the Brancati Center's DPP within 6 months of the intervention group start dates, who have children less than 18 years of age living in their households. National Diabetes Prevention Program Lifestyle Intervention (DPP): The National Diabetes Prevention Program lifestyle intervention (DPP) is a 12-month long, group-based lifestyle intervention for adults at high-risk for type 2 diabetes. The DPP will be delivered by certified coaches from the Johns Hopkins Brancati Center. The program uses the CDC's Prevent T2 curriculum, with a total of 32-34 sessions delivered over a 12-month period. In the initial "core" period (first 6 months), there are at least 16 sessions delivered on a weekly basis. In the "post-core" period, additional (at least 6) sessions are offered over a 6 month period. Sessions are delivered either in-person or via a virtual synchronous platform (Zoom).
Family Diabetes Prevention Program (Family DPP)
n=9 Participants
Adult participants will engage in the family-oriented Diabetes Prevention Program lifestyle intervention (Family DPP); this is an augmented version of the DPP lifestyle intervention. This 12-month, group-based lifestyle intervention will include all elements of the DPP lifestyle intervention as delivered by the Johns Hopkins Brancati Center using a CDC-approved curriculum, with additional child-focused sessions in which adult participants will learn about children's health-related behaviors. Children will be present at the child-focused sessions and family activities, and will be engaged in data collection. Groups will be "mixed," in that non-study participants (adults who are eligible for the DPP), may also participate. Family DPP: The Family DPP has been developed as an augmented version of the National Diabetes Prevention Program Lifestyle Intervention (DPP). It includes all elements of the 12-month, group-based DPP lifestyle intervention, led by a CDC certified-coach using a CDC-approved curriculum (involving around 32-34 sessions). The augmentations of the Family DPP include 2 additional sessions that address barriers to adults' own lifestyle change efforts related to being a caregiver of children and child-focused sessions to introduce basic concepts regarding healthy child lifestyle habits. The additional sessions that will be delivered to the adult DPP participant, and in which children, ages 5 through 12, can also be engaged.
Change in Adult Participant Dietary Pattern Related to Fruit and Vegetable Intake Frequency
Change in Frequency of Total Fruit Intake, baseline to 6 months
-0.38 number of times per day, in prior week
Standard Deviation 1.01
Change in Adult Participant Dietary Pattern Related to Fruit and Vegetable Intake Frequency
Change in Frequency of Total Fruit Intake, baseline to 12 months
0.30 number of times per day, in prior week
Standard Deviation 1.23
Change in Adult Participant Dietary Pattern Related to Fruit and Vegetable Intake Frequency
Change in Frequency of Total Vegetable Intake, baseline to 6 months
-.02 number of times per day, in prior week
Standard Deviation 0.87
Change in Adult Participant Dietary Pattern Related to Fruit and Vegetable Intake Frequency
Change in Frequency of Total Vegetable Intake, baseline to 12 months
0.02 number of times per day, in prior week
Standard Deviation 0.77

SECONDARY outcome

Timeframe: Baseline, 6 months and 12 months (end of intervention)

Population: This outcome was assessed among adult study participants in the intervention arm only; outcome was calculated for adult participants for whom data was collected at referenced time points (e.g., baseline and 6 months, and baseline and 12 months) AND who did not formally withdraw from the study. (This data was not collected in the control arm).

Questions from the BRFSS on sugary beverage intake, as assessed by participant recall (for 1 week period), which quantify frequency of intake of sugary beverages over 1 week-recall period; changes in intake patterns from baseline, at 6 and 12 months, will be assessed for adults in the Family DPP (intervention) arm.

Outcome measures

Outcome measures
Measure
Diabetes Prevention Program (DPP)
Adult participants who are engaged in the Centers for Disease Control and Prevention's (CDC) National Diabetes Prevention Program lifestyle intervention (DPP) as delivered by the Johns Hopkins Brancati Center; this is a 12-month long, group-based lifestyle intervention, delivered by a certified lifestyle coach using a CDC-approved curriculum. This "concurrent control" group will consist of adults who are enrolled in the Brancati Center's DPP within 6 months of the intervention group start dates, who have children less than 18 years of age living in their households. National Diabetes Prevention Program Lifestyle Intervention (DPP): The National Diabetes Prevention Program lifestyle intervention (DPP) is a 12-month long, group-based lifestyle intervention for adults at high-risk for type 2 diabetes. The DPP will be delivered by certified coaches from the Johns Hopkins Brancati Center. The program uses the CDC's Prevent T2 curriculum, with a total of 32-34 sessions delivered over a 12-month period. In the initial "core" period (first 6 months), there are at least 16 sessions delivered on a weekly basis. In the "post-core" period, additional (at least 6) sessions are offered over a 6 month period. Sessions are delivered either in-person or via a virtual synchronous platform (Zoom).
Family Diabetes Prevention Program (Family DPP)
n=9 Participants
Adult participants will engage in the family-oriented Diabetes Prevention Program lifestyle intervention (Family DPP); this is an augmented version of the DPP lifestyle intervention. This 12-month, group-based lifestyle intervention will include all elements of the DPP lifestyle intervention as delivered by the Johns Hopkins Brancati Center using a CDC-approved curriculum, with additional child-focused sessions in which adult participants will learn about children's health-related behaviors. Children will be present at the child-focused sessions and family activities, and will be engaged in data collection. Groups will be "mixed," in that non-study participants (adults who are eligible for the DPP), may also participate. Family DPP: The Family DPP has been developed as an augmented version of the National Diabetes Prevention Program Lifestyle Intervention (DPP). It includes all elements of the 12-month, group-based DPP lifestyle intervention, led by a CDC certified-coach using a CDC-approved curriculum (involving around 32-34 sessions). The augmentations of the Family DPP include 2 additional sessions that address barriers to adults' own lifestyle change efforts related to being a caregiver of children and child-focused sessions to introduce basic concepts regarding healthy child lifestyle habits. The additional sessions that will be delivered to the adult DPP participant, and in which children, ages 5 through 12, can also be engaged.
Change in Adult Participant Dietary Pattern Related to Sugary Beverage Intake Frequency
Change in Frequency of Sugary Beverage intake, baseline to 6 months
-0.10 number of times per day, in prior week
Standard Deviation 0.61
Change in Adult Participant Dietary Pattern Related to Sugary Beverage Intake Frequency
Change in Frequency of Sugary Beverage intake, baseline to 12 months
-0.07 number of times per day, in prior week
Standard Deviation 0.53

SECONDARY outcome

Timeframe: Baseline, 6 months and 12 months (end of intervention)

Population: This outcome was assessed among child study participants (in the intervention arm only; there were no children enrolled in the DPP (control arm); outcome was calculated for child participants for whom data was collected at referenced time points (e.g., baseline and 6 months, and baseline and 12 months) AND who did not formally withdraw from the study.

Questions from the YRBS 2017 modules on fruit and vegetable intake, which quantify intake of these food items over a 7-day period; questions will be asked of caregivers of all child participants and directly of children ages 9 through 12 years. Changes in intake patterns from baseline will be assessed.

Outcome measures

Outcome measures
Measure
Diabetes Prevention Program (DPP)
Adult participants who are engaged in the Centers for Disease Control and Prevention's (CDC) National Diabetes Prevention Program lifestyle intervention (DPP) as delivered by the Johns Hopkins Brancati Center; this is a 12-month long, group-based lifestyle intervention, delivered by a certified lifestyle coach using a CDC-approved curriculum. This "concurrent control" group will consist of adults who are enrolled in the Brancati Center's DPP within 6 months of the intervention group start dates, who have children less than 18 years of age living in their households. National Diabetes Prevention Program Lifestyle Intervention (DPP): The National Diabetes Prevention Program lifestyle intervention (DPP) is a 12-month long, group-based lifestyle intervention for adults at high-risk for type 2 diabetes. The DPP will be delivered by certified coaches from the Johns Hopkins Brancati Center. The program uses the CDC's Prevent T2 curriculum, with a total of 32-34 sessions delivered over a 12-month period. In the initial "core" period (first 6 months), there are at least 16 sessions delivered on a weekly basis. In the "post-core" period, additional (at least 6) sessions are offered over a 6 month period. Sessions are delivered either in-person or via a virtual synchronous platform (Zoom).
Family Diabetes Prevention Program (Family DPP)
n=11 Participants
Adult participants will engage in the family-oriented Diabetes Prevention Program lifestyle intervention (Family DPP); this is an augmented version of the DPP lifestyle intervention. This 12-month, group-based lifestyle intervention will include all elements of the DPP lifestyle intervention as delivered by the Johns Hopkins Brancati Center using a CDC-approved curriculum, with additional child-focused sessions in which adult participants will learn about children's health-related behaviors. Children will be present at the child-focused sessions and family activities, and will be engaged in data collection. Groups will be "mixed," in that non-study participants (adults who are eligible for the DPP), may also participate. Family DPP: The Family DPP has been developed as an augmented version of the National Diabetes Prevention Program Lifestyle Intervention (DPP). It includes all elements of the 12-month, group-based DPP lifestyle intervention, led by a CDC certified-coach using a CDC-approved curriculum (involving around 32-34 sessions). The augmentations of the Family DPP include 2 additional sessions that address barriers to adults' own lifestyle change efforts related to being a caregiver of children and child-focused sessions to introduce basic concepts regarding healthy child lifestyle habits. The additional sessions that will be delivered to the adult DPP participant, and in which children, ages 5 through 12, can also be engaged.
Change in Child Participant Fruit and Vegetable Intake Frequency
Change in Frequency of Total Fruit Intake, baseline to 6 months
0.02 number of times per day, in prior week
Standard Deviation 1.95
Change in Child Participant Fruit and Vegetable Intake Frequency
Change in Frequency of Total Fruit Intake, baseline to 12 months
-0.68 number of times per day, in prior week
Standard Deviation 1.17
Change in Child Participant Fruit and Vegetable Intake Frequency
Change in Frequency of Total Fruit Intake, 6 months to 12 months
-0.38 number of times per day, in prior week
Standard Deviation 1.79
Change in Child Participant Fruit and Vegetable Intake Frequency
Change in Frequency of Total Vegetable Intake, baseline to 6 months
-0.57 number of times per day, in prior week
Standard Deviation 1.39
Change in Child Participant Fruit and Vegetable Intake Frequency
Change in Frequency of Total Vegetable Intake, baseline to 12 months
-0.73 number of times per day, in prior week
Standard Deviation 1.51
Change in Child Participant Fruit and Vegetable Intake Frequency
Change in Frequency of Total Vegetable Intake, 6 months to 12 months
-0.21 number of times per day, in prior week
Standard Deviation 0.70

SECONDARY outcome

Timeframe: Baseline, 6 and 12 months

Population: This outcome was assessed among child study participants (in the intervention arm only; there were no children enrolled in the DPP (control arm); outcome was calculated for child participants for whom data was collected at referenced time points (e.g., baseline and 6 months, and baseline and 12 months) AND who did not formally withdraw from the study.

Questions from the Youth Risk Behavioral Surveillance System (YRBSS) on sugary beverage intake frequency over a 7-day period; questions will be asked of caregivers of all child participants and directly of children ages 9 through 12 years. Changes in intake patterns from baseline, at 6 and 12 months, will be assessed.

Outcome measures

Outcome measures
Measure
Diabetes Prevention Program (DPP)
Adult participants who are engaged in the Centers for Disease Control and Prevention's (CDC) National Diabetes Prevention Program lifestyle intervention (DPP) as delivered by the Johns Hopkins Brancati Center; this is a 12-month long, group-based lifestyle intervention, delivered by a certified lifestyle coach using a CDC-approved curriculum. This "concurrent control" group will consist of adults who are enrolled in the Brancati Center's DPP within 6 months of the intervention group start dates, who have children less than 18 years of age living in their households. National Diabetes Prevention Program Lifestyle Intervention (DPP): The National Diabetes Prevention Program lifestyle intervention (DPP) is a 12-month long, group-based lifestyle intervention for adults at high-risk for type 2 diabetes. The DPP will be delivered by certified coaches from the Johns Hopkins Brancati Center. The program uses the CDC's Prevent T2 curriculum, with a total of 32-34 sessions delivered over a 12-month period. In the initial "core" period (first 6 months), there are at least 16 sessions delivered on a weekly basis. In the "post-core" period, additional (at least 6) sessions are offered over a 6 month period. Sessions are delivered either in-person or via a virtual synchronous platform (Zoom).
Family Diabetes Prevention Program (Family DPP)
n=11 Participants
Adult participants will engage in the family-oriented Diabetes Prevention Program lifestyle intervention (Family DPP); this is an augmented version of the DPP lifestyle intervention. This 12-month, group-based lifestyle intervention will include all elements of the DPP lifestyle intervention as delivered by the Johns Hopkins Brancati Center using a CDC-approved curriculum, with additional child-focused sessions in which adult participants will learn about children's health-related behaviors. Children will be present at the child-focused sessions and family activities, and will be engaged in data collection. Groups will be "mixed," in that non-study participants (adults who are eligible for the DPP), may also participate. Family DPP: The Family DPP has been developed as an augmented version of the National Diabetes Prevention Program Lifestyle Intervention (DPP). It includes all elements of the 12-month, group-based DPP lifestyle intervention, led by a CDC certified-coach using a CDC-approved curriculum (involving around 32-34 sessions). The augmentations of the Family DPP include 2 additional sessions that address barriers to adults' own lifestyle change efforts related to being a caregiver of children and child-focused sessions to introduce basic concepts regarding healthy child lifestyle habits. The additional sessions that will be delivered to the adult DPP participant, and in which children, ages 5 through 12, can also be engaged.
Change in Child Participant Sugary Beverage Intake Frequency
Change in Frequency of Sugary Beverage Intake, baseline to 6 months
-0.08 number of times per day, in prior week
Standard Deviation 0.86
Change in Child Participant Sugary Beverage Intake Frequency
Change in Frequency of Sugary Beverage Intake, baseline to 12 months
-0.25 number of times per day, in prior week
Standard Deviation 1.39
Change in Child Participant Sugary Beverage Intake Frequency
Change in Frequency of Sugary Beverage Intake, 6 months to 12 months
-0.21 number of times per day, in prior week
Standard Deviation 1.13

SECONDARY outcome

Timeframe: Baseline, 6 months and 12 months (end of intervention)

Population: This outcome was assessed among child study participants (in the intervention arm only; there were no children enrolled in the DPP (control arm); outcome was calculated for child participants for whom data was collected at referenced time points (e.g., baseline and 6 months, and baseline and 12 months) AND who did not formally withdraw from the study.

Adaptation of questions from YRBSS regarding average number of hours of screen time/day, asked weekday or weekend over past 7 days. Questions will be asked of caregivers of all child participants and directly of children ages 9 through 12 years. (Options given of less than 1 hour, coded as 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours and 5 hours or more (coded as 5 hours). Changes in number of hours of screen time from baseline, at 6 and 12 months, will be assessed for children in the Family DPP (intervention) arm.

Outcome measures

Outcome measures
Measure
Diabetes Prevention Program (DPP)
Adult participants who are engaged in the Centers for Disease Control and Prevention's (CDC) National Diabetes Prevention Program lifestyle intervention (DPP) as delivered by the Johns Hopkins Brancati Center; this is a 12-month long, group-based lifestyle intervention, delivered by a certified lifestyle coach using a CDC-approved curriculum. This "concurrent control" group will consist of adults who are enrolled in the Brancati Center's DPP within 6 months of the intervention group start dates, who have children less than 18 years of age living in their households. National Diabetes Prevention Program Lifestyle Intervention (DPP): The National Diabetes Prevention Program lifestyle intervention (DPP) is a 12-month long, group-based lifestyle intervention for adults at high-risk for type 2 diabetes. The DPP will be delivered by certified coaches from the Johns Hopkins Brancati Center. The program uses the CDC's Prevent T2 curriculum, with a total of 32-34 sessions delivered over a 12-month period. In the initial "core" period (first 6 months), there are at least 16 sessions delivered on a weekly basis. In the "post-core" period, additional (at least 6) sessions are offered over a 6 month period. Sessions are delivered either in-person or via a virtual synchronous platform (Zoom).
Family Diabetes Prevention Program (Family DPP)
n=11 Participants
Adult participants will engage in the family-oriented Diabetes Prevention Program lifestyle intervention (Family DPP); this is an augmented version of the DPP lifestyle intervention. This 12-month, group-based lifestyle intervention will include all elements of the DPP lifestyle intervention as delivered by the Johns Hopkins Brancati Center using a CDC-approved curriculum, with additional child-focused sessions in which adult participants will learn about children's health-related behaviors. Children will be present at the child-focused sessions and family activities, and will be engaged in data collection. Groups will be "mixed," in that non-study participants (adults who are eligible for the DPP), may also participate. Family DPP: The Family DPP has been developed as an augmented version of the National Diabetes Prevention Program Lifestyle Intervention (DPP). It includes all elements of the 12-month, group-based DPP lifestyle intervention, led by a CDC certified-coach using a CDC-approved curriculum (involving around 32-34 sessions). The augmentations of the Family DPP include 2 additional sessions that address barriers to adults' own lifestyle change efforts related to being a caregiver of children and child-focused sessions to introduce basic concepts regarding healthy child lifestyle habits. The additional sessions that will be delivered to the adult DPP participant, and in which children, ages 5 through 12, can also be engaged.
Change in Child Participant Screen Time
Change in hours of sleep per night weekdays, baseline to 6 months
-0.28 hours of screen time/day, over past week
Standard Deviation 0.97
Change in Child Participant Screen Time
Change in hours of sleep per night weekdays, baseline to 12 months
-0.06 hours of screen time/day, over past week
Standard Deviation 0.56
Change in Child Participant Screen Time
Change in hours of sleep per night weekdays, 6 months to 12 months
0.13 hours of screen time/day, over past week
Standard Deviation 0.83
Change in Child Participant Screen Time
Change in hours of sleep per night weekends, baseline to 6 months
-0.44 hours of screen time/day, over past week
Standard Deviation 0.88
Change in Child Participant Screen Time
Change in hours of sleep per night weekends, baseline to 12 months
-0.25 hours of screen time/day, over past week
Standard Deviation 0.89
Change in Child Participant Screen Time
Change in hours of sleep per night weekends,6 months to 12 months
0.25 hours of screen time/day, over past week
Standard Deviation 0.89

SECONDARY outcome

Timeframe: Baseline, 6 months and 12 months (end of intervention)

Population: This outcome was assessed among child study participants (in the intervention arm only; there were no children enrolled in the DPP (control arm); outcome was calculated for child participants for whom data was collected at referenced time points (e.g., baseline and 6 months, and baseline and 12 months) AND who did not formally withdraw from the study.

Adaptation of questions from YRBSS regarding average number of hours of sleep per night on weekdays, over last week. Questions will be asked of caregivers of all child participants and directly of children ages 9 through 12 years. Changes will be assessed, at 6 and 12 months.

Outcome measures

Outcome measures
Measure
Diabetes Prevention Program (DPP)
Adult participants who are engaged in the Centers for Disease Control and Prevention's (CDC) National Diabetes Prevention Program lifestyle intervention (DPP) as delivered by the Johns Hopkins Brancati Center; this is a 12-month long, group-based lifestyle intervention, delivered by a certified lifestyle coach using a CDC-approved curriculum. This "concurrent control" group will consist of adults who are enrolled in the Brancati Center's DPP within 6 months of the intervention group start dates, who have children less than 18 years of age living in their households. National Diabetes Prevention Program Lifestyle Intervention (DPP): The National Diabetes Prevention Program lifestyle intervention (DPP) is a 12-month long, group-based lifestyle intervention for adults at high-risk for type 2 diabetes. The DPP will be delivered by certified coaches from the Johns Hopkins Brancati Center. The program uses the CDC's Prevent T2 curriculum, with a total of 32-34 sessions delivered over a 12-month period. In the initial "core" period (first 6 months), there are at least 16 sessions delivered on a weekly basis. In the "post-core" period, additional (at least 6) sessions are offered over a 6 month period. Sessions are delivered either in-person or via a virtual synchronous platform (Zoom).
Family Diabetes Prevention Program (Family DPP)
n=11 Participants
Adult participants will engage in the family-oriented Diabetes Prevention Program lifestyle intervention (Family DPP); this is an augmented version of the DPP lifestyle intervention. This 12-month, group-based lifestyle intervention will include all elements of the DPP lifestyle intervention as delivered by the Johns Hopkins Brancati Center using a CDC-approved curriculum, with additional child-focused sessions in which adult participants will learn about children's health-related behaviors. Children will be present at the child-focused sessions and family activities, and will be engaged in data collection. Groups will be "mixed," in that non-study participants (adults who are eligible for the DPP), may also participate. Family DPP: The Family DPP has been developed as an augmented version of the National Diabetes Prevention Program Lifestyle Intervention (DPP). It includes all elements of the 12-month, group-based DPP lifestyle intervention, led by a CDC certified-coach using a CDC-approved curriculum (involving around 32-34 sessions). The augmentations of the Family DPP include 2 additional sessions that address barriers to adults' own lifestyle change efforts related to being a caregiver of children and child-focused sessions to introduce basic concepts regarding healthy child lifestyle habits. The additional sessions that will be delivered to the adult DPP participant, and in which children, ages 5 through 12, can also be engaged.
Change in Child Participant Sleep Patterns
Change in number of hours of sleep on weekday in past week, baseline to 6 months
-0.83 hours of sleep on weekday, past week
Standard Deviation 1.41
Change in Child Participant Sleep Patterns
Change in number of hours of sleep on weekday in past week, baseline to 12 months
-0.75 hours of sleep on weekday, past week
Standard Deviation 1.39
Change in Child Participant Sleep Patterns
Change in number of hours of sleep on weekday in past week, 6 months to 12 months
0.25 hours of sleep on weekday, past week
Standard Deviation 1.46

SECONDARY outcome

Timeframe: Baseline, 6 months and 12 months (end of intervention)

Population: This outcome was assessed among adult study participants in the intervention arm only; outcome was calculated for adult participants for whom data was collected at referenced time points (e.g., baseline and 6 months, and baseline and 12 months) AND who did not formally withdraw from the study. (This data was not collected in the control arm).

Questionnaire exploring confidence in achieving behavioral goals related to physical activity, sleep and dietary modifications, using a Likert scale with options from 1 to 5, higher scores indicating higher perceived self-efficacy). Mean change in self-efficacy for each item from baseline (to 6 months and 12 months) will be assessed for adults in the Family DPP (intervention) arm.

Outcome measures

Outcome measures
Measure
Diabetes Prevention Program (DPP)
Adult participants who are engaged in the Centers for Disease Control and Prevention's (CDC) National Diabetes Prevention Program lifestyle intervention (DPP) as delivered by the Johns Hopkins Brancati Center; this is a 12-month long, group-based lifestyle intervention, delivered by a certified lifestyle coach using a CDC-approved curriculum. This "concurrent control" group will consist of adults who are enrolled in the Brancati Center's DPP within 6 months of the intervention group start dates, who have children less than 18 years of age living in their households. National Diabetes Prevention Program Lifestyle Intervention (DPP): The National Diabetes Prevention Program lifestyle intervention (DPP) is a 12-month long, group-based lifestyle intervention for adults at high-risk for type 2 diabetes. The DPP will be delivered by certified coaches from the Johns Hopkins Brancati Center. The program uses the CDC's Prevent T2 curriculum, with a total of 32-34 sessions delivered over a 12-month period. In the initial "core" period (first 6 months), there are at least 16 sessions delivered on a weekly basis. In the "post-core" period, additional (at least 6) sessions are offered over a 6 month period. Sessions are delivered either in-person or via a virtual synchronous platform (Zoom).
Family Diabetes Prevention Program (Family DPP)
n=11 Participants
Adult participants will engage in the family-oriented Diabetes Prevention Program lifestyle intervention (Family DPP); this is an augmented version of the DPP lifestyle intervention. This 12-month, group-based lifestyle intervention will include all elements of the DPP lifestyle intervention as delivered by the Johns Hopkins Brancati Center using a CDC-approved curriculum, with additional child-focused sessions in which adult participants will learn about children's health-related behaviors. Children will be present at the child-focused sessions and family activities, and will be engaged in data collection. Groups will be "mixed," in that non-study participants (adults who are eligible for the DPP), may also participate. Family DPP: The Family DPP has been developed as an augmented version of the National Diabetes Prevention Program Lifestyle Intervention (DPP). It includes all elements of the 12-month, group-based DPP lifestyle intervention, led by a CDC certified-coach using a CDC-approved curriculum (involving around 32-34 sessions). The augmentations of the Family DPP include 2 additional sessions that address barriers to adults' own lifestyle change efforts related to being a caregiver of children and child-focused sessions to introduce basic concepts regarding healthy child lifestyle habits. The additional sessions that will be delivered to the adult DPP participant, and in which children, ages 5 through 12, can also be engaged.
Change in Adult Caregiver Perceived Self-efficacy for Behavioral Change
Change from baseline in self-efficacy to achieve 150 min mod-vigorous physical activity/week,at 6mo
0.22 score on a scale
Standard Deviation 1.20
Change in Adult Caregiver Perceived Self-efficacy for Behavioral Change
Change from baseline in self-efficacy to achieve150 min mod-vigorous physical activity/week,at 12mo
0.37 score on a scale
Standard Deviation 0.92
Change in Adult Caregiver Perceived Self-efficacy for Behavioral Change
Change from baseline in self-efficacy for taking 2-min fitness break every 30 min when seated,at 6mo
0 score on a scale
Standard Deviation 1.22
Change in Adult Caregiver Perceived Self-efficacy for Behavioral Change
Change from baseline in self-efficacy for taking 2-min fitness break every 30 min when seated,at 12m
-0.25 score on a scale
Standard Deviation 1.58
Change in Adult Caregiver Perceived Self-efficacy for Behavioral Change
Change from baseline in self-efficacy for reducing sugary beverage intake, at 6mo
-0.33 score on a scale
Standard Deviation 0.5
Change in Adult Caregiver Perceived Self-efficacy for Behavioral Change
Change from baseline in self-efficacy for reducing sugary beverage intake, at 12mo
-0.25 score on a scale
Standard Deviation 0.46
Change in Adult Caregiver Perceived Self-efficacy for Behavioral Change
Change from baseline in self-efficacy for getting 7 or more hours of sleep per night, at 6mo
0 score on a scale
Standard Deviation 1.66
Change in Adult Caregiver Perceived Self-efficacy for Behavioral Change
Change from baseline in self-efficacy for getting more than 7 hours of sleep per night, at 12mo
0.75 score on a scale
Standard Deviation 0.89
Change in Adult Caregiver Perceived Self-efficacy for Behavioral Change
Change in self-efficacy for including non-starchy vegetable in meals daily, at 6mo
-0.22 score on a scale
Standard Deviation 0.97
Change in Adult Caregiver Perceived Self-efficacy for Behavioral Change
Change in self-efficacy for including non-starchy vegetable in meals daily, at 12mo
-0.125 score on a scale
Standard Deviation 0.64

SECONDARY outcome

Timeframe: Baseline, 6 months and 12 months (end of intervention)

Population: This outcome was assessed among child study participants (in the intervention arm only; there were no children enrolled in the DPP (control arm); outcome was calculated for child participants for whom data was collected at referenced time points (e.g., baseline and 6 months, and baseline and 12 months) AND who did not formally withdraw from the study.

Adaptations of questions from YRBS regarding number of days meeting physical activity goal/week. Questions will be asked of caregivers of all child participants and directly of children ages 9 through 12 years. Changes in activity patterns from baseline, including whether meeting daily physical activity guidelines, will be assessed for children in the Family DPP (intervention) arm.

Outcome measures

Outcome measures
Measure
Diabetes Prevention Program (DPP)
Adult participants who are engaged in the Centers for Disease Control and Prevention's (CDC) National Diabetes Prevention Program lifestyle intervention (DPP) as delivered by the Johns Hopkins Brancati Center; this is a 12-month long, group-based lifestyle intervention, delivered by a certified lifestyle coach using a CDC-approved curriculum. This "concurrent control" group will consist of adults who are enrolled in the Brancati Center's DPP within 6 months of the intervention group start dates, who have children less than 18 years of age living in their households. National Diabetes Prevention Program Lifestyle Intervention (DPP): The National Diabetes Prevention Program lifestyle intervention (DPP) is a 12-month long, group-based lifestyle intervention for adults at high-risk for type 2 diabetes. The DPP will be delivered by certified coaches from the Johns Hopkins Brancati Center. The program uses the CDC's Prevent T2 curriculum, with a total of 32-34 sessions delivered over a 12-month period. In the initial "core" period (first 6 months), there are at least 16 sessions delivered on a weekly basis. In the "post-core" period, additional (at least 6) sessions are offered over a 6 month period. Sessions are delivered either in-person or via a virtual synchronous platform (Zoom).
Family Diabetes Prevention Program (Family DPP)
n=11 Participants
Adult participants will engage in the family-oriented Diabetes Prevention Program lifestyle intervention (Family DPP); this is an augmented version of the DPP lifestyle intervention. This 12-month, group-based lifestyle intervention will include all elements of the DPP lifestyle intervention as delivered by the Johns Hopkins Brancati Center using a CDC-approved curriculum, with additional child-focused sessions in which adult participants will learn about children's health-related behaviors. Children will be present at the child-focused sessions and family activities, and will be engaged in data collection. Groups will be "mixed," in that non-study participants (adults who are eligible for the DPP), may also participate. Family DPP: The Family DPP has been developed as an augmented version of the National Diabetes Prevention Program Lifestyle Intervention (DPP). It includes all elements of the 12-month, group-based DPP lifestyle intervention, led by a CDC certified-coach using a CDC-approved curriculum (involving around 32-34 sessions). The augmentations of the Family DPP include 2 additional sessions that address barriers to adults' own lifestyle change efforts related to being a caregiver of children and child-focused sessions to introduce basic concepts regarding healthy child lifestyle habits. The additional sessions that will be delivered to the adult DPP participant, and in which children, ages 5 through 12, can also be engaged.
Change in Child Participant Physical Activity Levels
Change in number days/week achieving 60 minutes activity, over past week, baseline to 6 months
0.11 number of days per week
Standard Deviation 1.76
Change in Child Participant Physical Activity Levels
Change in number days/week achieving 60 minutes activity, over past week, baseline to 12 months
0.88 number of days per week
Standard Deviation 1.96
Change in Child Participant Physical Activity Levels
Change in number days/week achieving 60 minutes activity, over past week, 6 months to 12 months
0.88 number of days per week
Standard Deviation 2.53

SECONDARY outcome

Timeframe: Baseline, 6 months and 12 months (end of intervention)

Population: This outcome was assessed among adult study participants in the intervention arm only; outcome was calculated for adult participants for whom data was collected at referenced time points (e.g., baseline and 6 months, and baseline and 12 months) AND who did not formally withdraw from the study. (This data was not collected in the control arm).

Questionnaire exploring adult caregiver confidence in supporting child to achieve behavioral goals related to physical activity, sleep, screen time and diet, using a Likert scale from 1 to 5 with higher scores indicating higher perceived self-efficacy). Mean change in parenting self-efficacy overall and for each item from baseline, at 6 and 12 months, will be assessed for adults in the Family DPP (intervention) arm.

Outcome measures

Outcome measures
Measure
Diabetes Prevention Program (DPP)
Adult participants who are engaged in the Centers for Disease Control and Prevention's (CDC) National Diabetes Prevention Program lifestyle intervention (DPP) as delivered by the Johns Hopkins Brancati Center; this is a 12-month long, group-based lifestyle intervention, delivered by a certified lifestyle coach using a CDC-approved curriculum. This "concurrent control" group will consist of adults who are enrolled in the Brancati Center's DPP within 6 months of the intervention group start dates, who have children less than 18 years of age living in their households. National Diabetes Prevention Program Lifestyle Intervention (DPP): The National Diabetes Prevention Program lifestyle intervention (DPP) is a 12-month long, group-based lifestyle intervention for adults at high-risk for type 2 diabetes. The DPP will be delivered by certified coaches from the Johns Hopkins Brancati Center. The program uses the CDC's Prevent T2 curriculum, with a total of 32-34 sessions delivered over a 12-month period. In the initial "core" period (first 6 months), there are at least 16 sessions delivered on a weekly basis. In the "post-core" period, additional (at least 6) sessions are offered over a 6 month period. Sessions are delivered either in-person or via a virtual synchronous platform (Zoom).
Family Diabetes Prevention Program (Family DPP)
n=11 Participants
Adult participants will engage in the family-oriented Diabetes Prevention Program lifestyle intervention (Family DPP); this is an augmented version of the DPP lifestyle intervention. This 12-month, group-based lifestyle intervention will include all elements of the DPP lifestyle intervention as delivered by the Johns Hopkins Brancati Center using a CDC-approved curriculum, with additional child-focused sessions in which adult participants will learn about children's health-related behaviors. Children will be present at the child-focused sessions and family activities, and will be engaged in data collection. Groups will be "mixed," in that non-study participants (adults who are eligible for the DPP), may also participate. Family DPP: The Family DPP has been developed as an augmented version of the National Diabetes Prevention Program Lifestyle Intervention (DPP). It includes all elements of the 12-month, group-based DPP lifestyle intervention, led by a CDC certified-coach using a CDC-approved curriculum (involving around 32-34 sessions). The augmentations of the Family DPP include 2 additional sessions that address barriers to adults' own lifestyle change efforts related to being a caregiver of children and child-focused sessions to introduce basic concepts regarding healthy child lifestyle habits. The additional sessions that will be delivered to the adult DPP participant, and in which children, ages 5 through 12, can also be engaged.
Change in Parenting Self-efficacy for Child Health Behavior Change
Change from baseline in parenting self-efficacy for supporting child physical activity, at 6 mo
-0.33 score on Likert scale (1-5)
Standard Deviation 1
Change in Parenting Self-efficacy for Child Health Behavior Change
Change from baseline in parenting self-efficacy for supporting child physical activity, at 12mo
0.50 score on Likert scale (1-5)
Standard Deviation 1.07
Change in Parenting Self-efficacy for Child Health Behavior Change
Change from 6 mo in parenting self-efficacy for supporting child physical activity, at 12 mo
1 score on Likert scale (1-5)
Standard Deviation 0.93
Change in Parenting Self-efficacy for Child Health Behavior Change
Change from baseline in parenting self-efficacy for limiting child screen time, at 6mo
-0.25 score on Likert scale (1-5)
Standard Deviation 0.71
Change in Parenting Self-efficacy for Child Health Behavior Change
Change from baseline in parenting self-efficacy for limiting child screen time, at 12mo
0.38 score on Likert scale (1-5)
Standard Deviation 0.92
Change in Parenting Self-efficacy for Child Health Behavior Change
Change from 6mo in parenting self-efficacy for limiting child screen time, at 12mo
0.43 score on Likert scale (1-5)
Standard Deviation 0.54
Change in Parenting Self-efficacy for Child Health Behavior Change
Change from baseline in parenting self-efficacy for limiting child sugary beverage intake, at 6mo
-0.22 score on Likert scale (1-5)
Standard Deviation 1.20
Change in Parenting Self-efficacy for Child Health Behavior Change
Change from baseline in parenting self-efficacy for limiting child sugary beverage intake, at12 mo
0.25 score on Likert scale (1-5)
Standard Deviation 1.16
Change in Parenting Self-efficacy for Child Health Behavior Change
Change from 6mo in parenting self-efficacy for limiting child sugary beverage intake, at 12mo
0.63 score on Likert scale (1-5)
Standard Deviation 1.06
Change in Parenting Self-efficacy for Child Health Behavior Change
Change from baseline in parenting self-efficacy for supporting child sleep, at 6mo
-0.67 score on Likert scale (1-5)
Standard Deviation 0.71
Change in Parenting Self-efficacy for Child Health Behavior Change
Change from baseline in parenting self-efficacy for supporting child sleep, at 12 mo
0 score on Likert scale (1-5)
Standard Deviation 0.93
Change in Parenting Self-efficacy for Child Health Behavior Change
Change from 6 mo in parenting self-efficacy for supporting child sleep, at 12mo
0.63 score on Likert scale (1-5)
Standard Deviation 1.06
Change in Parenting Self-efficacy for Child Health Behavior Change
Change from baseline in parenting self-efficacy for supporting child fruit and veggie intake, at 6mo
0 score on Likert scale (1-5)
Standard Deviation 0.87
Change in Parenting Self-efficacy for Child Health Behavior Change
Change from baseline in parenting self-efficacy for supporting child fruit and veggie intake,at 12mo
-0.13 score on Likert scale (1-5)
Standard Deviation 0.93
Change in Parenting Self-efficacy for Child Health Behavior Change
Change from 6mo in parenting self-efficacy for supporting child fruit and veggie intake, at 12mo
-0.25 score on Likert scale (1-5)
Standard Deviation 0.89

SECONDARY outcome

Timeframe: Baseline, 6 months and 12 months (end of intervention)

Population: This outcome was assessed among adult AND child study participants in the intervention arm only; outcome was calculated for adult and child participants for whom data was collected at referenced time points (e.g., baseline and 6 months, and baseline and 12 months) AND who did not formally withdraw from the study. (This data was not collected in the control arm).

The Family Eating and Activity Habits Questionnaire-Revised (FEAHQ-R) is a 32-item, self-report instrument; score range 0-128 with likert scale options 0-4. It is a clinical tool that captures family member eating and activity habits and also factors related with obesity in the overall home environment for children and caregivers. A higher score is associated with less favorable or appropriate patterns. Mean changes in scores from baseline, at 6 and 12 months, will be assessed in the Family DPP (intervention) arm.

Outcome measures

Outcome measures
Measure
Diabetes Prevention Program (DPP)
Adult participants who are engaged in the Centers for Disease Control and Prevention's (CDC) National Diabetes Prevention Program lifestyle intervention (DPP) as delivered by the Johns Hopkins Brancati Center; this is a 12-month long, group-based lifestyle intervention, delivered by a certified lifestyle coach using a CDC-approved curriculum. This "concurrent control" group will consist of adults who are enrolled in the Brancati Center's DPP within 6 months of the intervention group start dates, who have children less than 18 years of age living in their households. National Diabetes Prevention Program Lifestyle Intervention (DPP): The National Diabetes Prevention Program lifestyle intervention (DPP) is a 12-month long, group-based lifestyle intervention for adults at high-risk for type 2 diabetes. The DPP will be delivered by certified coaches from the Johns Hopkins Brancati Center. The program uses the CDC's Prevent T2 curriculum, with a total of 32-34 sessions delivered over a 12-month period. In the initial "core" period (first 6 months), there are at least 16 sessions delivered on a weekly basis. In the "post-core" period, additional (at least 6) sessions are offered over a 6 month period. Sessions are delivered either in-person or via a virtual synchronous platform (Zoom).
Family Diabetes Prevention Program (Family DPP)
n=11 Participants
Adult participants will engage in the family-oriented Diabetes Prevention Program lifestyle intervention (Family DPP); this is an augmented version of the DPP lifestyle intervention. This 12-month, group-based lifestyle intervention will include all elements of the DPP lifestyle intervention as delivered by the Johns Hopkins Brancati Center using a CDC-approved curriculum, with additional child-focused sessions in which adult participants will learn about children's health-related behaviors. Children will be present at the child-focused sessions and family activities, and will be engaged in data collection. Groups will be "mixed," in that non-study participants (adults who are eligible for the DPP), may also participate. Family DPP: The Family DPP has been developed as an augmented version of the National Diabetes Prevention Program Lifestyle Intervention (DPP). It includes all elements of the 12-month, group-based DPP lifestyle intervention, led by a CDC certified-coach using a CDC-approved curriculum (involving around 32-34 sessions). The augmentations of the Family DPP include 2 additional sessions that address barriers to adults' own lifestyle change efforts related to being a caregiver of children and child-focused sessions to introduce basic concepts regarding healthy child lifestyle habits. The additional sessions that will be delivered to the adult DPP participant, and in which children, ages 5 through 12, can also be engaged.
Change in Family Eating/Activity Habits and Home Environment
Change from baseline in FEAHQ-R score for adult, at 12 months
-7.38 score on a scale
Standard Deviation 11.66
Change in Family Eating/Activity Habits and Home Environment
Change from 6 months in FEAHQ-R score for adult, at 12 months
-5.09 score on a scale
Standard Deviation 11.29
Change in Family Eating/Activity Habits and Home Environment
Change from baseline in FEAHQ-R score for child, at 6 months
3.33 score on a scale
Standard Deviation 6.83
Change in Family Eating/Activity Habits and Home Environment
Change from baseline in FEAHQ-R score for child, at 12 months
2.48 score on a scale
Standard Deviation 10.07
Change in Family Eating/Activity Habits and Home Environment
Change from 6 months in FEAHQ-R score for child, at 12 months
-1.40 score on a scale
Standard Deviation 3.26
Change in Family Eating/Activity Habits and Home Environment
Change from baseline in FEAHQ-R score for adult, at 6 months
-1.86 score on a scale
Standard Deviation 12.7

SECONDARY outcome

Timeframe: Baseline, 6 months and 12 months (end of intervention)

Population: This outcome was assessed among adult study participants in the intervention arm only; outcome was calculated for adult participants for whom data was collected at referenced time points (e.g., baseline and 6 months, and baseline and 12 months) AND who did not formally withdraw from the study. (This data was not collected in the control arm).

Questionnaire examining knowledge or awareness of age-specific pediatric guidelines for sleep, dietary intake, screen time and physical activity. 4 total questions, with percentage of questions answered correctly ranging from 0% to 100%. Mean change in the percentage of questions answered correctly from baseline, will be examined for adults in the Family DPP (intervention) arm.

Outcome measures

Outcome measures
Measure
Diabetes Prevention Program (DPP)
Adult participants who are engaged in the Centers for Disease Control and Prevention's (CDC) National Diabetes Prevention Program lifestyle intervention (DPP) as delivered by the Johns Hopkins Brancati Center; this is a 12-month long, group-based lifestyle intervention, delivered by a certified lifestyle coach using a CDC-approved curriculum. This "concurrent control" group will consist of adults who are enrolled in the Brancati Center's DPP within 6 months of the intervention group start dates, who have children less than 18 years of age living in their households. National Diabetes Prevention Program Lifestyle Intervention (DPP): The National Diabetes Prevention Program lifestyle intervention (DPP) is a 12-month long, group-based lifestyle intervention for adults at high-risk for type 2 diabetes. The DPP will be delivered by certified coaches from the Johns Hopkins Brancati Center. The program uses the CDC's Prevent T2 curriculum, with a total of 32-34 sessions delivered over a 12-month period. In the initial "core" period (first 6 months), there are at least 16 sessions delivered on a weekly basis. In the "post-core" period, additional (at least 6) sessions are offered over a 6 month period. Sessions are delivered either in-person or via a virtual synchronous platform (Zoom).
Family Diabetes Prevention Program (Family DPP)
n=11 Participants
Adult participants will engage in the family-oriented Diabetes Prevention Program lifestyle intervention (Family DPP); this is an augmented version of the DPP lifestyle intervention. This 12-month, group-based lifestyle intervention will include all elements of the DPP lifestyle intervention as delivered by the Johns Hopkins Brancati Center using a CDC-approved curriculum, with additional child-focused sessions in which adult participants will learn about children's health-related behaviors. Children will be present at the child-focused sessions and family activities, and will be engaged in data collection. Groups will be "mixed," in that non-study participants (adults who are eligible for the DPP), may also participate. Family DPP: The Family DPP has been developed as an augmented version of the National Diabetes Prevention Program Lifestyle Intervention (DPP). It includes all elements of the 12-month, group-based DPP lifestyle intervention, led by a CDC certified-coach using a CDC-approved curriculum (involving around 32-34 sessions). The augmentations of the Family DPP include 2 additional sessions that address barriers to adults' own lifestyle change efforts related to being a caregiver of children and child-focused sessions to introduce basic concepts regarding healthy child lifestyle habits. The additional sessions that will be delivered to the adult DPP participant, and in which children, ages 5 through 12, can also be engaged.
Change in Caregiver Knowledge Regarding Child Health Behaviors
Change from baseline in percentage of questions answered correctly, at 6 months
5.56 percentage of questions answered correct
Standard Deviation 30.0
Change in Caregiver Knowledge Regarding Child Health Behaviors
Change from baseline in percentage of questions answered correctly, at 12 months
25 percentage of questions answered correct
Standard Deviation 18.90
Change in Caregiver Knowledge Regarding Child Health Behaviors
Change from 6 months in percentage of questions answered correctly, at 12 months
21.88 percentage of questions answered correct
Standard Deviation 33.91

SECONDARY outcome

Timeframe: Baseline, 6 months and 12 months (end of intervention)

Population: This outcome was assessed among adult study participants in the intervention arm only; outcome was calculated for adult participants for whom data was collected at referenced time points (e.g., baseline and 6 months, and baseline and 12 months) AND who did not formally withdraw from the study. (This data was not collected in the control arm).

Questionnaire examining caregiver beliefs and attitudes towards age-specific guidelines for sleep, dietary intake, screen time and physical activity, using a Likert scale for extent to which respondent agrees or disagrees with statements (Likert Scale Options of 1-4: 1-Strongly Disagree to 4-Strongly Agree). Higher score indicates higher agreement with the statement. Mean change in score for each from baseline examined for adults in the Family DPP (intervention) arm.

Outcome measures

Outcome measures
Measure
Diabetes Prevention Program (DPP)
Adult participants who are engaged in the Centers for Disease Control and Prevention's (CDC) National Diabetes Prevention Program lifestyle intervention (DPP) as delivered by the Johns Hopkins Brancati Center; this is a 12-month long, group-based lifestyle intervention, delivered by a certified lifestyle coach using a CDC-approved curriculum. This "concurrent control" group will consist of adults who are enrolled in the Brancati Center's DPP within 6 months of the intervention group start dates, who have children less than 18 years of age living in their households. National Diabetes Prevention Program Lifestyle Intervention (DPP): The National Diabetes Prevention Program lifestyle intervention (DPP) is a 12-month long, group-based lifestyle intervention for adults at high-risk for type 2 diabetes. The DPP will be delivered by certified coaches from the Johns Hopkins Brancati Center. The program uses the CDC's Prevent T2 curriculum, with a total of 32-34 sessions delivered over a 12-month period. In the initial "core" period (first 6 months), there are at least 16 sessions delivered on a weekly basis. In the "post-core" period, additional (at least 6) sessions are offered over a 6 month period. Sessions are delivered either in-person or via a virtual synchronous platform (Zoom).
Family Diabetes Prevention Program (Family DPP)
n=11 Participants
Adult participants will engage in the family-oriented Diabetes Prevention Program lifestyle intervention (Family DPP); this is an augmented version of the DPP lifestyle intervention. This 12-month, group-based lifestyle intervention will include all elements of the DPP lifestyle intervention as delivered by the Johns Hopkins Brancati Center using a CDC-approved curriculum, with additional child-focused sessions in which adult participants will learn about children's health-related behaviors. Children will be present at the child-focused sessions and family activities, and will be engaged in data collection. Groups will be "mixed," in that non-study participants (adults who are eligible for the DPP), may also participate. Family DPP: The Family DPP has been developed as an augmented version of the National Diabetes Prevention Program Lifestyle Intervention (DPP). It includes all elements of the 12-month, group-based DPP lifestyle intervention, led by a CDC certified-coach using a CDC-approved curriculum (involving around 32-34 sessions). The augmentations of the Family DPP include 2 additional sessions that address barriers to adults' own lifestyle change efforts related to being a caregiver of children and child-focused sessions to introduce basic concepts regarding healthy child lifestyle habits. The additional sessions that will be delivered to the adult DPP participant, and in which children, ages 5 through 12, can also be engaged.
Change in Caregiver Attitudes Regarding Child Health Behaviors
Change from baseline in degree of agreement that child is at a healthy weight, at 6 months
0 change in Likert scale score
Standard Deviation 0.53
Change in Caregiver Attitudes Regarding Child Health Behaviors
Change from baseline in degree of agreement that child is at a healthy weight, at 12 months
0.38 change in Likert scale score
Standard Deviation 0.52
Change in Caregiver Attitudes Regarding Child Health Behaviors
Change from 6 months in degree of agreement that child is at a healthy weight, at 12 months
0.29 change in Likert scale score
Standard Deviation 0.49
Change in Caregiver Attitudes Regarding Child Health Behaviors
Change from baseline in degree of agreement that child gets enough sleep, at 6 months
-0.13 change in Likert scale score
Standard Deviation 0.35
Change in Caregiver Attitudes Regarding Child Health Behaviors
Change from baseline in degree of agreement that child gets enough sleep, at 12 months
-0.25 change in Likert scale score
Standard Deviation 0.46
Change in Caregiver Attitudes Regarding Child Health Behaviors
Change from 6 months in degree of agreement that child gets enough sleep, at 12 months
-0.13 change in Likert scale score
Standard Deviation 0.35
Change in Caregiver Attitudes Regarding Child Health Behaviors
Change from baseline in degree of agreement that child is as active as they need to be, at 6 months
-0.22 change in Likert scale score
Standard Deviation 1.20
Change in Caregiver Attitudes Regarding Child Health Behaviors
Change from baseline in degree of agreement that child is as active as they need to be, at 12 months
0.25 change in Likert scale score
Standard Deviation 1.04
Change in Caregiver Attitudes Regarding Child Health Behaviors
Change from 6 months in degree of agreement that child is as active as they need to be, at 12 months
0.25 change in Likert scale score
Standard Deviation 0.46
Change in Caregiver Attitudes Regarding Child Health Behaviors
Change from baseline in degree of agreement that child eats enough fruits and veggies, at 6 months
0.11 change in Likert scale score
Standard Deviation 0.60
Change in Caregiver Attitudes Regarding Child Health Behaviors
Change from baseline in degree of agreement that child eats enough fruits and veggies, at 12 months
0 change in Likert scale score
Standard Deviation 0.93
Change in Caregiver Attitudes Regarding Child Health Behaviors
Change from 6 months in degree of agreement that child eats enough fruits and veggies, at 12 months
-0.13 change in Likert scale score
Standard Deviation 1.13
Change in Caregiver Attitudes Regarding Child Health Behaviors
Change from baseline in degree of agreement that child needs to cut down sugary bev, at 6 months
-0.78 change in Likert scale score
Standard Deviation 0.97
Change in Caregiver Attitudes Regarding Child Health Behaviors
Change from baseline in degree of agreement that child needs to cut down sugary bev, at 12 months
-0.63 change in Likert scale score
Standard Deviation 1.19
Change in Caregiver Attitudes Regarding Child Health Behaviors
Change from 6 months in degree of agreement that child needs to cut down sugary bev, at 12 months
0.13 change in Likert scale score
Standard Deviation 0.99
Change in Caregiver Attitudes Regarding Child Health Behaviors
Change from baseline in degree of agreement that child needs to cut screen time, at 6 months
-0.33 change in Likert scale score
Standard Deviation 0.87
Change in Caregiver Attitudes Regarding Child Health Behaviors
Change from baseline in degree of agreement that child needs to cut screen time, at 12 months
-0.63 change in Likert scale score
Standard Deviation 1.19
Change in Caregiver Attitudes Regarding Child Health Behaviors
Change from 6 months in degree of agreement that child needs to cut screen time, at 12 months
-0.38 change in Likert scale score
Standard Deviation 0.52
Change in Caregiver Attitudes Regarding Child Health Behaviors
Change from baseline in degree of agreement that child's weight puts at risk for diabetes, at 6 mo
0.56 change in Likert scale score
Standard Deviation 0.73
Change in Caregiver Attitudes Regarding Child Health Behaviors
Change from baseline in degree of agreement that child's weight puts at risk for diabetes, at 12 mo
0.25 change in Likert scale score
Standard Deviation 0.46
Change in Caregiver Attitudes Regarding Child Health Behaviors
Change from 6 months in degree of agreement that child's weight puts at risk for diabetes, at 6 mo
-0.38 change in Likert scale score
Standard Deviation 0.52

Adverse Events

Diabetes Prevention Program (DPP)

Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths

Family Diabetes Prevention Program (Family DPP)

Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Diabetes Prevention Program (DPP)
n=10 participants at risk
Adult participants who are engaged in the Centers for Disease Control and Prevention's (CDC) National Diabetes Prevention Program lifestyle intervention (DPP) as delivered by the Johns Hopkins Brancati Center; this is a 12-month long, group-based lifestyle intervention, delivered by a certified lifestyle coach using a CDC-approved curriculum. This "concurrent control" group will consist of adults who are enrolled in the Brancati Center's DPP within 6 months of the intervention group start dates, who have children less than 18 years of age living in their households. National Diabetes Prevention Program Lifestyle Intervention (DPP): The National Diabetes Prevention Program lifestyle intervention (DPP) is a 12-month long, group-based lifestyle intervention for adults at high-risk for type 2 diabetes. The DPP will be delivered by certified coaches from the Johns Hopkins Brancati Center. The program uses the CDC's Prevent T2 curriculum, with a total of 32-34 sessions delivered over a 12-month period. In the initial "core" period (first 6 months), there are at least 16 sessions delivered on a weekly basis. In the "post-core" period, additional (at least 6) sessions are offered over a 6 month period. Sessions are delivered either in-person or via a virtual synchronous platform (Zoom).
Family Diabetes Prevention Program (Family DPP)
n=24 participants at risk
Adult participants will engage in the family-oriented Diabetes Prevention Program lifestyle intervention (Family DPP); this is an augmented version of the DPP lifestyle intervention. This 12-month, group-based lifestyle intervention will include all elements of the DPP lifestyle intervention as delivered by the Johns Hopkins Brancati Center using a CDC-approved curriculum, with additional child-focused sessions in which adult participants will learn about children's health-related behaviors. Children will be present at the child-focused sessions and family activities, and will be engaged in data collection. Groups will be "mixed," in that non-study participants (adults who are eligible for the DPP), may also participate. Family DPP: The Family DPP has been developed as an augmented version of the National Diabetes Prevention Program Lifestyle Intervention (DPP). It includes all elements of the 12-month, group-based DPP lifestyle intervention, led by a CDC certified-coach using a CDC-approved curriculum (involving around 32-34 sessions). The augmentations of the Family DPP include 2 additional sessions that address barriers to adults' own lifestyle change efforts related to being a caregiver of children and child-focused sessions to introduce basic concepts regarding healthy child lifestyle habits. The additional sessions that will be delivered to the adult DPP participant, and in which children, ages 5 through 12, can also be engaged.
Musculoskeletal and connective tissue disorders
Musculoskeletal injury
0.00%
0/10 • Up to 12 months
Serious or Potentially Serious Adverse Events were defined as: 1\) Event that was life threatening, or placed the pt at immediate risk of death; 2) Event that caused persistent or significant disability/incapacity (lasted at least 1 month and changed the pt's life); 3) Event that required or prolonged a hospitalization; 4) Pregnancy that resulted in congenital anomaly or birth defect; 5) Death; 6) Event that caused other significant hazards/potentially serious harm to research subjects/others.
4.2%
1/24 • Number of events 1 • Up to 12 months
Serious or Potentially Serious Adverse Events were defined as: 1\) Event that was life threatening, or placed the pt at immediate risk of death; 2) Event that caused persistent or significant disability/incapacity (lasted at least 1 month and changed the pt's life); 3) Event that required or prolonged a hospitalization; 4) Pregnancy that resulted in congenital anomaly or birth defect; 5) Death; 6) Event that caused other significant hazards/potentially serious harm to research subjects/others.
Gastrointestinal disorders
Hospitalization
10.0%
1/10 • Number of events 1 • Up to 12 months
Serious or Potentially Serious Adverse Events were defined as: 1\) Event that was life threatening, or placed the pt at immediate risk of death; 2) Event that caused persistent or significant disability/incapacity (lasted at least 1 month and changed the pt's life); 3) Event that required or prolonged a hospitalization; 4) Pregnancy that resulted in congenital anomaly or birth defect; 5) Death; 6) Event that caused other significant hazards/potentially serious harm to research subjects/others.
0.00%
0/24 • Up to 12 months
Serious or Potentially Serious Adverse Events were defined as: 1\) Event that was life threatening, or placed the pt at immediate risk of death; 2) Event that caused persistent or significant disability/incapacity (lasted at least 1 month and changed the pt's life); 3) Event that required or prolonged a hospitalization; 4) Pregnancy that resulted in congenital anomaly or birth defect; 5) Death; 6) Event that caused other significant hazards/potentially serious harm to research subjects/others.
Surgical and medical procedures
Elective surgery
0.00%
0/10 • Up to 12 months
Serious or Potentially Serious Adverse Events were defined as: 1\) Event that was life threatening, or placed the pt at immediate risk of death; 2) Event that caused persistent or significant disability/incapacity (lasted at least 1 month and changed the pt's life); 3) Event that required or prolonged a hospitalization; 4) Pregnancy that resulted in congenital anomaly or birth defect; 5) Death; 6) Event that caused other significant hazards/potentially serious harm to research subjects/others.
4.2%
1/24 • Number of events 1 • Up to 12 months
Serious or Potentially Serious Adverse Events were defined as: 1\) Event that was life threatening, or placed the pt at immediate risk of death; 2) Event that caused persistent or significant disability/incapacity (lasted at least 1 month and changed the pt's life); 3) Event that required or prolonged a hospitalization; 4) Pregnancy that resulted in congenital anomaly or birth defect; 5) Death; 6) Event that caused other significant hazards/potentially serious harm to research subjects/others.

Other adverse events

Adverse event data not reported

Additional Information

Maya Venkataramani MD, MPH

Johns Hopkins University Schoo of Medicine

Phone: 4109559869

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place