Family Diabetes Prevention Program Pilot Study

NCT ID: NCT05358444

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-08
• Study Completion Date: 2024-02-19

Brief Summary

This study will examine the feasibility and acceptability of a family-oriented augmentation of the Diabetes Prevention Program lifestyle intervention (DPP), called the Family DPP. It will also preliminarily examine adult and child health and health behavior outcomes. The DPP is a 12-month, group-based lifestyle intervention for adults at high-risk for type 2 diabetes, in which adult participants learn skills and strategies to achieve the program's goals of 5% weight loss and 150 minutes/week of moderate-vigorous physical activity. The Family DPP will consist of all elements of the evidence-based DPP, along with augmentations including additional child-focused sessions in which adult participants will learn about principles and strategies for promoting healthy lifestyle behaviors in children, ages 5 through 12 years. Children may participate in certain child-focused sessions, too. The non-randomized pilot feasibility study will consists of 2 arms/groups: 1) the concurrent "control" group, consisting of adults who are enrolled in the DPP; and 2) the "intervention" arm, in which the adult participants will engage in the Family DPP (and children may participate in certain aspects of the Family DPP focused on children). The study will recruit 10-15 adult-child dyads, for the "intervention" groups, and 10-15 adults for the concurrent control group. In addition to data collected from adult participants as a routine part of the DPP, the study will examine additional adult health behaviors and health outcomes and child health outcomes (change in body mass index z-score) and health behaviors at baseline, 6 months and 12 months (program end) among participants in the "intervention" group.

Conditions

PreDiabetes; Overweight and Obesity; Type 2 Diabetes; Overweight, Childhood; Obesity, Childhood; Lifestyle, Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

National Diabetes Prevention Program Lifestyle Intervention (DPP)

Intervention Type: BEHAVIORAL

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. These groups will be "mixed," in that non-study participants (adults who are eligible for the DPP), may also participate.

Group Type: EXPERIMENTAL

Family Diabetes Prevention Program (Family DPP)

Intervention Type: BEHAVIORAL

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 supplement the DPP's sessions to additionally address barriers to adults' own lifestyle change efforts related to being a caregiver of children AND to introduce basic concepts regarding healthy child habits related to dietary intake, physical activity and screen time, and sleep. The Family DPP will involve thus additional sessions that will be delivered to the adult DPP participant, and in which children, ages 5 through 12, may also be engaged.

Interventions

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).

Intervention Type: BEHAVIORAL

Family Diabetes Prevention Program (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 supplement the DPP's sessions to additionally address barriers to adults' own lifestyle change efforts related to being a caregiver of children AND to introduce basic concepts regarding healthy child habits related to dietary intake, physical activity and screen time, and sleep. The Family DPP will involve thus additional sessions that will be delivered to the adult DPP participant, and in which children, ages 5 through 12, may also be engaged.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Meeting eligibility criteria for the CDC's National Diabetes Prevention Program lifestyle intervention, which are:

1. 18 years of age and older;

2. not pregnant at time of enrollment;

3. body mass index (BMI) of ≥25 kg/m2 (≥23 kg/m2 , if of Asian race);

4. meet one of the following: a) have prediabetes (defined as fasting glucose of 100-125 mg/dL; plasma glucose measured 2 hours after 75 gm glucose load of 140 to 199 mg/dL, or A1c of 5.7% to 6.4%); b) history of clinically diagnosed gestational diabetes mellitus (GDM) during a previous pregnancy; c) high risk for diabetes based on CDC or American Diabetes Association (ADA) Diabetes Screening Test).

AND

2. being a primary caregiver of at least one eligible child aged 5 through 12 years at time of recruitment (defined as caring for the child, with a responsibility for the child's food, sleep and activity habits, at least 3 days out of the week)

1. being aged 5 through 12 years at time of recruitment;

2. not having a medical condition which leads to inability to comply with general pediatric dietary or physical activity goals; AND

3. not concurrently enrolled in a structured weight management program.

1. Being a participant in the Brancati Center's Diabetes Prevention Program, in a group that has started within 6 months of Intervention Arm group start

2. Lives with a child less than 18 years of age in their household

Exclusion Criteria

1. Conditions that would exclude their participation in the DPP lifestyle intervention which include:

1. pregnancy;

2. having end-stage renal disease;

3. having type 1 or type 2 diabetes.

2. They will also be excluded if they are concurrently enrolled in a structured weight management program.

1. having a medical condition which leads to inability to comply with general pediatric dietary or physical activity goals;

2. being enrolled in a structured weight management program.

For the Control Arm/Concurrent Control Group, this will only enroll ADULT participants.

• Minimum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maya S Venkataramani, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Countries

United States

References

Damschroder LJ, Moin T, Datta SK, Reardon CM, Steinle N, Weinreb J, Billington CJ, Maciejewski ML, Yancy WS Jr, Hughes M, Makki F, Richardson CR. Implementation and evaluation of the VA DPP clinical demonstration: protocol for a multi-site non-randomized hybrid effectiveness-implementation type III trial. Implement Sci. 2015 May 12;10:68. doi: 10.1186/s13012-015-0250-0.

Reference Type: BACKGROUND

PMID: 25962598 (View on PubMed)

Taveras EM, Mitchell K, Gortmaker SL. Parental confidence in making overweight-related behavior changes. Pediatrics. 2009 Jul;124(1):151-8. doi: 10.1542/peds.2008-2892.

Reference Type: BACKGROUND

PMID: 19564295 (View on PubMed)

Golan M. Fifteen years of the Family Eating and Activity Habits Questionnaire (FEAHQ): an update and review. Pediatr Obes. 2014 Apr;9(2):92-101. doi: 10.1111/j.2047-6310.2013.00144.x. Epub 2013 Feb 28.

Reference Type: BACKGROUND

PMID: 23447444 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1K23DK119581-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00310219

Identifier Type: -

Identifier Source: org_study_id