Trial Outcomes & Findings for Better Together Study (NCT NCT05275231)
NCT ID: NCT05275231
Last Updated: 2025-03-03
Results Overview
Which group of the study are participants choosing between the single participant group or the dyad. Preferences will be assessed by quantifying number enrolled in each group.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
108 participants
Primary outcome timeframe
Baseline
Results posted on
2025-03-03
Participant Flow
Participants were recruited from Emory Family Medicine Center. Participant enrollment began on April 4, 2022, and all follow-up assessments were completed by January 1, 2024 The study was a quasi-experimental design to understand preferences in this community. The PI offered a men-only group with very little interest in this group thus this arm was never carried forward. No subjects were enrolled in this group. Men-only group was not supposed to be a comparator arm.
Participant milestones
| Measure |
Dyads
This is a pragmatic, pre-post, pilot study. Participants will meet in groups of 12 for the SMA intervention at the conference room at the Emory Family Medicine Center in Dunwoody, Georgia. The intervention will consist of bi-weekly sessions over a 16-week period, with phone check-ins for the remaining weeks. Each session will last 60-90 minutes, and participants will engage in a total of 6 televisit sessions. Sessions will consist of a group-based program for all participants, followed by a personalized care plan, led by a physician. In this dyad-based group, participant's social partner must commit to attend all in-person sessions.
Intensive lifestyle interventions (ILIs): Intensive lifestyle interventions (ILIs) is a group-based programs designed to promote weight loss through a combination of diet, activity, and behavior change, decrease Type 2 Diabetes (T2D) incidence in people with prediabetes and reduced complications among people with T2D.
|
|---|---|
|
Overall Study
STARTED
|
54
|
|
Overall Study
COMPLETED
|
54
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
No baseline characteristics were collected from support group
Baseline characteristics by cohort
| Measure |
Participants
n=54 Participants
Participants who co-participated in a 5-session lifestyle intervention for diabetes management and prevention
|
Support Group
n=54 Participants
Support group comprised of participant's social partner.
|
Total
n=108 Participants
Total of all reporting groups
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|---|---|---|---|
|
Age, Continuous
|
52.8 years
STANDARD_DEVIATION 10.5 • n=54 Participants • No baseline characteristics were collected from support group
|
—
|
52.8 years
STANDARD_DEVIATION 10.5 • n=54 Participants • No baseline characteristics were collected from support group
|
|
Sex: Female, Male
Female
|
28 Participants
n=54 Participants • No baseline characteristics were collected on this group
|
—
|
28 Participants
n=54 Participants • No baseline characteristics were collected on this group
|
|
Sex: Female, Male
Male
|
26 Participants
n=54 Participants • No baseline characteristics were collected on this group
|
—
|
26 Participants
n=54 Participants • No baseline characteristics were collected on this group
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Native Language
Bengali
|
53 Participants
n=54 Participants • No baseline characteristics were collected on this group
|
—
|
53 Participants
n=54 Participants • No baseline characteristics were collected on this group
|
|
Native Language
Other
|
1 Participants
n=54 Participants • No baseline characteristics were collected on this group
|
—
|
1 Participants
n=54 Participants • No baseline characteristics were collected on this group
|
|
English Fluency
Very good
|
13 Participants
n=54 Participants • No baseline characteristics were collected on this group
|
—
|
13 Participants
n=54 Participants • No baseline characteristics were collected on this group
|
|
English Fluency
Good
|
21 Participants
n=54 Participants • No baseline characteristics were collected on this group
|
—
|
21 Participants
n=54 Participants • No baseline characteristics were collected on this group
|
|
English Fluency
Not good
|
16 Participants
n=54 Participants • No baseline characteristics were collected on this group
|
—
|
16 Participants
n=54 Participants • No baseline characteristics were collected on this group
|
|
English Fluency
Not good at all
|
4 Participants
n=54 Participants • No baseline characteristics were collected on this group
|
—
|
4 Participants
n=54 Participants • No baseline characteristics were collected on this group
|
|
Language Spoken at Home
Mostly English
|
0 Participants
n=54 Participants • No baseline characteristics were collected from support group
|
—
|
0 Participants
n=54 Participants • No baseline characteristics were collected from support group
|
|
Language Spoken at Home
Mix of English/ Native
|
10 Participants
n=54 Participants • No baseline characteristics were collected from support group
|
—
|
10 Participants
n=54 Participants • No baseline characteristics were collected from support group
|
|
Language Spoken at Home
Mostly Native
|
43 Participants
n=54 Participants • No baseline characteristics were collected from support group
|
—
|
43 Participants
n=54 Participants • No baseline characteristics were collected from support group
|
|
Language Spoken at Home
Other
|
1 Participants
n=54 Participants • No baseline characteristics were collected from support group
|
—
|
1 Participants
n=54 Participants • No baseline characteristics were collected from support group
|
|
Education
Some high school
|
8 Participants
n=54 Participants • No baseline characteristics were collected from support group
|
—
|
8 Participants
n=54 Participants • No baseline characteristics were collected from support group
|
|
Education
High School Graduate
|
5 Participants
n=54 Participants • No baseline characteristics were collected from support group
|
—
|
5 Participants
n=54 Participants • No baseline characteristics were collected from support group
|
|
Education
Some College
|
5 Participants
n=54 Participants • No baseline characteristics were collected from support group
|
—
|
5 Participants
n=54 Participants • No baseline characteristics were collected from support group
|
|
Education
unknown
|
36 Participants
n=54 Participants • No baseline characteristics were collected from support group
|
—
|
36 Participants
n=54 Participants • No baseline characteristics were collected from support group
|
|
Employment Status
Employed for wages
|
24 Participants
n=54 Participants • No baseline characteristics were collected from support group
|
—
|
24 Participants
n=54 Participants • No baseline characteristics were collected from support group
|
|
Employment Status
Self-employed
|
1 Participants
n=54 Participants • No baseline characteristics were collected from support group
|
—
|
1 Participants
n=54 Participants • No baseline characteristics were collected from support group
|
|
Employment Status
Homemaker
|
11 Participants
n=54 Participants • No baseline characteristics were collected from support group
|
—
|
11 Participants
n=54 Participants • No baseline characteristics were collected from support group
|
|
Employment Status
Student
|
1 Participants
n=54 Participants • No baseline characteristics were collected from support group
|
—
|
1 Participants
n=54 Participants • No baseline characteristics were collected from support group
|
|
Employment Status
Retired
|
13 Participants
n=54 Participants • No baseline characteristics were collected from support group
|
—
|
13 Participants
n=54 Participants • No baseline characteristics were collected from support group
|
|
Employment Status
Unemployed
|
4 Participants
n=54 Participants • No baseline characteristics were collected from support group
|
—
|
4 Participants
n=54 Participants • No baseline characteristics were collected from support group
|
|
Marital Status
Married
|
45 Participants
n=54 Participants • No baseline characteristics were collected from support group
|
—
|
45 Participants
n=54 Participants • No baseline characteristics were collected from support group
|
|
Marital Status
Divorced
|
1 Participants
n=54 Participants • No baseline characteristics were collected from support group
|
—
|
1 Participants
n=54 Participants • No baseline characteristics were collected from support group
|
|
Marital Status
Widowed
|
7 Participants
n=54 Participants • No baseline characteristics were collected from support group
|
—
|
7 Participants
n=54 Participants • No baseline characteristics were collected from support group
|
|
Marital Status
unknown
|
1 Participants
n=54 Participants • No baseline characteristics were collected from support group
|
—
|
1 Participants
n=54 Participants • No baseline characteristics were collected from support group
|
PRIMARY outcome
Timeframe: BaselinePopulation: No data was collected from the support group for this Outcome measure.
Which group of the study are participants choosing between the single participant group or the dyad. Preferences will be assessed by quantifying number enrolled in each group.
Outcome measures
| Measure |
Dyads
n=54 Participants
This is a pragmatic, pre-post, pilot study. Participants will meet in groups of 12 for the SMA intervention at the conference room at the Emory Family Medicine Center in Dunwoody, Georgia. The intervention will consist of bi-weekly sessions over a 16-week period, with phone check-ins for the remaining weeks. Each session will last 60-90 minutes, and participants will engage in a total of 6 televisit sessions. Sessions will consist of a group-based program for all participants, followed by a personalized care plan, led by a physician. In this dyad-based group, participant's social partner must commit to attend all in-person sessions.
Intensive lifestyle interventions (ILIs): Intensive lifestyle interventions (ILIs) is a group-based programs designed to promote weight loss through a combination of diet, activity, and behavior change, decrease Type 2 Diabetes (T2D) incidence in people with prediabetes and reduced complications among people with T2D.
|
Men Only
This is a pragmatic, pre-post, pilot study. Participants will meet in groups of 12 for the SMA intervention at the conference room at the Emory Family Medicine Center in Dunwoody, Georgia. the intervention will consist of bi-weekly sessions over a 16-week period, with phone check-ins for the remaining weeks. Each session will last 60-90 minutes, and participants will engage in a total of 6 televisit sessions. Sessions will consist of a group-based program for all participants, followed by a personalized care plan, led by a physician. In this group just the participant will receive the intervention.
Intensive lifestyle interventions (ILIs): Intensive lifestyle interventions (ILIs) is a group-based programs designed to promote weight loss through a combination of diet, activity, and behavior change, decrease Type 2 Diabetes (T2D) incidence in people with prediabetes and reduced complications among people with T2D.
|
|---|---|---|
|
Recruitment Group Preference
|
54 participants
|
—
|
PRIMARY outcome
Timeframe: BaselinePopulation: No data was collected on the support group for this outcome measure. 122 is the number of people who were approached for the study.
The proportion of adults who are contacted and informed about the study and who enroll during study baseline. Feasibility will be assessed by quantifying rate of enrollment, number of sessions attended by participants (for dyad arm, will assess participant and social contact, individually and together).
Outcome measures
| Measure |
Dyads
n=122 Participants
This is a pragmatic, pre-post, pilot study. Participants will meet in groups of 12 for the SMA intervention at the conference room at the Emory Family Medicine Center in Dunwoody, Georgia. The intervention will consist of bi-weekly sessions over a 16-week period, with phone check-ins for the remaining weeks. Each session will last 60-90 minutes, and participants will engage in a total of 6 televisit sessions. Sessions will consist of a group-based program for all participants, followed by a personalized care plan, led by a physician. In this dyad-based group, participant's social partner must commit to attend all in-person sessions.
Intensive lifestyle interventions (ILIs): Intensive lifestyle interventions (ILIs) is a group-based programs designed to promote weight loss through a combination of diet, activity, and behavior change, decrease Type 2 Diabetes (T2D) incidence in people with prediabetes and reduced complications among people with T2D.
|
Men Only
This is a pragmatic, pre-post, pilot study. Participants will meet in groups of 12 for the SMA intervention at the conference room at the Emory Family Medicine Center in Dunwoody, Georgia. the intervention will consist of bi-weekly sessions over a 16-week period, with phone check-ins for the remaining weeks. Each session will last 60-90 minutes, and participants will engage in a total of 6 televisit sessions. Sessions will consist of a group-based program for all participants, followed by a personalized care plan, led by a physician. In this group just the participant will receive the intervention.
Intensive lifestyle interventions (ILIs): Intensive lifestyle interventions (ILIs) is a group-based programs designed to promote weight loss through a combination of diet, activity, and behavior change, decrease Type 2 Diabetes (T2D) incidence in people with prediabetes and reduced complications among people with T2D.
|
|---|---|---|
|
Feasibility: Proportion of Subjects Who Enroll
|
54 participants enrolled
|
—
|
PRIMARY outcome
Timeframe: From baseline to week 16Population: The data collected for this outcome is only for the sessions attended together.
Number of sessions attended; for dyads, this would include sessions attended together and separately, over the 16-week study period. There were 5 sessions total.
Outcome measures
| Measure |
Dyads
n=54 Participants
This is a pragmatic, pre-post, pilot study. Participants will meet in groups of 12 for the SMA intervention at the conference room at the Emory Family Medicine Center in Dunwoody, Georgia. The intervention will consist of bi-weekly sessions over a 16-week period, with phone check-ins for the remaining weeks. Each session will last 60-90 minutes, and participants will engage in a total of 6 televisit sessions. Sessions will consist of a group-based program for all participants, followed by a personalized care plan, led by a physician. In this dyad-based group, participant's social partner must commit to attend all in-person sessions.
Intensive lifestyle interventions (ILIs): Intensive lifestyle interventions (ILIs) is a group-based programs designed to promote weight loss through a combination of diet, activity, and behavior change, decrease Type 2 Diabetes (T2D) incidence in people with prediabetes and reduced complications among people with T2D.
|
Men Only
This is a pragmatic, pre-post, pilot study. Participants will meet in groups of 12 for the SMA intervention at the conference room at the Emory Family Medicine Center in Dunwoody, Georgia. the intervention will consist of bi-weekly sessions over a 16-week period, with phone check-ins for the remaining weeks. Each session will last 60-90 minutes, and participants will engage in a total of 6 televisit sessions. Sessions will consist of a group-based program for all participants, followed by a personalized care plan, led by a physician. In this group just the participant will receive the intervention.
Intensive lifestyle interventions (ILIs): Intensive lifestyle interventions (ILIs) is a group-based programs designed to promote weight loss through a combination of diet, activity, and behavior change, decrease Type 2 Diabetes (T2D) incidence in people with prediabetes and reduced complications among people with T2D.
|
|---|---|---|
|
Retention: Number of Sessions Attended
|
4.7 sessions
Standard Deviation 0.53
|
—
|
PRIMARY outcome
Timeframe: Month 6Population: No data was collected from the support group for this Outcome measure.
Questionnaires assessed participant perceptions of ILI after the program to evaluate satisfaction with the program and suggestions for program improvement. Acceptability will be assessed by quantifying Likert-like scales of satisfaction of overall intervention. This is a 0 to 5 scale, where "0" represents the least level of satisfaction and "5" represents the highest level of satisfaction.
Outcome measures
| Measure |
Dyads
n=54 Participants
This is a pragmatic, pre-post, pilot study. Participants will meet in groups of 12 for the SMA intervention at the conference room at the Emory Family Medicine Center in Dunwoody, Georgia. The intervention will consist of bi-weekly sessions over a 16-week period, with phone check-ins for the remaining weeks. Each session will last 60-90 minutes, and participants will engage in a total of 6 televisit sessions. Sessions will consist of a group-based program for all participants, followed by a personalized care plan, led by a physician. In this dyad-based group, participant's social partner must commit to attend all in-person sessions.
Intensive lifestyle interventions (ILIs): Intensive lifestyle interventions (ILIs) is a group-based programs designed to promote weight loss through a combination of diet, activity, and behavior change, decrease Type 2 Diabetes (T2D) incidence in people with prediabetes and reduced complications among people with T2D.
|
Men Only
This is a pragmatic, pre-post, pilot study. Participants will meet in groups of 12 for the SMA intervention at the conference room at the Emory Family Medicine Center in Dunwoody, Georgia. the intervention will consist of bi-weekly sessions over a 16-week period, with phone check-ins for the remaining weeks. Each session will last 60-90 minutes, and participants will engage in a total of 6 televisit sessions. Sessions will consist of a group-based program for all participants, followed by a personalized care plan, led by a physician. In this group just the participant will receive the intervention.
Intensive lifestyle interventions (ILIs): Intensive lifestyle interventions (ILIs) is a group-based programs designed to promote weight loss through a combination of diet, activity, and behavior change, decrease Type 2 Diabetes (T2D) incidence in people with prediabetes and reduced complications among people with T2D.
|
|---|---|---|
|
Acceptability: Satisfaction Questionnaire
|
5 score on a scale
Standard Deviation 0
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, month 6Population: No data was collected from the support group for this Outcome measure.
Participant's weight will be measured in kilograms using a calibrated, standardized scale, and height will be measured in meters (m), using a standardized stadiometer. BMI will be calculated using the standard formula of kg/m\^2.
Outcome measures
| Measure |
Dyads
n=53 Participants
This is a pragmatic, pre-post, pilot study. Participants will meet in groups of 12 for the SMA intervention at the conference room at the Emory Family Medicine Center in Dunwoody, Georgia. The intervention will consist of bi-weekly sessions over a 16-week period, with phone check-ins for the remaining weeks. Each session will last 60-90 minutes, and participants will engage in a total of 6 televisit sessions. Sessions will consist of a group-based program for all participants, followed by a personalized care plan, led by a physician. In this dyad-based group, participant's social partner must commit to attend all in-person sessions.
Intensive lifestyle interventions (ILIs): Intensive lifestyle interventions (ILIs) is a group-based programs designed to promote weight loss through a combination of diet, activity, and behavior change, decrease Type 2 Diabetes (T2D) incidence in people with prediabetes and reduced complications among people with T2D.
|
Men Only
This is a pragmatic, pre-post, pilot study. Participants will meet in groups of 12 for the SMA intervention at the conference room at the Emory Family Medicine Center in Dunwoody, Georgia. the intervention will consist of bi-weekly sessions over a 16-week period, with phone check-ins for the remaining weeks. Each session will last 60-90 minutes, and participants will engage in a total of 6 televisit sessions. Sessions will consist of a group-based program for all participants, followed by a personalized care plan, led by a physician. In this group just the participant will receive the intervention.
Intensive lifestyle interventions (ILIs): Intensive lifestyle interventions (ILIs) is a group-based programs designed to promote weight loss through a combination of diet, activity, and behavior change, decrease Type 2 Diabetes (T2D) incidence in people with prediabetes and reduced complications among people with T2D.
|
|---|---|---|
|
Changes in Body Mass Index (BMI)
Baseline
|
26.56 kg/m2
Standard Deviation 3.71
|
—
|
|
Changes in Body Mass Index (BMI)
Month 6
|
25.92 kg/m2
Standard Deviation 4.94
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, month 6Waist circumference will be measured in centimeters (cm) by the World Health Organization recommended method.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, month 6Population: No data was collected from the support group for this Outcome measure.
Participant's systolic and diastolic blood pressure will be measured using standard procedures with a manual cuff. Diastolic blood pressure is the amount of pressure in the arteries when the heart is at rest between beats. Current guidelines identify normal diastolic blood pressure as lower than 80 mmHg.
Outcome measures
| Measure |
Dyads
n=52 Participants
This is a pragmatic, pre-post, pilot study. Participants will meet in groups of 12 for the SMA intervention at the conference room at the Emory Family Medicine Center in Dunwoody, Georgia. The intervention will consist of bi-weekly sessions over a 16-week period, with phone check-ins for the remaining weeks. Each session will last 60-90 minutes, and participants will engage in a total of 6 televisit sessions. Sessions will consist of a group-based program for all participants, followed by a personalized care plan, led by a physician. In this dyad-based group, participant's social partner must commit to attend all in-person sessions.
Intensive lifestyle interventions (ILIs): Intensive lifestyle interventions (ILIs) is a group-based programs designed to promote weight loss through a combination of diet, activity, and behavior change, decrease Type 2 Diabetes (T2D) incidence in people with prediabetes and reduced complications among people with T2D.
|
Men Only
This is a pragmatic, pre-post, pilot study. Participants will meet in groups of 12 for the SMA intervention at the conference room at the Emory Family Medicine Center in Dunwoody, Georgia. the intervention will consist of bi-weekly sessions over a 16-week period, with phone check-ins for the remaining weeks. Each session will last 60-90 minutes, and participants will engage in a total of 6 televisit sessions. Sessions will consist of a group-based program for all participants, followed by a personalized care plan, led by a physician. In this group just the participant will receive the intervention.
Intensive lifestyle interventions (ILIs): Intensive lifestyle interventions (ILIs) is a group-based programs designed to promote weight loss through a combination of diet, activity, and behavior change, decrease Type 2 Diabetes (T2D) incidence in people with prediabetes and reduced complications among people with T2D.
|
|---|---|---|
|
Changes in Diastolic Blood Pressure
Baseline
|
76.32 mm of HG
Standard Deviation 7.65
|
—
|
|
Changes in Diastolic Blood Pressure
Month 6
|
76.0 mm of HG
Standard Deviation 7.5
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, month 6Population: No data was collected from the support group for this Outcome measure.
Participant's Hemoglobin A1c (HbA1c) will be measured with a point-of-care testing (POCT) well-validated clinical instrument. Normal values for HbA1c are below 5.7% while values of 6.5% and above indicate diabetes.
Outcome measures
| Measure |
Dyads
n=51 Participants
This is a pragmatic, pre-post, pilot study. Participants will meet in groups of 12 for the SMA intervention at the conference room at the Emory Family Medicine Center in Dunwoody, Georgia. The intervention will consist of bi-weekly sessions over a 16-week period, with phone check-ins for the remaining weeks. Each session will last 60-90 minutes, and participants will engage in a total of 6 televisit sessions. Sessions will consist of a group-based program for all participants, followed by a personalized care plan, led by a physician. In this dyad-based group, participant's social partner must commit to attend all in-person sessions.
Intensive lifestyle interventions (ILIs): Intensive lifestyle interventions (ILIs) is a group-based programs designed to promote weight loss through a combination of diet, activity, and behavior change, decrease Type 2 Diabetes (T2D) incidence in people with prediabetes and reduced complications among people with T2D.
|
Men Only
This is a pragmatic, pre-post, pilot study. Participants will meet in groups of 12 for the SMA intervention at the conference room at the Emory Family Medicine Center in Dunwoody, Georgia. the intervention will consist of bi-weekly sessions over a 16-week period, with phone check-ins for the remaining weeks. Each session will last 60-90 minutes, and participants will engage in a total of 6 televisit sessions. Sessions will consist of a group-based program for all participants, followed by a personalized care plan, led by a physician. In this group just the participant will receive the intervention.
Intensive lifestyle interventions (ILIs): Intensive lifestyle interventions (ILIs) is a group-based programs designed to promote weight loss through a combination of diet, activity, and behavior change, decrease Type 2 Diabetes (T2D) incidence in people with prediabetes and reduced complications among people with T2D.
|
|---|---|---|
|
Changes in Hemoglobin A1c
Baseline
|
7.57 percentage of HbA1C
Standard Deviation 1.49
|
—
|
|
Changes in Hemoglobin A1c
Month 6
|
6.72 percentage of HbA1C
Standard Deviation 0.81
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, month 6Population: No data was collected from the support group for this Outcome measure.
Participant's weight will be measured in kilograms using a calibrated, standardized scale.
Outcome measures
| Measure |
Dyads
n=54 Participants
This is a pragmatic, pre-post, pilot study. Participants will meet in groups of 12 for the SMA intervention at the conference room at the Emory Family Medicine Center in Dunwoody, Georgia. The intervention will consist of bi-weekly sessions over a 16-week period, with phone check-ins for the remaining weeks. Each session will last 60-90 minutes, and participants will engage in a total of 6 televisit sessions. Sessions will consist of a group-based program for all participants, followed by a personalized care plan, led by a physician. In this dyad-based group, participant's social partner must commit to attend all in-person sessions.
Intensive lifestyle interventions (ILIs): Intensive lifestyle interventions (ILIs) is a group-based programs designed to promote weight loss through a combination of diet, activity, and behavior change, decrease Type 2 Diabetes (T2D) incidence in people with prediabetes and reduced complications among people with T2D.
|
Men Only
This is a pragmatic, pre-post, pilot study. Participants will meet in groups of 12 for the SMA intervention at the conference room at the Emory Family Medicine Center in Dunwoody, Georgia. the intervention will consist of bi-weekly sessions over a 16-week period, with phone check-ins for the remaining weeks. Each session will last 60-90 minutes, and participants will engage in a total of 6 televisit sessions. Sessions will consist of a group-based program for all participants, followed by a personalized care plan, led by a physician. In this group just the participant will receive the intervention.
Intensive lifestyle interventions (ILIs): Intensive lifestyle interventions (ILIs) is a group-based programs designed to promote weight loss through a combination of diet, activity, and behavior change, decrease Type 2 Diabetes (T2D) incidence in people with prediabetes and reduced complications among people with T2D.
|
|---|---|---|
|
Changes in Body Weight
Baseline
|
155.4 pounds
Standard Deviation 25.96
|
—
|
|
Changes in Body Weight
Month 6
|
152.8 pounds
Standard Deviation 25.60
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, month 6Population: No data was collected from the support group for this Outcome measure.
Participant's systolic and diastolic blood pressure will be measured using standard procedures with a manual cuff. Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg.
Outcome measures
| Measure |
Dyads
n=52 Participants
This is a pragmatic, pre-post, pilot study. Participants will meet in groups of 12 for the SMA intervention at the conference room at the Emory Family Medicine Center in Dunwoody, Georgia. The intervention will consist of bi-weekly sessions over a 16-week period, with phone check-ins for the remaining weeks. Each session will last 60-90 minutes, and participants will engage in a total of 6 televisit sessions. Sessions will consist of a group-based program for all participants, followed by a personalized care plan, led by a physician. In this dyad-based group, participant's social partner must commit to attend all in-person sessions.
Intensive lifestyle interventions (ILIs): Intensive lifestyle interventions (ILIs) is a group-based programs designed to promote weight loss through a combination of diet, activity, and behavior change, decrease Type 2 Diabetes (T2D) incidence in people with prediabetes and reduced complications among people with T2D.
|
Men Only
This is a pragmatic, pre-post, pilot study. Participants will meet in groups of 12 for the SMA intervention at the conference room at the Emory Family Medicine Center in Dunwoody, Georgia. the intervention will consist of bi-weekly sessions over a 16-week period, with phone check-ins for the remaining weeks. Each session will last 60-90 minutes, and participants will engage in a total of 6 televisit sessions. Sessions will consist of a group-based program for all participants, followed by a personalized care plan, led by a physician. In this group just the participant will receive the intervention.
Intensive lifestyle interventions (ILIs): Intensive lifestyle interventions (ILIs) is a group-based programs designed to promote weight loss through a combination of diet, activity, and behavior change, decrease Type 2 Diabetes (T2D) incidence in people with prediabetes and reduced complications among people with T2D.
|
|---|---|---|
|
Changes in Systolic Blood Pressure
Baseline
|
129.7 mm of Hg
Standard Deviation 19.40
|
—
|
|
Changes in Systolic Blood Pressure
Month 6
|
123.9 mm of Hg
Standard Deviation 13.95
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, month 6Population: No data was collected from the support group for this Outcome measure.
Participants will be asked to keep a daily activity log (minutes of exercise performed daily will be logged). All logged exercises will be considered physical activity. The study coordinators will measure the amount in hours of exercise performed and compare each participant's log at the different time points to asses in that subject's physical activity
Outcome measures
| Measure |
Dyads
n=54 Participants
This is a pragmatic, pre-post, pilot study. Participants will meet in groups of 12 for the SMA intervention at the conference room at the Emory Family Medicine Center in Dunwoody, Georgia. The intervention will consist of bi-weekly sessions over a 16-week period, with phone check-ins for the remaining weeks. Each session will last 60-90 minutes, and participants will engage in a total of 6 televisit sessions. Sessions will consist of a group-based program for all participants, followed by a personalized care plan, led by a physician. In this dyad-based group, participant's social partner must commit to attend all in-person sessions.
Intensive lifestyle interventions (ILIs): Intensive lifestyle interventions (ILIs) is a group-based programs designed to promote weight loss through a combination of diet, activity, and behavior change, decrease Type 2 Diabetes (T2D) incidence in people with prediabetes and reduced complications among people with T2D.
|
Men Only
This is a pragmatic, pre-post, pilot study. Participants will meet in groups of 12 for the SMA intervention at the conference room at the Emory Family Medicine Center in Dunwoody, Georgia. the intervention will consist of bi-weekly sessions over a 16-week period, with phone check-ins for the remaining weeks. Each session will last 60-90 minutes, and participants will engage in a total of 6 televisit sessions. Sessions will consist of a group-based program for all participants, followed by a personalized care plan, led by a physician. In this group just the participant will receive the intervention.
Intensive lifestyle interventions (ILIs): Intensive lifestyle interventions (ILIs) is a group-based programs designed to promote weight loss through a combination of diet, activity, and behavior change, decrease Type 2 Diabetes (T2D) incidence in people with prediabetes and reduced complications among people with T2D.
|
|---|---|---|
|
Changes in Physical Activity
Baseline
|
130.7 minutes/ week
Standard Deviation 187.8
|
—
|
|
Changes in Physical Activity
Month 6
|
245.5 minutes/ week
Standard Deviation 154.9
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, month 6Population: The average was collected by analyzing the points scored on each item (points rated 1-3). No data was collected from the support group for this Outcome measure.
Changes in diet will be measured using the Rapid Eating and Activity Assessment for Participants short version (REAP-S). The REAP-S consists of 13 scored questions. Responses of 'usually/often' receive 1 point, 'sometimes' receives 2 points, and 'rarely/never or does not apply to me' receives 3 points. Possible scores ranged from 13 to 39 with a higher score indicating a higher diet quality.
Outcome measures
| Measure |
Dyads
n=54 Participants
This is a pragmatic, pre-post, pilot study. Participants will meet in groups of 12 for the SMA intervention at the conference room at the Emory Family Medicine Center in Dunwoody, Georgia. The intervention will consist of bi-weekly sessions over a 16-week period, with phone check-ins for the remaining weeks. Each session will last 60-90 minutes, and participants will engage in a total of 6 televisit sessions. Sessions will consist of a group-based program for all participants, followed by a personalized care plan, led by a physician. In this dyad-based group, participant's social partner must commit to attend all in-person sessions.
Intensive lifestyle interventions (ILIs): Intensive lifestyle interventions (ILIs) is a group-based programs designed to promote weight loss through a combination of diet, activity, and behavior change, decrease Type 2 Diabetes (T2D) incidence in people with prediabetes and reduced complications among people with T2D.
|
Men Only
This is a pragmatic, pre-post, pilot study. Participants will meet in groups of 12 for the SMA intervention at the conference room at the Emory Family Medicine Center in Dunwoody, Georgia. the intervention will consist of bi-weekly sessions over a 16-week period, with phone check-ins for the remaining weeks. Each session will last 60-90 minutes, and participants will engage in a total of 6 televisit sessions. Sessions will consist of a group-based program for all participants, followed by a personalized care plan, led by a physician. In this group just the participant will receive the intervention.
Intensive lifestyle interventions (ILIs): Intensive lifestyle interventions (ILIs) is a group-based programs designed to promote weight loss through a combination of diet, activity, and behavior change, decrease Type 2 Diabetes (T2D) incidence in people with prediabetes and reduced complications among people with T2D.
|
|---|---|---|
|
Changes in Diet
Baseline
|
2.140 score on a scale
Standard Deviation 1.3
|
—
|
|
Changes in Diet
Month 6
|
2.05 score on a scale
Standard Deviation 1.31
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and month 6Participants' social contacts will complete the WCSS. The WCSS is a 30-item questionnaire asking about weight control practices. Responses are given on a 5-point scale when 0 = never and 4 = always. A total score is calculated by taking the average of responses and ranges from 0 to 4 where higher scores indicate greater use of strategies to lose or maintain weight.
Outcome measures
Outcome data not reported
Adverse Events
Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place