Family Diabetes Prevention Program Pilot Study

Not Applicable

Completed

• Conditions: Overweight, Childhood; Overweight and Obesity; Lifestyle, Healthy; Type 2 Diabetes; PreDiabetes; Obesity, Childhood
• Interventions: Behavioral: National Diabetes Prevention Program Lifestyle Intervention (DPP); Behavioral: Family Diabetes Prevention Program (Family DPP)

• Registration Number: NCT05358444
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-27
• Study First Submitted QC: 2022-05-02
• Study First Posted: 2022-05-03
• Study Start: 2022-07-08
• Primary Completion: 2024-02-19
• Study Completion: 2024-02-19
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diabetes Prevention Program (DPP)	National Diabetes Prevention Program Lifestyle Intervention (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.
Family Diabetes Prevention Program (Family DPP)	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.

Primary Outcome Measures

Name	Time	Method
Adult participant attendance in program as assessed by total number of program sessions attended, full program	12 months	The total number of all program sessions attended by the adult participant will be measured (inclusive of make-up sessions); this will also be examined for the subset of DPP sessions and child-focused sessions (if in Family DPP).
Adult participant attendance in program as assessed by percentage of program sessions attended, core	6 months	The percentage of all core program sessions attended by the adult participant will be measured (inclusive of make-up sessions); this will also be examined for the subset of DPP sessions and child-focused sessions (if in Family DPP).
Child participant attendance in Family Diabetes Prevention Program	12 months	The total number and percentage of child-focused sessions attended by the child participant will be examined for child participants in the Family DPP arm only.
Intervention Fidelity as assessed by a fidelity checklist	Up to 12 months	Using an adapted DPP fidelity checklist this will examine fidelity of delivery of select Family DPP sessions; including assessing percentage/amount of specific coaching tasks and content completed/delivered.
Adult participant attendance in program as assessed by percentage of program sessions attended, full program	12 months	The percentage of all program sessions attended by the adult participant will be measured (inclusive of make-up sessions); this will also be examined for the subset of DPP sessions and child-focused sessions (if in Family DPP).
Satisfaction with Family Diabetes Prevention Program as assessed by study team designed questionnaire	12 months (end of intervention)	Survey questions, using a Likert-scale (score 1-5; a higher score indicating greater satisfaction), exploring satisfaction with Family DPP content and structure.
Recruitment rate	During recruitment period, up to 12 weeks	Calculated as the percentage of eligible adult participants consenting to participation in trial over time. Calculated separately for intervention arm and concurrent control group.
Feasibility of measurement of child-related outcomes as assessed by the percentage of total child participants for whom data are collected	12 months	The percent of total child participants (in the intervention arm) for whom BMI data and also child-health behavior data are collected will be examined for the 12 month (end of program).
Survey Administration Feasibility as assessed by mean time for administration of surveys to participants	12 months	Mean time (minutes) for administration of surveys to adult participant and child participant in the Family DPP (intervention) arm.
Adult participant attendance in program as assessed by total number of program sessions attended, core	6 months	The total number of core period program sessions attended by the adult participant will be measured (inclusive of make-up sessions); this will also be examined for the subset of DPP sessions and child-focused sessions (if in Family DPP).
Cost of program delivery	12 months (end of intervention)	Total cost (in dollars) of program delivery (including staffing, materials, wrap-around support) per participant. Calculated separately for DPP and Family DPP (intervention) arm.

Secondary Outcome Measures

Name	Time	Method
Change in adult participant dietary pattern related to fruit and vegetable intake	Baseline, 6 months and 12 months (end of intervention)	Questions from the Behavioral Risk Factor Surveillance System (BRFSS) 2017 modules on fruit, vegetable and fruit juice intake as assessed by participant recall (for a 30 day period), which quantify frequency of intake of these food items over 30-day recall period; changes in intake patterns from baseline, at 6 and 12 months, will be assessed for adults in the Family DPP (intervention) arm.
Change in child participant sleep patterns	Baseline, 6 months and 12 months (end of intervention)	Adaptation of questions from YRBSS regarding average number of sleep on weekdays and weekends. Questions will be asked of caregivers of all child participants and directly of children ages 9 through 12 years. Changes in number of hours of sleep from baseline will be assessed, at 6 and 12 months, as well as whether child meeting sleep duration goals for children in the Family DPP (intervention) arm.
Adult participant physical activity achievement	12 months	Whether or not participant met the program goal of an average150 minutes/week of moderate-vigorous physical activity.
Change in child participant sugary beverage intake	Baseline, 6 and 12 months	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.
Change in adult participant dietary pattern related to sugary beverage intake	Baseline, 6 months and 12 months (end of intervention)	Questions from the BRFSS on sugary beverage intake, as assessed by participant recall (for a 30 day period), which quantify frequency of intake of sugary beverages; changes in intake patterns from baseline, at 6 and 12 months, will be assessed for adults in the Family DPP (intervention) arm.
Change in child participant fruit and vegetable intake	Baseline, 6 months and 12 months (end of intervention)	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.
Change in child Body Mass Index (BMI) z-score	Baseline and 12 months (end of intervention)	Percentage change in BMI z-score at end of program (12 months) compared to baseline, from BMI calculated from weight and height measurements during program ( in the Family DPP (intervention) arm.
Change in child participant physical activity levels	Baseline, 6 months and 12 months (end of intervention)	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.
Change in adult participant weight	Baseline and 12 months (end of intervention)	Percentage change in weight (kilograms) from baseline at end of program (12 months), from measured weight (self-report from home weight may be used depending on program delivery modality).
Adult participant physical activity as assessed by average duration of activity per week	12 months	Average number of minutes/week of moderate-vigorous physical activity by self report, at 12 months (end of program).
Change in child participant screen time	Baseline, 6 months and 12 months (end of intervention)	Adaptation of questions from YRBSS regarding average number of hours of screen time/day, asked for each day of week over past 7 days. Questions will be asked of caregivers of all child participants and directly of children ages 9 through 12 years. 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.
Change in caregiver knowledge regarding child health behaviors	Baseline, 6 months and 12 months (end of intervention)	Questionnaire examining knowledge or awareness of age-specific pediatric guidelines for sleep, dietary intake, screen time and physical activity. Percentage answered correctly overall and whether correct answer given for each item will be assessed, with changes in scores from baseline, will be examined for adults in the Family DPP (intervention) arm.
Change in caregiver attitudes regarding child health behaviors	Baseline, 6 months and 12 months (end of intervention)	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. Percentage answered correctly overall and whether correct answer given for each item will be assessed, with changes in scores from baseline examined for adults in the Family DPP (intervention) arm.
Change in adult caregiver perceived self-efficacy for behavioral change	Baseline, 6 months and 12 months (end of intervention)	Questionnaire exploring confidence in achieving behavioral goals related to physical activity, sleep and dietary modifications, using a Likert scale (scale ranging from 1-5, higher scores indicating higher perceived self-efficacy). Change in self-efficacy overall and for each item from baseline will be assessed for adults in the Family DPP (intervention) arm.
Change in Family Home Health Environment	Baseline, 6 months and 12 months (end of intervention)	The Family Eating and Activity Habits Questionnaire-Revised (FEAHQ-R) is a 32-item, self-report instrument; it is a clinical tool that captures family eating habits and also factors related with obesity in the overall home environment. Changes in scores from baseline, at 6 and 12 months, will be assessed in the Family DPP (intervention) arm.
Change in parenting self-efficacy for child health behavior change	Baseline, 6 months and 12 months (end of intervention)	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 (scale ranging from 1-5, higher scores indicating higher perceived self-efficacy). 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.

Trial Locations

Locations (1)

Johns Hopkins University School of Medicine; 🇺🇸 Baltimore, Maryland, United States