Family Diabetes Prevention Program Pilot Study

Type 2 Diabetes Clinical Trial

Official title:

Family Diabetes Prevention Program Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05358444
• Other study ID #: IRB00310219
• Secondary ID: 1K23DK119581-01A
• Status: Completed
• Phase: N/A
• Start date: July 8, 2022
• Est. completion date: February 19, 2024

Study information

• Verified date: March 2024
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 19, 2024
• Est. primary completion date: February 19, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years and older

Eligibility

Inclusion Criteria for the Intervention Arm:

• For ADULT participants, inclusion criteria are:

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)

• For CHILD participants, inclusion criteria are:

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.

Exclusion Criteria for Intervention Arm:

• For ADULT participants, exclusion criteria include

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.

• For CHILD participants: exclusion criteria include:

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.

• The inclusion criteria are:

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Glucose Intolerance
• Lifestyle, Healthy
• Obesity
• Obesity, Childhood
• Overweight
• Overweight and Obesity
• Overweight, Childhood
• Pediatric Obesity
• PreDiabetes
• Prediabetic State
• Type 2 Diabetes

Intervention

Behavioral:
• 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)
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.

Locations

Country	Name	City	State
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adult participant attendance in program as assessed by total number of program sessions attended, core	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).	6 months
Primary	Adult participant attendance in program as assessed by total number of program sessions attended, full program	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).	12 months
Primary	Adult participant attendance in program as assessed by percentage of program sessions attended, core	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).	6 months
Primary	Adult participant attendance in program as assessed by percentage of program sessions attended, full program	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).	12 months
Primary	Child participant attendance in Family Diabetes Prevention Program	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.	12 months
Primary	Feasibility of measurement of child-related outcomes as assessed by the percentage of total child participants for whom data are collected	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 at baseline data collection point.	Baseline
Primary	Feasibility of measurement of child-related outcomes as assessed by the percentage of total child participants for whom data are collected	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 6 month data collection time point.	6 months
Primary	Feasibility of measurement of child-related outcomes as assessed by the percentage of total child participants for whom data are collected	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).	12 months
Primary	Satisfaction with Family Diabetes Prevention Program as assessed by study team designed questionnaire	Survey questions, using a Likert-scale (score 1-5; a higher score indicating greater satisfaction), exploring satisfaction with Family DPP content and structure.	12 months (end of intervention)
Primary	Intervention Fidelity as assessed by a fidelity checklist	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.	Up to 12 months
Primary	Cost of program delivery	Total cost (in dollars) of program delivery (including staffing, materials, wrap-around support) per participant. Calculated separately for DPP and Family DPP (intervention) arm.	12 months (end of intervention)
Primary	Recruitment rate	Calculated as the percentage of eligible adult participants consenting to participation in trial over time. Calculated separately for intervention arm and concurrent control group.	During recruitment period, up to 12 weeks
Primary	Survey Administration Feasibility as assessed by mean time for administration of surveys to participants	Mean time (minutes) for administration of baseline surveys to adult participant and child participant in the Family DPP (intervention) arm.	Baseline
Primary	Survey Administration Feasibility as assessed by mean time for administration of surveys to participants	Mean time (minutes) for administration of surveys to adult participant and child participant at 6 month time point in the Family DPP (intervention) arm.	6 months
Primary	Survey Administration Feasibility as assessed by mean time for administration of surveys to participants	Mean time (minutes) for administration of surveys to adult participant and child participant in the Family DPP (intervention) arm.	12 months
Secondary	Change in adult participant weight	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).	Baseline and 12 months (end of intervention)
Secondary	Change in child Body Mass Index (BMI) z-score	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.	Baseline and 12 months (end of intervention)
Secondary	Adult participant physical activity as assessed by average duration of activity per week	Average number of minutes/week of moderate-vigorous physical activity by self report, at baseline.	Baseline
Secondary	Adult participant physical activity as assessed by average duration of activity per week	Average number of minutes/week of moderate-vigorous physical activity by self report, at 6 months into program.	6 months
Secondary	Adult participant physical activity as assessed by average duration of activity per week	Average number of minutes/week of moderate-vigorous physical activity by self report, at 12 months (end of program).	12 months
Secondary	Adult participant physical activity achievement	Whether or not participant met the program goal of an average150 minutes/week of moderate-vigorous physical activity.	12 months
Secondary	Change in adult participant dietary pattern related to fruit and vegetable intake	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.	Baseline, 6 months and 12 months (end of intervention)
Secondary	Change in adult participant dietary pattern related to sugary beverage intake	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.	Baseline, 6 months and 12 months (end of intervention)
Secondary	Change in child participant fruit and vegetable intake	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.	Baseline, 6 months and 12 months (end of intervention)
Secondary	Change in child participant sugary beverage intake	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.	Baseline, 6 and 12 months
Secondary	Change in child participant screen time	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.	Baseline, 6 months and 12 months (end of intervention)
Secondary	Change in child participant sleep patterns	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.	Baseline, 6 months and 12 months (end of intervention)
Secondary	Change in adult caregiver perceived self-efficacy for behavioral change	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.	Baseline, 6 months and 12 months (end of intervention)
Secondary	Change in child participant physical activity levels	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.	Baseline, 6 months and 12 months (end of intervention)
Secondary	Change in parenting self-efficacy for child health behavior change	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.	Baseline, 6 months and 12 months (end of intervention)
Secondary	Change in Family Home Health Environment	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.	Baseline, 6 months and 12 months (end of intervention)
Secondary	Change in caregiver knowledge regarding child health behaviors	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.	Baseline, 6 months and 12 months (end of intervention)
Secondary	Change in caregiver attitudes regarding child health behaviors	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.	Baseline, 6 months and 12 months (end of intervention)