Family Diabetes Prevention Program (Family DPP) for Type 2 Diabetes Mellitus

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Johns Hopkins University School of Medicine, Baltimore, MD
Type 2 Diabetes Mellitus+11 More
Family Diabetes Prevention Program (Family DPP) - Behavioral
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study 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 cluster-randomized trial consists of 2 arms: 1) the "control" arm, in which the adult participants will engage in the DPP (one group), 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 45 adult-child dyads, divided between one "control" group and 2 "intervention" groups. 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).

Eligible Conditions

  • Type 2 Diabetes Mellitus
  • Healthy Lifestyle Behaviors
  • PreDiabetes
  • Obesity
  • Overweight, Childhood

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

11 Primary · 16 Secondary · Reporting Duration: Baseline, 6 and 12 months

12 months
Adult participant attendance in program as assessed by percentage of program sessions attended, full program
Adult participant attendance in program as assessed by total number of program sessions attended, full program
Adult participant physical activity achievement
Adult participant physical activity as assessed by average duration of activity per week
Child participant attendance in Family Diabetes Prevention Program
Feasibility of measurement of child-related outcomes as assessed by the percentage of total child participants for whom data are collected
Survey Administration Feasibility as assessed by mean time for administration of surveys to participants
Month 12
Cost of program delivery
Satisfaction with Family Diabetes Prevention Program as assessed by study team designed questionnaire
6 months
Adult participant attendance in program as assessed by percentage of program sessions attended, core
Adult participant attendance in program as assessed by total number of program sessions attended, core
Month 12
Change in adult participant weight
Change in child Body Mass Index (BMI) z-score
Month 12
Change in child participant sugary beverage intake
Month 12
Change in Family Home Health Environment
Change in adult caregiver perceived self-efficacy for behavioral change
Change in adult participant dietary pattern related to fruit and vegetable intake
Change in adult participant dietary pattern related to sugary beverage intake
Change in caregiver attitudes regarding child health behaviors
Change in caregiver knowledge regarding child health behaviors
Change in child participant fruit and vegetable intake
Change in child participant physical activity levels
Change in child participant screen time
Change in child participant sleep patterns
Change in parenting self-efficacy for child health behavior change
Week 12
Recruitment rate
Up to 12 months
Intervention Fidelity as assessed by a fidelity checklist

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Diabetes Prevention Program (DPP)
1 of 2
Family Diabetes Prevention Program (Family DPP)
1 of 2
Active Control
Experimental Treatment

90 Total Participants · 2 Treatment Groups

Primary Treatment: Family Diabetes Prevention Program (Family DPP) · No Placebo Group · N/A

Family Diabetes Prevention Program (Family DPP)
Behavioral
Experimental Group · 1 Intervention: Family Diabetes Prevention Program (Family DPP) · Intervention Types: Behavioral
Diabetes Prevention Program (DPP)
Behavioral
ActiveComparator Group · 1 Intervention: National Diabetes Prevention Program Lifestyle Intervention (DPP) · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 6 and 12 months
Closest Location: Johns Hopkins University School of Medicine · Baltimore, MD
Photo of Baltimore 1Photo of Baltimore 2Photo of Baltimore 3
2001First Recorded Clinical Trial
1 TrialsResearching Type 2 Diabetes Mellitus
154 CompletedClinical Trials

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,094 Previous Clinical Trials
5,051,403 Total Patients Enrolled
117 Trials studying Type 2 Diabetes Mellitus
77,814 Patients Enrolled for Type 2 Diabetes Mellitus
Johns Hopkins UniversityLead Sponsor
2,033 Previous Clinical Trials
30,782,309 Total Patients Enrolled
11 Trials studying Type 2 Diabetes Mellitus
1,482 Patients Enrolled for Type 2 Diabetes Mellitus
Maya S Venkataramani, MD, MPHPrincipal InvestigatorJohns Hopkins University

Eligibility Criteria

Age Any Age · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a minimum age of 18 years.
You have a body mass index (BMI) of 25 or more.
You are a primary caregiver of at least one eligible child aged 5 through 12 years at time of recruitment.
You are 5 to 12 years old.
You are not having a medical condition which leads to inability to comply with general pediatric dietary or physical activity goals.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.