NCT05358444Completed
Family Diabetes Prevention Program Pilot Study
Source: ClinicalTrials.gov · Last updated 8 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 34 (actual)
- First submitted
- 27 Apr 2022
- Start date
- 8 Jul 2022
- Primary completion date
- 19 Feb 2024
- Lead sponsor
- Johns Hopkins University
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT05358444
What you commit to
- Study type: Interventional
- Participants enrolled: 34
- From 8 Jul 2022 to the primary completion date, 19 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- For CHILD participants: exclusion criteria include:
- having a medical condition which leads to inability to comply with general pediatric dietary or physical activity goals;
- being enrolled in a structured weight management program.
- For the Control Arm/Concurrent Control Group, this will only enroll ADULT participants.
Other illness
- For ADULT participants, exclusion criteria include
- Conditions that would exclude their participation in the DPP lifestyle intervention which include:
- pregnancy;
- having end-stage renal disease;
- having type 1 or type 2 diabetes.
- They will also be excluded if they are concurrently enrolled in a structured weight management program.
Age
- The inclusion criteria are:
- 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
- Lives with a child less than 18 years of age in their household
Who the study is looking for
- For ADULT participants, inclusion criteria are:
- Meeting eligibility criteria for the CDC's National Diabetes Prevention Program lifestyle intervention, which are:
- 18 years of age and older;
- not pregnant at time of enrollment;
- body mass index (BMI) of ≥25 kg/m2 (≥23 kg/m2 , if of Asian race);
- 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
- 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:
- being aged 5 through 12 years at time of recruitment;
- not having a medical condition which leads to inability to comply with general pediatric dietary or physical activity goals; AND
- not concurrently enrolled in a structured weight management program.
Age in the registry: 5 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins University School Of Medicine Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.