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Family Diabetes Prevention Program Pilot Study
NCT05358444 · View on ClinicalTrials.gov ↗
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 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.
Conditions Studied
Interventions
- BEHAVIORAL National Diabetes Prevention Program Lifestyle Intervention (DPP)
- BEHAVIORAL Family Diabetes Prevention Program (Family DPP)
Study Locations (1)
Maryland
- Johns Hopkins University School of Medicine — Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2022-07-08 |
| Est. Completion | 2024-02-19 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05358444
The ClinicalTrials.gov registry entry for NCT05358444 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,517 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 6 conditions, with Type 2 Diabetes appearing as the primary indexed condition, and to 2 interventions — of which National Diabetes Prevention Program Lifestyle Intervention (DPP) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05358444 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05358444 about?
NCT05358444 is a clinical study titled "Family Diabetes Prevention Program Pilot Study". 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-bas...
What is the current status of trial NCT05358444?
This trial is currently completed. It is a NA study. The enrollment target is 34 participants. The study started on 2022-07-08. Estimated completion is 2024-02-19.
What conditions does trial NCT05358444 study?
This clinical trial studies the following conditions: Type 2 Diabetes, Overweight and Obesity, PreDiabetes, Obesity, Childhood, Lifestyle, Healthy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05358444?
The interventions under investigation include: National Diabetes Prevention Program Lifestyle Intervention (DPP) (BEHAVIORAL), Family Diabetes Prevention Program (Family DPP) (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05358444?
This trial is sponsored by Johns Hopkins University, which has 1,517 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05358444 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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