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NCT05358444 · ClinicalTrials.gov registry record · NA
Family Diabetes Prevention Program Pilot Study
A NA study of Type 2 Diabetes and PreDiabetes, sponsored by Johns Hopkins University.
- Completed
- Registry status
- NA
- Development phase
- 34
- Enrollment target
- 1
- Study location
NCT05358444: Completed NA study of Type 2 Diabetes and PreDiabetes, sponsored by Johns Hopkins University.
NCT05358444 is a NA study of Type 2 Diabetes and PreDiabetes that has completed, run by Johns Hopkins University. The registered enrollment target is 34 participants, below the 3,924-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05358444, a NA study of Type 2 Diabetes and PreDiabetes, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- NA
- Development phase
- 34 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
The average total number of required core period program sessions attended by the adult participant (inclusive of make-up sessions) including all DPP (and, if in Family DPP, additional Family DPP sessions); for Family DPP adult participants this will also be examined for the subset of DPP sessions and additional Family DPP sessions.
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 |
What the finished NCT05358444 record still lists
NCT05358444 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 3,924-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (99% lower).
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.
NCT05358444 reports a single indexed study location in Maryland.
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, PreDiabetes, Overweight and Obesity, Obesity, Childhood, Lifestyle, Healthy.
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).
Who is sponsoring clinical trial NCT05358444?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT05358444's enrollment target sits among peer trials
34 250th of 327 higher than 76 of 327 other Type 2 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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