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NCT04618458 · ClinicalTrials.gov registry record · NA
Telehealth Diabetes Prevention Intervention for African American Youth
A NA study, sponsored by University of Mississippi Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 38
- Enrollment target
NCT04618458 is a NA study that has completed, run by University of Mississippi Medical Center. The registered enrollment target is 38 participants.
The verdict
NCT04618458, a NA study, has completed, sponsored by University of Mississippi Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 38 participants
- Enrollment target
Study Summary
The Telehealth Diabetes Prevention Intervention for the Next Generation of African American Youth (TELE-GEN) pilot study will evaluate the implementation and early efficacy of a telehealth diabetes prevention intervention for African American (AA) children (8- to 11-years) and their parents. Power to Prevent is a lifestyle diabetes prevention intervention from the Centers for Disease Control and Prevention that is based on the Diabetes Prevention Program and tailored for AA families. To investigators knowledge, this intervention has not been evaluated in a clinical trial with AA families with children at risk for type 2 diabetes mellitus (T2DM), nor been delivered via telehealth. Employing an effectiveness-implementation hybrid study design, investigators aim to concurrently (1) conduct a single arm pilot trial to assess the early efficacy of Power to Prevent delivered via telehealth to treat overweight/obesity in AA children and their parent, while (2) evaluating an implementation strategy for the uptake of the intervention by the pediatric weight management clinic at the University of Mississippi Medical Center. The primary outcome will be stabilization or reduction in BMI z-score in children (index participant) and reduction in parent BMI (co-participant). Parents (n=20) will receive the same telehealth diabetes prevention intervention, which will be delivered by a racially concordant, trained Lifestyle Coach using small-group videoconferencing (5 parents per group). Sessions will consist of nutrition and physical activity behavior change strategies (20 min), problem solving and decision-making skills to circumvent barriers to behavioral change (20 min), and family goal setting and action planning (20 min). Child and parent measures will be assessed at baseline, 12-weeks (post-intervention), and 30-weeks (follow-up). The implementation strategy has two targets: (1) the pediatric weight management clinical and clinical care team; and (2) overweight/obese pediatric
Interventions
- BEHAVIORAL Power to Prevent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2020-12-01 |
| Est. Completion | 2021-12-18 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04618458
The ClinicalTrials.gov registry entry for NCT04618458 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Mississippi Medical Center, which has 96 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Power to Prevent is the first listed.
NCT04618458 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04618458 about?
NCT04618458 is a clinical study titled "Telehealth Diabetes Prevention Intervention for African American Youth". The Telehealth Diabetes Prevention Intervention for the Next Generation of African American Youth (TELE-GEN) pilot study will evaluate the implementation and early efficacy of a telehealth diabetes prevention intervention for African American (AA) children (8- to 11-years) and their parents. Power t...
What is the current status of trial NCT04618458?
This trial is currently completed. It is a NA study. The enrollment target is 38 participants. The study started on 2020-12-01. Estimated completion is 2021-12-18.
What interventions are being tested in trial NCT04618458?
The interventions under investigation include: Power to Prevent (BEHAVIORAL).
Who is sponsoring clinical trial NCT04618458?
This trial is sponsored by University of Mississippi Medical Center, which has 96 total clinical trials registered on ClinicalTrials.gov.
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