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NCT04621045 · ClinicalTrials.gov registry record · NA
Active You: Feasibility of a Unique Physical Activity Program to Prevent Diabetes and Heart Disease
A NA study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- NA
- Development phase
- 52
- Enrollment target
NCT04621045: Completed NA study, sponsored by University of Pittsburgh.
NCT04621045 is a NA study that has completed, run by University of Pittsburgh. The registered enrollment target is 52 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04621045, a NA study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- NA
- Development phase
- 52 participants
- Enrollment target
Study Summary
Individuals who are overweight/obese are more vulnerable to type 2 diabetes (T2D). Current evidence suggests that PA, even without dietary prescription, can be efficacious in preventing T2D. Yet most Americans, especially those who are overweight/obese, are not physically active. Socioenvironmental barriers to physical activity (PA) such as body image concerns and limited access to fitness facilities contribute to the low levels of PA observed in overweight/obese adults. Web-based PA programs have been developed to address these barriers, but the outcomes have been marginal. Qualitative studies suggest that individuals who are overweight/obese prefer PA programs that feature people they can relate to especially in body size, fitness status and age. Previously, the investigators have included these preferences in a technology-based Physical Activity for The Heart (PATH) intervention that leverages open source platforms, such as YouTube, to promote PA in any setting. In this application, the investigators propose to test the feasibility and preliminary efficacy of PATH in promoting PA and reducing cardiometabolic risk in adults who are overweight/obese and at high risk of diabetes. In Aim 1 the investigators will conduct a 12-week randomized clinical trial including 52 adults who are overweight/obese and at high risk of diabetes to assess the feasibility and acceptability of PATH. In Aim 2 investigators will examine the trend in PA and cardiometabolic risk change from baseline to post-intervention. This approach is innovative because it leverages open source technologies to provide low-cost, action-oriented PA resources that match the preferences of adults who are overweight/obese. This contribution will be significant because PATH could offer a convenient, enjoyable and scalable program that features "similar others" to promote PA in overweight/obese adults at high risk of diabetes.
Primary Outcome
Will be indicated by ability to recruit, screen, and enroll the target sample within 6 months of commencing recruitment, and retention of ≥80% of the sample.
Interventions
- BEHAVIORAL The Physical Activity for The Heart (PATH) intervention
- BEHAVIORAL Be Active Your Way Booklet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2020-10-27 |
| Est. Completion | 2022-03-12 |
| Phase | NA |
What the finished NCT04621045 record still lists
NCT04621045 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which The Physical Activity for The Heart (PATH) intervention is the first listed.
NCT04621045 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04621045 about?
NCT04621045 is a clinical study titled "Active You: Feasibility of a Unique Physical Activity Program to Prevent Diabetes and Heart Disease". Individuals who are overweight/obese are more vulnerable to type 2 diabetes (T2D). Current evidence suggests that PA, even without dietary prescription, can be efficacious in preventing T2D. Yet most Americans, especially those who are overweight/obese, are not physically active. Socioenvironmental ...
What is the current status of trial NCT04621045?
This trial is currently completed. It is a NA study. The enrollment target is 52 participants. The study started on 2020-10-27. Estimated completion is 2022-03-12.
What interventions are being tested in trial NCT04621045?
The interventions under investigation include: The Physical Activity for The Heart (PATH) intervention (BEHAVIORAL), Be Active Your Way Booklet (BEHAVIORAL).
Who is sponsoring clinical trial NCT04621045?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04621045's enrollment target sits among peer trials
52 1272nd of 2000 higher than 722 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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