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NCT06440551 · ClinicalTrials.gov registry record · NA
Puerto Rican Obesity Intervention for Men
A NA study, sponsored by Medical College of Wisconsin.
- Not yet
- Registry status
- NA
- Development phase
- 48
- Enrollment target
NCT06440551: Clinical Trial NA study, sponsored by Medical College of Wisconsin.
NCT06440551 is a NA study that has not yet begun recruiting, run by Medical College of Wisconsin. The registered enrollment target is 48 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06440551, a NA study, has not yet begun recruiting, sponsored by Medical College of Wisconsin.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 48 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to address the high rates of overweight/obesity in Puerto Rican (PR) men. The main question it aims to answer is whether virtual culturally relevant classes supporting physical activity and healthy eating for Puerto Rican men at different levels of acculturation to the US culture, will help these men achieve clinically meaningful weight loss. The purpose of this project is to assess whether a virtual intervention tailored for Puerto Rican men that includes information about healthy eating, physical activity, sedentary behavior is feasible and acceptable compared to a general health (GH) intervention. It is also to determine whether this intervention leads to healthier eating, increased physical activity, less sedentary behavior (low activity), and clinically meaningful weight loss. Hypothesis 1: Test the feasibility (recruitment, retention, adherence, fidelity) and acceptability (treatment components, intervention leaders, telehealth modality, technology and equipment, intervention satisfaction, satisfaction with randomized study, and measures) of a randomized 4-month synchronous telehealth lifestyle intervention led by a community health promoter and behavioral health specialist, who will receive either: TeleSalud HE-PA/SB" or TeleSalud GH in 48 PR men. Hypothesis 2: Demonstrate proof -of-concept by achieving a clinically significant weight reduction of ≥ 5% of baseline weight in the TeleSalud HE-PA/SB intervention after 4 months and at the end of the 4-month maintenance compared to the TeleSalud General Health intervention. Researchers will compare this to a group that will receive information about general health topics - not healthy eating or physical activity. * Participants in both groups will meet via virtually for 4 months (twice per week for 3 months and once per week for 1 month). * Participants will then meet one per month for a maintenance session for the next 4 months.
Primary Outcome
Delivery will be measured by an adherence checklist. It will monitor consistency and accuracy in the delivery of the intervention.
Interventions
- BEHAVIORAL TeleSalud Healthy Eating- Physical Activity/Sedentary Behavior (HE-PA/SB)
- BEHAVIORAL TeleSalud General Health Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2026-09-01 |
| Est. Completion | 2027-08-31 |
| Phase | NA |
What is known before NCT06440551 opens enrollment
NCT06440551 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which TeleSalud Healthy Eating- Physical Activity/Sedentary Behavior (HE-PA/SB) is the first listed.
NCT06440551 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06440551 about?
NCT06440551 is a clinical study titled "Puerto Rican Obesity Intervention for Men". The goal of this clinical trial is to address the high rates of overweight/obesity in Puerto Rican (PR) men. The main question it aims to answer is whether virtual culturally relevant classes supporting physical activity and healthy eating for Puerto Rican men at different levels of acculturation to...
What is the current status of trial NCT06440551?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 48 participants. The study started on 2026-09-01. Estimated completion is 2027-08-31.
What interventions are being tested in trial NCT06440551?
The interventions under investigation include: TeleSalud Healthy Eating- Physical Activity/Sedentary Behavior (HE-PA/SB) (BEHAVIORAL), TeleSalud General Health Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT06440551?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06440551's enrollment target sits among peer trials
48 1381st of 2000 higher than 601 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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