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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 is a NA study that has not yet begun recruiting, run by Medical College of Wisconsin. The registered enrollment target is 48 participants.

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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.

Interventions

  • BEHAVIORAL TeleSalud Healthy Eating- Physical Activity/Sedentary Behavior (HE-PA/SB)
  • BEHAVIORAL TeleSalud General Health Intervention

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2026-09-01
Est. Completion 2027-08-31
Phase NA

Sponsor

Medical College of Wisconsin

447 total trials

What the Registry Record Tells You About NCT06440551

The ClinicalTrials.gov registry entry for NCT06440551 describes a study currently listed as not yet recruiting, categorized as NA. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical College of Wisconsin, which has 447 total studies on file at ClinicalTrials.gov.

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 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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