Puerto Rican Obesity Intervention for Men

Starting soon · Not applicable

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT06440551

Run by

Medical College of Wisconsin

People needed

48

Starts

2026-09-01

Expected to finish

2027-08-31

Last updated by the study team

2026-05-01

Who can join

Age: 35 and older. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Male of Puerto Rican descent over 35 years.
• BMI ≥25 by anthropometrically measured weight and height.
• Physically able to exercise (via the EASY tool [106, 107]; Appendix 2). If responses to the EASY indicate that medical clearance is needed, then able to receive medical clearance to participate in the study.
• Has access to secure computer or tablet in a private location with reliable internet connection to support video streaming
• Ability to understand and speak English. For those without a high-speed internet and private space to exercise, we will work with our community partners to identify a space with access to videoconferencing so they can attend the telehealth class.
• Exclusion:
• Does not understand/speak English.
• Plans to move from the Illinois or Wisconsin area during the study.
• Currently in a formal weight management program.
• Current or planned use of weight control or loss medication prescribed by a doctor.
• Currently exercising >1 time/week.
• Unable to attend study times.
• Serious medical problems or medications that would make protocol compliance difficult or dangerous, e.g., unable to engage in moderate \& eventually vigorous exercise, uncontrolled diabetes (A1C > 9) or hypertension (systolic >160 or diastolic >100), hypoglycemia, heart attack in the past six months, unstable angina, life-threatening arrhythmias, cancer that required treatment in the last 5 years (except non-melanoma skin cancers that have been cured). Patients who have been treated for cancer in the past 5 years may require different diet and PA recommendations than individuals without treatment for cancer in the past 5 years.
• In the EASY interview, if participant answers yes to the question that indicates they fall or always use an assisted device while walking.
• Current alcohol abuse (>35 alcoholic drinks/week); score of yes to > 2 questions on the CAGE alcohol scale (Appendix 1) [108].

Where it is running

• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.