Puerto Rican Obesity Intervention for Men

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.

Conditions

• Obesity

Interventions

BEHAVIORAL

TeleSalud Healthy Eating- Physical Activity/Sedentary Behavior (HE-PA/SB)

Participants will meet via telehealth for 4 months (twice a week for 3 months and then once per week for 1 month) for a TeleSalud HE-PA/SB Class, after which they will attend one maintenance meeting per month for 4 months. Weekly, Day 1 (Healthy Eating \& PA-SB Class): Participants will receive a 50-min. healthy eating class. Physical Activity- Sedentary Behavior (PA-SB) Class: By discussing barriers and strategies to overcome barriers, this will help to increase self-efficacy. We will engage in Latino-centered moderate impact (increasing to vigorous) aerobics with Latino or salsa movements and music for 45-50 minutes. Aspects of kickboxing aerobics will be integrated. Goal: Exercise a minimum of 150-250 min./ week of moderate intensity. Weekly, Day 2: PA-SB identical PA-SB to Day 1. Maintenance (Months 5-8): Meetings once/ month for 70 min. for HE/PA-SB class, including 25 min. to discuss diet and PA-SB barriers. Goal: Exercise a minimum of 150-250 min./week.

BEHAVIORAL

TeleSalud General Health Intervention

Weekly: Participants will meet via telehealth for 4 months (twice a week for 3 months and then once per week for 1 month) for a TeleSalud General Heath Class, after which they will attend one maintenance meeting per month for 4 months. Participants will meet and discuss general health topics (not diet or PA). Examples of the general health topics are: Back Pain, Muscle Strains, Alcohol Use, Stress \& Coping, Oral and Dental Health, Safety Tips, Emergency Preparedness. The content is relevant to Latinos, and information is focused on Latino men. Maintenance (Months 5-8): Participants will meet via telehealth once/ month for 70 min. to discuss general health topics. To enhance motivation to complete the study and assessments, this group will receive a copy of the TeleSalud HE-PA/SB intervention manual and related materials after the maintenance period ends.

Sponsors & Collaborators

• Medical College of Wisconsin

  lead OTHER

Principal Investigators

• Lisa Sanchez-Johnsen, PhD · Medical College of Wisconsin

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

35 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2027-05-31

Completion

2027-08-31

Countries

• United States

Study Locations