Puerto Rican Obesity Intervention for Men

Medical College of Wisconsin

Status: Not yet enrolling

Conditions: Obesity

Treatments: Behavioral: TeleSalud Healthy Eating- Physical Activity/Sedentary Behavior (HE-PA/SB); Behavioral: TeleSalud General Health Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06440551

0048231

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: Male

Ages: 35+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

1. Male of Puerto Rican descent over 35 years.
2. BMI ≥25 by anthropometrically measured weight and height.
3. 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.
4. Has access to secure computer or tablet in a private location with reliable internet connection to support video streaming
5. 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:

1. Does not understand/speak English.
2. Plans to move from the Illinois area during the study.
3. Currently in a formal weight management program.
4. Current or planned use of weight control or loss medication prescribed by a doctor.
5. Currently exercising >1 time/week.
6. Unable to attend study times.
7. 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.
8. In the EASY interview, if participant answers yes to the question that indicates they fall or always use an assisted device while walking.
9. Current alcohol abuse (>35 alcoholic drinks/week); score of yes to > 2 questions on the CAGE alcohol scale (Appendix 1) [108].

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 2 patient groups

Healthy Eating and Physical Activity - Intervention

Experimental group

Description:

Participants will attend virtual classes on increasing healthy eating, increasing physical activity, and decreasing sedentary behaviors.

Treatment:

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

General Health Topics - Control

Active Comparator group

Description:

Participants will attend virtual classes on general health topics.

Treatment:

Behavioral: TeleSalud General Health Intervention