Puerto Rican Obesity Intervention for Men

Overview

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)
  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
• 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

Primary outcome measures

• Acceptability- Fidelity: Delivery [Time frame: 4 months, 8 months]
• Acceptability- Fidelity: Receipt [Time frame: 4 months, 8 months]
• Acceptability- Fidelity: Enactment [Time frame: 4 months, 8 months]
• Acceptability- Helpfulness of Treatment Components [Time frame: 4 months, 8 months]
• Acceptability- Helpfulness/ Effectiveness of the Intervention Leaders [Time frame: 4 months, 8 months]
• Acceptability- Intervention Satisfaction [Time frame: 4 months, 8 months]
• Acceptability- Perceived Helpfulness/ Effectiveness of the Telehealth Modality, Technology, and Equipment [Time frame: Baseline, 4 months, 8 months]
• Acceptability- Satisfaction with Random Assignment to Groups [Time frame: Baseline, 4 months, 8 months]
• Dietary Intake: Number of Servings of Fruits [Time frame: Baseline, 4 months, 8 months]
• Dietary Intake: Number of Servings of Vegetables [Time frame: Baseline, 4 months, 8 months]

Secondary outcome measures (7)

• Body Mass Index [Time frame: Baseline, 4 months, 8 months]
• Outcome Expectations for Diet Questionnaire [Time frame: Baseline, 4 months, 8 months]
• Exercise Outcomes on the Outcomes Expectations Questionnaire [Time frame: Baseline, 4 months, 8 months]
• Self-Efficacy for Dietary Behaviors [Time frame: Baseline, 4 months, 8 months]
• Exercise Confidence Survey [Time frame: Baseline, 4 months, 8 months]
• Social Support and Eating Habits Survey [Time frame: Baseline, 4 months, 8 months]
• Social Support and Exercise Survey [Time frame: Baseline, 4 months, 8 months]

Eligibility criteria

Inclusion criteria

• 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) \[108\].

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Medical College of Wisconsin — Milwaukee

Identifiers

NCT: NCT06440551 · 0048231

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗