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Puerto Rican Obesity Intervention for Men

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
35 Years and older
Sex
Male only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether online classes designed for Puerto Rican men help them eat healthier, move more, sit less, and lose weight. It is for Puerto Rican men over age 35 who are overweight or have obesity. Researchers will compare these classes with general health classes over 8 months.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are a man of Puerto Rican descent and are older than 35.
  • Your BMI is 25 or higher. BMI is a measure based on your height and weight.
  • You can exercise safely and can get a doctor's approval if the study's exercise safety check says you need it.
  • You have access to a secure computer or tablet, a private space, and reliable internet for video classes. The study team can help find a space with video access if needed.
  • You can understand and speak English.

Who can't join

  • You cannot understand or speak English.
  • You plan to move away from the Illinois or Wisconsin area during the study, or you cannot attend at the study times.
  • You are in a formal weight management program, or you use or plan to use doctor-prescribed medicine for weight control or weight loss.
  • You currently exercise more than once a week.
  • You have a serious health problem or take medicine that makes the study hard or unsafe. Examples include being unable to do moderate and later harder exercise, poorly controlled diabetes (A1C above 9), blood pressure above 160 for the top number or 100 for the bottom number, or low blood sugar.
  • You had a heart attack in the past 6 months, have unstable chest pain or life-threatening heart rhythms, or needed cancer treatment in the past 5 years. Cured non-melanoma skin cancers do not count.
  • On the exercise safety check, you report falling or always using a device to help you walk.
  • You drink more than 35 alcoholic drinks a week or answer yes to more than 2 questions on the CAGE alcohol screening test.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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 or Wisconsin 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) \[108\].

Study sites (1)

WI