Puerto Rican Obesity Intervention for Men

NCT06440551 | Not Yet Recruiting DMC

• 1 other identifier: 0048231
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Diet; Physical Activity; Puerto Rican

Outcome Measures

Primary Outcomes (33)

• Acceptability- Fidelity: Delivery

  Delivery will be measured by an adherence checklist. It will monitor consistency and accuracy in the delivery of the intervention.

  4 months, 8 months

• Acceptability- Fidelity: Receipt

  Receipt will be measured by participants' self-reports of understanding and knowledge acquisition of content for both groups.

  4 months, 8 months

• Acceptability- Fidelity: Enactment

  Enactment will be measured by participants' self-report of changes in behavior based on targets of treatment (e.g., Healthy Eating, Physical Activity, and Sedentary Behavior, General Health.)

  4 months, 8 months

• Acceptability- Helpfulness of Treatment Components

  Perceived helpfulness/ effectiveness of various treatment components (12 questions, on a 5- point Likert scale: not at all to extremely effective) will be assessed. The average of the treatment component questions will be used as the overall dependent measure of the acceptability of the treatment components.

  4 months, 8 months

• Acceptability- Helpfulness/ Effectiveness of the Intervention Leaders

  Perceived helpfulness/ effectiveness of the intervention leaders (6 questions, on a 5-point Likert scale: not at alll to extremely helpful) will be assessed. The average of the questions will be used as the overall dependent measures of the acceptability of the intervention leaders.

  4 months, 8 months

• Acceptability- Intervention Satisfaction

  Acceptability- Assessed by an intervention satisfaction questionnaire (14 questions, on a 5- point Likert scale: not at all satisfied to extremely satisfied).

  4 months, 8 months

• Acceptability- Perceived Helpfulness/ Effectiveness of the Telehealth Modality, Technology, and Equipment

  Perceived helpfulness/ effectiveness of the telehealth modality, technology and equipment (3 questions, on 5-point Likert scale: not at all to extremely effective) will be assessed. The average of the telehealth components questions will be used as the overall dependent measure of the acceptability of the telehealth components.

  Baseline, 4 months, 8 months

• Acceptability- Satisfaction with Random Assignment to Groups

  Acceptability- Assessed by a questionnaire assessing satisfaction with being in a study with random assignment to groups (14 questions, on a 5-point Likert scale: not at all satisfied to extremely satisfied).

  Baseline, 4 months, 8 months

• Dietary Intake: Number of Servings of Fruits

  Changes in number of servings of fruits will be measured by the Automated Self-Administered 24- Hour (ASA24) Dietary Assessment Tool.

  Baseline, 4 months, 8 months

• Dietary Intake: Number of Servings of Vegetables

  Change in number of servings of vegetables will be measured by the Automated Self-Administered 24- Hour (ASA24) Dietary Assessment Tool.

  Baseline, 4 months, 8 months

• Dietary Intake: Percent of Calories from Saturated Fat

  Changes in percent of calories from saturated fat will be measured by the Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool.

  Baseline, 4 months, 8 months

• Dietary Intake: Total Energy Intake

  Changes in total energy intake will be measured by the Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool.

  Baseline, 4 months, 8 months

• Feasibility- Adherence- Monthly Attendance

  Feasibility- Adherence- Monthly: Will be measured by the frequency of attendance at each session on a monthly basis.

  4 months, 8 months

• Feasibility- Adherence- Number of Make-Up Sessions

  Feasibility- Adherence- Number of Make-Up Sessions: Will be assessed by frequency/counts of number of make-up sessions.

  4 months, 8 months

• Feasibility- Adherence- Number of Missed Sessions Overall

  Feasibility- Adherence- Number of Missed Sessions Overall: Will be assessed by frequency/ counts of the number of missed sessions overall (no make-up sessions).

  4 months, 8 months

• Feasibility- Adherence- Weekly Attendance

  Feasibility- Adherence- Weekly Attendance: Will be measured by the frequency of attendance at each session on a weekly basis.

  4 months, 8 months

• Feasibility- Recruitment- Number Enrolled

  Recruitment feasibility assessed by the number of participants enrolled.

  Pre-Intervention

• Feasibility- Recruitment- Number of Contacts

  Recruitment feasibility assessed by counts of the number of contacts.

  Pre-Intervention

• Feasibility- Recruitment- Rate of Consenting

  Recruitment feasibility assessed by the rate of consenting.

  Pre-Intervention

• Feasibility- Recruitment- Rate of Enrollment

  Recruitment feasibility assessed by the rate of enrollment.

  Pre-Intervention

• Feasibility- Recruitment- Rate of Screening

  Recruitment feasibility assessed by the rate of screening.

  Pre-Intervention

• Feasibility- Recruitment- Recruitment Method

  Feasibility assessed by tracking the method of recruitment.

  Pre-Intervention

• Feasibility- Recruitment- Response Rate

  Recruitment feasibility assessed by rate of response.

  Pre-Intervention

• Feasibility- Recruitment- Type of Contact

  Recruitment feasibility assessed by tracking the type of contact.

  Pre-Intervention

• Feasibility- Retention- Number Completed the intervention

  Retention assessed by counts and frequency of the number who completed the interventions.

  4 months, 8 months

• Feasibility- Recruitment- Number Screened

  Recruitment feasibility assessed by the count of number of individuals screened.

  Pre-Intervention

• Feasibility- Retention- Number of Classes Attended

  Retention- assessed by counts of the number of classes attended.

  4 months, 8 months

• Feasibility- Retention- Percent Completed the Interventions

  Retention assessed by the percent of participants who completed the interventions.

  4 months, 8 months

• Feasibility- Retention- Percent of Classes Attended

  Retention assessed by percent of classes attended.

  4 months, 8 months

• Feasibility- Recruitment- Number Consented

  Recruitment feasibility assessed by the number of participants who consented.

  Pre-Intervention

• Objective Physical Activity (Accelerometer)

  A triaxial wrist accelerometer (ActiGraph wGT3XBT) will measure objective physical activity. They will used the accelerometer during waking hours for 7 days on their non-dominant wrist.

  Baseline, 4 months, 8 months

• Subjective Physical Activity (International Physical Activity Questionnaire)

  The International Physical Activity Questionnaire long form- will measure sedentary and leisure and non-leisure time physical activity.

  Baseline, 4 months, 8 months

• Subjective Sedentary Behavior (International Physical Activity Questionnaire)

  The International Physical Activity Questionnaire long form- will measure sedentary and leisure and non-leisure time physical activity.

  Baseline, 4 months, 8 months

Secondary Outcomes (7)

• Body Mass Index

  Baseline, 4 months, 8 months

• Outcome Expectations for Diet Questionnaire

  Baseline, 4 months, 8 months

• Exercise Outcomes on the Outcomes Expectations Questionnaire

  Baseline, 4 months, 8 months

• Self-Efficacy for Dietary Behaviors

  Baseline, 4 months, 8 months

• Exercise Confidence Survey

  Baseline, 4 months, 8 months

Study Arms (2)

Healthy Eating and Physical Activity - Intervention

EXPERIMENTAL

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

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

General Health Topics - Control

ACTIVE COMPARATOR

Participants will attend virtual classes on general health topics.

Behavioral: TeleSalud General Health Intervention

Interventions

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

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.

Healthy Eating and Physical Activity - Intervention

TeleSalud General Health Intervention BEHAVIORAL

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.

General Health Topics - Control

Eligibility Criteria

• Age: 35 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

You may not qualify if:

• 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) \[108\].

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Lisa Sanchez-Johnsen, PhD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Sanchez-Johnsen, PhD

CONTACT

414-955-8057; LSanchezJohnsen@mcw.edu

Kelly Rifelj, MPA

CONTACT

4146517352; krifelj@mcw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: June 4, 2024
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

US (1)