Puerto Rican Obesity Intervention for Men

Obesity Clinical Trial

Official title:

Puerto Rican Obesity Intervention for Men

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06440551
• Other study ID #: 0048231
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 15, 2024
• Est. completion date: May 31, 2026

Study information

• Verified date: May 2024
• Source: Medical College of Wisconsin
• Contact: Lisa Sanchez-Johnsen, PhD
• Phone: 414-955-8057
• Email: LSanchezJohnsen[@]mcw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: May 31, 2026
• Est. primary completion date: May 15, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years and older

Eligibility

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 or, if needed, 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 and Spanish.

Exclusion Criteria:

• Does not understand/speak English or Spanish.

• Plans to move from the Illinois 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).

• Current alcohol abuse (>35 alcoholic drinks/week); score of yes to > 2 questions on the CAGE alcohol scale.

• Current recreational or illegal drug use.

Related Conditions & MeSH terms

• Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Feasibility- Recruitment- Number Enrolled	Recruitment feasibility assessed by the number of participants enrolled.	Pre-Intervention
Primary	Feasibility- Recruitment- Number of Contacts	Recruitment feasibility assessed by counts of the number of contacts.	Pre-Intervention
Primary	Feasibility- Recruitment- Rate of Consenting	Recruitment feasibility assessed by the rate of consenting.	Pre-Intervention
Primary	Feasibility- Recruitment- Rate of Enrollment	Recruitment feasibility assessed by the rate of enrollment.	Pre-Intervention
Primary	Feasibility- Recruitment- Rate of Screening	Recruitment feasibility assessed by the rate of screening.	Pre-Intervention
Primary	Feasibility- Recruitment- Recruitment Method	Feasibility assessed by tracking the method of recruitment.	Pre-Intervention
Primary	Feasibility- Recruitment- Response Rate	Recruitment feasibility assessed by rate of response.	Pre-Intervention
Primary	Feasibility- Recruitment- Type of Contact	Recruitment feasibility assessed by tracking the type of contact.	Pre-Intervention
Primary	Feasibility- Retention- Number Completed the intervention	Retention assessed by counts and frequency of the number who completed the interventions.	4 months, 8 months
Primary	Feasibility- Recruitment- Number Screened	Recruitment feasibility assessed by the count of number of individuals screened.	Pre-Intervention
Primary	Feasibility- Retention- Number of Classes Attended	Retention- assessed by counts of the number of classes attended.	4 months, 8 months
Primary	Feasibility- Retention- Percent Completed the Interventions	Retention assessed by the percent of participants who completed the interventions.	4 months, 8 months
Primary	Feasibility- Retention- Percent of Classes Attended	Retention assessed by percent of classes attended.	4 months, 8 months
Primary	Feasibility- Recruitment- Number Consented	Recruitment feasibility assessed by the number of participants who consented.	Pre-Intervention
Primary	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
Primary	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
Primary	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	Body Mass Index	Body Mass Index (BMI) will be assessed by objectively measured height and weight.	Baseline, 4 months, 8 months
Secondary	Outcome Expectations for Diet Questionnaire	Outcome expectations will be assessed by the Outcome Expectations for Diet Questionnaire. This measure will be used to assess the various components of Social Cognitive Theory which are guiding the TeleSalud HE-PA/SB intervention.	Baseline, 4 months, 8 months
Secondary	Exercise Outcomes on the Outcomes Expectations Questionnaire	Outcome expectations for Exercise will be assessed by the Exercise Outcomes on the Outcomes Expectations Questionnaire. This measure will be used to assess the various components of Social Cognitive Theory which are guiding the TeleSalud HE-PA/SB intervention.	Baseline, 4 months, 8 months
Secondary	Self-Efficacy for Dietary Behaviors	Self-efficacy will be assessed by the Self-Efficacy for Dietary Behaviors. This measure will be used to assess the various components of Social Cognitive Theory which are guiding the TeleSalud HE-PA/SB intervention.	Baseline, 4 months, 8 months
Secondary	Exercise Confidence Survey	Self-efficacy will be assessed by the Exercise Confidence Survey. This measure will be used to assess the various components of Social Cognitive Theory which are guiding the TeleSalud HE-PA/SB intervention.	Baseline, 4 months, 8 months
Secondary	Social Support and Eating Habits Survey	Social Support will be assessed by the Social Support and Exercise Survey and the Social Support and Eating Habits Survey. These measures will be used to assess the various components of Social Cognitive Theory which are guiding the TeleSalud HE-PA/SB intervention.	Baseline, 4 months, 8 months
Secondary	Social Support and Exercise Survey	Social Support will be assessed by the Social Support and Exercise Survey and the Social Support and Eating Habits Survey. These measures will be used to assess the various components of Social Cognitive Theory which are guiding the TeleSalud HE-PA/SB intervention.	Baseline, 4 months, 8 months