Puerto Rican Obesity Intervention for Men
- Conditions
- Obesity
- Interventions
- Behavioral: TeleSalud General Health InterventionBehavioral: TeleSalud Healthy Eating- Physical Activity/Sedentary Behavior (HE-PA/SB)
- Registration Number
- NCT06440551
- Lead Sponsor
- Medical College of Wisconsin
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Male
- Target Recruitment
- 48
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description General Health Topics - Control TeleSalud General Health Intervention Participants will attend virtual classes on general health topics. Healthy Eating and Physical Activity - Intervention TeleSalud Healthy Eating- Physical Activity/Sedentary Behavior (HE-PA/SB) Participants will attend virtual classes on increasing healthy eating, increasing physical activity, and decreasing sedentary behaviors.
- Primary Outcome Measures
Name Time Method Acceptability- Satisfaction with Random Assignment to Groups Baseline, 4 months, 8 months 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).
Dietary Intake: Number of Servings of Fruits Baseline, 4 months, 8 months Changes in number of servings of fruits will be measured by the Automated Self-Administered 24- Hour (ASA24) Dietary Assessment Tool.
Feasibility- Adherence- Number of Make-Up Sessions 4 months, 8 months Feasibility- Adherence- Number of Make-Up Sessions: Will be assessed by frequency/counts of number of make-up sessions.
Feasibility- Adherence- Weekly Attendance 4 months, 8 months Feasibility- Adherence- Weekly Attendance: Will be measured by the frequency of attendance at each session on a weekly basis.
Feasibility- Recruitment- Number Enrolled Pre-Intervention Recruitment feasibility assessed by the number of participants enrolled.
Feasibility- Retention- Percent Completed the Interventions 4 months, 8 months Retention assessed by the percent of participants who completed the interventions.
Acceptability- Perceived Helpfulness/ Effectiveness of the Telehealth Modality, Technology, and Equipment Baseline, 4 months, 8 months 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.
Dietary Intake: Total Energy Intake Baseline, 4 months, 8 months Changes in total energy intake will be measured by the Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool.
Feasibility- Recruitment- Recruitment Method Pre-Intervention Feasibility assessed by tracking the method of recruitment.
Feasibility- Retention- Percent of Classes Attended 4 months, 8 months Retention assessed by percent of classes attended.
Objective Physical Activity (Accelerometer) Baseline, 4 months, 8 months 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.
Subjective Sedentary Behavior (International Physical Activity Questionnaire) Baseline, 4 months, 8 months The International Physical Activity Questionnaire long form- will measure sedentary and leisure and non-leisure time physical activity.
Acceptability- Fidelity: Receipt 4 months, 8 months Receipt will be measured by participants' self-reports of understanding and knowledge acquisition of content for both groups.
Acceptability- Fidelity: Enactment 4 months, 8 months 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.)
Acceptability- Helpfulness of Treatment Components 4 months, 8 months 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.
Acceptability- Intervention Satisfaction 4 months, 8 months Acceptability- Assessed by an intervention satisfaction questionnaire (14 questions, on a 5- point Likert scale: not at all satisfied to extremely satisfied).
Dietary Intake: Number of Servings of Vegetables Baseline, 4 months, 8 months Change in number of servings of vegetables will be measured by the Automated Self-Administered 24- Hour (ASA24) Dietary Assessment Tool.
Feasibility- Adherence- Monthly Attendance 4 months, 8 months Feasibility- Adherence- Monthly: Will be measured by the frequency of attendance at each session on a monthly basis.
Feasibility- Adherence- Number of Missed Sessions Overall 4 months, 8 months Feasibility- Adherence- Number of Missed Sessions Overall: Will be assessed by frequency/ counts of the number of missed sessions overall (no make-up sessions).
Feasibility- Recruitment- Rate of Consenting Pre-Intervention Recruitment feasibility assessed by the rate of consenting.
Feasibility- Recruitment- Rate of Screening Pre-Intervention Recruitment feasibility assessed by the rate of screening.
Feasibility- Recruitment- Response Rate Pre-Intervention Recruitment feasibility assessed by rate of response.
Feasibility- Retention- Number Completed the intervention 4 months, 8 months Retention assessed by counts and frequency of the number who completed the interventions.
Feasibility- Retention- Number of Classes Attended 4 months, 8 months Retention- assessed by counts of the number of classes attended.
Acceptability- Fidelity: Delivery 4 months, 8 months Delivery will be measured by an adherence checklist. It will monitor consistency and accuracy in the delivery of the intervention.
Acceptability- Helpfulness/ Effectiveness of the Intervention Leaders 4 months, 8 months 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.
Dietary Intake: Percent of Calories from Saturated Fat Baseline, 4 months, 8 months Changes in percent of calories from saturated fat will be measured by the Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool.
Feasibility- Recruitment- Number Screened Pre-Intervention Recruitment feasibility assessed by the count of number of individuals screened.
Feasibility- Recruitment- Number Consented Pre-Intervention Recruitment feasibility assessed by the number of participants who consented.
Feasibility- Recruitment- Number of Contacts Pre-Intervention Recruitment feasibility assessed by counts of the number of contacts.
Feasibility- Recruitment- Rate of Enrollment Pre-Intervention Recruitment feasibility assessed by the rate of enrollment.
Feasibility- Recruitment- Type of Contact Pre-Intervention Recruitment feasibility assessed by tracking the type of contact.
Subjective Physical Activity (International Physical Activity Questionnaire) Baseline, 4 months, 8 months The International Physical Activity Questionnaire long form- will measure sedentary and leisure and non-leisure time physical activity.
- Secondary Outcome Measures
Name Time Method Body Mass Index Baseline, 4 months, 8 months Body Mass Index (BMI) will be assessed by objectively measured height and weight.
Outcome Expectations for Diet Questionnaire Baseline, 4 months, 8 months 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.
Exercise Outcomes on the Outcomes Expectations Questionnaire Baseline, 4 months, 8 months 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.
Exercise Confidence Survey Baseline, 4 months, 8 months 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.
Self-Efficacy for Dietary Behaviors Baseline, 4 months, 8 months 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.
Social Support and Eating Habits Survey Baseline, 4 months, 8 months 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.
Social Support and Exercise Survey Baseline, 4 months, 8 months 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.
Trial Locations
- Locations (1)
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States