Clinical trial NCT06440551: Puerto Rican Obesity Intervention for Men
Official title: Puerto Rican Obesity Intervention for Men
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity
Keywords: Diet
Physical Activity
Puerto Rican
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 48
Sex: MALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 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.

Primary outcomes:
measure: Acceptability- Fidelity: Delivery
timeFrame: 4 months, 8 months
measure: Acceptability- Fidelity: Receipt
timeFrame: 4 months, 8 months
measure: Acceptability- Fidelity: Enactment
timeFrame: 4 months, 8 months
measure: Acceptability- Helpfulness of Treatment Components
timeFrame: 4 months, 8 months
measure: Acceptability- Helpfulness/ Effectiveness of the Intervention Leaders
timeFrame: 4 months, 8 months
measure: Acceptability- Intervention Satisfaction
timeFrame: 4 months, 8 months
measure: Acceptability- Perceived Helpfulness/ Effectiveness of the Telehealth Modality, Technology, and Equipment
timeFrame: Baseline, 4 months, 8 months
measure: Acceptability- Satisfaction with Random Assignment to Groups
timeFrame: Baseline, 4 months, 8 months
measure: Dietary Intake: Number of Servings of Fruits
timeFrame: Baseline, 4 months, 8 months
measure: Dietary Intake: Number of Servings of Vegetables
timeFrame: Baseline, 4 months, 8 months
measure: Dietary Intake: Percent of Calories from Saturated Fat
timeFrame: Baseline, 4 months, 8 months
measure: Dietary Intake: Total Energy Intake
timeFrame: Baseline, 4 months, 8 months
measure: Feasibility- Adherence- Monthly Attendance
timeFrame: 4 months, 8 months
measure: Feasibility- Adherence- Number of Make-Up Sessions
timeFrame: 4 months, 8 months
measure: Feasibility- Adherence- Number of Missed Sessions Overall
timeFrame: 4 months, 8 months
measure: Feasibility- Adherence- Weekly Attendance
timeFrame: 4 months, 8 months
measure: Feasibility- Recruitment- Number Enrolled
timeFrame: Pre-Intervention
measure: Feasibility- Recruitment- Number of Contacts
timeFrame: Pre-Intervention
measure: Feasibility- Recruitment- Rate of Consenting
timeFrame: Pre-Intervention
measure: Feasibility- Recruitment- Rate of Enrollment
timeFrame: Pre-Intervention
measure: Feasibility- Recruitment- Rate of Screening
timeFrame: Pre-Intervention
measure: Feasibility- Recruitment- Recruitment Method
timeFrame: Pre-Intervention
measure: Feasibility- Recruitment- Response Rate
timeFrame: Pre-Intervention
measure: Feasibility- Recruitment- Type of Contact
timeFrame: Pre-Intervention
measure: Feasibility- Retention- Number Completed the intervention
timeFrame: 4 months, 8 months
measure: Feasibility- Recruitment- Number Screened
timeFrame: Pre-Intervention
measure: Feasibility- Retention- Number of Classes Attended
timeFrame: 4 months, 8 months
measure: Feasibility- Retention- Percent Completed the Interventions
timeFrame: 4 months, 8 months
measure: Feasibility- Retention- Percent of Classes Attended
timeFrame: 4 months, 8 months
measure: Feasibility- Recruitment- Number Consented
timeFrame: Pre-Intervention
measure: Objective Physical Activity (Accelerometer)
timeFrame: Baseline, 4 months, 8 months
measure: Subjective Physical Activity (International Physical Activity Questionnaire)
timeFrame: Baseline, 4 months, 8 months
measure: Subjective Sedentary Behavior (International Physical Activity Questionnaire)
timeFrame: Baseline, 4 months, 8 months
Secondary outcomes:
measure: Body Mass Index
timeFrame: Baseline, 4 months, 8 months
measure: Outcome Expectations for Diet Questionnaire
timeFrame: Baseline, 4 months, 8 months
measure: Exercise Outcomes on the Outcomes Expectations Questionnaire
timeFrame: Baseline, 4 months, 8 months
measure: Self-Efficacy for Dietary Behaviors
timeFrame: Baseline, 4 months, 8 months
measure: Exercise Confidence Survey
timeFrame: Baseline, 4 months, 8 months
measure: Social Support and Eating Habits Survey
timeFrame: Baseline, 4 months, 8 months
measure: Social Support and Exercise Survey
timeFrame: Baseline, 4 months, 8 months
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Lisa Sanchez-Johnsen, PhD
role: PRINCIPAL_INVESTIGATOR
References: