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Life sciences · Interventional Study
ClinicalTrials.gov · October 30, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Interventional Study.
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Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT06440551). This is a study registration, not published results. Lead sponsor: Medical College of Wisconsin. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 48 participants (ESTIMATED). Conditions: Obesity. Interventions: BEHAVIORAL: TeleSalud Healthy Eating- Physical Activity/Sedentary Behavior (HE-PA/SB); BEHAVIORAL: TeleSalud General Health Intervention. Primary outcome measures: Acceptability- Fidelity: Delivery , 4 months, 8 months; Acceptability- Fidelity: Receipt , 4 months, 8 months; Acceptability- Fidelity: Enactment , 4 months, 8 months; Acceptability- Helpfulness of Treatment Components , 4 months, 8 months; Acceptability- Helpfulness/ Effectiveness of the Intervention Leaders , 4 months, 8 months; Acceptability- Intervention Satisfaction , 4 months, 8 months; Acceptability- Perceived Helpfulness/ Effectiveness of the Telehealth Modality, Technology, and Equipment , Baseline, 4 months, 8 months; Acceptability- Satisfaction with Random Assignment to Groups , Baseline, 4 months, 8 months; Dietary Intake: Number of Servings of Fruits , Baseline, 4 months, 8 months; Dietary Intake: Number of Servings of Vegetables , Baseline, 4 months, 8 months; Dietary Intake: Percent of Calories from Saturated Fat , Baseline, 4 months, 8 months; Dietary Intake: Total Energy Intake , Baseline, 4 months, 8 months; Feasibility- Adherence- Monthly Attendance , 4 months, 8 months; Feasibility- Adherence- Number of Make-Up Sessions , 4 months, 8 months; Feasibility- Adherence- Number of Missed Sessions Overall , 4 months, 8 months; Feasibility- Adherence- Weekly Attendance , 4 months, 8 months; Feasibility- Recruitment- Number Enrolled , Pre-Intervention; Feasibility- Recruitment- Number of Contacts , Pre-Intervention; Feasibility- Recruitment- Rate of Consenting , Pre-Intervention; Feasibility- Recruitment- Rate of Enrollment , Pre-Intervention; Feasibility- Recruitment- Rate of Screening , Pre-Intervention; Feasibility- Recruitment- Recruitment Method , Pre-Intervention; Feasibility- Recruitment- Response Rate , Pre-Intervention; Feasibility- Recruitment- Type of Contact , Pre-Intervention; Feasibility- Retention- Number Completed the intervention , 4 months, 8 months; Feasibility- Recruitment- Number Screened , Pre-Intervention; Feasibility- Retention- Number of Classes Attended , 4 months, 8 months; Feasibility- Retention- Percent Completed the Interventions , 4 months, 8 months; Feasibility- Retention- Percent of Classes Attended , 4 months, 8 months; Feasibility- Recruitment- Number Consented , Pre-Intervention; Objective Physical Activity (Accelerometer) , Baseline, 4 months, 8 months; Subjective Physical Activity (International Physical Activity Questionnaire) , Baseline, 4 months, 8 months; Subjective Sedentary Behavior (International Physical Activity Questionnaire) , Baseline, 4 months, 8 months. 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.