Virtual Classes for Obesity
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using weight control or loss medication prescribed by a doctor.
What data supports the effectiveness of the treatment TeleSalud General Health Intervention, TeleSalud Healthy Eating- Physical Activity/Sedentary Behavior (HE-PA/SB) for obesity?
Research shows that telephone-based interventions, like those used in TeleSalud, are effective in promoting healthy behaviors such as physical activity and weight management. Studies have found that these interventions can lead to significant weight loss and high patient satisfaction, making them a promising approach for managing obesity.12345
Is the Virtual Classes for Obesity treatment safe for humans?
The research on web-based and telephone-based interventions for promoting healthy eating and physical activity suggests they are generally safe and can lead to positive health changes, such as improved cholesterol levels and increased physical activity, without significant safety concerns reported.46789
How is the TeleSalud General Health Intervention treatment for obesity different from other treatments?
The TeleSalud General Health Intervention is unique because it uses virtual classes and telehealth (remote healthcare services) to promote healthy eating and physical activity, making it more accessible and convenient compared to traditional in-person programs. This approach leverages technology to provide ongoing support and education, which can enhance adherence to lifestyle changes necessary for weight management.13469
What is the purpose of this trial?
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.
Research Team
Lisa Sanchez-Johnsen, PhD
Principal Investigator
Medical College of Wisconsin
Eligibility Criteria
This trial is for Puerto Rican men struggling with obesity. It's designed to see if virtual classes on healthy eating and physical activity can help them lose weight. Men must be willing to participate in online sessions twice a week initially, then less frequently.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a 4-month virtual telehealth lifestyle intervention focusing on healthy eating, physical activity, and reducing sedentary behavior
Maintenance
Participants attend monthly maintenance sessions to support continued healthy behaviors
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- TeleSalud General Health Intervention
- TeleSalud Healthy Eating- Physical Activity/Sedentary Behavior (HE-PA/SB)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical College of Wisconsin
Lead Sponsor