Virtual Classes for Obesity

Overseen By Lisa Sanchez-Johnsen, PhD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Must not be taking: Weight loss drugs

Disqualifiers: Uncontrolled diabetes, Hypertension, Heart attack, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 16 weeks

48 Participants Needed

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. ^{1 2 3 4 5}

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. ^{4 6 7 8 9}

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. ^{1 3 4 6 9}

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

I am a Puerto Rican man over 35 years old.

BMI ≥25 by anthropometrically measured weight and height

I am physically capable of exercising or can get medical clearance to do so.

Exclusion Criteria

Plans to move from the Illinois area during the study

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

Current recreational or illegal drug use

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 4-month virtual telehealth lifestyle intervention focusing on healthy eating, physical activity, and reducing sedentary behavior

16 weeks

Twice per week for 3 months, once per week for 1 month

Maintenance

Participants attend monthly maintenance sessions to support continued healthy behaviors

4 months

1 visit per month

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 months

Treatment Details

Interventions

• TeleSalud General Health Intervention
• TeleSalud Healthy Eating- Physical Activity/Sedentary Behavior (HE-PA/SB)

Trial Overview Researchers are testing two types of virtual interventions: one focused on promoting healthy eating and physical activity (HE-PA/SB), and another providing general health information. The goal is to determine which leads to better outcomes like weight loss.

Participant Groups

Group I: Healthy Eating and Physical Activity - Intervention Experimental Treatment 1 Intervention

Participants will attend virtual classes on increasing healthy eating, increasing physical activity, and decreasing sedentary behaviors.

Group II: General Health Topics - Control Active Control 1 Intervention

Participants will attend virtual classes on general health topics.

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Findings from Research

A randomized controlled trial involving 467 obesity rehabilitation patients showed that a combined planning and telephone aftercare intervention significantly increased physical activity levels after 12 months, with participants engaging in 58 more minutes of activity per week compared to the control group.

Despite the increase in physical activity, the intervention did not lead to a significant reduction in body weight compared to standard care, suggesting that enhancing physical activity alone may still help reduce health risks for obese patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A combined planning and telephone aftercare intervention for obese patients: effects on physical activity and body weight after one year. Ströbl, V., Knisel, W., Landgraf, U., et al.[2014]

Integrating the Get Healthy Service, a telephone-delivered coaching program, with standard multidisciplinary care led to significant weight loss and improvements in body mass index for participants, with the intervention group losing an average of 12.6 kg over 6 months.

Both the control and intervention groups showed similar health improvements, indicating that the telephone coaching service is a viable adjunct to obesity treatment, with high patient satisfaction reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Telephone Health Coaching Integration with Standard Multidisciplinary Care for Adults with Obesity Attending a Weight Management Service: A Pilot Study. Driscoll, S., Meyerowitz-Katz, G., Ahlenstiel, G., et al.[2022]

Participants in a telehealth trial for obesity management reported that telephone and text message support were highly beneficial, providing motivation and accountability.

The study indicates strong acceptability of these communication methods, suggesting they could be effectively integrated into community-based obesity management programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participant perspectives of a telehealth trial investigating the use of telephone and text message support in obesity management: a qualitative evaluation. Lewis, E., Hassmén, P., Pumpa, KL.[2021]

A pilot trial involving 34 rural women showed that a 6-month behavioral weight loss program delivered via group phone calls resulted in greater weight loss (mean 14.9 kg) compared to individual phone counseling (mean 9.5 kg), indicating that group support may enhance treatment efficacy.

The group phone-based treatment was not only more effective, with 62% of participants achieving a 10% weight loss goal compared to 50% in the individual condition, but it was also found to be more cost-effective, suggesting a promising strategy for obesity management in rural areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group versus individual phone-based obesity treatment for rural women. Befort, CA., Donnelly, JE., Sullivan, DK., et al.[2021]

A review of 30 studies on web-based interventions for preventing overweight and obesity found that 93% reported positive changes in physical activity levels, dietary habits, and psychological factors.

While the meta-analysis indicated improvements in fruit and vegetable consumption and physical activity, these changes were not statistically significant, suggesting that web-based interventions can raise awareness and encourage healthy behaviors, but may need further optimization for greater impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of web-based interventions to prevent excessive weight gain. Maon, S., Edirippulige, S., Ware, R., et al.[2012]

References

1. Sweden pubmed.ncbi.nlm.nih.gov

A combined planning and telephone aftercare intervention for obese patients: effects on physical activity and body weight after one year. [2014]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy of Telephone Health Coaching Integration with Standard Multidisciplinary Care for Adults with Obesity Attending a Weight Management Service: A Pilot Study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Participant perspectives of a telehealth trial investigating the use of telephone and text message support in obesity management: a qualitative evaluation. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Increasing the use of preventative health services to promote healthy eating, physical activity and weight management: the acceptability and potential effectiveness of a proactive telemarketing approach. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Exercise in Obesity-the Role of Technology in Health Services: Can This Approach Work? [2022]

6. Ireland pubmed.ncbi.nlm.nih.gov

Optimizing acceptability and feasibility of an evidence-based behavioral intervention for obese adults with obesity-related co-morbidities or additional risk factors for co-morbidities: an open-pilot intervention study in secondary care. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of a Telephone-Based Lifestyle Intervention on Weight, Body Composition, and Metabolic Biomarkers in Rural Ohio: Results from a Randomized Pilot Study. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Group versus individual phone-based obesity treatment for rural women. [2021]

9. England pubmed.ncbi.nlm.nih.gov

The use of web-based interventions to prevent excessive weight gain. [2012]