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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help Puerto Rican men living in the U.S. lose weight through virtual classes focused on healthy eating and physical activity. Researchers seek to determine if these personalized virtual sessions, which also promote reducing sedentary behavior, are more effective than general health classes (TeleSalud General Health Intervention). Eligible participants are Puerto Rican men over 35 years old with a BMI of 25 or higher, who can exercise and have access to a reliable internet connection. The goal is to assess whether these tailored classes can lead to healthier lifestyles and a weight loss of at least 5% from the starting weight. As an unphased trial, this study offers a unique opportunity to participate in innovative research aimed at improving health and lifestyle.

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 prior data suggests that these virtual classes are safe for participants?

Previous studies have shown that virtual health programs focusing on healthy eating and physical activity are safe and well-tolerated. Research shows that adults in these programs often engage in moderate exercise, which links to modest weight loss and better health. About two-thirds of overweight or obese adults want to lose weight, and 40% succeed in losing at least 5% of their body weight through similar lifestyle changes.

These findings suggest that the virtual classes tested in this trial are likely safe for participants. The focus on healthy eating and increased activity aligns with proven methods for managing weight. Similar programs have reported no major negative effects, indicating that participants generally handle these activities well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these virtual classes for obesity because they offer a fresh approach to tackling the condition. Unlike typical in-person programs that require travel and scheduling, these classes are delivered online, making them more accessible to participants regardless of location. The intervention focuses specifically on boosting healthy eating and physical activity while reducing sedentary behavior, which is tailored to modern lifestyle challenges. This method could potentially reach more people and provide ongoing support, making it a promising tool in the fight against obesity.

What evidence suggests that this trial's virtual classes could be effective for weight loss in Puerto Rican men?

Research has shown that online programs, such as the TeleSalud Healthy Eating-Physical Activity/Sedentary Behavior (HE-PA/SB), which participants in this trial may receive, can effectively encourage healthier habits. Studies have found that these eHealth programs help people become more active and spend less time sitting. A review of several studies found that these online programs positively affected physical activity in adults with obesity, leading to small to medium improvements. Other research highlights significant benefits in increasing activity and reducing sitting time through telehealth programs. This evidence suggests that the TeleSalud HE-PA/SB program could help participants lose weight meaningfully. ^{1 6 7 8 9}

Who Is on the Research Team?

Lisa Sanchez-Johnsen, PhD

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

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

Has access to secure computer or tablet in a private location with reliable internet connection to support video streaming

Exclusion Criteria

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

Plans to move from the Illinois area during the study

Current recreational or illegal drug use

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

Citations

1. withpower.com withpower.com/trial/phase-obesity-7-2024-06ecb

Virtual Classes for Obesity · Info for Participants Research shows that telephone-based interventions, like those used in TeleSalud, are effective in promoting healthy behaviors such as physical activity and ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34159684/

eHealth interventions targeting nutrition, physical activity, ... eHealth interventions targeting nutrition, physical activity, sedentary behavior, or obesity in adults: A scoping review of systematic reviews.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12069164/

A meta‐analysis of eHealth interventions to promote ... The overall effects of recent eHealth interventions on the physical activity outcomes in adults with obesity were positive and ranged from small to medium in ...

4. researchgate.net researchgate.net/publication/345675218_Assessing_telehealth_interventions_for_physical_activity_and_sedentary_behavior_self-management_in_adults_with_type_2_diabetes_mellitus_An_integrative_review

Assessing telehealth interventions for physical activity and ... Significant improvements in physical activity and sedentary behavior were identified in web and mobile phone‐based interventions. Modest ...

5. researchgate.net researchgate.net/publication/352680784_eHealth_interventions_targeting_nutrition_physical_activity_sedentary_behavior_or_obesity_in_adults_A_scoping_review_of_systematic_reviews

eHealth interventions targeting nutrition, physical activity, ... A vast body of evidence regarding eHealth interventions for nutrition, physical activity, sedentary behavior, and obesity exists.

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK565813/

Physical activity, sedentary behaviour, and obesity - NCBI - NIH Moderate-intensity physical activity performed for 150–250 minutes per week appears to prevent weight gain and may produce modest weight loss in adults.

7. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-023-16372-6

Clustering of diet, physical activity and sedentary behaviour ... This review examines the prevalence of clusters of PA, sedentary time, and dietary behaviours, and how clusters relate to physical and mental health indicators

8. mdpi.com mdpi.com/1660-4601/18/11/5557

Physical Activity, Sleep, and Sedentary Behavior among ... Nearly two-thirds of overweight or obese adults indicate their desire to reduce body mass (weight), and around 40% of those are able to lose at least 5% of ...

9. cdc.gov cdc.gov/dnpao-data-trends-maps/about/index.html

Nutrition, Physical Activity, and Obesity Data This interactive database provides national and state data about the health status and behaviors of Americans.