Remote Lifestyle Interventions for Obesity

Overseen By Sherry Pagoto, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Connecticut

Must not be taking: Weight affecting meds

Disqualifiers: Pregnancy, Bipolar, Bariatric surgery, others

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

Compensation: Varies

Number of Visits: 24

Duration: 52 weeks

328 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you do not take medications that affect weight, so you may need to stop those if you are currently taking them.

What data supports the effectiveness of the treatment Asynchronous Remote Lifestyle Intervention, Synchronous Remote Lifestyle Intervention for obesity?

Research shows that remote interventions, like phone calls and text messages, are effective in helping people stick to lifestyle changes and improve health outcomes in obesity management. Additionally, studies have developed cost-effective, technology-supported weight-loss programs that are delivered entirely remotely, showing promising results in weight loss. ^{1 2 3 4 5}

Is remote lifestyle intervention for obesity safe for humans?

Research on remote lifestyle interventions, like telephone-based programs, suggests they are generally safe for humans. These interventions have been used to promote healthy eating and physical activity without reported safety concerns. ^{1 2 3 6 7}

How does the Remote Lifestyle Intervention treatment for obesity differ from other treatments?

The Remote Lifestyle Intervention treatment for obesity is unique because it is delivered entirely remotely, using technology like telephone calls and text messages to support lifestyle changes. This approach is particularly beneficial for individuals in rural areas or those with limited access to in-person programs, making it more accessible and scalable compared to traditional, face-to-face interventions. ^{1 2 4 5 6}

What is the purpose of this trial?

The goal of this clinical trial is to learn if a group-based digital weight loss program that is delivered asynchronously (via an online platform) is as effective as one that is delivered synchronously (via weekly videoconference meetings). In the asynchronous condition, participants can engage with their group any time 24/7. In the synchronous condition, participants can engage with their group once a week at a videoconference meeting. The main questions it aims to answer are: Will participants in each condition lose about the same amount of weight? Will the participants in the asynchronous condition participate more than those in the synchronous condition? Will the participants in the asynchronous condition feel more connected to each other than those in the synchronous condition? Will the asynchronous condition cost less to deliver per pound lost than the synchronous condition? Participants will: Receive a digital weight loss program that lasts 1 year and then volunteer participants will be selected to lead the group for 1 year following the program, a phase called the "peer-led weight loss maintenance phase." Complete study assessments at baseline, 6, 12, 18, and 24 months.

Research Team

Sherry Pagoto, PhD

Principal Investigator

University of Connecticut

Eligibility Criteria

This trial is for individuals with a BMI of 27-45 who are regular users of Facebook and have both Bluetooth or Wi-Fi at home and a smartphone. They should be active online, having posted or replied on social platforms at least once weekly in the recent past.

Inclusion Criteria

I have Bluetooth or WiFi at home for connecting a scale.

I own a smartphone.

My BMI is between 27 and 45.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 1-year behavioral weight loss program delivered either asynchronously via private Facebook groups or synchronously via weekly videoconference meetings

52 weeks

Weekly engagement (synchronous) or 24/7 access (asynchronous)

Peer-led weight loss maintenance

Volunteer participants take over the leadership role of the group for the following year, with brief training on how to lead

1 year

Follow-up

Participants are monitored for weight loss maintenance and engagement at 6, 12, 18, and 24 months

24 months

Treatment Details

Interventions

• Asynchronous Remote Lifestyle Intervention
• Synchronous Remote Lifestyle Intervention

Trial Overview The study compares two digital weight loss programs: one where participants interact any time they want (asynchronous), and another with weekly video meetings (synchronous). It will measure weight loss effectiveness, participation levels, feelings of connectedness, and cost efficiency over a year.

Participant Groups

Group I: Asynchronous Experimental Treatment 1 Intervention

This arm involves a 1 year behavioral weight loss program delivered in private Facebook groups led by a professional weight loss counselor. At the end of 1 year, volunteer participants will take over the leadership role of the group for the following year. Volunteers will receive a brief training on how to lead a private Facebook group.

Group II: Synchronous Active Control 1 Intervention

This arm involves a 1 year behavioral weight loss program delivered via weekly videoconference meetings led by a professional weight loss counselor. At the end of 1 year, volunteer participants will take over the leadership role of the meetings for the following year. Volunteers will receive a brief training on how to lead videoconference meetings.

Who Is Running the Clinical Trial?

University of Connecticut

Lead Sponsor

Trials

194

Recruited

162,000+

Findings from Research

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]

The Opt-IN study, involving 562 adults with obesity, identified an effective weight-loss treatment package that included 12 coaching calls, buddy training, and primary care provider reports, resulting in an average weight loss of 6.1 kg for a cost of $427 per person.

By systematically evaluating treatment components, the study found that increasing coaching calls from 12 to 24 did not enhance weight loss, allowing for a more cost-effective and efficient obesity treatment strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Factorial Experiment to Optimize Remotely Delivered Behavioral Treatment for Obesity: Results of the Opt-IN Study. Spring, B., Pfammatter, AF., Marchese, SH., et al.[2021]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

Multiprofessional intervention and telenursing in the treatment of obese people in the COVID-19 pandemic: a pragmatic clinical trial. [2022]

2. 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]

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

Remotely Delivered Interventions for Obesity Treatment. [2020]

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

A Factorial Experiment to Optimize Remotely Delivered Behavioral Treatment for Obesity: Results of the Opt-IN Study. [2021]

5. Brazil pubmed.ncbi.nlm.nih.gov

Effect of nursing telemonitoring on the knowledge of obese women: clinical trial. [2020]

6. 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]

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

Remote Treatment Successfully Delivers a Usual Care Weight Loss and Lifestyle Intervention in Adults with Morbid Obesity. [2022]