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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods of delivering a digital weight loss program to determine which is more effective and engaging. One group interacts anytime through a private Facebook group (Asynchronous Remote Lifestyle Intervention), while the other meets weekly via video calls (Synchronous Remote Lifestyle Intervention). The trial aims to determine if both methods aid weight loss and how connected participants feel to their groups. It seeks individuals with a BMI between 27 and 45, who regularly use Facebook and own a smartphone. As an unphased trial, this study provides a unique opportunity to explore innovative weight loss methods and contribute to valuable research.

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 prior data suggests that these remote lifestyle interventions are safe for participants?

Research shows that both types of remote lifestyle programs—one done independently and one with weekly video meetings—are generally easy to follow. These digital weight loss plans help people lose weight by changing their diet and exercise habits.

Previous studies have found that similar remote programs successfully aid weight loss and improve health. Participants in these programs reported feeling comfortable and involved, with no major safety concerns. This suggests a safe and supportive experience while working on weight loss.

Since this study does not test a new drug or medical device but rather a method of providing weight loss support, the safety risks are much lower than in typical clinical trials. Overall, evidence suggests these programs are a safe option for managing weight from home. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these remote lifestyle interventions for obesity because they offer flexible and accessible ways to support weight loss. Unlike traditional in-person programs, the asynchronous intervention uses private Facebook groups, allowing participants to engage at their convenience, which can be more accommodating to different schedules. The synchronous intervention takes a different approach by offering structured weekly videoconference meetings, providing real-time interaction and support. Both methods empower participants to eventually lead their groups, promoting long-term, sustainable lifestyle changes. This approach could significantly broaden access to effective weight loss support, reaching people who might otherwise struggle to attend in-person sessions.

What evidence suggests that this trial's treatments could be effective for obesity?

This trial will compare two remote lifestyle interventions for obesity: a synchronous program and an asynchronous program. Research has shown that both live (synchronous) and on-your-own-time (asynchronous) online programs can aid in weight loss. One study found that the difference in weight loss between these two methods is usually less than 2% after 6 and 12 months. Participants in the synchronous arm will engage in live programs, which are particularly effective when they include human coaching. Those in the asynchronous arm will participate in on-your-own-time programs, which might result in slightly less weight loss compared to in-person methods, but they offer flexibility by allowing participation at any time. Overall, both types of programs show promise in helping people manage their weight. ^{1 2 5 6 7}

Who Is on the Research Team?

Sherry Pagoto, PhD

Principal Investigator

University of Connecticut

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39700497/

Protocol for a Randomized Noninferiority Trial We hypothesize that the percent weight loss difference between conditions at 6 and 12 months will be less than 2% and that the asynchronous ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39191926/

Randomized non-inferiority trial comparing an asynchronous ... Results revealed a remotely-delivered asynchronous lifestyle intervention resulted in slightly less weight loss than an in-person version but may be more ...

3. researchprotocols.org researchprotocols.org/2024/1/e65323/

Comparing Synchronous and Asynchronous Remotely ... We hypothesize that the percent weight loss difference between conditions at 6 and 12 months will be less than 2% and that the asynchronous ...

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/25/NCT06393725/Prot_SAP_000.pdf

A Non-Inferiority Trial Comparing Synchronous and ... While some evidence shows that remote and in-person lifestyle interventions produce fairly similar outcomes when delivered synchronously, we ...

5. mdpi.com mdpi.com/2076-328X/14/6/480

Patient Adherence to a Real-World Digital, Asynchronous ... This study adopted a mixed methods approach to assess why and after how long patients tend to discontinue Australia's largest DWLS.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11695951/

Comparing Synchronous and Asynchronous Remotely ... This is a randomized noninferiority trial comparing 2 remotely delivered lifestyle interventions: one that is delivered synchronously via videoconference ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/osp4.70036?utm_source=tldrbio.tech&utm_medium=referral&utm_campaign=biotech-pharma-updates-january-26-27-2025

Long‐Term Weight Loss Outcomes in a Virtual ... This retrospective study of a virtually-delivered obesity care program found that program users lost 8% of their body weight on average at ...