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NCT Number: NCT06393725

Synchronous vs Asynchronous Remotely Delivered Lifestyle Interventions

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Connecticut

Storrs, Connecticut, 06269, United States

About this study

Lifestyle interventions have had established efficacy for decades but they are costly and have poor scalability. Remotely-delivered lifestyle interventions have increased the potential for scale and systematic reviews have found that they are effective, especially those that include human coaching. Some remote lifestyle interventions are synchronous, such that they are delivered via videoconferencing or phone. Other remote lifestyle interventions are asynchronous, such that they are delivered via online platforms that allow for clinicians and patients to engage via text exchanges or via online groups where patients engage with a clinician and each other by posting messages and contributing to discussion threads. The advantage of asynchronous approaches are 24/7 accessibility which makes them conducive to "just in time" support, allowing patients to engage anytime they want to, as opposed to in scheduled blocks of time each week. Asynchronous, remote interventions may also be more scalable than synchronous remote interventions. A trial of two asynchronous, remote lifestyle interventions-one with a group of 94 participants and one with a group of 40 participants revealed similar weight loss and acceptability between conditions. The larger group was also more sustainable, such that participants continued to engage in the group for longer when the groups were turned over to participants to lead themselves for a year after the intervention ended-a period referred to as the peer-led maintenance phase. The next step in this research is to examine how an asynchronous, remote intervention compares to a synchronous, remote intervention, not only in short term weight loss, but also in sustainability, scalability, and weight loss maintenance. Now that the feasibility of conducing large asynchronous, remote groups has been established, the proposed trial will randomize participants to large groups (n=82) in both conditions, which will allow the comparison of synchronous to asynchronous remote interventions that are scaled up to a level established as acceptable for asynchronous remote interventions. The purpose of the proposed trial is to determine whether an asynchronous, remote lifestyle intervention is non-inferior to a synchronous, remote lifestyle intervention in weight loss at 6 and 12 months, but more scalable and sustainable, and thus producing greater weight loss maintenance at 18 and 24 months. Establishing evidence for asynchronous interventions is more important than ever given that telehealth reimbursement for behavioral health has recently expanded but is still limited to synchronous forms of remote care. Asynchronous interventions may be more convenient for some people and possibly more scalable but for this treatment model to reach its potential, evidence for efficacy is needed to inform reimbursement policy. The hypothesis is that an asynchronous, remote lifestyle intervention will produce similar initial weight loss as a synchronous, remote version but will be less expensive, more sustainable, and generate greater collective efficacy, which will drive greater weight loss maintenance at 18 and 24 months.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI 27-45
  • has Bluetooth or wifi connectivity at home (for scale)
  • goes on Facebook at least 5 days per week over the past 2 weeks
  • has posted/replied at least once a week in the past 2 weeks (per self-report)
  • has a smart phone

Exclusion criteria

  • Pregnant or lactating or plans to during study period
  • bipolar disorder, substance abuse, psychosis, bulimia, binge eating disorder, or severe depression
  • had bariatric surgery or plans to during the study
  • currently taking meds affecting weight
  • lost ≥5% of weight in past 6 months
  • participating in another weight loss program or plans to during the study
  • chronic pain or medical condition that interferes with the ability to exercise
  • type 1 diabetes
  • unable to walk ¼ mile unaided without stopping
  • nicotine user

Treatment and study plan

Asynchronous Remote Lifestyle Intervention

Behavioral

A 1 year lifestyle intervention based on the Diabetes Prevention Program to be delivered asynchronously via a private Facebook group led by a professional weight loss counselor. In the subsequent year, a Peer-Led Maintenance Phase will occur in which a participant volunteer will lead the group after receiving a brief training.

Synchronous Remote Lifestyle Intervention

Behavioral

A 1 year lifestyle intervention based on the Diabetes Prevention Program to be delivered synchronously via weekly videoconference group meetings led by a professional weight loss counselor. In the subsequent year, a Peer-Led Maintenance Phase will occur in which a participant volunteer will lead the group after receiving a brief training.

Primary outcomes

  1. Percent of baseline weight loss at 6 months

    Time frame: 6 months

    Percent weight loss

  2. Percent of baseline weight loss at 12 months

    Time frame: 12 months

    Percent weight loss

Secondary outcomes

  1. Word count of participant engagement in 1 year

    Time frame: 1 year

    word count

  2. Word count of participant engagement in 2 years

    Time frame: 2 years

    word count

  3. Collective Efficacy

    Time frame: 1 year

    Online Collective Efficacy Scale score out of a range of 0-210 where higher scores indicate greater collective efficacy

  4. Collective Efficacy

    Time frame: 2 years

    Online Collective Efficacy Scale score out of a range of 0-210 where higher scores indicate greater collective efficacy

  5. Cost in dollars per pound lost

    Time frame: 1 year

    Intervention cost will be computed for each participant and then divided by pounds lost

  6. Cost in dollars per pound lost

    Time frame: 2 years

    Intervention cost will be computed for each participant and then divided by pounds lost

  7. Percent of baseline weight lost at 18 months

    Time frame: 18 months

    Percent weight loss

  8. Percent of baseline weight lost at 24 months

    Time frame: 24 months

    Percent weight loss

Sponsors and collaborators

Lead sponsor

University of Connecticut

Other

Registry information

Official study title

A Non-Inferiority Trial Comparing Synchronous and Asynchronous Remotely Delivered Lifestyle Interventions

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
May 1, 2024
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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