Synchronous vs Asynchronous Remotely Delivered Lifestyle Interventions

NCT ID: NCT06393725

Last Updated: 2025-05-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 328 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-06
• Study Completion Date: 2028-06-30

Brief Summary

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.

Detailed Description

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Asynchronous

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 Type: EXPERIMENTAL

Asynchronous Remote Lifestyle Intervention

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Synchronous Remote Lifestyle Intervention

Intervention Type: 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.

Interventions

Asynchronous Remote Lifestyle Intervention

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.

Intervention Type: BEHAVIORAL

Synchronous Remote Lifestyle Intervention

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Connecticut

OTHER

Sponsor Role: lead

Responsible Party

Sherry Pagoto

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sherry Pagoto, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Connecticut

Locations

University of Connecticut

Storrs, Connecticut, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sherry Pagoto, PhD

Role: CONTACT

sherry.pagoto@uconn.edu

(860) 486-5917

Facility Contacts

Sherry Pagoto, PhD

Role: primary

sherry.pagoto@uconn.edu

860-486-2313

References

Pagoto S, Xu R, Bannor R, Idiong C, Goetz J, Fernandes D. Comparing Synchronous and Asynchronous Remotely Delivered Lifestyle Interventions: Protocol for a Randomized Noninferiority Trial. JMIR Res Protoc. 2024 Dec 19;13:e65323. doi: 10.2196/65323.

Reference Type: DERIVED

PMID: 39700497 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

H23-0383

Identifier Type: -

Identifier Source: org_study_id