Synchronous vs Asynchronous Remotely Delivered Lifestyle Interventions

Part of paid clinical trials in Storrs, Connecticut.

Sponsor
University of Connecticut
Study ID
NCT06393725
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Feb 6, 2025
Status verified
May 2025
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
328 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Percent of baseline weight loss at 6 months [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of ConnecticutStorrsConnecticut06269
Sherry Pagoto, PhD
860-486-2313
Sherry Pagoto, PhD (PRINCIPAL_INVESTIGATOR)

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