Synchronous vs Asynchronous Remotely Delivered Lifestyle Interventions
A Non-Inferiority Trial Comparing Synchronous and Asynchronous Remotely Delivered Lifestyle Interventions
1 other identifier
interventional
328
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Feb 2025
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2024
CompletedFirst Posted
Study publicly available on registry
May 1, 2024
CompletedStudy Start
First participant enrolled
February 6, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
May 11, 2025
May 1, 2025
2.9 years
April 25, 2024
May 8, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Percent of baseline weight loss at 6 months
Percent weight loss
6 months
Percent of baseline weight loss at 12 months
Percent weight loss
12 months
Secondary Outcomes (8)
Word count of participant engagement in 1 year
1 year
Word count of participant engagement in 2 years
2 years
Collective Efficacy
1 year
Collective Efficacy
2 years
Cost in dollars per pound lost
1 year
- +3 more secondary outcomes
Study Arms (2)
Asynchronous
EXPERIMENTALThis 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.
Synchronous
ACTIVE COMPARATORThis 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Connecticut
Storrs, Connecticut, 06269, United States
Related Publications (1)
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.
PMID: 39700497DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sherry Pagoto, PhD
University of Connecticut
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 25, 2024
First Posted
May 1, 2024
Study Start
February 6, 2025
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
June 30, 2028
Last Updated
May 11, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- Data will be made available 1 year following the end of the trial. It will be available for 5 years.
- Access Criteria
- (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
The data and associated documentation will be made available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. Datasets will be stored with encryption and will be shared only after verification of human subjects institutional review board approval is obtained. By requesting human studies approval, we will be able to track recipients of the data, the type of data analyses proposed, and subsequent research findings. All storage and sharing of data will be in accordance with the policy and approval of University of Connecticut institutional review board.