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Accepted for/Published in: JMIR Research Protocols

Date Submitted: Aug 12, 2024
Date Accepted: Nov 2, 2024

The final, peer-reviewed published version of this preprint can be found here:

Comparing Synchronous and Asynchronous Remotely Delivered Lifestyle Interventions: Protocol for a Randomized Noninferiority Trial

Pagoto S, Xu R, Bannoe 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;13:e65323

DOI: 10.2196/65323

PMID: 39700497

PMCID: 11695951

Comparing synchronous and asynchronous remotely-delivered lifestyle interventions: Protocol for a randomized non-inferiority trial

  • Sherry Pagoto; 
  • Ran Xu; 
  • Richard Bannoe; 
  • Christie Idiong; 
  • Jared Goetz; 
  • Denise Fernandes

ABSTRACT

Background:

Remotely-delivered lifestyle interventions have emerged to increase the reach and accessibility of traditional interventions which involve numerous in-person visits for months to a year. Remote interventions can be delivered synchronously via videoconference software or phone or asynchronously via online platforms. Asynchronously-delivered interventions are convenient and flexible in that they allow people to participate any time and as such, they may be more sustainable. Evidence for asynchronous interventions is needed given their potential for convenience and sustainability which may have implications for long-term weight loss maintenance.

Objective:

This is a randomized non-inferiority trial comparing two remotely-delivered lifestyle interventions: one that is delivered synchronously via videoconference meetings and one that is delivered asynchronously via private Facebook groups.

Methods:

We will randomize 328 participants who have a body mass index between 27-45 kg/m2 to two remotely-delivered lifestyle interventions, one that is delivered synchronously and one that is delivered asynchronously. The synchronous lifestyle intervention will be delivered via videoconference group sessions while the asynchronous lifestyle intervention will be delivered via private Facebook groups. The lifestyle intervention in both conditions is based on the Diabetes Prevention Program Lifestyle Intervention. The intervention goals are to lose 5-10% of baseline weight and to work toward 300 minutes per week of moderate intensity physical activity. The core intervention will last for 12 months and be led by counselors in each group. This will be followed by a 12-month maintenance phase to be led by participant volunteers from each group. Participant engagement and weight loss maintenance will be assessed during this phase. The primary outcome is mean percent weight loss at 6 and 12 months. Secondary outcomes include participant engagement, collective efficacy, and intervention delivery cost. We will also compare conditions on weight loss maintenance and engagement at 18 and 24 months.

Results:

Participant recruitment will begin in October 2024. We will use intent-to-treat analyses to test whether the asynchronous condition is non-inferior to the synchronous condition in percent weight loss at 6 and 12 months. We set a non-inferiority margin of 2% such that we hypothesize that the percent weight loss difference between conditions will be less than 2%. We hypothesize that engagement as defined as mean word count per participant will be higher in the asynchronous condition at 12- and 24-months. We also hypothesize that the asynchronous condition will cost less to deliver per pound lost. Finally, we hypothesize that the asynchronous condition will have greater weight loss maintenance and engagement at 18- and 24-months.

Conclusions:

If hypotheses are confirmed, this work will provide evidence that asynchronously-delivered remote interventions are as efficacious as synchronously-delivered ones and more sustainable such that people will engage in them longer and retain more weight loss for less cost. Clinical Trial: Registered with ClinicalTrials.gov NCT06393725.


 Citation

Please cite as:

Pagoto S, Xu R, Bannoe 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;13:e65323

DOI: 10.2196/65323

PMID: 39700497

PMCID: 11695951

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