Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06393725
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-04-25
Brief Title:
Synchronous vs Asynchronous Remotely Delivered Lifestyle Interventions
Sponsor:
University of Connecticut
Organization:
University of Connecticut
Study Overview
Official Title:
A Non-Inferiority Trial Comparing Synchronous and Asynchronous Remotely Delivered Lifestyle Interventions
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 247 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 we call the peer-led weight loss maintenance phase Complete study assessments at baseline 6 12 18 and 24 months
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 we call 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 247 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 We conducted a trial of two asynchronous remote lifestyle interventions-one with a group of 94 participants and one with a group of 40 participants Findings revealed similar weight loss and acceptability between conditions We also found that the larger group was more sustainable such that participants continued to engage in the group for longer when we turned the groups over to participants to lead themselves for a year after the intervention ended-a period we 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 weve established the feasibility of conducing large asynchronous remote groups in the proposed trial we will randomize participants to large groups n82 in both conditions which will allow us to compare synchronous to asynchronous remote interventions that are scaled up to a level that we have established is 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 We hypothesize 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None