Synchronous vs Asynchronous Remotely Delivered Lifestyle Interventions

Obesity Clinical Trial

Official title:

A Non-Inferiority Trial Comparing Synchronous and Asynchronous Remotely Delivered Lifestyle Interventions

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06393725
• Other study ID #: H23-0383
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: June 30, 2028

Study information

• Verified date: April 2024
• Source: University of Connecticut
• Contact: Sherry Pagoto, PhD
• Phone: (860) 486-5917
• Email: sherry.pagoto[@]uconn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 we call the "peer-led weight loss maintenance phase." Complete study assessments at baseline, 6, 12, 18, and 24 months.

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. 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 we've established the feasibility of conducing large asynchronous, remote groups, in the proposed trial we will randomize participants to large groups (n=82) 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 328
• Est. completion date: June 30, 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Connecticut

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight	Percent weight loss	6 months
Primary	Weight	Percent weight loss	12 months
Secondary	Participant Engagement	word count	1 year
Secondary	Participant Engagement	word count	2 years
Secondary	Collective Efficacy	Online Collective Efficacy Scale score out of a range of 0-210	1 year
Secondary	Collective Efficacy	Online Collective Efficacy Scale score out of a range of 0-210	2 years
Secondary	Cost per pound lost	Intervention cost will be computed for each participant and then divided by pounds lost	1 year
Secondary	Cost per pound lost	Intervention cost will be computed for each participant and then divided by pounds lost	2 years
Secondary	Weight loss maintenance	Percent weight loss	18 months
Secondary	Weight loss maintenance	Percent weight loss	24 months