Protocol for a randomized non-inferiority trial

ABSTRACT

Background:

Remotely-delivered way of life interventions have emerged to extend the attain and accessibility of conventional interventions which contain quite a few in-person visits for months to a 12 months. Remote interventions might be delivered synchronously through videoconference software program or telephone or asynchronously through on-line platforms. Asynchronously-delivered interventions are handy and versatile in that they permit individuals to take part any time and as such, they might be extra sustainable. Evidence for asynchronous interventions is required given their potential for comfort and sustainability which can have implications for long-term weight reduction upkeep.

Objective:

This is a randomized non-inferiority trial evaluating two remotely-delivered way of life interventions: one that’s delivered synchronously through videoconference conferences and one that’s delivered asynchronously through non-public Facebook teams.

Methods:

We will randomize 328 members who’ve a physique mass index between 27-45 kg/m2 to 2 remotely-delivered way of life interventions, one that’s delivered synchronously and one that’s delivered asynchronously. The synchronous way of life intervention will probably be delivered through videoconference group periods whereas the asynchronous way of life intervention will probably be delivered through non-public Facebook teams. The way of life intervention in each circumstances is predicated on the Diabetes Prevention Program Lifestyle Intervention. The intervention targets are to lose 5-10% of baseline weight and to work towards 300 minutes per week of average depth bodily exercise. The core intervention will final for 12 months and be led by counselors in every group. This will probably be adopted by a 12-month upkeep part to be led by participant volunteers from every group. Participant engagement and weight reduction upkeep will probably be assessed throughout this part. The major final result is imply p.c weight reduction at 6 and 12 months. Secondary outcomes embrace participant engagement, collective efficacy, and intervention supply value. We will even examine circumstances on weight reduction upkeep and engagement at 18 and 24 months.

Results:

Participant recruitment will start in October 2024. We will use intent-to-treat analyses to check whether or not the asynchronous situation is non-inferior to the synchronous situation in p.c weight reduction at 6 and 12 months. We set a non-inferiority margin of two% such that we hypothesize that the p.c weight reduction distinction between circumstances will probably be lower than 2%. We hypothesize that engagement as outlined as imply phrase depend per participant will probably be increased within the asynchronous situation at 12- and 24-months. We additionally hypothesize that the asynchronous situation will value much less to ship per pound misplaced. Finally, we hypothesize that the asynchronous situation can have larger weight reduction upkeep and engagement at 18- and 24-months.

Conclusions:

If hypotheses are confirmed, this work will present proof that asynchronously-delivered distant interventions are as efficacious as synchronously-delivered ones and extra sustainable such that individuals will have interaction in them longer and retain extra weight reduction for much less value. Clinical Trial: Registered with ClinicalTrials.gov NCT06393725.