The TOTAL trial for weight management participation: A randomized controlled trial protocol

Area of Science:

• Obesity Medicine
• Behavioral Science
• Clinical Trial Design

Background:

• Evidence-based obesity treatments (behavioral, medications, surgery) are underutilized in the Veterans Health Administration (VHA).
• A significant gap exists in patient uptake of available obesity management strategies within the VHA system.

Purpose of the Study:

• To describe the protocol for a randomized controlled trial (RCT) evaluating the TOTAL intervention.
• To increase patient initiation and engagement with evidence-based obesity treatments.

Main Methods:

• Multi-site, parallel RCT involving Veterans with BMI ≥ 27, randomized to TOTAL or usual care.
• TOTAL intervention includes an educational video and motivational interviewing sessions via televideo.
• Primary outcome: initiation of behavioral weight management treatment within 18 months; secondary outcomes include AOM initiation, surgery referral, and weight change.

Main Results:

• The study aims to enroll 494 participants to adequately power the RCT.
• Primary outcome is the initiation of behavioral weight management treatment.
• Secondary outcomes assess sustained treatment, anti-obesity medication use, bariatric surgery referral, and weight change.

Conclusions:

• The TOTAL intervention combines patient education with motivational interviewing to enhance obesity treatment delivery.
• If effective, the intervention warrants further evaluation for broader implementation in the VHA and other healthcare systems.