TOTAL: A Multisite RCT

NCT05346575 | Active Not Recruiting DMC

• 2 other identifiers: IIR 20-3222021-1441
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 2

Brief Summary

Nearly 8 in 10 Veterans meet criteria for overweight/obesity. Three evidence-based treatment options are available within VA (behavioral weight management \[MOVE!\], obesity medications, and bariatric surgery). However, all treatments are significantly underutilized. This study will evaluate the effectiveness of a novel intervention designed to increase obesity treatment initiation and subsequently weight loss within VA. The intervention, Teaching Obesity Treatment Options to Adult Learners (TOTAL), involves an educational video and multiple motivational sessions delivered via telemedicine. If effective, TOTAL could be implemented throughout VA without requiring significant resources and could be integrated into the existing VA behavioral weight management program, MOVE!, which is present at nearly every VA medical center.

Conditions

Obesity; Overweight

Keywords

Bariatric Surgery; Weight-Loss Drugs; Diet, Therapy; Physical Activity; Body Mass Index; Veteran

Outcome Measures

Primary Outcomes (1)

• Obesity treatment initiation

  Attendance at an individual or group MOVE! visit within 18 months of randomization. Assessed at baseline and 18 months via VA electronic health record review.

  18 months

Secondary Outcomes (4)

• Sustained obesity treatment

  18 months

• Obesity medication initiation

  18 months

• Bariatric surgery referral

  18 months

• Weight Change

  18 months

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

Participants randomized to this arm will receive the usual obesity care, but will complete assessments every 6 months.

Behavioral: Usual care

TOTAL intervention

EXPERIMENTAL

Participants randomized to this arm will watch the TOTAL intervention video and participate in 1:1 motivational sessions every 6 months. Participants will also complete assessments every 6 months.

Behavioral: Teaching Obesity Treatments to Adult Learners (TOTAL)

Interventions

Teaching Obesity Treatments to Adult Learners (TOTAL) BEHAVIORAL

TOTAL includes both video component and motivational telemedicine calls delivered via VA Video Connect (VVC) by a study interventionist. We will invite study participants to watch the 18-minute video at least once. The motivational component of TOTAL will consist of three telemedicine-based (VVC), one-on-one, 30-minute calls at 1 week, 6 months, and 12 months after randomization. This timing was selected so Veterans would have regular interactions with the interventionist within one year of initiating the intervention. Each motivational session will be tailored to where Veterans are in the treatment initiation process. Electronic outcome assessment surveys will be sent to the participants at baseline, at each motivational telemedicine visit, and for the 18 month assessment.

TOTAL intervention

Usual care BEHAVIORAL

The usual care group will be electronically sent the 1-week, 6-month, 12-month, 18-month assessments. All usual care participants will be offered the opportunity to watch the educational video component of TOTAL after the final outcome assessment is performed (18 months post-randomization). Veterans in the usual care arm will also have access to the MOVE! program via referrals from the PCP or self-referral to MOVE!. If they initiate treatment in MOVE!, they may progress through MOVE! and receive obesity medications or be referred for bariatric surgery if they choose to do so.

Usual Care

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veterans will be eligible for this study if they have had no MOVE! visit attendance within the last 12 months, no previous bariatric surgery, not currently on weight loss medications, and a BMI of 30 kg/m2 or 27-29.9 + an obesity-related comorbidity

You may not qualify if:

• Veterans will be not be eligible for this study if they are pregnant or are planning to become pregnant within the study period, currently breast feeding, have cancer not in remission, do not have access to a telephone, have severe hearing/visual impairment, weigh more than 420 lbs (due to scale limitations).

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, 90073-1003, United States

Location

William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, 53705-2254, United States

Location

MeSH Terms

Conditions

Obesity; Overweight; Motor Activity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Luke M Funk, MD MPH

  William S. Middleton Memorial Veterans Hospital, Madison, WI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All study team members will be blinded to the block randomization sizes except the biostatisticians. Outcome assessors will be masked to a participants randomization assignment. Interventionists (Study team member administering the TOTAL intervention) will notify participants randomized to the TOTAL intervention. The outcomes assessor will administer assessment surveys to all participants and will remain blinded from each participants intervention status.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: A multi-site, two-arm, parallel randomized control trial to test the effectiveness of the TOTAL intervention vs. usual care on initiation if obesity treatment among Veterans with overweight/obesity.

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 26, 2022
• Study Start: January 23, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: October 27, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)