Clinical trial

TOTAL: A Multisite RCT

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT05346575

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 70 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity, Overweight

Full registry criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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).

Treatments and study arms

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.

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.

Primary outcomes

Obesity treatment initiation18 months

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.

Study locations

2 locations were listed when this page was built. The first 40 are shown.

William S. Middleton Memorial Veterans Hospital, Madison, WI🇺🇸 Madison, Wisconsin, United States

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VA Greater Los Angeles Healthcare System, West Los Angeles, CA🇺🇸 West Los Angeles, California, United States

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