Clinical trial NCT04878289: Teaching Obesity Treatment Options to Adult Learners Intervention Via VA Video Connect
Official title: A Non-randomized Pilot Study of the Teaching Obesity Treatment Options to Adult Learners (TOTAL) Intervention Via VA Video Connect (VVC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: telemedicine
Veterans Health Administration
VHA
behavioral weight management
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2021-05-07
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study is to assess the feasibility and acceptability of Teaching Obesity Treatment Options to Adult Learners (TOTAL intervention), which includes an educational video about obesity treatment options within VA in conjunction with three telemedicine motivational sessions to increase obesity treatment initiation. 10 participants will be recruited from the Madison VA Medical Center. Participation involves 3.5 hours of total time with study follow up to 18 months.

Detailed description: Obesity is the second leading cause of death in the U.S. The treatment of obesity and its related comorbidities, including cardiovascular disease and diabetes, exceeds $150 billion annually. "Morbidly" or "severely" obese patients, defined by a body mass index (BMI) of 35 kg/m² or greater, are especially high risk for serious complications due to the metabolic and physiologic derangements that occur with severe obesity. Within the Veterans Health Administration (VA) system, nearly 600,000 patients are severely obese. These Veterans exert significant costs on the VA system, experience poorer quality of life, and have shortened lifespans. Bariatric surgery is the most effective treatment for severe obesity for weight loss, comorbidity resolution, and quality of life. Bariatric surgery is supported as a treatment option by many national societies, including those representing primary care and endocrinology. However, less than 1% of Veterans who qualify for bariatric surgery undergo it. The investigator's previous research indicates that two important barriers to obesity treatment participation are poor Veteran knowledge about the risks of obesity and obesity treatment options, and lack of Veteran motivation.

The goal of this study is to assess the feasibility and acceptability of Teaching Obesity Treatment Options to Adult Learners (TOTAL intervention) among Veterans with overweight/obesity who are not participating in MOVE! program (a Weight Management Program, supported by VA's National Center for Health Promotion and Disease Prevention (NCP). The primary outcomes will be recruitment and retention rates and acceptability of TOTAL. The secondary outcomes include MOVE! program initiation sustained MOVE! participation, obesity medication receipt, bariatric surgery referral, and weight loss 18 months post-intervention.

The investigators propose to pilot test the TOTAL intervention for up to 10 Veterans with overweight/obesity who are not currently participating in MOVE!. Once participants are consented and baseline data are obtained, participants will view the TOTAL video and participate in three one-on-one, 30-minute motivational sessions via VVC at 1-week, 6-months, and 12-months. All VVC sessions will be audio recorded. 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. Further, the investigators will conduct 15-minute participant interviews after each motivational session to assess how the TOTAL educational video and the motivational sessions are received by Veterans using VVC. These interviews will not be audio-recorded. Lastly, participants will complete a brief post-assessment at the 18-month visit to obtain information about their obesity initiation/treatment as well as their final weight.

Eligibility criteria: Inclusion Criteria:

* Veteran
* BMI of 30 or greater, or
* BMI of 27 or greater with an obesity-related comorbidity
* Primary Care Physician visit within the past 12 months

Exclusion Criteria:

* Participation in the MOVE! program within the past 12 months
* Receipt of a weight-loss medication within the past 12 months
* Bariatric surgery referral within the past 12 months
* Has had bariatric surgery
* Previous stomach or small intestine surgery (at discretion of the PI)
* Severe medical condition that would preclude meaningful participation in the study
* Pregnancy or intended pregnancy during the study period
* Current breast feeding
* Cancer not in remission
* Lack of regular access to a telephone
* Lack of regular access to internet-connected device with a microphone such as a computer/laptop/tablet/smart phone
* Non-English speaking
* Hearing impairment

Primary outcomes:
measure: Recruitment: Number of Participants Consented Compared to Number of Recruitment Letters Sent
timeFrame: up to 18 months
measure: Retention: Number of Participants Who Completed the Intervention Compared to Number of Participants Consented
timeFrame: up to 18 months
measure: Acceptability
timeFrame: 1 week
measure: Acceptability
timeFrame: 6 months
measure: Acceptability
timeFrame: 12 months
Secondary outcomes:
measure: Number of Participants who initiated Obesity Treatment
timeFrame: up to 18 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: William S. Middleton VA Hospital
state: Wisconsin
Study officials:
affiliation: William S. Middleton VA
name: Luke M Funk, MD, MPH, FACS
role: PRINCIPAL_INVESTIGATOR
References: