Teaching Obesity Treatment Options to Adult Learners Intervention Via VA Video Connect

Overweight and Obesity Clinical Trial

— TOTAL  

Official title:

A Non-randomized Pilot Study of the Teaching Obesity Treatment Options to Adult Learners (TOTAL) Intervention Via VA Video Connect (VVC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04878289
• Other study ID #: 2020-1043
• Secondary ID: A539712SMPH/SURG
• Status: Completed
• Phase: N/A
• Start date: April 15, 2021
• Est. completion date: June 20, 2023

Study information

• Verified date: June 2023
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: June 20, 2023
• Est. primary completion date: June 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• TOTAL with Motivational Telemedicine Sessions
Teaching Obesity Treatment Options to Adult Learners Educational Video with 3, 30 minute motivational sessions at 1 week, 6 months, and 12 months after viewing video

Locations

Country	Name	City	State
United States	William S. Middleton VA Hospital	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment: Number of Participants Consented Compared to Number of Recruitment Letters Sent	The ratio of consented participants to number of recruitment letters sent will measure the level of recruitment in this pilot study.	up to 18 months
Primary	Retention: Number of Participants Who Completed the Intervention Compared to Number of Participants Consented	The ratio of participants who watched the video and completed all three telemedicine sessions to the number of participants consented will measure the level of retention in this pilot study.	up to 18 months
Primary	Acceptability	Participants will be asked about their perceptions of watching the video and completing the motivational sessions via VVC at each session (1 week, 6 months, 12 months). Participant perceptions will be summarized qualitatively.	1 week
Primary	Acceptability	Participants will be asked about their perceptions of watching the video and completing the motivational sessions via VVC at each session (1 week, 6 months, 12 months). Participant perceptions will be summarized qualitatively.	6 months
Primary	Acceptability	Participants will be asked about their perceptions of watching the video and completing the motivational sessions via VVC at each session (1 week, 6 months, 12 months). Participant perceptions will be summarized qualitatively.	12 months
Secondary	Number of Participants who initiated Obesity Treatment	Attendance at a MOVE! visit (chart review); participation in another behavioral weight loss program (self-report), data collected at baseline, 1 week, 6 months, 12 months, 18 months	up to 18 months