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

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TOTAL with Motivational Telemedicine Sessions
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring telemedicine, Veterans Health Administration, VHA, behavioral weight management

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • William S. Middleton VA Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TOTAL Intervention

Arm Description

TOTAL video and participate in three one-on-one, 30-minute motivational sessions via VVC at 1-week, 6-months, and 12-months

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
May 4, 2021
Last Updated
June 26, 2023
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT04878289
Brief Title
Teaching Obesity Treatment Options to Adult Learners Intervention Via VA Video Connect
Acronym
TOTAL
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
April 15, 2021 (Actual)
Primary Completion Date
June 20, 2023 (Actual)
Study Completion Date
June 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
telemedicine, Veterans Health Administration, VHA, behavioral weight management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TOTAL Intervention
Arm Type
Experimental
Arm Description
TOTAL video and participate in three one-on-one, 30-minute motivational sessions via VVC at 1-week, 6-months, and 12-months
Intervention Type
Behavioral
Intervention Name(s)
TOTAL with Motivational Telemedicine Sessions
Intervention Description
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
Primary Outcome Measure Information:
Title
Recruitment: Number of Participants Consented Compared to Number of Recruitment Letters Sent
Description
The ratio of consented participants to number of recruitment letters sent will measure the level of recruitment in this pilot study.
Time Frame
up to 18 months
Title
Retention: Number of Participants Who Completed the Intervention Compared to Number of Participants Consented
Description
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.
Time Frame
up to 18 months
Title
Acceptability
Description
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.
Time Frame
1 week
Title
Acceptability
Description
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.
Time Frame
6 months
Title
Acceptability
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of Participants who initiated Obesity Treatment
Description
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
Time Frame
up to 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luke M Funk, MD, MPH, FACS
Organizational Affiliation
William S. Middleton VA
Official's Role
Principal Investigator
Facility Information:
Facility Name
William S. Middleton VA Hospital
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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