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Teaching Obesity Treatment Options to Adult Learners Trial (TOTAL)

Primary Purpose

Obesity, Patient Education, Weight Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Video
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Obesity focused on measuring Obesity, Patient Education, Weight Loss

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Veterans scheduled to attend an in-person MOVE! visit led by a dietitian at the main VA hospital.

Exclusion Criteria:

  • No access to telephone, doesn't speak English as their primary language, has undergone bariatric surgery

Sites / Locations

  • William S. Middleton Memorial Veterans Hospital, Madison, WI

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

Intervention

Arm Description

Patient attends a MOVE! visit (weight management visit).

Patient attends a MOVE! visit (weight management visit) and watches an educational video describing obesity treatment options available in the VA.

Outcomes

Primary Outcome Measures

Recruitment
The proportion of patients who were contacted by the study team who also consented and provided baseline assessment data.
Retention
The proportion of patients who consented and completed the baseline assessment who also completed the post assessment.

Secondary Outcome Measures

Full Information

First Posted
February 25, 2019
Last Updated
July 19, 2023
Sponsor
VA Office of Research and Development
Collaborators
The Clowes Fund, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03856320
Brief Title
Teaching Obesity Treatment Options to Adult Learners Trial
Acronym
TOTAL
Official Title
A Randomized Pilot Study of a Video-based Obesity Educational Intervention (CDA 15-060)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
May 13, 2019 (Actual)
Primary Completion Date
February 18, 2020 (Actual)
Study Completion Date
February 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
The Clowes Fund, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Obesity is the second leading cause of death in the U.S. The treatment of obesity and its related health issues, 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 their weight. Within the Veterans Health Administration (VA) system, nearly 600,000 patients are severely obese. These Veterans create significant costs for 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, resolving weight-related health issues, 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. Reasons for low utilization are unclear, although the investigators' preliminary research suggests that there are various patient, provider and system level barriers to severe obesity care. The goal of this study is to pilot-test an educational video that aligns patient preferences with treatment options to improve the care that severely obese Veterans receive.
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. Reasons for low utilization are unclear, although the investigators' preliminary research suggests that there are various patient, provider and system level barriers to severe obesity care. The goal of this study is to pilot-test an educational video that aligns patient preferences with treatment options to optimize the care that severely obese Veterans receive.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Patient Education, Weight Loss
Keywords
Obesity, Patient Education, Weight Loss

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
An educational video describing obesity treatment options available in the VA.
Masking
Outcomes Assessor
Masking Description
The outcomes assessor will be blinded to the patient's allocation.
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Patient attends a MOVE! visit (weight management visit).
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Patient attends a MOVE! visit (weight management visit) and watches an educational video describing obesity treatment options available in the VA.
Intervention Type
Behavioral
Intervention Name(s)
Educational Video
Intervention Description
An educational video describing obesity treatment options available in the VA.
Primary Outcome Measure Information:
Title
Recruitment
Description
The proportion of patients who were contacted by the study team who also consented and provided baseline assessment data.
Time Frame
1 year
Title
Retention
Description
The proportion of patients who consented and completed the baseline assessment who also completed the post assessment.
Time Frame
7-14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Veterans scheduled to attend an in-person MOVE! visit led by a dietitian at the main VA hospital. Exclusion Criteria: No access to telephone, doesn't speak English as their primary language, has undergone bariatric surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luke M Funk, MD MPH
Organizational Affiliation
William S. Middleton Memorial Veterans Hospital, Madison, WI
Official's Role
Principal Investigator
Facility Information:
Facility Name
William S. Middleton Memorial Veterans Hospital, Madison, WI
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705-2254
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34258469
Citation
Funk LM, Breuer CR, Venkatesh M, Muraveva A, Alagoz E, Hanlon BM, Raffa SD, Voils CI. Protocol and short-term results for a feasibility randomized controlled trial of a video intervention for Veterans with obesity: The TOTAL (Teaching Obesity Treatment Options to Adult Learners) pilot study. Contemp Clin Trials Commun. 2021 Jun 29;23:100816. doi: 10.1016/j.conctc.2021.100816. eCollection 2021 Sep.
Results Reference
derived

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Teaching Obesity Treatment Options to Adult Learners Trial

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