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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03856320
Other study ID # CDX 18-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 13, 2019
Est. completion date February 18, 2020

Study information

Verified date July 2023
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date February 18, 2020
Est. primary completion date February 18, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Educational Video
An educational video describing obesity treatment options available in the VA.

Locations

Country Name City State
United States William S. Middleton Memorial Veterans Hospital, Madison, WI Madison Wisconsin

Sponsors (2)

Lead Sponsor Collaborator
VA Office of Research and Development The Clowes Fund, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recruitment The proportion of patients who were contacted by the study team who also consented and provided baseline assessment data. 1 year
Primary Retention The proportion of patients who consented and completed the baseline assessment who also completed the post assessment. 7-14 days
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