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Trial record 10 of 564 for:    Recruiting, Not yet recruiting, Available Studies | Teaching

Teaching Obesity Treatment Options to Adult Learners Trial (TOTAL)

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ClinicalTrials.gov Identifier: NCT03856320
Recruitment Status : Recruiting
First Posted : February 27, 2019
Last Update Posted : May 15, 2019
Sponsor:
Collaborator:
The Clowes Fund, Inc.
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Obesity Patient Education Weight Loss Behavioral: Educational Video Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: An educational video describing obesity treatment options available in the VA.
Masking: Single (Outcomes Assessor)
Masking Description: The outcomes assessor will be blinded to the patient's allocation.
Primary Purpose: Health Services Research
Official Title: A Randomized Pilot Study of a Video-based Obesity Educational Intervention (CDA 15-060)
Actual Study Start Date : May 13, 2019
Estimated Primary Completion Date : May 13, 2020
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Weight Control

Arm Intervention/treatment
No Intervention: Usual Care
Patient attends a MOVE! visit (weight management visit).
Experimental: Intervention
Patient attends a MOVE! visit (weight management visit) and watches an educational video describing obesity treatment options available in the VA.
Behavioral: Educational Video
An educational video describing obesity treatment options available in the VA.




Primary Outcome Measures :
  1. Recruitment [ Time Frame: 1 year ]
    The proportion of patients who were contacted by the study team who also consented and provided baseline assessment data.

  2. Retention [ Time Frame: 7-14 days ]
    The proportion of patients who consented and completed the baseline assessment who also completed the post assessment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03856320


Contacts
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Contact: Sally A Jolles, MA MA (608) 280-7222 Sally.Jolles@va.gov
Contact: Catherine R Breuer, MS (608) 280-7007 Catherine.Breuer@va.gov

Locations
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United States, Wisconsin
William S. Middleton Memorial Veterans Hospital, Madison, WI Recruiting
Madison, Wisconsin, United States, 53705
Contact: Sally A Jolles, MA MA    608-280-7222    Sally.Jolles@va.gov   
Contact: Catherine R Breuer, MS    (608) 280-7007    Catherine.Breuer@va.gov   
Principal Investigator: Luke M Funk, MD MPH         
Sponsors and Collaborators
VA Office of Research and Development
The Clowes Fund, Inc.
Investigators
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Principal Investigator: Luke M Funk, MD MPH William S. Middleton Memorial Veterans Hospital, Madison, WI

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03856320     History of Changes
Other Study ID Numbers: CDX 18-001
First Posted: February 27, 2019    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by VA Office of Research and Development:
Obesity
Patient Education
Weight Loss
Additional relevant MeSH terms:
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Obesity
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes