NCT03856320

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 27, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

May 13, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2020

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

April 14, 2021

Completed
Last Updated

July 25, 2023

Status Verified

July 1, 2023

Enrollment Period

9 months

First QC Date

February 25, 2019

Results QC Date

February 23, 2021

Last Update Submit

July 19, 2023

Conditions

ObesityPatient EducationWeight Loss

Keywords

ObesityPatient EducationWeight Loss

Outcome Measures

Primary Outcomes (2)

  • Recruitment

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

    1 year

  • Retention

    The proportion of patients who consented and completed the baseline assessment who also completed the post assessment.

    7-14 days

Study Arms (2)

Usual Care

NO INTERVENTION

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

Intervention

EXPERIMENTAL

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

Behavioral: Educational Video

Interventions

Educational VideoBEHAVIORAL

An educational video describing obesity treatment options available in the VA.

Intervention

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, 53705-2254, United States

Location

Related Publications (1)

  • 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.

    PMID: 34258469DERIVED

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Results Point of Contact

Title
Dr. Luke Funk
Organization
William S. Middleton VA Hospital
Luke.Funk@va.gov
608-256-1901

Study Officials

  • Luke M Funk, MD MPH

    William S. Middleton Memorial Veterans Hospital, Madison, WI

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcomes assessor will be blinded to the patient's allocation.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: An educational video describing obesity treatment options available in the VA.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2019

First Posted

February 27, 2019

Study Start

May 13, 2019

Primary Completion

February 18, 2020

Study Completion

February 18, 2020

Last Updated

July 25, 2023

Results First Posted

April 14, 2021

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)