NCT03856320: TOTAL

Teaching Obesity Treatment Options to Adult Learners Trial

Completed NA Results posted Last updated 25 July 2023

What this trial tests

NA trial testing Educational Video in Obesity in 42 participants. Completed in 18 February 2020.

Timeline

13 May 2019

Primary endpoint
18 February 2020

18 February 2020

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	health services research
Enrollment	42
Start date	13 May 2019
Primary completion	18 February 2020
Estimated completion	18 February 2020
Sites	1 location across United States

Drugs / interventions tested

• Educational Video

Conditions studied

• Obesity — all drugs for Obesity →
• Patient Education — all drugs for Patient Education →
• Weight Loss — all drugs for Weight Loss →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 18 to 75, any sex, with Obesity or Patient Education. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Recruitment Primary · 1 year

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

Group	Value	95% CI
All Attempted Recruitment	42

Retention Primary · 7-14 days

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

Group	Value	95% CI
Retention	40

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Funk LM, Breuer CR, Venkatesh M, Muraveva A, et al · · 2021 · cited 2× · PMID 34258469 · DOI 10.1016/j.conctc.2021.100816