Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Multicenter Study
. 2024 Sep:144:107611.
doi: 10.1016/j.cct.2024.107611. Epub 2024 Jun 22.

The TOTAL trial for weight management participation: A randomized controlled trial protocol

Luke M Funk  1 , Christine B Williams  2 , Catherine R Breuer  2 , Scott Hetzel  3 , Stephanie C LaSage  4 , Cenia J Villasenor  4 , Tannaz Moin  5 , Jessica Cook  6 , Emmanuel Sampene  3 , Kevin T Stroupe  7 , Esra Alagoz  2 , Susan D Raffa  8 , Corrine I Voils  9
Affiliations
Multicenter Study

The TOTAL trial for weight management participation: A randomized controlled trial protocol

Luke M Funk et al. Contemp Clin Trials. 2024 Sep.

Abstract

Background: The three types of evidence-based treatment options for adults with overweight and obesity - behavioral weight management, anti-obesity medications (AOM), and bariatric surgery - are underutilized in the Veterans Health Administration (VHA) system. Our objective in this manuscript is to describe the study protocol for an adequately powered randomized controlled trial (RCT) of a behavioral intervention: TOTAL (Teaching Obesity Treatment Options to Adult Learners) to increase patient uptake of obesity treatment.

Methods: In this multi-site, parallel, RCT, eligible Veterans with a body mass index [BMI] ≥ 27 who had not received obesity treatment within the past 12 months were randomly assigned to TOTAL or usual care. TOTAL involves watching an 18-min video that highlights obesity health risks, pros/cons of all three evidence-based obesity treatments, and expected treatment outcomes. It also includes motivational sessions delivered via televideo at 2 weeks, 6 months, and 12 months after the video (target n = 494 participants). The primary outcome is initiation of behavioral weight management treatment within 18 months of randomization. Secondary outcomes include sustained behavioral weight management treatment, initiation of AOM, bariatric surgery referral, and weight change across 18 months.

Conclusion: TOTAL, which seeks to increase delivery of weight management treatment within the largest integrated health system in the U.S., combines patient education with motivational interviewing components. If efficacious in this trial, further evaluation of intervention effectiveness and implementation throughout the VHA and other healthcare systems would be warranted.

Keywords: Anti-obesity medications; Bariatric surgery; Behavior change; Obesity; Trial registration: ClinicalTrials.govNCT05346575; Veterans health administration; Weight loss.

PubMed Disclaimer

Conflict of interest statement

Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Figure 1.
Figure 1.
TOTAL Conceptual Model
Figure 2.
Figure 2.
Study design
See this image and copyright information in PMC

References

    1. Fryar CD, Carroll MD, Afful J, Prevalence of Overweight, Obesity, and Severe Obesity Among Adults Aged 20 and Over: United States, 1960–1962 Through 2017–2018, 2020. https://www.cdc.gov/nchs/data/hestat/obesity-adult-17-18/obesity-adult.htm. (Accessed March 1 2024).
    1. Breland JY, Phibbs CS, Hoggatt KJ, Washington DL, Lee J, Haskell S, Uchendu US, Saechao FS, Zephyrin LC, Frayne SM, The Obesity Epidemic in the Veterans Health Administration: Prevalence Among Key Populations of Women and Men Veterans, J Gen Intern Med 32(Suppl 1) (2017) 11–17. - PMC - PubMed
    1. Pantalone KM, Hobbs TM, Chagin KM, Kong SX, Wells BJ, Kattan MW, Bouchard J, Sakurada B, Milinovich A, Weng W, Bauman J, Misra-Hebert AD, Zimmerman RS, Burguera B, Prevalence and recognition of obesity and its associated comorbidities: cross-sectional analysis of electronic health record data from a large US integrated health system, BMJ Open 7(11) (2017) e017583. - PMC - PubMed
    1. Faeh D, Braun J, Tarnutzer S, Bopp M, Obesity but not overweight is associated with increased mortality risk, Eur J Epidemiol 26(8) (2011) 647–55. - PubMed
    1. Nguyen NT, Magno CP, Lane KT, Hinojosa MW, Lane JS, Association of hypertension, diabetes, dyslipidemia, and metabolic syndrome with obesity: findings from the National Health and Nutrition Examination Survey, 1999 to 2004, J Am Coll Surg 207(6) (2008) 928–34. - PubMed

Publication types

Substances