Evidence map›Paper›PMID 38914310›Full record

ArticleContemporary clinical trials2024

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

Luke M Funk, Christine B Williams, Catherine R Breuer, Scott Hetzel, Stephanie C LaSage, Cenia J Villasenor, Tannaz Moin, Jessica Cook, Emmanuel Sampene, Kevin T Stroupe and 3 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
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  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Luke M FunkWilliam S. Middleton Veterans Affairs Hospital, Madison, WI, USA; Department of Surgery, University of Wisconsin-Madison, Madison, WI, USA. Electronic address: luke.funk@va.gov.
Christine B WilliamsDepartment of Surgery, University of Wisconsin-Madison, Madison, WI, USA.
Catherine R BreuerDepartment of Surgery, University of Wisconsin-Madison, Madison, WI, USA.
Scott HetzelDepartment of Biostatistics and Medical Informatics, University of Wisconsin-Madison, Madison, WI, USA.
Stephanie C LaSageWilliam S. Middleton Veterans Affairs Hospital, Madison, WI, USA.
Cenia J VillasenorWilliam S. Middleton Veterans Affairs Hospital, Madison, WI, USA.
Tannaz MoinDepartment of Medicine, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA; Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles, CA, USA.
Jessica CookWilliam S. Middleton Veterans Affairs Hospital, Madison, WI, USA; Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA; Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.
Emmanuel SampeneDepartment of Biostatistics and Medical Informatics, University of Wisconsin-Madison, Madison, WI, USA.
Kevin T StroupeCenter of Innovation for Complex Chronic Healthcare, Edward Hines, Jr. VA Hospital, Hines, IL, USA; Parkinson School of Health Sciences and Public Health, Loyola University Chicago, Maywood, IL, USA.
Esra AlagozDepartment of Surgery, University of Wisconsin-Madison, Madison, WI, USA.
Susan D RaffaDepartment of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA; Veterans Health Administration National Center for Health Promotion and Disease Prevention, Washington, DC, USA.
Corrine I VoilsWilliam S. Middleton Veterans Affairs Hospital, Madison, WI, USA; Department of Surgery, University of Wisconsin-Madison, Madison, WI, USA.

Funding

Teaching Obesity Treatment Options to Adult Learners (TOTAL): A Multi-site RCTI01HX003354 · VA · WM S. MIDDLETON MEMORIAL VETERANS HOSP · PI FUNK, LUKE M · 2022 to 2025
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HSR&D Senior Research Career Scientist AwardIK6HX003157 · VA · DURHAM VA MEDICAL CENTER · PI MATTHEW L MACIEJEWSKI · 2020 to 2026
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HSRD VA I01 HX003354HSRD VA IK6 HX003157
6 · The paper itself

Abstract

backgroundThe 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.

methodsIn 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.

conclusionTOTAL, 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.

Indexed as

Bariatric SurgeryBehavior TherapyObesityAdultAnti-Obesity AgentsBody Mass IndexFemaleHumansMaleMotivational InterviewingMulticenter Studies as TopicOverweightRandomized Controlled Trials as TopicUnited StatesUnited States Department of Veterans AffairsVeteransAnti-Obesity AgentsAnti-obesity medicationsBariatric surgeryBehavior changeObesityTrial registration: ClinicalTrials.govNCT05346575Veterans health administrationWeight loss

Identifiers

PMID38914310
PMCPMC11323199

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.