Evidence mapPaperPMID 39707544Full record

Trial reportTrials2024

Factors associated with male recruitment in a multi-site randomized behavioral clinical trial targeting the metabolic syndrome: analysis of screening and recruitment data from the ELM trial.

Chen Yeh, Melissa M Crane, Bryce Daniels, Barbara Lohse, Kelly Karavolos, Tami Olinger, Jacinda Nicklas, Lynda H Powell, Sumihiro Suzuki

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled TrialComparative Study
In one paragraph

Trial report in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04036006 (A National Trial of the ELM Lifestyle Program and Remission of the Metabolic Syndrome), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

NCT04036006 nacompletednot on this map

A National Trial of the ELM Lifestyle Program and Remission of the Metabolic Syndrome

TypeinterventionalSponsorRush University Medical CenterRan2019 to 2024Enrolled618ConditionsMetabolic SyndromeArmsGroup-Based Program, Self-Directed Program
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. An exploratory study to understand how rurality status and demographic characteristics are associated with enrollment, engagement, and retention in a digital health intervention targeting the Appalachian region.The Journal of rural health : official journal of the American Rural Health Association and the National Rural Health Care Association · 2025
    Trial
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

9 authors.

Chen YehRush University Medical Center, Chicago, IL, USA.ORCID http://orcid.org/0000-0003-1320-3870
Melissa M CraneRush University Medical Center, Chicago, IL, USA.ORCID http://orcid.org/0000-0002-1458-2692
Bryce DanielsRush University Medical Center, Chicago, IL, USA.ORCID http://orcid.org/0000-0002-9419-3776
Barbara LohseRochester Institute of Technology, Rochester, NY, USA.ORCID http://orcid.org/0000-0002-9959-9038
Kelly KaravolosRush University Medical Center, Chicago, IL, USA.ORCID http://orcid.org/0000-0003-4611-2828
Tami OlingerRush University Medical Center, Chicago, IL, USA.ORCID http://orcid.org/0000-0002-8895-0523
Jacinda NicklasUniversity of Colorado School of Medicine, Aurora, CO, USA.ORCID http://orcid.org/0000-0003-4418-5919
Lynda H PowellRush University Medical Center, Chicago, IL, USA.ORCID http://orcid.org/0000-0002-3527-8227
Sumihiro SuzukiRush University Medical Center, Chicago, IL, USA. Sumihiro_Suzuki@rush.edu.ORCID http://orcid.org/0000-0002-6408-9580

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMales are underrepresented in behavioral clinical trials of lifestyle. The aim of this exploratory study was to investigate factors associated with trial interest in males at different stages of recruitment and overall, into a multi-site behavioral trial targeting lifestyle change and remission of the metabolic syndrome. Similar analyses were performed for female participation to investigate the uniqueness or consistency with the findings for males.

methodsData collected at various stages of recruitment in an ongoing multi-site behavioral clinical trial were used. A series of logistic regressions compared respondents who moved forward to the next step of the screening process versus those who did not. These analyses were stratified by sex. A chi-squared test was used to directly compare proportions of men and women who chose to advance to the next step.

resultsMales who showed interest in the trial were more likely to be self-aware of their current health risk. Comparison of males and females showed that men tended to lose interest earlier in the recruitment process (58.3% of men vs. 66.5% of women attended an in-person information session, p < 0.001), but the proportion that moved forward among those who demonstrated initial interest was similar in men and women.

conclusionEfforts to increase male enrollment in behavioral clinical trials will benefit from a focus on early stages of recruitment, aiming to increase potential participants' initial levels of interest and awareness of their health risk. As men and women differ in the reasons they choose to participate in a behavioral trial, recruitment should be tailored to sex to maximize trial participation.

trial registrationClinicalTrials.gov NCT04036006. Registered on July 29, 2019. https://clinicaltrials.gov/study/NCT04036006.

Indexed as

Behavior TherapyMass ScreeningMetabolic SyndromePatient SelectionSex FactorsAdultAgedFemaleHealth Knowledge, Attitudes, PracticeHumansMaleMiddle AgedRisk Reduction BehaviorTreatment OutcomeBehavioral clinical trialsMale recruitmentMetabolic syndrome

Identifiers

PMID39707544
PMCPMC11662765

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

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 Socratic graph.