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.
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.
What it found
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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.
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.
A National Trial of the ELM Lifestyle Program and Remission of the Metabolic Syndrome
Who cites it
1 citing paper in PubMed.
- 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 · 2025Trial
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
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.
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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.