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

Factors Affecting Male Participation in a Behavioral Clinical Trial

Background

Males are often underrepresented in lifestyle-related clinical trials. This study aimed to explore what influences men’s interest in participating in a multi-site trial focused on lifestyle changes for metabolic syndrome. We also compared these findings with female participation to identify any differences.

Methods

We analyzed data collected during different recruitment stages of the ongoing trial. We used logistic regression to compare those who progressed in the screening process to those who did not, separating the results by sex. A chi-squared test was conducted to compare the proportions of men and women who advanced in the recruitment process.

Results

Men interested in the trial were more likely to recognize their health risks. However, men tended to lose interest earlier in the recruitment process, with 58.3% attending an information session compared to 66.5% of women (p < 0.001). Despite this, the rates of progression for those initially interested were similar for both genders.

Conclusion

To boost male enrollment in behavioral trials, focus on enhancing their initial interest and health awareness during early recruitment stages. Since men and women have different motivations for participating, recruitment strategies should be tailored to each gender to maximize participation.

Trial Registration

ClinicalTrials.gov NCT04036006. Registered on July 29, 2019. View Trial.

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