A Self-Guided Lifestyle Intervention for Young Men: Findings from the ACTIVATE Randomized Pilot Trial

BACKGROUND: Young men are at high risk for developing obesity-related health complications, yet are markedly underrepresented in lifestyle interventions. This pilot study examined the feasibility and preliminary efficacy of a lifestyle intervention (self-guided + health risk messaging) targeting young men. METHODS: 35 young men (Age = 29.3 ± 4.27; BMI = 30.8 ± 4.26; 34% racial/ethnic minority) were randomly assigned to the intervention or delayed treatment control. The intervention (ACTIVATE) included 1 virtual group session, digital tools (wireless scale, self-monitoring app), access to self-paced content via a secure website, and 12 weekly texts to reinforce health risk messaging. Fasted objective weight was assessed remotely at baseline and 12-weeks. Perceived risk was assessed via survey at baseline, 2-week, and 12-week. T-tests were used to compare weight outcomes between arms. Linear regressions examined the association between percent weight change and perceived risk change. RESULTS: Recruitment was successful as evidenced by 109% of target enrollment achieved in a 2-month period. Retention was 86% at 12 weeks, with no differences by arm (p = 0.17). Participants in the intervention arm experienced modest weight loss at 12 weeks, whereas slight gains were observed in the control arm (−1.6% ± 2.5 vs. +0.31% ± 2.8, p = 0.04). Change in perceived risk was not associated with change in percent weight (p > 0.05). CONCLUSIONS: A self-guided lifestyle intervention showed initial promise for weight management among young men, but these findings are limited by small sample size. More research is needed to bolster weight loss outcomes while retaining the scalable self-guided approach. CLINICAL TRIAL REGISTRATION: NCT04267263 (https://www.clinicaltrials.gov/ct2/show/NCT04267263).