A gender- and culturally-sensitive weight loss intervention for Hispanic males: The ANIMO randomized controlled trial pilot study protocol and recruitment methods

David O Garcia, Luis A Valdez, Melanie L Bell, Kyle Humphrey, Melanie Hingle, Marylyn McEwen, Steven P Hooker, David O Garcia, Luis A Valdez, Melanie L Bell, Kyle Humphrey, Melanie Hingle, Marylyn McEwen, Steven P Hooker

Abstract

Hispanic men have the highest rates of overweight and obesity when compared to men of other racial/ethnic groups, placing them at increased risk for obesity-related disease. Yet, Hispanic men are grossly underrepresented in weight loss research. Tailored intervention strategies to improve obesity treatment programs for this vulnerable racial/ethnic subgroup are needed. This manuscript describes recruitment strategies, methodology, and participant characteristics of the ANIMO study, a 24-week randomized controlled pilot trial testing the effects of a gender- and culturally-sensitive weight loss intervention (GCSWLI) on body weight in Hispanic men compared to a wait-list control condition. The ANIMO study included two phases. The first phase was a 12-week GCSWLI. Participants attended weekly in-person individual sessions guided by a trained bilingual Hispanic male lifestyle coach, were prescribed a daily reduced calorie goal, and 225 min of moderate-intensity physical activity per week. In the second phase, GCSWLI participants received bi-weekly phone calls across a 12-week follow-up. Wait-list control (WLC) participants from phase 1 received the GCSWLI plus mobile health technology support. Recruitment strategies included face-to-face efforts at a swap meet (outdoor marketplace), family/friend referrals, printed advertisements and social media. Recruitment, screening, and participant enrollment occurred over three months. Overall, 143 men expressed interest in participation. Of these, 115 were screened and 78% (n = 90) were eligible to participate; 45% of enrolled participants (n = 52) completed baseline assessments and 43% (n = 50) were randomized (mean age of 43.3 ± 11.4 years; BMI: 34.1 ± 5.3 kg/m2; 58% Spanish monolingual). Parameter estimates from ANIMO will support future adequately powered trials for this health disparate population.

Trial registration: ClinicalTrials.gov: NCT02783521.

Keywords: Hispanic; Men; Recruitment; Weight loss; mHealth.

Figures

Fig. 1
Fig. 1
Study phases and participant randomization for the ANIMO Pilot Study.
Fig. 2
Fig. 2
Screening and recruitment process for the ANIMO pilot study.

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