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

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 registrationClinicalTrials.gov: NCT02783521

A Gender- and Culturally Sensitive Weight Loss Intervention for Hispanic Men: Results From the Animo Pilot Randomized Controlled Trial

“…Recruitment was perhaps the largest success of the study. In total, 115 individuals were screened and 50 participants recruited within a 3-month period equating to approximately 4 participants per week (Garcia et al, 2018). A large reason for this success was the utilization of in-person recruitment efforts at a local swap meet (outdoor marketplace).…”

“…Details of the Animo (a Spanish term for motivation or encouragement) recruitment, retention, study design, protocol, participant baseline characteristics and measures can be found in previously published material (Garcia et al, 2018). Briefly, the Animo pilot study was a 24-week randomized controlled trial conducted July 2016-February 2017 that investigated feasibility and tested the effects of a gender-and culturally-sensitive weight loss intervention (GCSWLI) on body weight in Hispanic men compared to a waitlist control (WLC) group.…”

“…Full demographic and clinical characteristics of participants have been published elsewhere (Garcia et al, 2018). The mean age of GCSWLI participants was 45.5 years (SD 10.4) compared to 41.0 years (12.1) in WLC participants.…”

“…One strength of the study was our comprehensive framework used to develop the intervention taking into consideration factors related to gender and culture (Garcia et al, 2018). Another strength was our study's contribution to the limited research examining effective culturally-tailored behavioral weight loss programs for Spanish-speaking Hispanic men.…”

“…A variety of interpersonal, sociocultural, and environmental factors were identified by Hispanic men suggesting weight loss programs should be tailored to meet their unique needs. Based on these findings, we developed a pilot gender-and culturally-sensitive weight loss intervention for Hispanic men with overweight and obesity (Garcia et al, 2018). The purpose of the current study was to assess the feasibility, acceptability and preliminary efficacy of a gender-and culturally-sensitive weight loss intervention in 50 overweight/obese Hispanic males.…”