Gender- and Culturally-Sensitive Weight Loss Intervention for Hispanic Males
Condition: Overweight; Obesity
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      The investigators propose to 1) assess the feasibility, acceptability and preliminary
      efficacy of a gender- and culturally-sensitive weight loss intervention in 48
      overweight/obese Hispanic males ages 18-64 over 12 weeks; 2) assess participant
      characteristics and process measures related to the uptake of mobile-health (mHealth)
      technology in overweight/obese Hispanic males over 12 weeks; and 3) assess pathologic changes
      in the liver in Hispanic men enrolled in a 12-week weight loss intervention using a
      non-invasive MRI as a therapeutic response biomarker.
    

Detailed description: 
      In the U.S., Hispanic males have the highest rate of overweight and obesity when compared to
      males of other racial/ethnic groups placing them at greater risk for obesity-related disease.
      Yet, current literature is lacking to inform on best practices to engage Hispanic males in
      weight loss and/or to promote a successful weight loss trajectory. Without this information
      the health disparities associated with obesity and obesity-related chronic disease will
      continue. Evidence exists to support behavioral weight loss in reducing obesity-related
      health risks. There are limited data to suggest these programs are effective for men and no
      data to support the feasibility and effectiveness of these programs among Hispanic males
      despite this being the fastest growing and highest burdened group for obesity-related disease
      within the U.S. population. Using existing practice guidelines and evidence from recently
      completed in-depth qualitative interviews in overweight/obese Hispanic males, the
      investigators will test a novel intervention approach to address this gap in knowledge. The
      investigators propose to 1) assess the feasibility, acceptability and preliminary efficacy of
      a gender- and culturally-sensitive weight loss intervention in 48 overweight/obese Hispanic
      males ages 18-64 over 12 weeks; 2) assess participant characteristics and process measures
      related to the uptake of mobile-health (mHealth) technology in overweight/obese Hispanic
      males over 12 weeks; and 3) assess pathologic changes in the liver in Hispanic men enrolled
      in a 12-week weight loss intervention using a non-invasive MRI as a therapeutic response
      biomarker. This project will challenge current research paradigms for Hispanic males by
      testing a gender- and culturally-sensitive weight loss intervention and providing highly
      impactful formative research on the use of novel mHealth self-monitoring technologies to
      facilitate dietary/physical activity behavior changes. Given the Hispanic population is the
      fastest growing in the U.S., efforts to identify strategies to promote weight control among
      Hispanic males has potential to significantly impact public health. The expected outcome of
      the proposed project is the identification of feasible and appropriate weight loss
      intervention strategies to improve engagement and weight management in this vulnerable ethnic
      group.
    

Intervention name(s): Counseling sessions; Wait List Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): During the first 12 weeks, intervention participants will attend weekly 30-45-minute individual counseling sessions guided by a trained bilingual Hispanic male lifestyle coach. Counseling sessions will be tailored to the needs of the participants (e.g., evening/weekend sessions, waiting/childcare area). After 12 weeks, intervention group participants will receive bi-weekly phone calls across a 12-week follow-up. Phone calls will last approximately 10 minutes in duration and study staff will follow a script to review current body weight, eating and activity behaviors, and specific barriers for weight loss/maintenance or diet/physical activity behaviors.; After 12 weeks, the wait list control will receive the weight loss intervention plus mHealth technology support. It will include tailored, targeted text messaging and real-time self-monitoring support including beverage tracking cups, which provide the amount of calories users are consuming through beverages on a daily basis, and wearable activity monitors.Behavioral constructs used for the intervention group will be maintained during this intervention delivery thereby ensuring all participants have the appropriate tools to continue weight loss efforts regardless of mHealth use.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hispanic men; Weight loss; Diet; Physical activity; Intervention