NCT02783521

Gender- and Culturally-Sensitive Weight Loss Intervention for Hispanic Males

Feasibility of a Gender- and Culturally-Sensitive Weight Loss Intervention for Hispanic Males

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Arizona · Academic / Other
• Sex: Male
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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.

Conditions

• Overweight
• Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Counseling sessions	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.
BEHAVIORAL	Wait List Control	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.

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2016-05-26
• Last updated: 2017-11-01

Locations

1 site across 1 country: United States