FEASIBILITY OF A GENDER- AND CULTURALLY-SENSITIVEWEIGHT LOSS INTERVENTION FOR HISPANIC MALES
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.
Study phase: I
Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.
18-64 years of age
BMI between 25 to 45.0 kg/m² (NOTE: The investigators elected to cap this at 45.0 kg/m² to minimize potential risks and to reduce the potential for obesity to limit exercise participation)
Ability to provide informed consent and health risk assessment prior to participation in this study
Speak, read, and write either English and/or Spanish
Uncontrolled diabetes mellitus
History of bariatric surgery
Report medical condition or treatment for a medical condition that could affect body weight or ability to engage in structured physical activity that is consistent with the intervention for this study
Current congestive heart failure, angina, uncontrolled arrhythmia, or other symptoms indicative of an increased acute risk for a cardiovascular event
Resting systolic blood pressure of ?150 mmHg or resting diastolic blood pressure of ?90 mmHg
Eating disorders that would contraindicate weight loss or physical activity
Alcohol or substance abuse
Currently treated for psychological issues (i.e. depression, bipolar disorder, etc.), taking psychotropic medications with the previous 12 months, or hospitalized for depression within the previous 5 years
Report exercise on ?3 days per week for ? 20 minutes per day over the past 3 months
Report weight loss of ?5% or participating in a weight reduction diet program in the past 3 months
Report plans to relocate to a location that limits their access to the study site or having employment, personal, or travel commitments that prohibit attendance to all of the scheduled assessments
Primary disease category: Obesity & Weight Control
This study is enrolling healthy volunteers.
Projected enrollment dates: June 2016 to May 2017
Official study title: FEASIBILITY OF A GENDER- AND CULTURALLY-SENSITIVEWEIGHT LOSS INTERVENTION FOR HISPANIC MALES