Gender- and Culturally-Sensitive Weight Loss Intervention for Hispanic Males
Completed · Not applicable
Conditions studied: Overweight, Obesity
In brief
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.
Key facts
- Study ID
- NCT02783521
- Run by
- University of Arizona
- People needed
- 50
- Starts
- 2016-05-01
- Expected to finish
- 2017-02-01
- Last updated by the study team
- 2017-11-01
Who can join
Age: 18 and older, up to 64. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Arizona Collaboratory for Metabolic Disease Prevention and Treatment — Tucson, Arizona, United States
Full record on ClinicalTrials.gov
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