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



Status:Completed
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 64
Updated:11/3/2017
Start Date:May 2016
End Date:February 2017

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Feasibility of a Gender- and Culturally-Sensitive Weight 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.

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.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
1
site
Tucson, Arizona 85714
Principal Investigator: David O Garcia, PhD
Phone: 520-626-5470
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from
Tucson, AZ
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