Clinical trial NCT02783521: Gender- and Culturally-Sensitive Weight Loss Intervention for Hispanic Males
Official title: Feasibility of a Gender- and Culturally-Sensitive Weight Loss Intervention for Hispanic Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Keywords: Hispanic men
Weight loss
Diet
Physical activity
Intervention
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2016-05-26
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Study Recruitment: Interest in Participation
timeFrame: Baseline
measure: Study Recruitment: Screened for Eligibility
timeFrame: Baseline
measure: Study Recruitment: Eligibility
timeFrame: Baseline
measure: Study Recruitment: Enrollment
timeFrame: Baseline
measure: Retention
timeFrame: Week 24
measure: Treatment Satisfaction/Acceptability
timeFrame: Week 24
Secondary outcomes:
measure: Change in body weight.
timeFrame: 6, 12, 18, and 24 weeks
measure: Change in physical activity
timeFrame: 6, 12, 18, and 24 weeks
measure: Change in dietary intake
timeFrame: 12 and 24 weeks
measure: Change in liver fat content (intervention only)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Collaboratory for Metabolic Disease Prevention and Treatment
state: Arizona
Study officials:
affiliation: University of Arizona
name: David O. Garcia, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Lindberg NM, Stevens VJ, Halperin RO. Weight-loss interventions for Hispanic populations: the role of culture. J Obes. 2013;2013:542736. doi: 10.1155/2013/542736. Epub 2013 Feb 26.
citation: Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, Hu FB, Hubbard VS, Jakicic JM, Kushner RF, Loria CM, Millen BE, Nonas CA, Pi-Sunyer FX, Stevens J, Stevens VJ, Wadden TA, Wolfe BM, Yanovski SZ; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Obesity Society. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):2985-3023. doi: 10.1016/j.jacc.2013.11.004. Epub 2013 Nov 12. No abstract available.
citation: Pagoto SL, Schneider KL, Oleski JL, Luciani JM, Bodenlos JS, Whited MC. Male inclusion in randomized controlled trials of lifestyle weight loss interventions. Obesity (Silver Spring). 2012 Jun;20(6):1234-9. doi: 10.1038/oby.2011.140. Epub 2011 Jun 2.
citation: Garcia DO, Valdez LA, Hooker SP. Hispanic Male's Perspectives of Health Behaviors Related to Weight Management. Am J Mens Health. 2017 Sep;11(5):1547-1559. doi: 10.1177/1557988315619470. Epub 2015 Dec 3.
citation: Garcia DO, Valdez LA, Aceves B, Bell ML, Rabe BA, Villavicencio EA, Marrero DG, Melton F, Hooker SP. mHealth-Supported Gender- and Culturally Sensitive Weight Loss Intervention for Hispanic Men With Overweight and Obesity: Single-Arm Pilot Study. JMIR Form Res. 2022 Sep 21;6(9):e37637. doi: 10.2196/37637.
citation: Garcia DO, Valdez LA, Bell ML, Humphrey K, Hingle M, McEwen M, Hooker SP. A gender- and culturally-sensitive weight loss intervention for Hispanic males: The ANIMO randomized controlled trial pilot study protocol and recruitment methods. Contemp Clin Trials Commun. 2018 Feb 9;9:151-163. doi: 10.1016/j.conctc.2018.01.010. eCollection 2018 Mar.