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

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University of Arizona

Status

Completed

Conditions

Overweight
Obesity

Treatments

Behavioral: Counseling sessions
Behavioral: Wait List Control

Study type

Interventional

Funder types

Other

Identifiers

NCT02783521
1604536275

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

Male

Ages

18 to 64 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

Intervention
Experimental group
Description:
Includes changing eating behaviors, increasing physical activity, and attending regular in-person weight loss meetings for 12 weeks. To support additional weight loss/weight maintenance, participants will receive bi-weekly phone calls across a 12 week follow-up.
Treatment:
Behavioral: Counseling sessions
Wait List Control
Other group
Description:
Wait-list control participants will not receive any intervention for the first 12 weeks. After 12 weeks, participants will receive the weight loss intervention plus mHealth technology support.
Treatment:
Behavioral: Wait List Control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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