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临床试验/NCT02783521
NCT02783521已完成不适用

Feasibility of a Gender- and Culturally-Sensitive Weight Loss Intervention for Hispanic Males

University of Arizona2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Retention

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Intervention

Experimental

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.

干预措施: Counseling sessions (Behavioral)

Wait List Control

Other

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.

干预措施: Wait List Control (Behavioral)

结局指标

主要结局

Retention

时间窗: Week 24

Retention will be measured as the number of participants who remain in the study at 24 weeks, divided by the number enrolled.

Study Recruitment: Interest in Participation

时间窗: Baseline

The number of Hispanic men who contact the researchers and express interest in participation.

Study Recruitment: Screened for Eligibility

时间窗: Baseline

The number of Hispanic men screened for eligibility.

Study Recruitment: Eligibility

时间窗: Baseline

The number of Hispanic men eligible/ineligible for study inclusion and reason for ineligibility.

Study Recruitment: Enrollment

时间窗: Baseline

The number of Hispanic men enrolled in the study.

Treatment Satisfaction/Acceptability

时间窗: Week 24

Participants will be asked to rate their overall satisfaction with the intervention at 24 weeks and if they would recommend the program to others. Participants will also be asked questions regarding satisfaction with their overall progress and for changing dietary and PA habits, and weight

次要结局

  • Change in body weight.(6, 12, 18, and 24 weeks)
  • Change in physical activity(6, 12, 18, and 24 weeks)
  • Change in dietary intake(12 and 24 weeks)
  • Change in liver fat content (intervention only)(12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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