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临床试验/NCT03037502
NCT03037502已完成不适用

Tailoring a Lifestyle Intervention to Address Obesity Disparities Among Men

Vanderbilt University4 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2019年6月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
4
主要终点
Change in weight at 3-months post-baseline

研究概览

简要总结

If the investigators are to adequately address the health needs of African American and Latino men, both culture and gender must be considered when developing and implementing strategies to encourage weight loss and increase their healthy eating and physical activity.The aim of this project is to develop and test gendered, culturally and contextually relevant messages that will be used in a future, web- based tailored intervention to encourage healthy eating and physical activity in African American and Latino men. This study is part of a larger research agenda that for a decade has focused on understanding and reducing chronic disease risk among African American and Latino men. Because men are more likely than women to engage in over 30 behaviors known to increase their risk of injury, morbidity, and mortality, improving men's health requires understanding the social and cultural factors that help explain sex differences in health. Operationalizing gender in individually-tailored health communications has great potential to unlock the potential of health communications and interventions to engage and improve the health of men and particularly African American and Latino men. To date, no community-based intervention has produced clinically significant improvements in weight loss, healthy eating or physical activity in Latino and African American men. It also is unclear how technology can be used to promote these behaviors in this population. Thus, there is a need to develop healthy eating, physical activity and weight loss interventions specifically targeted and tailored to African American and Latino men that explores the utility of technology. This intervention content and focus represents a novel strategy to promote health equity by using technology-based health care innovations to improve healthy eating and active living by addressing a root cause of unhealthy behavior in men: notions of manhood. The investigators focus on gender and manhood because they are under-explored factors that shape men's health behaviors.

详细描述

The overall aim of this study is to develop and pilot an individualized weight-loss intervention for obese middle-aged African American and Latino men and to explore how the genetically predicted BMI relates to outcomes. Using strategies previously employed by the PI to develop individually-tailored materials for African American men, the proposed study is designed to develop person-specific materials for Latino men (Specific Aim 1). Investigators also will pilot a behavioral weight loss intervention for 35-64 year old African American men in Nashville and Latino men in Miami (Specific Aims 2-3), and explore how the phenotypic expression of obesity shapes and is affected by behavioral and physiological changes (Specific Aim 4). The proposed intervention includes (a) person-specific goals/ messages (via web and text), (b) self-monitoring (via wearable device and text), (c) small group training and education (including social support) and (d) educational and community-based information and resources (via web and text).

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
None

入排标准

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

入选标准

  • Age: 35-64 at enrollment
  • Race/ ethnicity: African American/ Black or Latino/ Hispanic
  • BMI: 27-50
  • Fluent in English (Nashville and Miami) or Spanish (Miami)
  • Provide informed consent
  • Weight less than 400 pounds

排除标准

  • Preexisting condition that prohibits at least moderate physical activity
  • Serious medical condition that is likely to hinder accurate measurement of weight, for which weight loss is contraindicated or that would cause weight loss
  • Prior or planned bariatric surgery
  • Chronic use of medications that are likely to cause weight gain or cause weight loss
  • No cell phone or land-line phone
  • Participant in another obesity, eating or physical activity program or study
  • Psychiatric hospitalization or in-patient substance abuse treatment in the last 12 months

结局指标

主要结局

Change in weight at 3-months post-baseline

时间窗: 3-months post-baseline of participation

Investigators will report weight change in absolute terms from baseline.

次要结局

  • Change in weight classification(3-months post baseline of participation)
  • Percent change in weight at 3-months post-baseline(3-months post-baseline of participation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Derek Griffith

Director of the Center for Research on Men's Health

Vanderbilt University

研究点 (4)

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