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临床试验/NCT02953977
NCT02953977已完成不适用

Strong Men, Strong Communities: Cultural Tradition to Improve Native Men's Health

Washington State University2 个研究点 分布在 1 个国家目标入组 257 人开始时间: 2018年6月15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
257
试验地点
2
主要终点
Change from baseline weight

研究概览

简要总结

SMSC will inform the design and implementation of culturally informed, community-based lifestyle interventions for diabetes prevention in AI men in our partner communities and elsewhere, as well as in men of other minority groups who experience a heavy burden of diabetes.

详细描述

American Indian (AI) males experience profound health disparities compared to their counterparts in all other U.S. racial and ethnic groups. AI men have the highest age-adjusted prevalence of type 2 diabetes (~18%) among U.S. men, while non-Hispanic White men have the lowest (~7%). In recent decades, AIs have seen a disproportionate increase in diabetes-related complications and mortality compared to all other groups, such that age-adjusted diabetes death rates in AI men are now almost twice those in White men.

Several large randomized, con trolled trials in non-AIs confirm that type 2 diabetes can be prevented or delayed by interventions that promote healthy lifestyles, but little empirical data exist on interventions to prevent diabetes in AI men. In the clinic-based U.S. Diabetes Prevention Program (DPP), only 55 out of 3,234 participants were AI men. Similarly, in the diabetes prevention programs in Native communities, participation by AI males is low, ranging from 33% to 74%. Many explanations have been posited for the low participation rates among men of all races in lifestyle interventions. Recruiting AI men in clinic-based programs is difficult because they tend to seek clinical care less often than women. AI men's perceptions of normative health behaviors and gender roles may also discourage participation, particularly in mixed-gender groups. Therefore, an urgent need exists for diabetes risk reduction programs tailored to the unique values and habits of AI men, with a particular focus on recruitment and retention

研究设计

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

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Must be male and self-reported American Indian; ages 18-75, A BMI ≥25 kg/m2 and/or a waist circumference >90 cm for men; no prior diabetes diagnosis; No history of heart disease, serious illness, cancer diagnosis in the last five years, or other conditions that may impede or prohibit participation; reliable internet access; access to a computer, tablet, or smartphone; have an active email address; and, willingness to consent to randomization

排除标准

  • Females, under 18 years old or older than 75 years

结局指标

主要结局

Change from baseline weight

时间窗: 6 months

7.5% weight loss from baseline weight

次要结局

  • Changes in Stages of Change for healthy eating and physical activity(12 months)
  • Change in dietary habits and consumption and frequency of physical activity(6 months)

研究者

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

Denise Dillard

Professor

Washington State University

研究点 (2)

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