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临床试验/NCT02952352
NCT02952352已完成不适用

A Culturally Tailored Intervention to Prevent Diabetes in American Indian Men

Washington State University4 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2017年3月1日最近更新:
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
113
试验地点
4
主要终点
Weight

研究概览

简要总结

To reduce modifiable diabetes risk factors' in overweight and obese AI men residing on the Colville reservation through a community-based, culturally informed intervention, the study specifically aims to: 1. conduct focus groups and interviews with adult members of Colville tribe to inform the adaptation, manualization and implementation of a culturally informed diabetes prevention program among overweight and obese AI men; 2. evaluate the effectiveness of a community-based, culturally informed diabetes prevention intervention by assessing between group changes.

详细描述

To reduce modifiable diabetes risk factors' in overweight and obese AI men residing on the Colville reservation through a community-based, culturally informed intervention, the study specifically aims to: 1. conduct focus groups and interviews with adult members of Colville tribe to inform the adaptation, manualization and implementation of a culturally informed diabetes prevention program among overweight and obese AI men; 2. evaluate the effectiveness of a community-based, culturally informed diabetes prevention intervention by assessing between group changes in: Primary Outcomes: weight, dietary fat and caloric intake, vegetable consumption, and physical activity; Secondary Outcomes: physical fitness, blood pressure, lipids, self-reported quality of life; and, 3. evaluate the sustainability of the diabetes prevention intervention by assessing participant perceptions of program component fit through focus group discussions with participants in the intervention and telephone interviews with those who left the program.

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
None

入排标准

年龄范围
21 Years 至 65 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; Reside in or near Colville tribe; ages 21-65, 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; and, willingness to consent to randomization

排除标准

  • Females, under 18 years old or older than 65 years

研究组 & 干预措施

Delayed Intervention

Other

Diabetes Prevention Program

干预措施: Diabetes Prevention Program (Behavioral)

Diabetes Intervention

Experimental

Diabetes Prevention Program

干预措施: Diabetes Prevention Program (Behavioral)

结局指标

主要结局

Weight

时间窗: 12 Weeks

Percent weight loss

次要结局

  • Systolic and diastolic blood pressure(12 weeks)
  • Stages of Change for weight loss(12 weeks)

研究者

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

Odile Madesclaire

Senior Research Program and Operations Manager

Washington State University

研究点 (4)

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