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临床试验/NCT01042886
NCT01042886已完成不适用

Partnerships to Overcome Obesity Disparities in Hawaii

University of Hawaii2 个研究点 分布在 1 个国家目标入组 277 人开始时间: 2007年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
277
试验地点
2
主要终点
Weight in kilograms (kg)

研究概览

简要总结

The PILI 'Ohana CBPR partnership implemented a pilot study to determine whether a Family plus Community focused intervention will improve weight loss maintenance compared to Standard follow-up in overweight/obese Native Hawaiian (NH) and other Pacific People (PP) adults (> 18 yr. old) after receiving a standard individual-focused behavioral intervention. The primary hypothesis was that overweight/obese NH and PP adults that undergo a combined family-focused plus community-focused intervention vs. a standard follow-up after receiving a standard individual-focused behavioral intervention will have significantly higher rates of weight loss maintenance.

详细描述

The long term mission of the PILI 'Ohana Program is to integrate community wisdom and expertise with scientific methods to conduct research on health disparities with a specific emphasis on obesity in NHs and PPs. Recognizing that recent advances in medicine such as the reduction of cardiovascular disease mortality and the prevention of type 2 diabetes mellitus, have not translated into benefits for all sectors of the U.S. population, especially ethnic and racial minority populations, the PILI 'Ohana Program aims to address this gap through community-academic partnerships focused on interventions to promote change in obesity-related disparities in NH and PP communities. One of the scientific goals of the PILI 'Ohana Program focused on designing and implementing research activities aimed at completing a pilot intervention study to provide the basis for a more definitive, hypothesis-driven 5-year research study in the future.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Native Hawaiian, Filipino or other Pacific Islander ethnic background;
  • Age 18 years or older;
  • Overweight or Obese defined as BMI > 25 kg/m2 (NH or Pacific Islanders) or > 23 kg/m2 (Filipino ethnic background);
  • Willing and able to follow a behavioral weight loss intervention program that could potentially include 150 minutes of brisk walking per week (or equivalent) and a dietary regimen designed to induce weight loss of ~1-2 lbs per week;
  • Able to identify at least 2-3 family, friends or co-workers that would be willing to support the participant during the course of the study.

排除标准

  • Survival less than 6 months;
  • Planning to move out of the community during the intervention study period (16 months);
  • Pregnancy;
  • Any dietary or exercise restrictions that would prevent an individual from fully participating in the intervention protocol (i.e. end stage renal disease on a renal diet, etc.);
  • Any co-morbid condition (physical and mental disabilities) that would prevent the individual from participating in the intervention protocol (i.e. severe arthritis, hemi-paresis, major psychiatric illness, eating disorders, etc.).

结局指标

主要结局

Weight in kilograms (kg)

时间窗: Baseline, 3-month follow-up, and 9-month follow-up

Physical functioning measured by a 6-minute walk test

时间窗: Baseline, 3-month follow-up, and 9-month follow-up

次要结局

  • Blood pressure(Baseline, 3-month follow-up, and 9-month follow-up)
  • Change in dietary fat intake based on self-report(Baseline, 3-month follow-up, and 9-month follow-up)
  • Change in physical activity level based on self-report(Baseline, 3-month follow-up, and 9-month follow-up)

研究者

发起方
University of Hawaii
申办方类型
Other

研究点 (2)

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