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临床试验/NCT00938535
NCT00938535已完成不适用

Community Based Obesity Prevention Among Black Women

Duke University2 个研究点 分布在 1 个国家目标入组 194 人开始时间: 2009年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
194
试验地点
2
主要终点
Change in BMI. We have set a target of BMI maintenance among those randomized to the intervention condition.

研究概览

简要总结

This study will evaluate the efficacy of a behavioral intervention, designed to prevent weight gain among overweight and low obese (25-34.9 kg/m2) Black women (aged 25-44), compared to usual care.

详细描述

Obesity prevention among Black women is a major public health priority; presently, nearly 54% of the adult Black female population is obese. To date, most intervention attention has been focused on weight reduction among the overweight and obese. However, both conditions are notoriously recalcitrant to treatment, particularly among Blacks. We posit that obesity prevention might represent a particularly effective intervention strategy for overweight Black women. Most studies have shown that Black women have a greater social acceptance of overweight, less body weight dissatisfaction, and higher ideal body weights, compared to Whites. Furthermore, numerous studies have shown that obesity is less lethal and causes fewer co-morbidities among Black vs. White women, suggesting that maintaining overweight may be an appropriate public health goal for Black women. We posit that an intervention approach that emphasizes maintaining overweight, while preventing the transition to obesity will resonate among the target population. Very few obesity prevention RCTs appear in the published literature and, to our knowledge, none have been conducted solely among Black women.

We propose to randomize overweight, Black women (n=184) to either usual care (UC) or an obesity prevention (OP) intervention condition. The OP condition is comprised of several intervention components that will be delivered over 12 months; each participant will receive a tailored action plan, tailored print materials, monthly coaching calls, and weekly self-monitoring via an interactive voice response system. Assessments will be taken at baseline, 6, 12, and 18 months post baseline.

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
25 Years 至 44 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • African-American
  • Ages 25-44
  • BMI between 25-34.9 kg/m2
  • Patients with at least 1 visit in the previous 24 months to a participating Community Health Center

排除标准

  • Not currently pregnant
  • Not given birth within the past 12 months
  • No history of myocardial infarction or stroke in last 2 years

结局指标

主要结局

Change in BMI. We have set a target of BMI maintenance among those randomized to the intervention condition.

时间窗: 6, 12 and 18 months post baseline

次要结局

  • Obesity related biomarkers(6, 12 and 18 months post baseline)
  • Change in obesity risk behaviors(6, 12 and 18 months post baseline)
  • Measures of body composition(6, 12 and 18 months post baseline)
  • Psychosocial mediators(6, 12 and 18 months post baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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