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临床试验/NCT01855282
NCT01855282已完成不适用

Pasos Saludables: A Pilot Intervention to Prevent Obesity and Diabetes Among Latino Farm Workers

University of California, Davis3 个研究点 分布在 1 个国家目标入组 254 人开始时间: 2010年4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
254
试验地点
3
主要终点
Change in BMI

研究概览

简要总结

This is a study to assess the effectiveness of a culturally appropriate behavioral intervention to reduce obesity levels and ultimately the risk of developing diabetes type II in immigrant Latino farm workers. Workers enrolled in a 2:1 ratio by random allocation into an intervention or control arm of the study. The intervention participants received weekly classes for 10 weeks with education on diabetes, diet and physical activity and practical exercises. Both control and intervention were measured for weight, waist circumference, fasting blood glucose and interviewed before and after the study intervention. The main hypothesis was that intervention, but not control participants, would experience reduction in body measurements after the intervention.

详细描述

A more detailed description is not desired as noted above.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18 -60
  • BMI between 20 -38
  • Willing to attend 10 weekly education sessions
  • Able to speak and understand Spanish
  • Have medical insurance

排除标准

  • Fasting blood glucose about 126mg/dL unless physician attests fit to participate
  • Pregnancy or trying to conceive, or breastfeeding
  • On therapeutic diets
  • On medications that affect weight
  • If spouse / cohabitant already in the study
  • Not a farm worker working for the Reiter Affiliated Companies

结局指标

主要结局

Change in BMI

时间窗: Before intervention and after (12-14 weeks after first assessment)

Weight and Height assessed for both control and intervention participants before intervention program and then assessed 2-3 weeks after the intervention period completed.

次要结局

  • Change in Waist Circumference(Measured before and after intervention (12 - 13 weeks after first assessment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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