Assessment of an Intervention to Prevent Obesity and Diabetes in Latino Farm Workers (Pasos)
2017年5月11日 更新者：University of California, Davis
Pasos Saludables: A Pilot Intervention to Prevent Obesity and Diabetes Among Latino Farm Workers
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.
研究概览
详细说明
A more detailed description is not desired as noted above.
研究类型
介入性
注册 (实际的)
254
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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California
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Oxnard、California、美国、93030
- Reiter Affiliated Companies
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Watsonville、California、美国、95076
- Reiter Affiliated Companies
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 60年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Aged 18 -60
- BMI between 20 -38
- Willing to attend 10 weekly education sessions
- Able to speak and understand Spanish
- Have medical insurance
Exclusion Criteria:
- Fasting blood glucose about 126mg/dL unless physician attests fit to participate
- Pregnancy or trying to conceive, or breastfeeding
- Diabetic
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Behavioral intervention
Behavioral intervention consisting of 10 educational sessions promoting healthy diet and increased physical activity.
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Intervention participants attended up to 10 educational sessions teaching them about diabetes, and modifiable lifestyle factors (behaviors) to reduce the risk of diabetes by controlling weight.
Sessions were conducted by Promotoras using culturally sensitive and appropriate materials and themes.
Group activities and support were also emphasized.
The control participants like the intervention were measured and interviewed before and again after the intervention sessions, but received no educational instruction or materials.
其他名称：
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有源比较器：Control
Control arm received no behavioral intervention
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Intervention participants attended up to 10 educational sessions teaching them about diabetes, and modifiable lifestyle factors (behaviors) to reduce the risk of diabetes by controlling weight.
Sessions were conducted by Promotoras using culturally sensitive and appropriate materials and themes.
Group activities and support were also emphasized.
The control participants like the intervention were measured and interviewed before and again after the intervention sessions, but received no educational instruction or materials.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in BMI
大体时间：Before intervention and after (12-14 weeks after first assessment)
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Weight and Height assessed for both control and intervention participants before intervention program and then assessed 2-3 weeks after the intervention period completed.
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Before intervention and after (12-14 weeks after first assessment)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Waist Circumference
大体时间：Measured before and after intervention (12 - 13 weeks after first assessment
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Waist circumference measured in both control and intervention participants using a standard protocol.
Conducted before intervention started and again 2-3 weeks after the intervention sessions finished.
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Measured before and after intervention (12 - 13 weeks after first assessment
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in fasting blood glucose
大体时间：Measured before intervention and after (12-13 weeks after first assessment)
|
Fasting blood glucose was a voluntary assessment and therefore not conducted in all participants.
Blood glucose was assessed from a middle digit using a sterile lancet and Accu-Check Advantage Blood Glucose Meter.
It was assessed before the start of the intervention and after completion in both controls and intervention participants.
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Measured before intervention and after (12-13 weeks after first assessment)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Marc B Schenker, MD、University of California, Davis
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年4月1日
初级完成 (实际的)
2011年2月1日
研究完成 (实际的)
2011年4月1日
研究注册日期
首次提交
2013年5月8日
首先提交符合 QC 标准的
2013年5月13日
首次发布 (估计)
2013年5月16日
研究记录更新
最后更新发布 (实际的)
2017年5月15日
上次提交的符合 QC 标准的更新
2017年5月11日
最后验证
2017年5月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- 219631
- S-MSPREIT (其他标识符：UC Davis)
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.