Translating Obesity and Diabetes Prevention Into the Worksite for Immigrant Populations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 554
- 试验地点
- 1
- 主要终点
- Change in BMI
研究概览
简要总结
This is a cluster randomized trial (CRT) 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. Randomization is at the farm ranch level. Individuals at intervention ranches will receive a multi-week curriculum at the work-site on diabetes, diet and physical activity and optional supplemental sessions in the evening and weekends. The investigators will adopt the intent-to-treat principle for the primary analysis. Individuals on control ranches will receive no health educational instruction. The primary outcome is BMI. The investigators hypothesize that intervention ranches will achieve significant improvement in obesity and diabetes risk factors as compared to control ranches.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Work at Reiter Brothers Inc. (RBI), a partner, or affiliate company
- •Able to speak and understand Spanish
- •Willing to attend weekly sessions for length of intervention
- •Plan to stay in the area for the next three months
排除标准
- •Workers without Spanish language comprehension
- •Pregnant women and those planning a pregnancy within six months
- •Women who are breastfeeding, unless discontinuing breastfeeding within one month
- •Individuals who, without health care provider approval, are: unable to undertake moderate physical exercise, taking medicine for high blood pressure or heart conditions, have bone or joint problems, lose consciousness or fall due to dizziness, or have developed chest pain within the last month
- •Individuals taking medications that affect weight
- •Individuals with therapeutic diets
- •Diabetic status determined by health care professional after HbA1c testing result is >6.5%
- •If spouse / cohabitant is already in the study
研究组 & 干预措施
Behavioral intervention
Behavioral intervention consisting of 12 educational sessions promoting healthy diet and increased physical activity
干预措施: Behavioral Intervention (Behavioral)
Control
Control arm receives no health-related behavioral intervention
干预措施: Control (Other)
结局指标
主要结局
Change in BMI
时间窗: Measured at baseline prior to the intervention; immediately following the intervention (12 weeks after first assessment) and again at 6 months, 1 year, and 1.5 years post-intervention.
Weight and height will be assessed at each data collection point and concurrently for control and intervention participants on matched ranches.
次要结局
- Change in hemoglobin A1c (HbA1c)(Measured at baseline prior to the intervention; immediately following the intervention (12 weeks after first assessment) and again at 1 year post-intervention.)
- Cost analysis(Quarterly beginning a year prior to implementation of the intervention and concluding 1.5 years post-intervention.)
- Change in cholesterol(Measured at baseline prior to the intervention; immediately following the intervention (12 weeks after first assessment) and again at 1 year post-intervention.)
- Change in behavior and lifestyle factors(Measured at baseline prior to the intervention; immediately following the intervention (12 weeks after first assessment) and again at 1 year post-intervention.)
- Change in waist circumference(Measured at baseline prior to the intervention; immediately following the intervention (12 weeks after first assessment) and again at 6 months, 1 year, and 1.5 years post-intervention.)
- Change in blood pressure(Measured at baseline prior to the intervention; immediately following the intervention (12 weeks after first assessment) and again at 6 months, 1 year, and 1.5 years post-intervention.)