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临床试验/NCT02813668
NCT02813668已完成不适用

Worksite Lifestyle Program for Reducing Diabetes and Cardiovascular Risk in India

Emory University2 个研究点 分布在 1 个国家目标入组 2,108 人开始时间: 2017年5月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,108
试验地点
2
主要终点
Number of Participants Reaching Two or More Cardiometabolic Risk Goals

研究概览

简要总结

This study will test the implementation, effectiveness, cost-effectiveness, and acceptability of a worksite lifestyle improvement program that includes lifestyle education classes led by trained individuals from the worksite and improvements in the worksite environment that will make it easier for employees at risk for diabetes or with unmedicated diabetes to lose weight, exercise more, and eat a healthier diet. A total of 2000 participants across 10 worksites in South, Central, and East India will be involved in this study.

详细描述

This study will implement and evaluate in a pre-post design trial the acceptability, delivery, effectiveness, and cost-effectiveness of a worksite-based lifestyle improvement package including a peer-led lifestyle change education program (described below) augmented with changes in the worksite environment that promote social support, healthy eating and exercise. The lifestyle education program will include 2000 adults with prediabetes (HbA1c of 5.7-6.4%) or unmedicated diabetes (HbA1c ≥ 6.5% identified at screening) across ten diverse worksites in India (changes to the worksite environment will impact a much broader population of employees). A mixed methods approach will be used to evaluate implementation of the program.

Participants at high risk for diabetes or with unmedicated diabetes will be enrolled in a lifestyle intervention training program that includes strategies to maintain a healthy weight, maintain healthy blood glucose levels, eat a healthy diet, increase physical activity, overcome barriers, and build social support. Participants will be assigned two goals to achieve during lifestyle classes; to increase the physical activity to at least 150 minutes per week of moderate level activity and lose at least 5% of their baseline body weight. Participants also will be given knowledge and tools necessary to improve their diet quality and quantity.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

  • BMI ≥23 kg/m2 and/or waist circumference ≥90 cm for men and ≥80 cm for women
  • Prediabetic (HbA1c of 5.7-6.4%) or diabetic (HbA1c≥6.5%)

排除标准

  • Currently taking any diabetes medications
  • Pregnant or breastfeeding
  • History of heart disease, current serious illness, or conditions which would impede participation in an unsupervised physical activity and diet change program

结局指标

主要结局

Number of Participants Reaching Two or More Cardiometabolic Risk Goals

时间窗: Annually up to 2 years

The primary outcome assessing program effectiveness is a composite of achieving two or more cardiometabolic risk goals; participants will be scored on the number of risk factors they improve on (0-3) with success delineated by a HbA1c decrease ≥0.5%; a systolic blood pressure decrease ≥5 mm Hg; and a decrease in plasma triglycerides ≥10 mg/dl. Number of participants reaching two or more cardiometabolic Risk Goals will be reported.

次要结局

  • Mean Body Weight(Baseline, Annually up to 2 years)
  • Number of New Diabetes Cases(Baseline, end of follow up (up to 2 years post-baseline))
  • Prevalence of Hypertension(Annually up to 2 years)
  • Mean Fasting Plasma Glucose(Baseline, annually up to 2 years)
  • Mean Low Density Lipoprotein (LDL)(Baseline, Annually up to 2 years)
  • Mean High Density Lipoprotein (HDL)(Baseline, Annually up to 2 years)
  • Blood Pressure (BP)(Baseline, Annually up to 2 years)
  • Mean Hemoglobin A1c (HbA1c) Level(Baseline, annually up to 2 years)
  • Waist Circumference(Baseline, Annually up to 2 years)
  • Number of Patients With Prediabetes or Newly Detected Diabetes That Achieve Normoglycemia Rates(End of study follow-up (Up to 2 years post-intervention))
  • Mean Body Mass Index (BMI)(Baseline, Annually up to 2 years)
  • Number of Patients Overweight or Obese(Baseline, Annually up to 2 years)
  • Mean Triglycerides Level(Baseline, annually up to 2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mary Beth Weber

Associate Professor

Emory University

研究点 (2)

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