Worksite Lifestyle Program for Reducing Diabetes and Cardiovascular Risk in India
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes
- Sponsor
- Emory University
- Enrollment
- 2108
- Locations
- 2
- Primary Endpoint
- Number of Participants Reaching Two or More Cardiometabolic Risk Goals
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Mary Beth Weber
Associate Professor
Emory University
Eligibility Criteria
Inclusion Criteria
- •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%)
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Number of Participants Reaching Two or More Cardiometabolic Risk Goals
Time Frame: 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.
Secondary Outcomes
- 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)