Worksite Lifestyle Program for Reducing Diabetes and Cardiovascular Risk in India

Study Overview
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Brief Summary
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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
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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.

Official Title
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Worksite Lifestyle Program for Reducing Diabetes and Cardiovascular Risk in India

Conditions
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Diabetes, Heart Disease, Obesity

Intervention / Treatment
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* Behavioral: Lifestyle Intervention Training Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle Intervention Training Program<br>Participants at risk for developing diabetes or with unmedicated diabetes will participate in a lifestyle intervention training program. Individuals in the training program, as well as un-enrolled workers at the study sites, will be exposed to positive changes at the worksite to promote increased physical activity and healthier diets. | Behavioral: Lifestyle Intervention Training Program<br>* Participants will be placed into a peer-led classes of 10 to 12 people. The curriculum contains sixteen core sessions that occur weekly for four months followed by an eight month maintenance period. During lifestyle classes, participants will learn strategies for eating a healthy diet, increasing physical activity, overcoming barriers, building social support, reaching and maintaining a healthy wait, and maintaining healthy blood glucose levels. Participants will also be assigned goals to achieve; increasing physical activity and losing 5% of their baseline body weight. During maintenance, participants will receive biweekly SMS text messages providing lifestyle advice tips and encouragement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Reaching Two or More Cardiometabolic Risk Goals | 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. | Annually up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure (BP) | Blood pressure in mmHg will be measured with an automated blood pressure machine annually, from baseline to the end of follow-up (up to two years). Blood pressure measurements are as follows: Normal = systolic, less than 120 and diastolic, less than 80 Prehypertension = systolic, 120 - 139 or diastolic , 80 - 89 High Blood Pressure/(Hypertension) Stage 1 = systolic, 140 - 159 or diastolic, 90 - 99 High Blood Pressure (Hypertension) Stage 2 = systolic, 160 or higher or diastolic, 100 or higher Hypertensive Crisis (Emergency care needed) = systolic, Higher than 180 or diastolic, Higher than 110 | Baseline, Annually up to 2 years | 
| Mean Hemoglobin A1c (HbA1c) Level | HbA1c will be assessed via blood draw and processing annually, from baseline to the end of study follow-up (up to 2 years). | Baseline, annually up to 2 years | 
| Number of New Diabetes Cases | Number of new cases of diabetes is the number of participants diagnosed with a new onset of diabetes using the HbA1c test (HbA1c levels of 6.5% or higher indicate diabetes). Number of new cases of diabetes will be collected annually, from baseline to the end of study follow-up (up to 2 years). | Baseline, end of follow up (up to 2 years post-baseline) | 
| Mean Fasting Plasma Glucose | Fasting plasma glucose will be assessed via blood draw. Fasting plasma glucose will be collected annually, from baseline to the end of study follow-up (up to 2 years). A normal fasting blood sugar on awakening is less under 100 mg/dl. | Baseline, annually up to 2 years | 
| Mean Body Mass Index (BMI) | BMI will be calculated in kg/m^2 from annual measures of height (m) and weight (kg). BMI will be collected annually, from baseline to the end of study follow-up (up to 2 years). | Baseline, Annually up to 2 years | 
| Mean Body Weight | Weight will be measured in kilograms using a digital scale. Weight will be collected annually post-intervention from baseline to the end of study follow-up (up to 2 years). | Baseline, Annually up to 2 years | 
| Waist Circumference | Waist circumference will be measured in centimeters using a non-elastic measuring tape. Waist circumference will be collected annually, from baseline to the end of study follow-up (up to 2 years). | Baseline, Annually up to 2 years | 
| Number of Patients Overweight or Obese | The number of participants of participants who are overweight or obese will be calculated from the body mass index annually, from baseline to the end of study follow-up (up to two years). Overweight and Obesity will be defined using WHO-recommended outpoints for Asian populations: overweight = BMI of 23-<27.5 kg/m^2 and obese = BMI of 27.5 kg/m2 or greater. | Baseline, Annually up to 2 years | 
| Prevalence of Hypertension | Number of participants with hypertension will be calculated from annual blood pressure measurements, from baseline to the end of study follow-up (up to two years). Hypertension is defined as the following: Stage 1: systolic 140 - 159 mmHg or diastolic 90 - 99 mmHg; Stage 2: systolic 160 mmHg or higher, or diastolic 100 mmHg or higher; hypertensive crisis (emergency care needed): systolic higher than 180 mmHg or diastolic higher than 110 mmHg. | Annually up to 2 years | 
| Mean Triglycerides Level | Plasma triglycerides will be assessed via blood draw and will be assessed annually, from baseline to the end of study follow-up (up to two years). | Baseline, annually up to 2 years | 
| Mean Low Density Lipoprotein (LDL) | LDL cholesterol will be assessed via blood draw and will be measured annually, from baseline to the end of study follow-up (up to two years). | Baseline, Annually up to 2 years | 
| Mean High Density Lipoprotein (HDL) | HDL cholesterol will be assessed via blood draw and will be measured annually, from baseline to the end of study follow-up (up to 2 years). | Baseline, Annually up to 2 years | 
| Number of Patients With Prediabetes or Newly Detected Diabetes That Achieve Normoglycemia Rates | Number of participants with Dysglycemia (HbA1c > 5.7%) that reach normoglycemia (HbA1c < 5.7%) at the end of the study (up to two years). | End of study follow-up (Up to 2 years post-intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutrition, Occupational Health