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NCT Number: NCT02813668

Worksite Lifestyle Program for Reducing Diabetes and Cardiovascular Risk in India

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.

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Key information

Conditions

Diabetes Body Weight Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Disease Heart Diseases Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Madras Diabetes Research Foundation, Chennai, India

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Intervention Training Program

Behavioral

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.

Primary outcomes

  1. 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

  1. Blood Pressure (BP)

    Time frame: Baseline, Annually up to 2 years

    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

  2. Mean Hemoglobin A1c (HbA1c) Level

    Time frame: Baseline, annually up to 2 years

    HbA1c will be assessed via blood draw and processing annually, from baseline to the end of study follow-up (up to 2 years).

  3. Number of New Diabetes Cases

    Time frame: Baseline, end of follow up (up to 2 years post-baseline)

    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).

  4. Mean Fasting Plasma Glucose

    Time frame: Baseline, annually up to 2 years

    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.

  5. Mean Body Mass Index (BMI)

    Time frame: Baseline, Annually up to 2 years

    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).

  6. Mean Body Weight

    Time frame: Baseline, Annually up to 2 years

    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).

  7. Waist Circumference

    Time frame: Baseline, Annually up to 2 years

    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).

  8. Number of Patients Overweight or Obese

    Time frame: Baseline, Annually up to 2 years

    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.

  9. Prevalence of Hypertension

    Time frame: Annually up to 2 years

    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.

  10. Mean Triglycerides Level

    Time frame: Baseline, annually up to 2 years

    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).

  11. Mean Low Density Lipoprotein (LDL)

    Time frame: Baseline, Annually up to 2 years

    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).

  12. Mean High Density Lipoprotein (HDL)

    Time frame: Baseline, Annually up to 2 years

    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).

  13. Number of Patients With Prediabetes or Newly Detected Diabetes That Achieve Normoglycemia Rates

    Time frame: End of study follow-up (Up to 2 years post-intervention)

    Number of participants with Dysglycemia (HbA1c > 5.7%) that reach normoglycemia (HbA1c < 5.7%) at the end of the study (up to two years).

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Madras Diabetes Research Foundation
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Public Health Foundation of India

Registry information

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jun 27, 2016
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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