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Worksite Lifestyle Program for Reducing Diabetes and Cardiovascular Risk in India

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02813668
Recruitment Status : Suspended (Study activities involving participants are suspended due to COVID-19)
First Posted : June 27, 2016
Last Update Posted : May 29, 2020
Sponsor:
Collaborators:
Public Health Foundation of India
Madras Diabetes Research Foundation
Information provided by (Responsible Party):
Venkat Narayan, Emory University

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 for 5 years.

Condition or disease Intervention/treatment Phase
Diabetes Heart Disease Obesity Behavioral: Lifestyle Intervention Training Program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2065 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Worksite Lifestyle Program for Reducing Diabetes and Cardiovascular Risk in India
Actual Study Start Date : May 2, 2017
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Arm Intervention/treatment
Experimental: Lifestyle Intervention Training Program
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
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 Outcome Measures :
  1. Percent of Participants Reaching Two or more Cardiometabolic Risk Goals [ Time Frame: End of Follow-Up (Up to Five 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.


Secondary Outcome Measures :
  1. Change in Blood Pressure [ Time Frame: Annually, Up to Five Years ]

    Blood pressure in mmHg will be measured with an automated blood pressure machine annually, from baseline to the end of study (up to five 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. Change in mean Hemoglobin A1c (HbA1c) Level [ Time Frame: Annually, Up to Five Years ]
    HbA1c will be assessed via blood draw and processing annually, from baseline to the end of study (up to five years).

  3. Diabetes Incidence [ Time Frame: Annually, Up to Five Years ]
    Diabetes incidence 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). Diabetes incidence will be collected annually, from baseline to the end of study (up to five years).

  4. Percent of Participants Reaching Cardiometabolic Risk Goals [ Time Frame: Annually, Up to Five Years ]
    The percentage of participants who reach 0, 1, 2 or 3 of the following cardiometabolic risk goals: a HbA1c decrease ≥0.5%; a systolic blood pressure decrease ≥5 mm Hg; and a decrease in plasma triglycerides ≥10 mg/dl. This percentage will be collected annually, from baseline to the end of study (up to five years).

  5. Change in Mean Fasting Plasma Glucose [ Time Frame: Annually, Up to Five Years ]
    Fasting plasma glucose will be assessed via blood draw. Fasting plasma glucose will be collected annually, from baseline to the end of study (up to five years). A normal fasting blood sugar on awakening is less under 100 mg/dl.

  6. Change in Mean Body Mass Index (BMI) [ Time Frame: Annually, Up to Five Years ]
    BMI will be calculated in kg/m2 from annual measures of height (m) and weight (kg). BMI will be collected annually, from baseline to the end of study (up to five years).

  7. Change in Mean Body Weight [ Time Frame: Annually, Up to Five Years ]
    Weight will be measured in kilograms using a digital scale. Weight will be collected annually, from baseline to the end of study (up to five years).

  8. Change in Waist circumference [ Time Frame: Annually, Up to Five 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 (up to five years).

  9. Change in Percent Overweight/Obese [ Time Frame: Annually, Up to Five Years ]
    The percentage of participants who are overweight or obese will be calculated from the body mass index annually, from baseline to the end of study (up to five years). Overweight and Obesity will be defined using WHO-recommended outpoints for Asian populations: overweight = BMI of 23-<27.5 kg/m2 and obese = BMI of 27.5 kg/m2 or greater.

  10. Prevalence of Hypertension [ Time Frame: Annually, Up to Five Years ]

    Prevalence of hypertension will be calculated from annual blood pressure measurements annually, from baseline to the end of study (up to five years). Hypertension is defined as the following:

    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


  11. Change in Mean Triglycerides Level [ Time Frame: Annually, Up to Five Years ]
    Plasma triglycerides will be assessed via blood draw and will be assessed annually, from baseline to the end of study (up to five years).

  12. Change in Mean Low Density Lipoprotein (LDL) [ Time Frame: Annually, Up to Five Years ]
    LDL cholesterol will be assessed via blood draw and will be measured annually, from baseline to the end of study (up to five years).

  13. Change in Mean High Density Lipoprotein (HDL) [ Time Frame: Annually, Up to Five Years ]
    HDL cholesterol will be assessed via blood draw and will be measured annually, from baseline to the end of study (up to five years).

  14. Change in Physical Activity assessed by the Global Physical Activity Questionnaire (GPAQ) [ Time Frame: Annually, Up to Five Years ]
    The GPAQ collects information on physical activity participation in three settings (or domains) as well as sedentary behavior, comprising 16 questions. A higher score indicates more vigorous physical activity.

  15. Quality of Life assessed by the EuroQol Five Dimensions (EQ-5D) Questionnaire [ Time Frame: Annually, Up to Five Years ]
    The EQ-5D is a standardized instrument for measuring generic health status. A higher score indicates a poorer quality of life.

  16. Self-reported health assessed by the Short Form (SF-12) Health Survey [ Time Frame: Annually, Up to Five Years ]
    The SF-12 asks participants to respond to questions regarding how they view their health and how frequently physical activity and mental health affect daily activities. Scores are based on a physical health scale (PCS) and a mental health scale (MCS). Lower scores indicate poorer health and higher scores indicate better health.

  17. Worker Absenteeism Rate [ Time Frame: Annually, Up to Five Years ]
    Worksite records will be reviewed to determine rates of worker absenteeism.

  18. Presenteeism [ Time Frame: Annually, Up to Five Years ]
    Worksite records will be reviewed to determine rates of worker presenteeism.

  19. Rate of Worker Turn-Over [ Time Frame: Annually, Up to Five Years ]
    Worksite records will be reviewed to determine rates of worker turn-over.

  20. Change in Lifestyle Class Attendance [ Time Frame: Baseline, Year 1 ]
    Attendance will be taken at each lifestyle education class and the number of diet and exercise records returned will be recorded at baseline and year 1 (duration of lifestyle class).

  21. Change in Healthy Diet Score [ Time Frame: Annually, Up to Five Years ]
    A healthy diet score will be calculated from the food frequency questionnaire and other diet related questions.

  22. Reaching Study Goals [ Time Frame: Baseline, Year 1 (the duration of the lifestyle education classes) ]
    Participants will be scored as reaching 0, 1, or 2 study goals if (1) they reach the weight loss goal of 7% or greater of baseline weight and/or (2) they reach the physical activity goal of increasing physical activity to 150 minutes or more of moderate-level activity per week.

  23. Program Fidelity [ Time Frame: Years 0-5 ]
    Program fidelity will be determined annually at each site by measuring study-affiliated activities by the health education team, study canteen, and worksite management, changes in the worksite environment, and management support for the program through checklists, audits of the canteens, and in-depth interviews with employees and managers/supervisors.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813668


Locations
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India
Madras Diabetes Research Foundation
Chennai, India
Public Health Foundation of India
New Delhi, India
Sponsors and Collaborators
Emory University
Public Health Foundation of India
Madras Diabetes Research Foundation
Investigators
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Principal Investigator: Venkat Narayan, MD Emory University
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Responsible Party: Venkat Narayan, Professor, Emory University
ClinicalTrials.gov Identifier: NCT02813668    
Other Study ID Numbers: IRB00080327
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Venkat Narayan, Emory University:
Nutrition
Occupational Health
Additional relevant MeSH terms:
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Heart Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cardiovascular Diseases