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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

Tracking Information
First Submitted Date  ICMJE June 17, 2016
First Posted Date  ICMJE June 27, 2016
Last Update Posted Date May 29, 2020
Actual Study Start Date  ICMJE May 2, 2017
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2016)
  • 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
  • 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).
  • 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).
  • 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).
  • 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.
  • 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).
  • 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).
  • 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).
  • 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.
  • 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
  • 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).
  • 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).
  • 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).
  • 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.
  • 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.
  • 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.
  • Worker Absenteeism Rate [ Time Frame: Annually, Up to Five Years ]
    Worksite records will be reviewed to determine rates of worker absenteeism.
  • Presenteeism [ Time Frame: Annually, Up to Five Years ]
    Worksite records will be reviewed to determine rates of worker presenteeism.
  • Rate of Worker Turn-Over [ Time Frame: Annually, Up to Five Years ]
    Worksite records will be reviewed to determine rates of worker turn-over.
  • 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).
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Worksite Lifestyle Program for Reducing Diabetes and Cardiovascular Risk in India
Official Title  ICMJE Worksite Lifestyle Program for Reducing Diabetes and Cardiovascular Risk in India
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Diabetes
  • Heart Disease
  • Obesity
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Behavioral: Lifestyle Intervention Training Program
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Actual Enrollment  ICMJE
 (submitted: May 21, 2019)
2065
Original Estimated Enrollment  ICMJE
 (submitted: June 22, 2016)
2000
Estimated Study Completion Date  ICMJE January 2021
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02813668
Other Study ID Numbers  ICMJE IRB00080327
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Venkat Narayan, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE
  • Public Health Foundation of India
  • Madras Diabetes Research Foundation
Investigators  ICMJE
Principal Investigator: Venkat Narayan, MD Emory University
PRS Account Emory University
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP