Worksite Lifestyle Program for Reducing Diabetes and Cardiovascular Risk in India

• ClinicalTrials.gov Identifier: NCT02813668
• Recruitment Status: Completed
• First Posted: June 27, 2016
• Results First Posted: September 8, 2023
• Last Update Posted: September 21, 2023
• Sponsor: Emory University
• Collaborators: Public Health Foundation of India; Madras Diabetes Research Foundation; National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): Mary Beth Weber, Emory University

Study Description

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.

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 2108 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
• Actual Primary Completion Date: January 15, 2022
• Actual Study Completion Date: January 15, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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).

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Mary Beth Weber, PhD; Emory University

  Study Documents (Full-Text)

Documents provided by Mary Beth Weber, Emory University:

Study Protocol and Statistical Analysis Plan  [PDF] March 31, 2023

Informed Consent Form  [PDF] November 27, 2018

More Information

• Responsible Party: Mary Beth Weber, Associate Professor, Emory University
• ClinicalTrials.gov Identifier: NCT02813668
• Other Study ID Numbers: IRB00080327; R01HL125442 ( U.S. NIH Grant/Contract )
• First Posted: June 27, 2016
• Results First Posted: September 8, 2023
• Last Update Posted: September 21, 2023
• Last Verified: September 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mary Beth Weber, Emory University:

Nutrition; Occupational Health

Additional relevant MeSH terms:

Heart Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Cardiovascular Diseases