Worksite Lifestyle Program for Reducing Diabetes and Cardiovascular Risk in India

Obesity Clinical Trial

Official title:

Worksite Lifestyle Program for Reducing Diabetes and Cardiovascular Risk in India

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02813668
• Other study ID #: IRB00080327
• Secondary ID: R01HL125442
• Status: Completed
• Phase: N/A
• Start date: May 2, 2017
• Est. completion date: January 15, 2022

Study information

• Verified date: September 2023
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2108
• Est. completion date: January 15, 2022
• Est. primary completion date: January 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Heart Disease
• Heart Diseases
• Obesity

Intervention

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.

Locations

Country	Name	City	State
India	Madras Diabetes Research Foundation	Chennai
India	Public Health Foundation of India	New Delhi

Sponsors (4)

Lead Sponsor	Collaborator
Emory University	Madras Diabetes Research Foundation, National Heart, Lung, and Blood Institute (NHLBI), Public Health Foundation of India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)