Clinical trial NCT02813668: Worksite Lifestyle Program for Reducing Diabetes and Cardiovascular Risk in India
Official title: Worksite Lifestyle Program for Reducing Diabetes and Cardiovascular Risk in India
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Heart Disease
Obesity
Keywords: Nutrition
Occupational Health
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Public Health Foundation of India
name: Madras Diabetes Research Foundation
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2016-06-27
Enrollment: 2108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
measure: Number of Participants Reaching Two or More Cardiometabolic Risk Goals
timeFrame: Annually up to 2 years
Secondary outcomes:
measure: Blood Pressure (BP)
timeFrame: Baseline, Annually up to 2 years
measure: Mean Hemoglobin A1c (HbA1c) Level
timeFrame: Baseline, annually up to 2 years
measure: Number of New Diabetes Cases
timeFrame: Baseline, end of follow up (up to 2 years post-baseline)
measure: Mean Fasting Plasma Glucose
timeFrame: Baseline, annually up to 2 years
measure: Mean Body Mass Index (BMI)
timeFrame: Baseline, Annually up to 2 years
measure: Mean Body Weight
timeFrame: Baseline, Annually up to 2 years
measure: Waist Circumference
timeFrame: Baseline, Annually up to 2 years
measure: Number of Patients Overweight or Obese
timeFrame: Baseline, Annually up to 2 years
measure: Prevalence of Hypertension
timeFrame: Annually up to 2 years
measure: Mean Triglycerides Level
timeFrame: Baseline, annually up to 2 years
measure: Mean Low Density Lipoprotein (LDL)
timeFrame: Baseline, Annually up to 2 years
measure: Mean High Density Lipoprotein (HDL)
timeFrame: Baseline, Annually up to 2 years
measure: Number of Patients With Prediabetes or Newly Detected Diabetes That Achieve Normoglycemia Rates
timeFrame: End of study follow-up (Up to 2 years post-intervention)
Other outcomes:
Locations:
city: Chennai
country: India
facility: Madras Diabetes Research Foundation
city: New Delhi
country: India
facility: Public Health Foundation of India
Study officials:
affiliation: Emory University
name: Mary Beth Weber, PhD
role: PRINCIPAL_INVESTIGATOR
References: