N/A
N=2,108
Worksite Lifestyle Program for Reducing Diabetes and Cardiovascular Risk in India
Diabetes · Heart Disease · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT02813668 ↗Enrolled (actual)
2,108
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Number of Participants Reaching Two or More Cardiometabolic Risk Goals — 485; 351 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lifestyle Intervention Training Program (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reaching Two or More Cardiometabolic Risk Goals |
485; 351 | — |
| SECONDARY Blood Pressure (BP) |
132.28; 127; 128.4; 85.21; 83.6; 83.8 | — |
| SECONDARY Mean Hemoglobin A1c (HbA1c) Level |
6.41; 6.1; 6.3 | — |
| SECONDARY Number of New Diabetes Cases |
660; 481 | — |
| SECONDARY Mean Fasting Plasma Glucose |
105.80; 108.6; 113.6 | — |
| SECONDARY Mean Body Mass Index (BMI) |
27.35; 27.2; 27.1 | — |
| SECONDARY Mean Body Weight |
74.2; 73.4; 72.7 | — |
| SECONDARY Waist Circumference |
95.5; 93.7; 94.0 | — |
| SECONDARY Number of Patients Overweight or Obese |
639; 653; 604; 863; 604; 524 | — |
| SECONDARY Prevalence of Hypertension |
388; 307; 68; 13; 357; 280 | — |
| SECONDARY Mean Triglycerides Level |
140.58; 148.8; 155.8 | — |
| SECONDARY Mean Low Density Lipoprotein (LDL) |
117.0; 119.0; 121.6 | — |
| SECONDARY Mean High Density Lipoprotein (HDL) |
43.54; 44.2; 43.9 | — |
| SECONDARY Number of Patients With Prediabetes or Newly Detected Diabetes That Achieve Normoglycemia Rates |
330 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02813668). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.