Worksite Lifestyle Program for Reducing Diabetes and Cardiovascular Risk in India

Emory University

Status: Completed

Conditions: Diabetes; Obesity; Heart Disease

Treatments: Behavioral: Lifestyle Intervention Training Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02813668

R01HL125442 (U.S. NIH Grant/Contract)

IRB00080327

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,108 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

2,108 participants in 1 patient group

Lifestyle Intervention Training Program

Experimental group

Description:

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.

Treatment:

Behavioral: Lifestyle Intervention Training Program