NCT02813668

Worksite Lifestyle Program for Reducing Diabetes and Cardiovascular Risk in India

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,108 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes
• Heart Disease
• Obesity

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-05-02
• Primary completion: 2022-01-15
• Completion: 2022-01-15
• First posted: 2016-06-27
• Last updated: 2023-09-21
• Results posted: 2023-09-08

Locations

2 sites across 1 country: India