NCT03249610

Randomized Control Trial for Overweight Employees in Worksites

Worksite Intervention Trial With Multi-Component Lifestyle Intervention and Digital Health Platform for Reduction of Body Weight and Cardio-metabolic Risk Factors

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Diabetes Foundation, India · Academic / Other
• Sex: All
• Age: 25 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Impact of lifestyle intervention in at-risk Asian Indians at worksite remains largely unexplored. The aim of this study was to assess impact of the multi-component interventions on body weight, body fat patterning and cardio-metabolic risk factors in overweight individuals working in corporate worksites in New Delhi, north India.

Detailed description

A randomized open label clinical trial is planned in 4 worksites. The total study duration is 18 months. Four workplace sites will be divided into two active intervention and two control sites. Intensive awareness generation activities for overweight and obese employees and a general awareness health, nutrition and physical education programme for the rest of the employees. The study subjects will be part of awareness sessions which will be conducted in the 6 month intervention period. Besides group sessions individual diet charts will also be worked out by a trained nutritionist. Physical activity advice will be provided to them keeping their specific requirements in mind. Pedometers will be provided to them and they will be encouraged to walk for 15 minutes in pre-lunch period. Leg movements at the desk will also be encouraged.

Conditions

• Diabetes Mellitus, Type 2
• Metabolic Syndrome
• Lifestyle Risk Reduction

Interventions

Type	Name	Description
BEHAVIORAL	Lifestyle intervention	Intervention Trial with Multi-Component Lifestyle Intervention for reduction of body weight and cardio-metabolic risk factors

Timeline

• Start date: 2014-03-11
• Primary completion: 2017-03-12
• Completion: 2017-06-15
• First posted: 2017-08-15
• Last updated: 2017-08-15