Randomized Control Trial for Overweight Employees in Worksites

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Behavioral: Lifestyle intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Overweight (≥23kg/m 2 ) individuals in the age group 25-55 years Individuals who are willing to participate in the study Exclusion Criteria: Previously diagnosed diabetics and patients with coronary artery disease. Have received any medication within last one month which could potentially influence insulin secretion, insulin sensitivity, (e.g. metformin, thiazolidinediones, steroids etc.) and on any medication that activate steroid and xenobiotic receptors Pregnant and lactating women Severe end organ damage or chronic diseases:renal/hepatic failure, any malignancy, major systemic illness etc. Known case of HIV infection Unwillingness to participate in the study

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Jindal Steel Pvt Ltd<br>Lifestyle intervention given | Behavioral: Lifestyle intervention<br>* Intervention Trial with Multi-Component Lifestyle Intervention for reduction of body weight and cardio-metabolic risk factors<br>|
| Experimental: Maruti Udyog Ltd<br>Lifestyle intervention given | Behavioral: Lifestyle intervention<br>* Intervention Trial with Multi-Component Lifestyle Intervention for reduction of body weight and cardio-metabolic risk factors<br>|
| No Intervention: Tata Capital<br>Control arm so no intervention given | |
| No Intervention: Powergrid Corporation<br>Control arm so no intervention given | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with reduced Body Mass Index | Body Mass Index measured in kg/m^2 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with reduced Fasting Blood Glucose | Fasting Blood Glucose measured in mg/dl | 6 months |