Randomized Control Trial for Overweight Employees in Worksites

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-11

Study Completion Date

2017-06-15

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.

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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.

Conditions

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Diabetes Mellitus, Type 2 Metabolic Syndrome Lifestyle Risk Reduction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Jindal Steel Pvt Ltd

Lifestyle intervention given

Group Type EXPERIMENTAL

Lifestyle intervention

Intervention Type BEHAVIORAL

Intervention Trial with Multi-Component Lifestyle Intervention for reduction of body weight and cardio-metabolic risk factors

Maruti Udyog Ltd

Lifestyle intervention given

Group Type EXPERIMENTAL

Lifestyle intervention

Intervention Type BEHAVIORAL

Intervention Trial with Multi-Component Lifestyle Intervention for reduction of body weight and cardio-metabolic risk factors

Tata Capital

Control arm so no intervention given

Group Type NO_INTERVENTION

No interventions assigned to this group

Powergrid Corporation

Control arm so no intervention given

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lifestyle intervention

Intervention Trial with Multi-Component Lifestyle Intervention for reduction of body weight and cardio-metabolic risk factors

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes