Randomized Control Trial for Overweight Employees in Worksites

August 12, 2017 updated by: Dr Anoop Misra, Diabetes Foundation, India

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects with reduced Body Mass Index
Time Frame: 6 months
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
Time Frame: 6 months
Fasting Blood Glucose measured in mg/dl
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diabetes Foundation, India

Collaborators

Sprim Advanced Life Sciences
Abbott

Investigators

  • Principal Investigator: Dr. Anoop Misra, Diabetes Foundation, India

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2014

Primary Completion (Actual)

March 12, 2017

Study Completion (Actual)

June 15, 2017

Study Registration Dates

First Submitted

July 1, 2017

First Submitted That Met QC Criteria

August 12, 2017

First Posted (Actual)

August 15, 2017

Study Record Updates

Last Update Posted (Actual)

August 15, 2017

Last Update Submitted That Met QC Criteria

August 12, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Worksite_2014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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