Randomized Control Trial for Overweight Employees in Worksites

Sponsor

Diabetes Foundation, India (Other)

Overall Status

Completed

CT.gov ID

NCT03249610

Collaborator

Sprim Advanced Life Sciences (Other), Abbott (Industry)

300

Enrollment

Arms

39.2

Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2 Metabolic Syndrome Lifestyle Risk Reduction	Behavioral: Lifestyle intervention	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Mar 11, 2014

Actual Primary Completion Date :

Mar 12, 2017

Actual Study Completion Date :

Jun 15, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Number of subjects with reduced Body Mass Index [6 months]
Body Mass Index measured in kg/m^2

Secondary Outcome Measures

Number of subjects with reduced Fasting Blood Glucose [6 months]
Fasting Blood Glucose measured in mg/dl

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Diabetes Foundation, India
Sprim Advanced Life Sciences
Abbott

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr Anoop Misra, Professor, Diabetes Foundation, India

ClinicalTrials.gov Identifier:

NCT03249610

Other Study ID Numbers:

Worksite_2014

First Posted:

Aug 15, 2017

Last Update Posted:

Aug 15, 2017

Last Verified:

Aug 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Metabolic Syndrome

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Aug 15, 2017