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
1 other identifier
interventional
300
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
Started Mar 2014
Longer than P75 for not_applicable diabetes-mellitus-type-2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 12, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2017
CompletedFirst Submitted
Initial submission to the registry
July 1, 2017
CompletedFirst Posted
Study publicly available on registry
August 15, 2017
CompletedAugust 15, 2017
August 1, 2017
3 years
July 1, 2017
August 12, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Number of subjects with reduced Body Mass Index
Body Mass Index measured in kg/m\^2
6 months
Secondary Outcomes (1)
Number of subjects with reduced Fasting Blood Glucose
6 months
Study Arms (4)
Jindal Steel Pvt Ltd
EXPERIMENTALLifestyle intervention given
Maruti Udyog Ltd
EXPERIMENTALLifestyle intervention given
Tata Capital
NO INTERVENTIONControl arm so no intervention given
Powergrid Corporation
NO INTERVENTIONControl arm so no intervention given
Interventions
Intervention Trial with Multi-Component Lifestyle Intervention for reduction of body weight and cardio-metabolic risk factors
Eligibility Criteria
You may qualify if:
- Overweight (≥23kg/m 2 ) individuals in the age group 25-55 years
- Individuals who are willing to participate in the study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Diabetes Foundation, Indialead
- Sprim Advanced Life Sciencescollaborator
- Abbottcollaborator
Related Publications (1)
Shrivastava U, Fatma M, Mohan S, Singh P, Misra A. Randomized Control Trial for Reduction of Body Weight, Body Fat Patterning, and Cardiometabolic Risk Factors in Overweight Worksite Employees in Delhi, India. J Diabetes Res. 2017;2017:7254174. doi: 10.1155/2017/7254174. Epub 2017 Nov 29.
PMID: 29318159DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr. Anoop Misra
Diabetes Foundation, India
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 1, 2017
First Posted
August 15, 2017
Study Start
March 11, 2014
Primary Completion
March 12, 2017
Study Completion
June 15, 2017
Last Updated
August 15, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will not share