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Randomized Control Trial for Overweight Employees in Worksites

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lifestyle intervention
Sponsored by
Diabetes Foundation, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 2

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    No Intervention

    No Intervention

    Arm Label

    Jindal Steel Pvt Ltd

    Maruti Udyog Ltd

    Tata Capital

    Powergrid Corporation

    Arm Description

    Lifestyle intervention given

    Lifestyle intervention given

    Control arm so no intervention given

    Control arm so no intervention given

    Outcomes

    Primary Outcome Measures

    Number of subjects with reduced Body Mass Index
    Body Mass Index measured in kg/m^2

    Secondary Outcome Measures

    Number of subjects with reduced Fasting Blood Glucose
    Fasting Blood Glucose measured in mg/dl

    Full Information

    First Posted
    July 1, 2017
    Last Updated
    August 12, 2017
    Sponsor
    Diabetes Foundation, India
    Collaborators
    Sprim Advanced Life Sciences, Abbott
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03249610
    Brief Title
    Randomized Control Trial for Overweight Employees in Worksites
    Official Title
    Worksite Intervention Trial With Multi-Component Lifestyle Intervention and Digital Health Platform for Reduction of Body Weight and Cardio-metabolic Risk Factors
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 11, 2014 (Actual)
    Primary Completion Date
    March 12, 2017 (Actual)
    Study Completion Date
    June 15, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Diabetes Foundation, India
    Collaborators
    Sprim Advanced Life Sciences, Abbott

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 2, Metabolic Syndrome, Lifestyle Risk Reduction

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    300 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Jindal Steel Pvt Ltd
    Arm Type
    Experimental
    Arm Description
    Lifestyle intervention given
    Arm Title
    Maruti Udyog Ltd
    Arm Type
    Experimental
    Arm Description
    Lifestyle intervention given
    Arm Title
    Tata Capital
    Arm Type
    No Intervention
    Arm Description
    Control arm so no intervention given
    Arm Title
    Powergrid Corporation
    Arm Type
    No Intervention
    Arm Description
    Control arm so no intervention given
    Intervention Type
    Behavioral
    Intervention Name(s)
    Lifestyle intervention
    Intervention Description
    Intervention Trial with Multi-Component Lifestyle Intervention for reduction of body weight and cardio-metabolic risk factors
    Primary Outcome Measure Information:
    Title
    Number of subjects with reduced Body Mass Index
    Description
    Body Mass Index measured in kg/m^2
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Number of subjects with reduced Fasting Blood Glucose
    Description
    Fasting Blood Glucose measured in mg/dl
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dr. Anoop Misra
    Organizational Affiliation
    Diabetes Foundation, India
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29318159
    Citation
    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.
    Results Reference
    derived

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