<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03249610</url>
  </required_header>
  <id_info>
    <org_study_id>Worksite_2014</org_study_id>
    <nct_id>NCT03249610</nct_id>
  </id_info>
  <brief_title>Randomized Control Trial for Overweight Employees in Worksites</brief_title>
  <official_title>Worksite Intervention Trial With Multi-Component Lifestyle Intervention and Digital Health Platform for Reduction of Body Weight and Cardio-metabolic Risk Factors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Diabetes Foundation, India</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sprim Advanced Life Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Abbott</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Diabetes Foundation, India</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Impact of lifestyle intervention in at-risk Asian Indians at worksite remains largely&#xD;
      unexplored. The aim of this study was to assess impact of the multi-component interventions&#xD;
      on body weight, body fat patterning and cardio-metabolic risk factors in overweight&#xD;
      individuals working in corporate worksites in New Delhi, north India.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized open label clinical trial is planned in 4 worksites. The total study duration is&#xD;
      18 months. Four workplace sites will be divided into two active intervention and two control&#xD;
      sites. Intensive awareness generation activities for overweight and obese employees and a&#xD;
      general awareness health, nutrition and physical education programme for the rest of the&#xD;
      employees. The study subjects will be part of awareness sessions which will be conducted in&#xD;
      the 6 month intervention period. Besides group sessions individual diet charts will also be&#xD;
      worked out by a trained nutritionist. Physical activity advice will be provided to them&#xD;
      keeping their specific requirements in mind. Pedometers will be provided to them and they&#xD;
      will be encouraged to walk for 15 minutes in pre-lunch period. Leg movements at the desk will&#xD;
      also be encouraged.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 11, 2014</start_date>
  <completion_date type="Actual">June 15, 2017</completion_date>
  <primary_completion_date type="Actual">March 12, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of subjects with reduced Body Mass Index</measure>
    <time_frame>6 months</time_frame>
    <description>Body Mass Index measured in kg/m^2</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with reduced Fasting Blood Glucose</measure>
    <time_frame>6 months</time_frame>
    <description>Fasting Blood Glucose measured in mg/dl</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <condition>Metabolic Syndrome</condition>
  <condition>Lifestyle Risk Reduction</condition>
  <arm_group>
    <arm_group_label>Jindal Steel Pvt Ltd</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lifestyle intervention given</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Maruti Udyog Ltd</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lifestyle intervention given</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tata Capital</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control arm so no intervention given</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Powergrid Corporation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control arm so no intervention given</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Lifestyle intervention</intervention_name>
    <description>Intervention Trial with Multi-Component Lifestyle Intervention for reduction of body weight and cardio-metabolic risk factors</description>
    <arm_group_label>Jindal Steel Pvt Ltd</arm_group_label>
    <arm_group_label>Maruti Udyog Ltd</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Overweight (≥23kg/m 2 ) individuals in the age group 25-55 years&#xD;
&#xD;
          -  Individuals who are willing to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previously diagnosed diabetics and patients with coronary artery disease.&#xD;
&#xD;
          -  Have received any medication within last one month which could potentially influence&#xD;
             insulin secretion, insulin sensitivity, (e.g. metformin, thiazolidinediones, steroids&#xD;
             etc.) and on any medication that activate steroid and xenobiotic receptors&#xD;
&#xD;
          -  Pregnant and lactating women&#xD;
&#xD;
          -  Severe end organ damage or chronic diseases:renal/hepatic failure, any malignancy,&#xD;
             major systemic illness etc.&#xD;
&#xD;
          -  Known case of HIV infection&#xD;
&#xD;
          -  Unwillingness to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr. Anoop Misra</last_name>
    <role>Principal Investigator</role>
    <affiliation>Diabetes Foundation, India</affiliation>
  </overall_official>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>August 12, 2017</last_update_submitted>
  <last_update_submitted_qc>August 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Diabetes Foundation, India</investigator_affiliation>
    <investigator_full_name>Dr Anoop Misra</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03249610
org study id: Worksite_2014
nct id: NCT03249610
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Number of subjects with reduced Body Mass Index
time frame: 6 months
description: Body Mass Index measured in kg/m^2
measure: Number of subjects with reduced Fasting Blood Glucose
time frame: 6 months
description: Fasting Blood Glucose measured in mg/dl
arm group label: Jindal Steel Pvt Ltd
arm group type: Experimental
description: Lifestyle intervention given
arm group label: Maruti Udyog Ltd
arm group type: Experimental
description: Lifestyle intervention given
arm group label: Tata Capital
arm group type: No Intervention
description: Control arm so no intervention given
arm group label: Powergrid Corporation
arm group type: No Intervention
description: Control arm so no intervention given
intervention type: Behavioral
intervention name: Lifestyle intervention
description: Intervention Trial with Multi-Component Lifestyle Intervention for reduction of body weight and cardio-metabolic risk factors
arm group label: Jindal Steel Pvt Ltd
arm group label: Maruti Udyog Ltd
criteria: 
gender: All
minimum age: 25 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dr. Anoop Misra
role: Principal Investigator
affiliation: Diabetes Foundation, India
responsible party type: Principal Investigator
investigator affiliation: Diabetes Foundation, India
investigator full name: Dr Anoop Misra
investigator title: Professor
mesh term: Metabolic Syndrome
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No