<clinical_study>
  <!-- This xml conforms to an XML Schema at:
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  <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/NCT01703611</url>
  </required_header>
  <id_info>
    <org_study_id>Academy-India-1</org_study_id>
    <secondary_id>IINS-ANDF/2011/01</secondary_id>
    <nct_id>NCT01703611</nct_id>
  </id_info>
  <brief_title>Diabetes in India Nutrition Guidelines Study (DINGS)</brief_title>
  <acronym>DINGS</acronym>
  <official_title>Diabetes in India Nutrition Guidelines Study (DINGS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Academy of Nutrition and Dietetics</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Indian Institute of Nutritional Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Abbott Healthcare Private Limited (in India)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Academy of Nutrition and Dietetics</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A clinical trial to compare the patient outcomes from usual nutrition therapy by dietitians&#xD;
      in India to patient outcomes from guideline-based Medical Nutrition Therapy (MNT).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A cluster randomized clinical trial to compare patient outcomes from two different nutrition&#xD;
      interventions by dietitians in India for persons with Type 2 Diabetes Mellitus (usual care vs&#xD;
      Medical Nutrition Therapy provided according to the Academy of Nutrition and Dietetics&#xD;
      Evidence-Based Nutrition Practice Guidelines)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HbAIc decrease</measure>
    <time_frame>6 months and 12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Weight change</measure>
    <time_frame>6 month and 12 month</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Lipid panel</measure>
    <time_frame>6 month and 12 month</time_frame>
    <description>Total Cholesterol, LDL Cholesterol, HDL Cholesterol and Triglycerides</description>
  </other_outcome>
  <other_outcome>
    <measure>Blood pressure</measure>
    <time_frame>6 months and 12 months</time_frame>
    <description>Systolic and Diastolic change from baseline measure</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">238</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>MNT according to AND EBNPG for Type 2 DM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Six or more Medical Nutrition Therapy visits(education and counseling on diet, self management, and lifestyle changes) provided over a 12 month period according to Academy of Nutrition and Dietetic Evidence Based Nutrition Practice Guidelines (EBPGN) (www.guidelines.gov)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Nutrition Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Visits for usual nutrition therapy (diet and lifestyle changes) provided by dietitians over a 12 month period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MNT according to AND EBNPG for Type 2 DM</intervention_name>
    <description>Six or more Medical Nutrition Therapy visits(education and counseling on diet, self management, and lifestyle changes) provided over a 12 month period according to Academy of Nutrition and Dietetic Evidence Based Nutrition Practice Guidelines (EBNPG)(www.guidelines.gov)</description>
    <arm_group_label>MNT according to AND EBNPG for Type 2 DM</arm_group_label>
    <other_name>Nutrition Counseling</other_name>
    <other_name>Nutrition Care</other_name>
    <other_name>Nutrition Therapy</other_name>
    <other_name>Evidence Based Nutrition Practice</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual Nutrition Care</intervention_name>
    <description>Usual nutrition care in India</description>
    <arm_group_label>Usual Nutrition Care</arm_group_label>
    <other_name>Nutrition Counselling</other_name>
    <other_name>Nutrition Therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion and exclusion criteria for participant selection is listed both for the&#xD;
        dietitians and patient participants.&#xD;
&#xD;
        Dietitian Participant&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  RD and Indian ICC CDE RD&#xD;
&#xD;
          -  Active practice (at least two years post-professional degree), with enough newly&#xD;
             diagnosed type 2 DM patients or patients not seen by an RD for the previous year, to&#xD;
             be able to recruit four to six of them into the study each week&#xD;
&#xD;
               -  Work in an Diabetes centers and hospital diabetes outpatient or private practice&#xD;
                  with diabetologist to provide medical oversight for study&#xD;
&#xD;
               -  Have written approval from immediate supervisor and diabetologist indicating that&#xD;
                  MNT visits can be provided without cost to research study in accordance with ADA&#xD;
                  EBNPG and data collection can be accommodated.&#xD;
&#xD;
               -  Have computer and internet access. Minimum requirements are Microsoft Internet&#xD;
                  Explorer 8.0 with 1024 x 768 screen resolution in 256 colors. The browser must be&#xD;
                  enabled for Java, JavaScript and cookies&#xD;
&#xD;
               -  Have stable internet connection (no prolonged periods without or frequent&#xD;
                  disruptions in internet service&#xD;
&#xD;
               -  Have land phone line and faxing capabilities&#xD;
&#xD;
               -  Able to provide data documentation electronically or in a paper format&#xD;
&#xD;
               -  Obtain approval from their facility's Independent Ethics Committee (equivalent to&#xD;
                  US Institutional Review Board) for participation in the study (if required by the&#xD;
                  institution)&#xD;
&#xD;
               -  Able to adjust the institution's habitual counseling session schedule and&#xD;
                  duration as required by the study protocol&#xD;
&#xD;
               -  Commit to attendance during the full course of face to face training for three&#xD;
                  days (including part of a weekend), to be held at Chennai, India, and participate&#xD;
                  in the Webinars and conference calls&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Small clientele of adult type 2 DM,&#xD;
&#xD;
          -  Fewer than two years' active clinical practice experience post-professional degree,&#xD;
&#xD;
          -  Unable to comply with the other inclusion criteria (see inclusion section above).&#xD;
&#xD;
        Patient Participant&#xD;
&#xD;
        Patients' Inclusion Criteria:&#xD;
&#xD;
          -  Must be over 19 years of age&#xD;
&#xD;
          -  Must have medical diagnosis for treatment of type 2 DM,&#xD;
&#xD;
          -  Patient must agree to return for follow-up visits (or data collection visit) during&#xD;
             the 12 months study period&#xD;
&#xD;
          -  Not seen by RD for one year prior to being recruited to the study&#xD;
&#xD;
        Patients' Exclusion Criteria:&#xD;
&#xD;
          -  Currently being seen by RD for MNT&#xD;
&#xD;
          -  Participated in nutritional consults with RD in past year&#xD;
&#xD;
          -  Having insulin prescribed for DM treatment at time of recruitment&#xD;
&#xD;
          -  Pregnant or lactating at time of study&#xD;
&#xD;
          -  History of end stage renal disease or renal insufficiency; history of CVA, CAD or MI;&#xD;
             COPD; CHF; untreated depression; severe psychiatric illness; cancer diagnosis in&#xD;
             previous two years or on-going radiation or chemotherapy treatment&#xD;
&#xD;
          -  Unplanned surgery requiring more than one overnight stay in the hospital within the&#xD;
             previous week to initial visit&#xD;
&#xD;
          -  The presence of cognitive or physical limitations that preclude making lifestyle or&#xD;
             dietary changes as assessed by the RD during the initial interview&#xD;
&#xD;
          -  Unable to return to office for data collection at 6 and 12 months and unable to commit&#xD;
             to follow-up visits for EBNPG.&#xD;
&#xD;
        Patient Dis-enrollment or Stop Point for Study Participation&#xD;
&#xD;
        Patient will no longer be in the study after he/she reports the onset of:&#xD;
&#xD;
          -  End stage renal disease or renal insufficiency;&#xD;
&#xD;
          -  CVA, CAD or MI;&#xD;
&#xD;
          -  COPD;&#xD;
&#xD;
          -  Depression, severe psychiatric illness;&#xD;
&#xD;
          -  Cancer diagnosis and treatment;&#xD;
&#xD;
          -  CHF;&#xD;
&#xD;
          -  Unplanned surgery requiring more than one overnight stay in the hospital within the&#xD;
             previous week;&#xD;
&#xD;
          -  Pregnant,&#xD;
&#xD;
          -  Any onset of cognitive or physical limitations that preclude making lifestyle or&#xD;
             dietary changes per RD assessment during study period,&#xD;
&#xD;
          -  Other acute/chronic complications that could exacerbate the patient's diabetic&#xD;
             condition or general well-being.&#xD;
&#xD;
          -  Physician starts injectable insulin therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Esther F Myers, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Academy of Nutrition and Dietetics</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Varsha (none), PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shri Shradda Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Naomi Trostler, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hebrew University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nagajuna Hospital</name>
      <address>
        <city>Vijayawada</city>
        <state>Andhra Pradesh</state>
        <zip>520007</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barman Diabetes Specialties</name>
      <address>
        <city>Guwahati</city>
        <state>Assam</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dia Care 1 &amp; 2</name>
      <address>
        <city>Amadavad</city>
        <state>Gujarat</state>
        <zip>380015</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fortis Escorts Hospital</name>
      <address>
        <city>Faridabad</city>
        <state>Haryana</state>
        <zip>121007</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asian Institute of Medical Sciences</name>
      <address>
        <city>Faridabad</city>
        <state>Haryana</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Malabar Institute of Medical Sciences</name>
      <address>
        <city>Calicut</city>
        <state>Kerala</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Caritis Hospital</name>
      <address>
        <city>Kottayam</city>
        <state>Kerala</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BhaktiVedanta Hospital</name>
      <address>
        <city>Mumbai</city>
        <state>Maharashtra</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Star Hospitals</name>
      <address>
        <city>Hyderabad</city>
        <state>Pradesh</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Santokba Durlabji Memorial Hospital</name>
      <address>
        <city>Jaipur</city>
        <state>Rajasthan</state>
        <zip>302015</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sundaram Medical Foundation</name>
      <address>
        <city>Chennai</city>
        <state>Tamilnadu</state>
        <zip>600040</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PSG Hospitals</name>
      <address>
        <city>Coimbatore</city>
        <state>Tamilnadu</state>
        <zip>641004</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanjay Gandhi Post Graduate Institute</name>
      <address>
        <city>Lucknow</city>
        <zip>226014</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fortis Hospital</name>
      <address>
        <city>Uttar Pradesh</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>October 6, 2012</study_first_submitted>
  <study_first_submitted_qc>October 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2012</study_first_posted>
  <last_update_submitted>February 18, 2016</last_update_submitted>
  <last_update_submitted_qc>February 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nutrition</keyword>
  <keyword>Medical Nutrition Therapy</keyword>
  <keyword>Diabetes Mellitus</keyword>
  <keyword>Nutrition outcomes</keyword>
  <keyword>Evidence Based Guidelines</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <!-- 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/NCT01703611
org study id: Academy-India-1
secondary id: IINS-ANDF/2011/01
nct id: NCT01703611
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
A clinical trial to compare the patient outcomes from usual nutrition therapy by dietitians
      in India to patient outcomes from guideline-based Medical Nutrition Therapy (MNT).
A cluster randomized clinical trial to compare patient outcomes from two different nutrition
      interventions by dietitians in India for persons with Type 2 Diabetes Mellitus (usual care vs
      Medical Nutrition Therapy provided according to the Academy of Nutrition and Dietetics
      Evidence-Based Nutrition Practice Guidelines)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: HbAIc decrease
time frame: 6 months and 12 months
measure: Weight change
time frame: 6 month and 12 month
measure: Lipid panel
time frame: 6 month and 12 month
description: Total Cholesterol, LDL Cholesterol, HDL Cholesterol and Triglycerides
measure: Blood pressure
time frame: 6 months and 12 months
description: Systolic and Diastolic change from baseline measure
arm group label: MNT according to AND EBNPG for Type 2 DM
arm group type: Experimental
description: Six or more Medical Nutrition Therapy visits(education and counseling on diet, self management, and lifestyle changes) provided over a 12 month period according to Academy of Nutrition and Dietetic Evidence Based Nutrition Practice Guidelines (EBPGN) (www.guidelines.gov)
arm group label: Usual Nutrition Care
arm group type: Active Comparator
description: Visits for usual nutrition therapy (diet and lifestyle changes) provided by dietitians over a 12 month period.
intervention type: Other
intervention name: MNT according to AND EBNPG for Type 2 DM
description: Six or more Medical Nutrition Therapy visits(education and counseling on diet, self management, and lifestyle changes) provided over a 12 month period according to Academy of Nutrition and Dietetic Evidence Based Nutrition Practice Guidelines (EBNPG)(www.guidelines.gov)
arm group label: MNT according to AND EBNPG for Type 2 DM
other name: Nutrition Counseling
other name: Nutrition Care
other name: Nutrition Therapy
other name: Evidence Based Nutrition Practice
intervention type: Other
intervention name: Usual Nutrition Care
description: Usual nutrition care in India
arm group label: Usual Nutrition Care
other name: Nutrition Counselling
other name: Nutrition Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Esther F Myers, PhD
role: Principal Investigator
affiliation: Academy of Nutrition and Dietetics
last name: Varsha (none), PhD
role: Principal Investigator
affiliation: Shri Shradda Hospital
last name: Naomi Trostler, PhD
role: Principal Investigator
affiliation: Hebrew University
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: India
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2