<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/NCT03037099</url>
  </required_header>
  <id_info>
    <org_study_id>HEALD-GI</org_study_id>
    <nct_id>NCT03037099</nct_id>
  </id_info>
  <brief_title>Healthy Eating and Active Living for Diabetes: Glycemic Index</brief_title>
  <acronym>HEALD-GI</acronym>
  <official_title>Enhancing Glycemic Index Knowledge and Application Among Adults With Type-2 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Athabasca University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Canadian Foundation for Dietetic Research (CFDR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Athabasca University</source>
  <oversight_info>
    <has_dmc>No</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>
      The main purpose of this study is to examine the effectiveness of enhanced GI-targeted&#xD;
      nutrition education on dietary behaviour and intakes among adults with type 2 diabetes.&#xD;
      Sixty-six eligible participants will be randomized into two equal groups using a pragmatic&#xD;
      randomized controlled trial design.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study proposes to examine the effectiveness of enhanced GI-targeted nutrition education&#xD;
      on dietary behaviour and intakes among adults with type 2 diabetes.&#xD;
&#xD;
      Adults with type 2 diabetes will take part in this study and will be randomly assigned to&#xD;
      either the HEALD-GI program (intervention) or in usual care (control). To evaluate the&#xD;
      effectiveness of the program, 66 eligible participants drawn from the Alberta's Caring for&#xD;
      Diabetes Cohort will be randomized into two equal groups using a pragmatic randomized&#xD;
      controlled trial design. The control will receive only standard printed copies of Canada Food&#xD;
      Guide and Canadian Diabetes Association (CDA) GI resources. The intervention group will&#xD;
      receive additional GI concept information including GI values of foods, low GI recipes,&#xD;
      menus, and application through websites with chat rooms, online videos, and print materials.&#xD;
      These will be reinforced through email, text messaging/phone calls, and postal mail. GI&#xD;
      knowledge and skill, self-efficacy, dietary intakes (using 3-day food record), anthropometry&#xD;
      (body mass), and clinical measures (glycated hemoglobin A1c, systolic blood pressure), will&#xD;
      be assessed at baseline and three months post-intervention.&#xD;
&#xD;
      The primary outcome will be change in GI related dietary behaviour and intake measured using&#xD;
      3-day food records (baseline and 3 months). Secondary outcomes include: 1) body mass, 2)&#xD;
      glycemic control (hemoglobin A1c), 3) systolic blood pressure.&#xD;
&#xD;
      Significance:&#xD;
&#xD;
      Sufficient evidence is needed regarding the best approach for increasing uptake of current&#xD;
      Canadian Diabetes Association (CDA) evidence-based recommendation to include low GI foods in&#xD;
      daily meal planning as an effective dietary self-care practice for glycemic control among&#xD;
      people with type 2 diabetes. Findings from this study will help determine if, and how, the&#xD;
      current approach to disseminating the CDA dietary recommendations pertaining to GI concept&#xD;
      could be improved for better uptake using the most efficient and cost effective&#xD;
      patient-centered approaches to nutrition self-management. Besides, evidence generated will&#xD;
      contribute to addressing some of the controversies regarding the clinical usefulness of the&#xD;
      GI concept.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">June 30, 2018</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>Dietary glycemic index</measure>
    <time_frame>12 weeks</time_frame>
    <description>arbitrary units</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body mass</measure>
    <time_frame>12 weeks</time_frame>
    <description>kilograms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic control (hemoglobin A1c)</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic blood pressure</measure>
    <time_frame>12 weeks</time_frame>
    <description>mmHg</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">67</enrollment>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Enhanced GI Concept Education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will receive enhanced GI concept nutrition education including GI values of foods, low GI recipes, menus, and application through websites with chat rooms, online videos and print materials. These will be reinforced through email, text messaging/phone calls, and postal mail.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual care group will receive only standard printed copies of Canada Food Guide and Canadian Diabetes Association GI resources.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Enhanced GI Concept Education</intervention_name>
    <arm_group_label>Enhanced GI Concept Education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals 18 years of age or older; identified as having T2DM and currently enrolled&#xD;
             in the Alberta's Caring for Diabetes cohort study&#xD;
&#xD;
          -  Able to read, understand, and converse in English&#xD;
&#xD;
          -  Willing to provide informed consent and currently living in Edmonton.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those taking exogenous insulin and having physiological and /or medical conditions&#xD;
             that interfere with normal digestive functions.&#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>Steven T Johnson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Athabasca University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Athabasca University</name>
      <address>
        <city>Athabasca</city>
        <state>Alberta</state>
        <zip>T9S 3A3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alliance for Canadain Health Outcomes Research in Diabetes</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2E1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>http://www.achord.ca</url>
    <description>Research group</description>
  </link>
  <reference>
    <citation>Al Sayah F, Majumdar SR, Soprovich A, Wozniak L, Johnson ST, Qiu W, Rees S, Johnson JA. The Alberta's Caring for Diabetes (ABCD) Study: Rationale, Design and Baseline Characteristics of a Prospective Cohort of Adults with Type 2 Diabetes. Can J Diabetes. 2015 Oct;39 Suppl 3:S113-9. doi: 10.1016/j.jcjd.2015.05.005. Epub 2015 Aug 1.</citation>
    <PMID>26243463</PMID>
  </reference>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>August 18, 2016</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>July 9, 2018</last_update_submitted>
  <last_update_submitted_qc>July 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Athabasca University</investigator_affiliation>
    <investigator_full_name>Steven T. Johnson</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Glycemic index</keyword>
  <keyword>dietary intakes</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>
  <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/NCT03037099
org study id: HEALD-GI
nct id: NCT03037099
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main purpose of this study is to examine the effectiveness of enhanced GI-targeted
      nutrition education on dietary behaviour and intakes among adults with type 2 diabetes.
      Sixty-six eligible participants will be randomized into two equal groups using a pragmatic
      randomized controlled trial design.
This study proposes to examine the effectiveness of enhanced GI-targeted nutrition education
      on dietary behaviour and intakes among adults with type 2 diabetes.

      Adults with type 2 diabetes will take part in this study and will be randomly assigned to
      either the HEALD-GI program (intervention) or in usual care (control). To evaluate the
      effectiveness of the program, 66 eligible participants drawn from the Alberta's Caring for
      Diabetes Cohort will be randomized into two equal groups using a pragmatic randomized
      controlled trial design. The control will receive only standard printed copies of Canada Food
      Guide and Canadian Diabetes Association (CDA) GI resources. The intervention group will
      receive additional GI concept information including GI values of foods, low GI recipes,
      menus, and application through websites with chat rooms, online videos, and print materials.
      These will be reinforced through email, text messaging/phone calls, and postal mail. GI
      knowledge and skill, self-efficacy, dietary intakes (using 3-day food record), anthropometry
      (body mass), and clinical measures (glycated hemoglobin A1c, systolic blood pressure), will
      be assessed at baseline and three months post-intervention.

      The primary outcome will be change in GI related dietary behaviour and intake measured using
      3-day food records (baseline and 3 months). Secondary outcomes include: 1) body mass, 2)
      glycemic control (hemoglobin A1c), 3) systolic blood pressure.

      Significance:

      Sufficient evidence is needed regarding the best approach for increasing uptake of current
      Canadian Diabetes Association (CDA) evidence-based recommendation to include low GI foods in
      daily meal planning as an effective dietary self-care practice for glycemic control among
      people with type 2 diabetes. Findings from this study will help determine if, and how, the
      current approach to disseminating the CDA dietary recommendations pertaining to GI concept
      could be improved for better uptake using the most efficient and cost effective
      patient-centered approaches to nutrition self-management. Besides, evidence generated will
      contribute to addressing some of the controversies regarding the clinical usefulness of the
      GI concept.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Dietary glycemic index
time frame: 12 weeks
description: arbitrary units
measure: Body mass
time frame: 12 weeks
description: kilograms
measure: Glycemic control (hemoglobin A1c)
time frame: 12 weeks
measure: Systolic blood pressure
time frame: 12 weeks
description: mmHg
arm group label: Enhanced GI Concept Education
arm group type: Experimental
description: This group will receive enhanced GI concept nutrition education including GI values of foods, low GI recipes, menus, and application through websites with chat rooms, online videos and print materials. These will be reinforced through email, text messaging/phone calls, and postal mail.
arm group label: Usual Care
arm group type: No Intervention
description: Usual care group will receive only standard printed copies of Canada Food Guide and Canadian Diabetes Association GI resources.
intervention type: Behavioral
intervention name: Enhanced GI Concept Education
arm group label: Enhanced GI Concept Education
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Steven T Johnson, PhD
role: Principal Investigator
affiliation: Athabasca University
facility: 
facility: 
country: Canada
url: http://www.achord.ca
description: Research group
citation: Al Sayah F, Majumdar SR, Soprovich A, Wozniak L, Johnson ST, Qiu W, Rees S, Johnson JA. The Alberta's Caring for Diabetes (ABCD) Study: Rationale, Design and Baseline Characteristics of a Prospective Cohort of Adults with Type 2 Diabetes. Can J Diabetes. 2015 Oct;39 Suppl 3:S113-9. doi: 10.1016/j.jcjd.2015.05.005. Epub 2015 Aug 1.
PMID: 26243463
responsible party type: Principal Investigator
investigator affiliation: Athabasca University
investigator full name: Steven T. Johnson
investigator title: Associate Professor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No