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Healthy Eating and Active Living for Diabetes: Glycemic Index (HEALD-GI)

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ClinicalTrials.gov Identifier: NCT03037099
Recruitment Status : Completed
First Posted : January 31, 2017
Last Update Posted : July 10, 2018
Sponsor:
Collaborators:
University of Alberta
Canadian Foundation for Dietetic Research (CFDR)
Information provided by (Responsible Party):
Steven T. Johnson, Athabasca University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: Enhanced GI Concept Education Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Enhancing Glycemic Index Knowledge and Application Among Adults With Type-2 Diabetes Mellitus
Actual Study Start Date : January 2017
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Enhanced GI Concept Education
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.
Behavioral: Enhanced GI Concept Education
No Intervention: Usual Care
Usual care group will receive only standard printed copies of Canada Food Guide and Canadian Diabetes Association GI resources.



Primary Outcome Measures :
  1. Dietary glycemic index [ Time Frame: 12 weeks ]
    arbitrary units


Secondary Outcome Measures :
  1. Body mass [ Time Frame: 12 weeks ]
    kilograms

  2. Glycemic control (hemoglobin A1c) [ Time Frame: 12 weeks ]
  3. Systolic blood pressure [ Time Frame: 12 weeks ]
    mmHg



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals 18 years of age or older; identified as having T2DM and currently enrolled in the Alberta's Caring for Diabetes cohort study
  • Able to read, understand, and converse in English
  • Willing to provide informed consent and currently living in Edmonton.

Exclusion Criteria:

  • Those taking exogenous insulin and having physiological and /or medical conditions that interfere with normal digestive functions.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037099


Locations
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Canada, Alberta
Athabasca University
Athabasca, Alberta, Canada, T9S 3A3
Alliance for Canadain Health Outcomes Research in Diabetes
Edmonton, Alberta, Canada, T6G 2E1
Sponsors and Collaborators
Athabasca University
University of Alberta
Canadian Foundation for Dietetic Research (CFDR)
Investigators
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Principal Investigator: Steven T Johnson, PhD Athabasca University

Additional Information:
Publications:
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Responsible Party: Steven T. Johnson, Associate Professor, Athabasca University
ClinicalTrials.gov Identifier: NCT03037099     History of Changes
Other Study ID Numbers: HEALD-GI
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Steven T. Johnson, Athabasca University:
Glycemic index
dietary intakes

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases