Healthy Eating and Active Living for Diabetes: Glycemic Index (HEALD-GI)
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Enhanced GI Concept Education
Sponsored by

About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring Glycemic index, dietary intakes
Eligibility 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.
Sites / Locations
- Athabasca University
- Alliance for Canadain Health Outcomes Research in Diabetes
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Enhanced GI Concept Education
Usual Care
Arm 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.
Usual care group will receive only standard printed copies of Canada Food Guide and Canadian Diabetes Association GI resources.
Outcomes
Primary Outcome Measures
Dietary glycemic index
arbitrary units
Secondary Outcome Measures
Body mass
kilograms
Glycemic control (hemoglobin A1c)
Systolic blood pressure
mmHg
Full Information
NCT ID
NCT03037099
First Posted
August 18, 2016
Last Updated
July 9, 2018
Sponsor
Athabasca University
Collaborators
University of Alberta, Canadian Foundation for Dietetic Research (CFDR)
1. Study Identification
Unique Protocol Identification Number
NCT03037099
Brief Title
Healthy Eating and Active Living for Diabetes: Glycemic Index
Acronym
HEALD-GI
Official Title
Enhancing Glycemic Index Knowledge and Application Among Adults With Type-2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Athabasca University
Collaborators
University of Alberta, Canadian Foundation for Dietetic Research (CFDR)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Glycemic index, dietary intakes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Enhanced GI Concept Education
Arm Type
Experimental
Arm 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 Title
Usual Care
Arm Type
No Intervention
Arm 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(s)
Enhanced GI Concept Education
Primary Outcome Measure Information:
Title
Dietary glycemic index
Description
arbitrary units
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Body mass
Description
kilograms
Time Frame
12 weeks
Title
Glycemic control (hemoglobin A1c)
Time Frame
12 weeks
Title
Systolic blood pressure
Description
mmHg
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven T Johnson, PhD
Organizational Affiliation
Athabasca University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Athabasca University
City
Athabasca
State/Province
Alberta
ZIP/Postal Code
T9S 3A3
Country
Canada
Facility Name
Alliance for Canadain Health Outcomes Research in Diabetes
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2E1
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26243463
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.
Results Reference
background
Links:
URL
http://www.achord.ca
Description
Research group
Learn more about this trial
Healthy Eating and Active Living for Diabetes: Glycemic Index
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