Healthy Eating and Active Living for Diabetes: Glycemic Index (HEALD-GI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03037099|
Recruitment Status : Completed
First Posted : January 31, 2017
Last Update Posted : July 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Behavioral: Enhanced GI Concept Education||Not Applicable|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||67 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
- Dietary glycemic index [ Time Frame: 12 weeks ]arbitrary units
- Body mass [ Time Frame: 12 weeks ]kilograms
- Glycemic control (hemoglobin A1c) [ Time Frame: 12 weeks ]
- Systolic blood pressure [ Time Frame: 12 weeks ]mmHg
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
|Athabasca, Alberta, Canada, T9S 3A3|
|Alliance for Canadain Health Outcomes Research in Diabetes|
|Edmonton, Alberta, Canada, T6G 2E1|
|Principal Investigator:||Steven T Johnson, PhD||Athabasca University|