Healthy Eating and Active Living for Diabetes: Glycemic Index

Type 2 Diabetes Clinical Trial

— HEALD-GI  

Official title:

Enhancing Glycemic Index Knowledge and Application Among Adults With Type-2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03037099
• Other study ID #: HEALD-GI
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: July 2018
• Source: Athabasca University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• Enhanced GI Concept Education

Locations

Country	Name	City	State
Canada	Athabasca University	Athabasca	Alberta
Canada	Alliance for Canadain Health Outcomes Research in Diabetes	Edmonton	Alberta

Sponsors (3)

Lead Sponsor	Collaborator
Athabasca University	Canadian Foundation for Dietetic Research (CFDR), University of Alberta

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dietary glycemic index	arbitrary units	12 weeks
Secondary	Body mass	kilograms	12 weeks
Secondary	Glycemic control (hemoglobin A1c)		12 weeks
Secondary	Systolic blood pressure	mmHg	12 weeks

External Links

•   Funding agency
•   Research group