Clinical trial NCT03037099: Healthy Eating and Active Living for Diabetes: Glycemic Index
Official title: Enhancing Glycemic Index Knowledge and Application Among Adults With Type-2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Glycemic index
dietary intakes
Lead sponsor: Athabasca University
Sponsor class: OTHER
Collaborators: name: University of Alberta
name: Canadian Foundation for Dietetic Research (CFDR)
First posted: 2017-01-31
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Dietary glycemic index
timeFrame: 12 weeks
Secondary outcomes:
measure: Body mass
timeFrame: 12 weeks
measure: Glycemic control (hemoglobin A1c)
timeFrame: 12 weeks
measure: Systolic blood pressure
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Athabasca
country: Canada
facility: Athabasca University
state: Alberta
city: Edmonton
country: Canada
facility: Alliance for Canadain Health Outcomes Research in Diabetes
state: Alberta
Study officials:
affiliation: Athabasca University
name: Steven T Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.