Healthy Eating and Active Living for Diabetes: Glycemic Index

NCT ID: NCT03037099

Last Updated: 2018-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-06-30

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Enhanced GI Concept Education

Intervention Type BEHAVIORAL

Usual Care

Usual care group will receive only standard printed copies of Canada Food Guide and Canadian Diabetes Association GI resources.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Enhanced GI Concept Education

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alberta

OTHER

Sponsor Role collaborator

Canadian Foundation for Dietetic Research (CFDR)

OTHER

Sponsor Role collaborator

Athabasca University

OTHER

Sponsor Role lead

Responsible Party

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Steven T. Johnson

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Steven T Johnson, PhD

Role: PRINCIPAL_INVESTIGATOR

Athabasca University

Locations

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Athabasca University

Athabasca, Alberta, Canada

Site Status

Alliance for Canadain Health Outcomes Research in Diabetes

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 26243463 (View on PubMed)

Related Links

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http://www.achord.ca

Research group

Other Identifiers

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HEALD-GI

Identifier Type: -

Identifier Source: org_study_id

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