Healthy Eating and Active Living for Diabetes: Glycemic Index (HEALD-GI)

July 9, 2018 updated by: Steven T. Johnson, Athabasca University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Athabasca, Alberta, Canada, T9S 3A3
        • Athabasca University
      • Edmonton, Alberta, Canada, T6G 2E1
        • Alliance for Canadain Health Outcomes Research in Diabetes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dietary glycemic index
Time Frame: 12 weeks
arbitrary units
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body mass
Time Frame: 12 weeks
kilograms
12 weeks
Glycemic control (hemoglobin A1c)
Time Frame: 12 weeks
12 weeks
Systolic blood pressure
Time Frame: 12 weeks
mmHg
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Athabasca University

Collaborators

University of Alberta
Canadian Foundation for Dietetic Research (CFDR)

Investigators

  • Principal Investigator: Steven T Johnson, PhD, Athabasca University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

June 30, 2018

Study Completion (Actual)

June 30, 2018

Study Registration Dates

First Submitted

August 18, 2016

First Submitted That Met QC Criteria

January 27, 2017

First Posted (Estimate)

January 31, 2017

Study Record Updates

Last Update Posted (Actual)

July 10, 2018

Last Update Submitted That Met QC Criteria

July 9, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEALD-GI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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