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Completed

NCT Number: NCT03037099

Healthy Eating and Active Living for Diabetes: Glycemic Index

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Athabasca University, Athabasca, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Enhanced GI Concept Education

Behavioral

Primary outcomes

  1. Dietary glycemic index

    Time frame: 12 weeks

    arbitrary units

Secondary outcomes

  1. Body mass

    Time frame: 12 weeks

    kilograms

  2. Glycemic control (hemoglobin A1c)

    Time frame: 12 weeks

  3. Systolic blood pressure

    Time frame: 12 weeks

    mmHg

Sponsors and collaborators

Lead sponsor

Athabasca University

Other

Collaborators

  • Canadian Foundation for Dietetic Research (CFDR)
  • University of Alberta

Registry information

Official study title

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

Acronym: HEALD-GI

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 31, 2017
Registry last updated
Jul 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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