NCT03037099

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 31, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

July 10, 2018

Status Verified

July 1, 2018

Enrollment Period

1.5 years

First QC Date

August 18, 2016

Last Update Submit

July 9, 2018

Conditions

Keywords

Glycemic indexdietary intakes

Outcome Measures

Primary Outcomes (1)

  • Dietary glycemic index

    arbitrary units

    12 weeks

Secondary Outcomes (3)

  • Body mass

    12 weeks

  • Glycemic control (hemoglobin A1c)

    12 weeks

  • Systolic blood pressure

    12 weeks

Study Arms (2)

Enhanced GI Concept Education

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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

Interventions

Enhanced GI Concept Education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Those taking exogenous insulin and having physiological and /or medical conditions that interfere with normal digestive functions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Athabasca University

Athabasca, Alberta, T9S 3A3, Canada

Location

Alliance for Canadain Health Outcomes Research in Diabetes

Edmonton, Alberta, T6G 2E1, Canada

Location

Related 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.

    PMID: 26243463BACKGROUND

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Steven T Johnson, PhD

    Athabasca University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 18, 2016

First Posted

January 31, 2017

Study Start

January 1, 2017

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

July 10, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations