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The Impact of Glycemic Index Education on Lowering Dietary GI in Gestational Diabetes Mellitus

Primary Purpose

Gestational Diabetes Mellitus

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Low Glycemic Index Education
Sponsored by
IWK Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gestational Diabetes Mellitus focused on measuring Gestational Diabetes, Glycaemic or Glycemic Index, Nutrition, Education, Behaviour

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Of or over 18 years of age
  • Diagnosed with GDM according to Diabetes Canada
  • At or over than 20 weeks gestation
  • At or less than 32 weeks gestation
  • Being followed at IWK Health Centre
  • Willing and able to give informed consent
  • Willing and able to complete study protocol
  • Currently living in Nova Scotia

Exclusion Criteria; women who:

  • have been diagnosed with acute or chronic illness, other than GDM and PCOS, that may impact carbohydrate digestion metabolism.
  • are currently taking a medication (other than insulin) that may affect carbohydrate metabolism.
  • have multi-fetal pregnancy in current pregnancy.
  • have insurmountable language barriers.

Sites / Locations

  • IWK Health CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard Care

Low Glycemic Index

Arm Description

Participants will attend a 30-45 min workshop. Trainees will review Diabetes Canada Clinical Practice Guidelines Job Aids (Just the Basics, the Handy Portion Guide, and Basic Carbohydrate Counting) and teach data provision skills (how to complete a three day diet record).

Standard care + Glycemic Index. Participants will attend a 30-45 min workshop. Trainees will review Diabetes Canada Clinical Practice Guidelines Job Aids (Just the Basics, the Handy Portion Guide, and Basic Carbohydrate Counting) and teach data provision skills (how to complete a three day diet record). Diabetes Canada and Dietitian's Canada resources on glycemic index will also be reviewed: the Glycemic Index Food Guide, Flip Cards, and Recipes.

Outcomes

Primary Outcome Measures

Transfer/KM Level 3: Change in average dietary GI
Average dietary GI; diet record at baseline, 4-6 weeks post-intervention, 4-6 weeks postpartum

Secondary Outcome Measures

Satisfaction/ KM Level 1: Reaction
Mixed form Questionnaire (GIQ): Close ended format with True or False, Multiple Choice, and Likert Scale choices. Open-ended questions for feedback.
Knowledge/KM Level 2: Learning
Average Quiz Score: Close-ended format, Scored by correct answers.
Acceptability and Applicability of Education/KM Level 3: Transfer (Behaviour Change)
Mixed form Questionnaire (GIQ): Close ended format using Likert Scale and True or False choices. Open-ended questions for feedback.
Results/KM Level 4: Glycemic Control (rate of Self-monitored blood glucose levels within range)
Medical Record (standard care 2-4 time-points per day)
Maternal Demographics (eg. age, ethnicity, language spoken, education level and work status)
Mixed-form Questionnaire (GIQ) and Medical Chart
Maternal Height
Medical Record, measured in cm.
Maternal Pre-Pregnancy body weight
Medical Record, measured in kg.
Maternal Weight, during pregnancy
Medical Record, measured in kg.

Full Information

First Posted
October 20, 2019
Last Updated
March 29, 2022
Sponsor
IWK Health Centre
Collaborators
Mount Saint Vincent University, Dalhousie University, The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT04272840
Brief Title
The Impact of Glycemic Index Education on Lowering Dietary GI in Gestational Diabetes Mellitus
Official Title
Adapting a National Glycemic Index Education Platform for Nova Scotian Patients and Clinicians Treating Gestational Diabetes Mellitus Using Distance Education Strategies.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 24, 2019 (Actual)
Primary Completion Date
May 31, 2022 (Anticipated)
Study Completion Date
August 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IWK Health Centre
Collaborators
Mount Saint Vincent University, Dalhousie University, The Hospital for Sick Children

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Gestational Diabetes Mellitus (GDM) incidence is increasing worldwide, and within Canada, the Atlantic provinces statistically have been found to have highest prevalence of diabetes. Increasing evidence supports the benefit of following a low glycaemic index (GI) diet in GDM and the Canadian Diabetes Guidelines recommends replacing high GI foods for low GI foods. Despite recommendation to adapt a low GI diet in GDM, there are limitations and barriers recognized to GI utility largely focused on knowledge translation. There is sufficient research to support a low GI diet in benefiting outcomes of GDM, therefore the GI in GDM Online trial will investigate the feasibility and effectiveness of a distance low GI education intervention, adapted from Diabetes Canada's GI materials, on producing a difference in average dietary GI between a group with the intervention and standard care.
Detailed Description
The incidence of Gestational Diabetes Mellitus (GDM) has been progressively increasing worldwide, with a global prevalence of gestational hyperglycaemia estimated at 16.9%. In Canada, Atlantic provinces have been recorded with the highest prevalence of diabetes at 6%. The Diabetes Canada Practice Guidelines recommends the low glycemic index (GI) diet to type 1 and 2 diabetes mellitus and has recently updated its guidelines to include a recommendation for GDM. This said, barriers to GI knowledge translation have been identified. This study uses a prospective parallel randomized control trial design. Procedures and materials have been adapted from NCT01589757. The Kirkpatrick Model (Reaction, Learning, Behaviour, and Results) informed intervention development and evaluation strategies. The purpose of this study is to evaluate whether a distance low GI education intervention, adapted from Diabetes Canada's GI education materials, will significantly yield a lower average GI (primary outcome) in participants than traditional standard care medical nutrition therapy for Gestational Diabetes Mellitus. We hypothesize that participants who receive the low GI intervention will have a lower dietary GI than those who received usual IWK standard care for GDM.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus
Keywords
Gestational Diabetes, Glycaemic or Glycemic Index, Nutrition, Education, Behaviour

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective Randomized Control Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Participants will attend a 30-45 min workshop. Trainees will review Diabetes Canada Clinical Practice Guidelines Job Aids (Just the Basics, the Handy Portion Guide, and Basic Carbohydrate Counting) and teach data provision skills (how to complete a three day diet record).
Arm Title
Low Glycemic Index
Arm Type
Experimental
Arm Description
Standard care + Glycemic Index. Participants will attend a 30-45 min workshop. Trainees will review Diabetes Canada Clinical Practice Guidelines Job Aids (Just the Basics, the Handy Portion Guide, and Basic Carbohydrate Counting) and teach data provision skills (how to complete a three day diet record). Diabetes Canada and Dietitian's Canada resources on glycemic index will also be reviewed: the Glycemic Index Food Guide, Flip Cards, and Recipes.
Intervention Type
Behavioral
Intervention Name(s)
Low Glycemic Index Education
Intervention Description
Educational materials layering Glycemic Index education onto Canada's Food Guide and Diabetes Canada recommendations.
Primary Outcome Measure Information:
Title
Transfer/KM Level 3: Change in average dietary GI
Description
Average dietary GI; diet record at baseline, 4-6 weeks post-intervention, 4-6 weeks postpartum
Time Frame
From baseline to 4-6 weeks postpartum
Secondary Outcome Measure Information:
Title
Satisfaction/ KM Level 1: Reaction
Description
Mixed form Questionnaire (GIQ): Close ended format with True or False, Multiple Choice, and Likert Scale choices. Open-ended questions for feedback.
Time Frame
From baseline to 4-6 weeks postpartum
Title
Knowledge/KM Level 2: Learning
Description
Average Quiz Score: Close-ended format, Scored by correct answers.
Time Frame
From baseline to 4-6 weeks postpartum
Title
Acceptability and Applicability of Education/KM Level 3: Transfer (Behaviour Change)
Description
Mixed form Questionnaire (GIQ): Close ended format using Likert Scale and True or False choices. Open-ended questions for feedback.
Time Frame
From 4-6 weeks post-intervention to 4-6 weeks post-partum
Title
Results/KM Level 4: Glycemic Control (rate of Self-monitored blood glucose levels within range)
Description
Medical Record (standard care 2-4 time-points per day)
Time Frame
From Baseline to 4-6 weeks post-partum
Title
Maternal Demographics (eg. age, ethnicity, language spoken, education level and work status)
Description
Mixed-form Questionnaire (GIQ) and Medical Chart
Time Frame
Baseline
Title
Maternal Height
Description
Medical Record, measured in cm.
Time Frame
Baseline
Title
Maternal Pre-Pregnancy body weight
Description
Medical Record, measured in kg.
Time Frame
Baseline
Title
Maternal Weight, during pregnancy
Description
Medical Record, measured in kg.
Time Frame
From Baseline to 4-6 weeks post-partum.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Of or over 18 years of age Diagnosed with GDM according to Diabetes Canada At or over than 20 weeks gestation At or less than 32 weeks gestation Being followed at IWK Health Centre Willing and able to give informed consent Willing and able to complete study protocol Currently living in Nova Scotia Exclusion Criteria; women who: have been diagnosed with acute or chronic illness, other than GDM and PCOS, that may impact carbohydrate digestion metabolism. are currently taking a medication (other than insulin) that may affect carbohydrate metabolism. have multi-fetal pregnancy in current pregnancy. have insurmountable language barriers.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shannan Grant, PhD, PDt
Phone
902-457-5400
Email
shannan.grant2@msvu.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Julianne Leblanc, BSc
Phone
(902)470-6532
Email
julianne.leblanc@iwk.nshealth.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shannan Grant, PhD, PDt
Organizational Affiliation
IWK Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shannan Grant, PDt,MSc,PhD
Phone
(902)457-5400
Email
shannan.grant@iwk.nshealth.ca
First Name & Middle Initial & Last Name & Degree
Julianne LeBlanc, MSc Student
Phone
(902)470-6532
Email
julianne.leblanc@iwk.nshealth.ca

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29650105
Citation
Diabetes Canada Clinical Practice Guidelines Expert Committee; Feig DS, Berger H, Donovan L, Godbout A, Kader T, Keely E, Sanghera R. Diabetes and Pregnancy. Can J Diabetes. 2018 Apr;42 Suppl 1:S255-S282. doi: 10.1016/j.jcjd.2017.10.038. No abstract available. Erratum In: Can J Diabetes. 2018 Jun;42(3):337.
Results Reference
background
PubMed Identifier
27553869
Citation
Draffin CR, Alderdice FA, McCance DR, Maresh M, Harper Md Consultant Physician R, McSorley O, Holmes VA. Exploring the needs, concerns and knowledge of women diagnosed with gestational diabetes: A qualitative study. Midwifery. 2016 Sep;40:141-7. doi: 10.1016/j.midw.2016.06.019. Epub 2016 Jun 29.
Results Reference
background
Citation
Layes, A. The Burden of Diabetes in Atlantic Canada. Public Health Agency of Canada, Atlantic Regional Office; 2011.
Results Reference
background
PubMed Identifier
22254100
Citation
Grant SM, Wolever TMS. Perceived barriers to application of glycaemic index: valid concerns or lost in translation? Nutrients. 2011 Mar;3(3):330-340. doi: 10.3390/nu3030330. Epub 2011 Feb 28.
Results Reference
background
PubMed Identifier
29958308
Citation
Johnston S, Coyer FM, Nash R. Kirkpatrick's Evaluation of Simulation and Debriefing in Health Care Education: A Systematic Review. J Nurs Educ. 2018 Jul 1;57(7):393-398. doi: 10.3928/01484834-20180618-03.
Results Reference
background
Links:
URL
https://www150.statcan.gc.ca/n1/pub/82-625-x/2018001/article/54982-eng.pdf
Description
Statistics Canada: Diabetes (2017)

Learn more about this trial

The Impact of Glycemic Index Education on Lowering Dietary GI in Gestational Diabetes Mellitus

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