NCT04272840

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

October 20, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

October 24, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

2.6 years

First QC Date

October 20, 2019

Last Update Submit

March 29, 2022

Conditions

Gestational Diabetes Mellitus

Keywords

Gestational DiabetesGlycaemic or Glycemic IndexNutritionEducationBehaviour

Outcome Measures

Primary Outcomes (1)

  • 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

    From baseline to 4-6 weeks postpartum

Secondary Outcomes (8)

  • Satisfaction/ KM Level 1: Reaction

    From baseline to 4-6 weeks postpartum

  • Knowledge/KM Level 2: Learning

    From baseline to 4-6 weeks postpartum

  • Acceptability and Applicability of Education/KM Level 3: Transfer (Behaviour Change)

    From 4-6 weeks post-intervention to 4-6 weeks post-partum

  • Results/KM Level 4: Glycemic Control (rate of Self-monitored blood glucose levels within range)

    From Baseline to 4-6 weeks post-partum

  • Maternal Demographics (eg. age, ethnicity, language spoken, education level and work status)

    Baseline

  • +3 more secondary outcomes

Study Arms (2)

Standard Care

NO INTERVENTION

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).

Low Glycemic Index

EXPERIMENTAL

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.

Behavioral: Low Glycemic Index Education

Interventions

Low Glycemic Index EducationBEHAVIORAL

Educational materials layering Glycemic Index education onto Canada's Food Guide and Diabetes Canada recommendations.

Low Glycemic Index

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

RECRUITING

Related Publications (5)

  • 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.

    PMID: 29650105BACKGROUND

  • 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.

    PMID: 27553869BACKGROUND

  • Layes, A. The Burden of Diabetes in Atlantic Canada. Public Health Agency of Canada, Atlantic Regional Office; 2011.

    BACKGROUND

  • 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.

    PMID: 22254100BACKGROUND

  • 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.

    PMID: 29958308BACKGROUND

Related Links

MeSH Terms

Conditions

Diabetes, GestationalBehavior

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Shannan Grant, PhD, PDt

    IWK Health Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shannan Grant, PhD, PDt

CONTACT

902-457-5400shannan.grant2@msvu.ca

Julianne Leblanc, BSc

CONTACT

(902)470-6532julianne.leblanc@iwk.nshealth.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective Randomized Control Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Affiliated Scientist

Study Record Dates

First Submitted

October 20, 2019

First Posted

February 17, 2020

Study Start

October 24, 2019

Primary Completion

May 31, 2022

Study Completion

August 30, 2022

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)