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

NCT ID: NCT04272840

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-24
• Study Completion Date: 2022-08-30

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.

Conditions

Gestational Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Care

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Low Glycemic Index

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.

Group Type: EXPERIMENTAL

Low Glycemic Index Education

Intervention Type: BEHAVIORAL

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

Interventions

Low Glycemic Index Education

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

Intervention Type: BEHAVIORAL

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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mount Saint Vincent University

OTHER

Sponsor Role: collaborator

Dalhousie University

OTHER

Sponsor Role: collaborator

The Hospital for Sick Children

OTHER

Sponsor Role: collaborator

IWK Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Shannan Grant

Affiliated Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shannan Grant, PhD, PDt

Role: PRINCIPAL_INVESTIGATOR

IWK Health Centre

Locations

IWK Health Centre

Halifax, Nova Scotia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Shannan Grant, PhD, PDt

Role: CONTACT

shannan.grant2@msvu.ca

902-457-5400

Julianne Leblanc, BSc

Role: CONTACT

julianne.leblanc@iwk.nshealth.ca

(902)470-6532

Facility Contacts

Shannan Grant, PDt,MSc,PhD

Role: primary

shannan.grant@iwk.nshealth.ca

(902)457-5400

Julianne LeBlanc, MSc Student

Role: backup

julianne.leblanc@iwk.nshealth.ca

(902)470-6532

References

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.

Reference Type: BACKGROUND

PMID: 29650105 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27553869 (View on PubMed)

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 22254100 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29958308 (View on PubMed)

Related Links

https://www150.statcan.gc.ca/n1/pub/82-625-x/2018001/article/54982-eng.pdf

Statistics Canada: Diabetes (2017)

Other Identifiers

GI in GDM Online

Identifier Type: -

Identifier Source: org_study_id