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

Gestational Diabetes Mellitus Clinical Trial

Official title:

Adapting a National Glycemic Index Education Platform for Nova Scotian Patients and Clinicians Treating Gestational Diabetes Mellitus Using Distance Education Strategies.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04272840
• Other study ID #: GI in GDM Online
• Status: Recruiting
• Phase: N/A
• Start date: October 24, 2019
• Est. completion date: August 30, 2022

Study information

• Verified date: March 2022
• Source: IWK Health Centre
• Contact: Shannan Grant, PhD, PDt
• Phone: 902-457-5400
• Email: shannan.grant2[@]msvu.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 30, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus

Intervention

Behavioral:
• Low Glycemic Index Education
Educational materials layering Glycemic Index education onto Canada's Food Guide and Diabetes Canada recommendations.

Locations

Country	Name	City	State
Canada	IWK Health Centre	Halifax	Nova Scotia

Sponsors (4)

Lead Sponsor	Collaborator
IWK Health Centre	Dalhousie University, Mount Saint Vincent University, The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

References & 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. Erratum in: Can J Diabetes. 2018 Jun;42(3):337. — View 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. — View Citation

Grant SM, Wolever TM. Perceived barriers to application of glycaemic index: valid concerns or lost in translation? Nutrients. 2011 Mar;3(3):330-40. doi: 10.3390/nu3030330. Epub 2011 Feb 28. Review. — View 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. Review. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	From baseline to 4-6 weeks postpartum
Secondary	Knowledge/KM Level 2: Learning	Average Quiz Score: Close-ended format, Scored by correct answers.	From baseline to 4-6 weeks postpartum
Secondary	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.	From 4-6 weeks post-intervention to 4-6 weeks post-partum
Secondary	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)	From Baseline to 4-6 weeks post-partum
Secondary	Maternal Demographics (eg. age, ethnicity, language spoken, education level and work status)	Mixed-form Questionnaire (GIQ) and Medical Chart	Baseline
Secondary	Maternal Height	Medical Record, measured in cm.	Baseline
Secondary	Maternal Pre-Pregnancy body weight	Medical Record, measured in kg.	Baseline
Secondary	Maternal Weight, during pregnancy	Medical Record, measured in kg.	From Baseline to 4-6 weeks post-partum.

External Links

•   Statistics Canada: Diabetes (2017)