Clinical trial NCT04272840: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Gestational Diabetes Mellitus
Keywords: Gestational Diabetes
Glycaemic or Glycemic Index
Nutrition
Education
Behaviour
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
Collaborators: name: Mount Saint Vincent University
name: Dalhousie University
name: The Hospital for Sick Children
First posted: 2020-02-17
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective Randomized Control Trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Transfer/KM Level 3: Change in average dietary GI
timeFrame: From baseline to 4-6 weeks postpartum
Secondary outcomes:
measure: Satisfaction/ KM Level 1: Reaction
timeFrame: From baseline to 4-6 weeks postpartum
measure: Knowledge/KM Level 2: Learning
timeFrame: From baseline to 4-6 weeks postpartum
measure: Acceptability and Applicability of Education/KM Level 3: Transfer (Behaviour Change)
timeFrame: From 4-6 weeks post-intervention to 4-6 weeks post-partum
measure: Results/KM Level 4: Glycemic Control (rate of Self-monitored blood glucose levels within range)
timeFrame: From Baseline to 4-6 weeks post-partum
measure: Maternal Demographics (eg. age, ethnicity, language spoken, education level and work status)
timeFrame: Baseline
measure: Maternal Height
timeFrame: Baseline
measure: Maternal Pre-Pregnancy body weight
timeFrame: Baseline
measure: Maternal Weight, during pregnancy
timeFrame: From Baseline to 4-6 weeks post-partum.
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
Study officials:
affiliation: IWK Health Centre
name: Shannan Grant, PhD, PDt
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: Layes, A. The Burden of Diabetes in Atlantic Canada. Public Health Agency of Canada, Atlantic Regional Office; 2011.
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.
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.