Gestational Diabetes Mellitus
Conditions
Keywords
Gestational Diabetes, Glycaemic or Glycemic Index, Nutrition, Education, Behaviour
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.
Interventions
BEHAVIORALLow Glycemic Index Education
Educational materials layering Glycemic Index education onto Canada's Food Guide and Diabetes Canada recommendations.
Sponsors
Mount Saint Vincent University
Dalhousie University
The Hospital for Sick Children
IWK Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective Randomized Control Trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transfer/KM Level 3: Change in average dietary GI | From baseline to 4-6 weeks postpartum | Average dietary GI; diet record at baseline, 4-6 weeks post-intervention, 4-6 weeks postpartum |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction/ KM Level 1: Reaction | From baseline to 4-6 weeks postpartum | 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 | From baseline to 4-6 weeks postpartum | Average Quiz Score: Close-ended format, Scored by correct answers. |
| Acceptability and Applicability of Education/KM Level 3: Transfer (Behaviour Change) | From 4-6 weeks post-intervention to 4-6 weeks post-partum | 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) | From Baseline to 4-6 weeks post-partum | Medical Record (standard care 2-4 time-points per day) |
| Maternal Demographics (eg. age, ethnicity, language spoken, education level and work status) | Baseline | Mixed-form Questionnaire (GIQ) and Medical Chart |
| Maternal Height | Baseline | Medical Record, measured in cm. |
| Maternal Pre-Pregnancy body weight | Baseline | Medical Record, measured in kg. |
| Maternal Weight, during pregnancy | From Baseline to 4-6 weeks post-partum. | Medical Record, measured in kg. |
Countries
Canada
Contacts
Primary ContactShannan Grant, PhD, PDt
Backup ContactJulianne Leblanc, BSc
Outcome results
None listed