Adapting a National Glycemic Index Education Platform for Nova Scotian Patients and Clinicians Treating Gestational Diabetes Mellitus Using Distance Education Strategies.
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Transfer/KM Level 3: Change in average dietary GI
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
Transfer/KM Level 3: Change in average dietary GI
时间窗: From baseline to 4-6 weeks postpartum
Average dietary GI; diet record at baseline, 4-6 weeks post-intervention, 4-6 weeks postpartum
次要结局
- Knowledge/KM Level 2: Learning(From baseline to 4-6 weeks postpartum)
- Maternal Height(Baseline)
- Maternal Pre-Pregnancy body weight(Baseline)
- 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)
- Maternal Weight, during pregnancy(From Baseline to 4-6 weeks post-partum.)
- Satisfaction/ KM Level 1: Reaction(From baseline to 4-6 weeks postpartum)
研究者
Shannan Grant
Affiliated Scientist
IWK Health Centre