Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Gestational Diabetes Mellitus
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Prospective Randomized Control TrialMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

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 Gu...

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.

Tracking Information

NCT #
NCT04272840
Collaborators
  • Mount Saint Vincent University
  • Dalhousie University
  • The Hospital for Sick Children
Investigators
Not Provided