Randomized Controlled Multi-center Study of the New Nordic Diet in Gestational Diabetes Mellitus
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Gestational Diabetes
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Parallel AssignmentMasking: Double (Investigator, Outcomes Assessor)Masking Description: Outcome is HbA1c at week 37 of gestation and lab personnel are masked to treatment allocation. Initial data reaching the Investigators will not have the code broken.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 50 years
- Gender
- Only males
Description
Gestational diabetes mellitus (GDM) is associated with severe adverse outcomes for mother and newborn. Recently introduced Swedish guidelines on GDM diagnosis will at least double the prevalence of diagnosed women. The first line of treatment in GDM is diet and exercise treatment. Even so, there is ...
Gestational diabetes mellitus (GDM) is associated with severe adverse outcomes for mother and newborn. Recently introduced Swedish guidelines on GDM diagnosis will at least double the prevalence of diagnosed women. The first line of treatment in GDM is diet and exercise treatment. Even so, there is a recognized knowledge gap as to what diet treatment is optimal. In routine care today, diagnosed women are provided by midwife with the same diet advice as patients with diabetes type 2 and these are broad and general. Only rarely are the diet advice provided by a dietician. In nutrition research, most evidence for health benefits of a diet has been demonstrated for the Mediterranean diet. Further, the New Nordic Diet (NND) was recently developed to mimic the Mediterranean diet yet builds on foods grown in the Nordic climate. Interestingly, a diet intake in line with NND among Norwegian mothers was associated with lower risk for excessive pregnancy weight gain. In addition, associations have been shown between NND and lower risk for cardiovascular disease, obesity, inflammatory risk markers, serum lipids, colorectal cancer and total mortality. Hence, it seems likely that diet treatment with NND to women with GDM would be superior to routine care, but this has never been investigated. The main aim of the planned study is to investigate among women with GDM if a diet intervention during pregnancy according to NND, compared to routine care, will reduce complications for woman and newborn. Main outcome is glycosylated haemoglobin A (HbA1c) at gestational age 37 weeks. HbA1c captures recent average blood glucose levels, with the last 30 days accounting for 50% of the value. High glucose levels during pregnancy involve severe health risks for mother and neonate. The hypothesis is that women receiving qualified counseling on NND will experience less adverse health outcomes for herself and her newborn, than will women treated in routine care.
Tracking Information
- NCT #
- NCT04169243
- Collaborators
- Swedish Council for Working Life and Social Research
- Investigators
- Principal Investigator: Anna Winkvist, PhD Göteborg University