Randomized Controlled Trial Intervention With New Nordic DIet in Women With GestatiOnal Diabetes Mellitus: iNDIGO

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2022
The study evaluates whether the New Nordic Diet, compared to routine care, will improve glucose control, among women developing gestational diabetes mellitus during pregnancy. Originally, a 10 wk intervention with qualified counseling on New Nordic Diet was planned, and effects on glycosylated haemoglobin A (HbA1c) at gestational age 37 weeks was planned as main outcome. Recruitment started in spring 2020 but had to be halted due to covid-19. Instead, we now conduct a more comprehensive version of the study, with a more intensive intervention consisting of distributed food bags plus dietary counselling for two weeks, and with continuous glucose monitoring during these two weeks to measure main outcome. This is more sensitive to small changes than is HbA1c. With this shorter and more intensive intervention we believe we can address our original hypothesis yet adjust to impacts of the covid-19 situation on the population and health care system.
Epistemonikos ID: 777d950c3b3591eb0b838a432d530118e8711e4c
First added on: Jul 25, 2023