Clinical trial NCT04169243: Randomized Controlled Trial Intervention With New Nordic DIet in Women With GestatiOnal Diabetes Mellitus: iNDIGO
Official title: Randomized Controlled Trial Intervention With New Nordic DIet in Women With GestatiOnal Diabetes Mellitus: iNDIGO
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gestational Diabetes Mellitus
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Swedish Council for Working Life and Social Research
First posted: 2019-11-19
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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 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, thus focusing on gastronomical potential and sustainability. 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 randomized controlled trial Intervention with new Nordic DIet in women with GestatiOnal diabetes mellitus (iNDIGO) is to test if the NND compared with usual care will improve glucose control in women with GDM. The iNDIGO study is a randomized parallel, single-blinded, controlled trial. In total, 50 women diagnosed with GDM are recruited and randomized to receive either a NND (intervention) or usual care (control) for 14 days. Participants receive a two-week menu and provided with food bags containing ingredients for dishes and foods to be used. Primary outcome is glycemic control (specifically time in target) measured using continuous glucose monitoring. Compliance to the dietary intervention will be tested using known dietary biomarkers and adherence questionnaires. Maternal socio-demographic and clinical data, biological samples, dietary intake and physical activity will be collected at enrollment and at the end of intervention (30-32 weeks' gestation).

Eligibility criteria: Inclusion Criteria:

* pregnant women with diagnosis of gestational diabetes in pregnancy wks 24-28.

Exclusion Criteria:

* multiple pregnancies
* not understanding/able to read Swedish or English
* unwilling to follow a dietary intervention
* manifest diabetes

Primary outcomes:
measure: Time in Target at gestational week 32
timeFrame: At week 32 of pregnancy
Secondary outcomes:
measure: Pregnancy weight gain
timeFrame: Pre-pregnant weight up to delivery
measure: Incidence of pregnancy-induced hypertension
timeFrame: Up to delivery
measure: Incidence of pre-eclampsia
timeFrame: Up to delivery
measure: Prevalence of use of insulin/Metformin treatment
timeFrame: Up to delivery
measure: Incidence of preterm delivery
timeFrame: Up to 37 completed weeks
measure: Incidence of Caesarean sections
timeFrame: Up to delivery
measure: Health-related quality of life
timeFrame: Up to 1 year postpartum
measure: Incidence of LGA
timeFrame: At delivery
measure: Incidence of shoulder displacement
timeFrame: At delivery
measure: Apgar scores measurements
timeFrame: At delivery
measure: Additional measurements from continuous glucose monitoring at wk 32
timeFrame: At gestational week 32
measure: Additional measurements from continuous glucose monitoring at wk 36
timeFrame: At gestational week 36
measure: Incidence of macrosomia
timeFrame: At delivery
measure: Nutritional status
timeFrame: During pregnancy
measure: Diet quality measuremen¨t
timeFrame: Up to delivery
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Antenatal care
city: Stockholm
country: Sweden
facility: Region Stockholm
city: Umeå
country: Sweden
facility: Region Västerbotten
Study officials:
affiliation: Göteborg University
name: Anna Winkvist, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Karlsson T, Augustin H, Lindqvist M, Otten J, Petersson K, Storck-Lindholm E, Mogren I, Winkvist A. Effect of the New Nordic Diet compared with usual care on glucose control in gestational diabetes mellitus: Study protocol for the randomized controlled trial intervention with new Nordic DIet in women with GestatiOnal diabetes mellitus (iNDIGO). Contemp Clin Trials. 2022 Apr;115:106706. doi: 10.1016/j.cct.2022.106706. Epub 2022 Feb 12.