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

Gestational Diabetes Mellitus Clinical Trial

— iNDIGO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04169243
• Other study ID #: iNDIGO2018-00483
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: December 2025

Study information

• Verified date: August 2023
• Source: Göteborg University
• Contact: Anna Winkvist, PhD
• Phone: 46-31-7863728
• Email: anna.winkvist[@]nutrition.gu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus

Intervention

Behavioral:
• New Nordic Diet
The New Nordic Diet conforms with the Nordic Nutrition Recommendations and incorporates environmental sustainability and planetary health. It includes rapeseed oil, whole grain bread, wild fish, seafood and game, potatoes, root vegetables, cabbages, Nordic fruits and berries. A two-week menu including all daily meals has been created to ensure dietary goals of the New Nordic Diet intervention: fish and shellfish intake = 3 times/w (fatty fish at least once per week), = 500 g fruit, berries, vegetables and legumes daily (legumes as main protein source at least twice per week), whole-grain cereal products, rapeseed oil for cooking/dressing and three table spoons of nuts and seeds per day.

Other:
• Control
The control women receive diet advice according to usual care, which may be a short meeting with the regular midwife or a short meeting with a dietician. From the study, they will receive a gift certificate that can be used in grocery stores.

Locations

Country	Name	City	State
Sweden	Antenatal care	Göteborg
Sweden	Region Stockholm	Stockholm
Sweden	Region Västerbotten	Umeå

Sponsors (2)

Lead Sponsor	Collaborator
Göteborg University	Swedish Council for Working Life and Social Research

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time in Target at gestational week 32	Percentage of time in target (TIT) range 3.5-7.8 mmol/L measured with continuous glucose monitoring	At week 32 of pregnancy
Secondary	Pregnancy weight gain	Weight gain during pregnancy from self-reported pre-pregnancy weight until delivery	Pre-pregnant weight up to delivery
Secondary	Incidence of pregnancy-induced hypertension	Diagnosis of pregnancy-induced hypertension	Up to delivery
Secondary	Incidence of pre-eclampsia	Diagnosis of pre-eclampsia	Up to delivery
Secondary	Prevalence of use of insulin/Metformin treatment	Decision to put woman on medication for the gestational diabetes, such as metformin or insulin	Up to delivery
Secondary	Incidence of preterm delivery	Delivery before 37 completed weeks	Up to 37 completed weeks
Secondary	Incidence of Caesarean sections	Delivery by caesarean sections	Up to delivery
Secondary	Health-related quality of life	Health-related quality of life, calculated from questionnaire information from RAND-36	Up to 1 year postpartum
Secondary	Incidence of LGA	Large-for-gestational age born infant	At delivery
Secondary	Incidence of shoulder displacement	Shoulder displacement of newborn infant	At delivery
Secondary	Apgar scores measurements	Apgar scores measured at 1, 5 and 10 minutes after delivery	At delivery
Secondary	Additional measurements from continuous glucose monitoring at wk 32	mean glucose, CV, SD, MAGE, % time with values >7.8 mmol/L, % time with values <3.5 mmol/L, glucose in different time periods, and AUC	At gestational week 32
Secondary	Additional measurements from continuous glucose monitoring at wk 36	mean glucose, CV, SD, MAGE, % time with values >7.8 mmol/L, % time with values <3.5 mmol/L, glucose in different time periods, and AUC	At gestational week 36
Secondary	Incidence of macrosomia	Diagnosis of macrosomia in newborn infant	At delivery
Secondary	Nutritional status	Nutritional status (vitamins and minerals) of mother during pregnancy	During pregnancy
Secondary	Diet quality measuremen¨t	Diet intake quality of mother during pregnancy	Up to delivery