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

Study Overview
=================
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).

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

Conditions
-----------------
Gestational Diabetes Mellitus

Intervention / Treatment
-----------------
* Behavioral: New Nordic Diet
* Other: Control


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Women randomized to the New Nordic Diet meet the study dietician at week 30 for 1.5 hr of individual diet treatment according to the New Nordic Diet and a cognitive behavioral approach. The diet advice include evenly distributed meals over the day, foods low in fat and rich in fibre, 500 g fruit and vegetables daily, fish 2-3 times a week and keyhole foods. Participants will prepare their own food but are provided with recipes and food bags containing ingredients and foods to be consumed during the two-week intervention At gestational age 32 weeks, women meet with a dietitian and will be instructed to continue with the New Nordic Diet diet throughout pregnancy on their own. | Behavioral: New Nordic Diet<br>* 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.<br>|
| Active Comparator: Control<br>The control women receive diet advice according to usual care. | Other: Control<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy weight gain | Weight gain during pregnancy from self-reported pre-pregnancy weight until delivery | Pre-pregnant weight up to delivery | 
| Incidence of pregnancy-induced hypertension | Diagnosis of pregnancy-induced hypertension | Up to delivery | 
| Incidence of pre-eclampsia | Diagnosis of pre-eclampsia | Up to delivery | 
| 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 | 
| Incidence of preterm delivery | Delivery before 37 completed weeks | Up to 37 completed weeks | 
| Incidence of Caesarean sections | Delivery by caesarean sections | Up to delivery | 
| Health-related quality of life | Health-related quality of life, calculated from questionnaire information from RAND-36 | Up to 1 year postpartum | 
| Incidence of LGA | Large-for-gestational age born infant | At delivery | 
| Incidence of shoulder displacement | Shoulder displacement of newborn infant | At delivery | 
| Apgar scores measurements | Apgar scores measured at 1, 5 and 10 minutes after delivery | At delivery | 
| 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 | 
| 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 | 
| Incidence of macrosomia | Diagnosis of macrosomia in newborn infant | At delivery | 
| Nutritional status | Nutritional status (vitamins and minerals) of mother during pregnancy | During pregnancy | 
| Diet quality measuremen¨t | Diet intake quality of mother during pregnancy | Up to delivery |