Dietary Management of Gestational Diabetes

Study Overview
=================
Brief Summary
-----------------
eMOM is a randomized, controlled trial to compare the effects of two different dietary interventions during pregnancy. The comparison is based on tissue glucose content (using continuous glucose monitoring system) in pregnant women and on neonate body composition. The recruited women (n=60) have been diagnosed with gestational diabetes mellitus, and are of Caucasian origin. Of the study diets, one is moderately carbohydrate restricted and the other one is high on plant-based protein with an emphasis on healthy Nordic foods. The study has two two-week study periods that are carried out on approximately gestational weeks 24-28 (period I) and 34-36 (period II). Continuous glucose monitoring and other measurements (accelerometer, 3-day food record, gut microbiota, serum lipids, metabolomics, epigenetics etc.) are done during these study periods. At the beginning of the study, before study period I, the participants are randomized to either one of the intervention diets. The first study period consists of a crossover phase in which the participants receive three days' worth of food according to one of the intervention diets (according to the randomization) after which there is a three-day wash-out period. After the wash-out period, the participants receive three days' worth of food according to the other diet. After the first study period, a nutritionist advises the lastly followed intervention diet to the participant and the diet is followed until delivery. To ensure the diet is followed, the participants gets at least three personal face-to-face counseling sessions, phone calls, mobile reminders, recipes and food items. After delivery, the infant's body composition, epigenetic markers of cord blood and placenta, gut microbiome and urine metabolomics are measured.

Official Title
-----------------
Effects of Guided Dietary Patterns on Metabolic Outcomes in Overweight Pregnant Women With Gestational Diabetes and on Offspring Body Composition

Conditions
-----------------
Diabetes, Gestational, Dietary Modification, Glucose Intolerance During Pregnancy, Body Composition, Birth Weight

Intervention / Treatment
-----------------
* Other: Carbohydrate restricted diet
* Other: Plant-protein based diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Gestational diabetes at enrollment Exclusion Criteria: Gestational weeks exceed 28+6 Multiple pregnancy Food allergies or restrictions (other than lactose intolerance) Mother's or father's ethnic background other than Caucasian Type 1 or type 2 diabetes Medication which affects glucose metabolism Cholesterol medication Drug or alcohol abuse Psychiatric illness which affects participation in the study Factors hampering communication (e.g. lack of Finnish skills)
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carbohydrate restricted diet<br>Dietary intervention: moderately carbohydrate restricted diet. Parallel phase starts after study period I and the diet is followed until labor. | Other: Carbohydrate restricted diet<br>* The intervention is implemented by individual face-to-face counseling and mobile-phone counseling by a nutritionist, as well as food bags and recipes suitable for the diet. Targets: fruits and vegetables 500 g/d, fish 2 times/wk, low-fat instead of high-fat meat, red meat ≤ 3 times/wk, low-fat instead of high-fat dairy, high-fibre instead of low-fibre grains, vegetable oils (excluding palm oil and coconut oil) and soft margarine instead of animal fats, moderate reduction of carbohydrates (targets for macronutrients: carbohydrates 40 E%; fat 40 E%; protein 20 E%; dietary fiber 32g, energy intake approximately 2000 kcal/d; protein intake 20 E%; sucrose: <10 E%; fatty acids: saturated fatty acids < 10 E%, polyunsaturated fatty acids 5-10 E% and the rest of fat as monounsaturated fatty acids)<br>|
| Experimental: Plant-protein based diet<br>Dietary intervention: plant-protein based diet, en emphasis on healthy Nordic foods. Parallel phase starts after study period I and the diet is followed until labor. | Other: Plant-protein based diet<br>* The intervention is implemented by individual face-to-face counseling and mobile-phone counseling by a nutritionist, as well as food bags and recipes suitable for the diet. Targets: fruits and vegetables 1 kg/d; fish 3/wk; high-fibre grains, mainly rye, oat and barley; plant protein instead of meat protein; low-fat fermented dairy instead of other dairy; rapeseed oil and rapeseed-based margarine instead of other fats; no carbohydrate restriction (targets for macronutrients: carbohydrates 50 E%; fat 30 E%; protein 20 E%; dietary fiber 36g, energy intake approximately 2000 kcal/d; protein intake 20 E%; sucrose: <10 E%; fatty acids: saturated fatty acids < 10 E%, polyunsaturated fatty acids 5-10 E% and the rest of fat as monounsaturated fatty acids)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mother: The percentage of time spent within the gestational diabetes glucose target range (<7,8 mmol/l) in cross-over phase | Measured with FreeStyle®Libre, Continuous Glucose Monitoring system | Study period I: during a 3 day intervention-diet period within gestational weeks 24-28 | 
| Mother: The percentage of time spent within the gestational diabetes glucose target range (<7,8 mmol/l) | Measured with FreeStyle®Libre, Continuous Glucose Monitoring system | Study period II: during a 14 day period within gestational weeks 34-36 | 
| Child: Neonatal body fat% | Neonatal body fat%; Measured with PEA POD Cosmed® Infant Body Composition Assessment system | one measure within 0-2 days after birth of the child | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mother: Glycaemic variability in crossover phase | Measured with FreeStyle®Libre, Continuous Glucose Monitoring system | Study period I: during a 3 day intervention-diet period within gestational weeks 24-28 | 
| Mother: Glycaemic variability | Measured with FreeStyle®Libre, Continuous Glucose Monitoring system | Study period II: during a 14 day period within gestational weeks 34-36 | 
| Percentage of participants on GDM medication |  | Up to 42 gestational weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nutrition, Dietary Counseling, Diet, Pregnancy