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Dietary Management of Gestational Diabetes (eMOM)

Primary Purpose

Diabetes, Gestational, Dietary Modification, Glucose Intolerance During Pregnancy

Status
Active
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Carbohydrate restricted diet
Plant-protein based diet
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes, Gestational focused on measuring Nutrition, Dietary Counseling, Diet, Pregnancy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Helsinki university central hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Carbohydrate restricted diet

Plant-protein based diet

Arm Description

Dietary intervention: moderately carbohydrate restricted diet. Parallel phase starts after study period I and the diet is followed until labor.

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.

Outcomes

Primary Outcome Measures

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
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
Child: Neonatal body fat%
Neonatal body fat%; Measured with PEA POD Cosmed® Infant Body Composition Assessment system

Secondary Outcome Measures

Mother: Glycaemic variability in crossover phase
Measured with FreeStyle®Libre, Continuous Glucose Monitoring system
Mother: Glycaemic variability
Measured with FreeStyle®Libre, Continuous Glucose Monitoring system
Percentage of participants on GDM medication

Full Information

First Posted
September 20, 2018
Last Updated
January 16, 2023
Sponsor
Helsinki University Central Hospital
Collaborators
University of Helsinki, Aalto University, Finnish Institute for Health and Welfare, City of Helsinki, UKK Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03681054
Brief Title
Dietary Management of Gestational Diabetes
Acronym
eMOM
Official Title
Effects of Guided Dietary Patterns on Metabolic Outcomes in Overweight Pregnant Women With Gestational Diabetes and on Offspring Body Composition
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 3, 2018 (Actual)
Primary Completion Date
June 5, 2020 (Actual)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
Collaborators
University of Helsinki, Aalto University, Finnish Institute for Health and Welfare, City of Helsinki, UKK Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Gestational, Dietary Modification, Glucose Intolerance During Pregnancy, Body Composition, Birth Weight
Keywords
Nutrition, Dietary Counseling, Diet, Pregnancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Carbohydrate restricted diet
Arm Type
Experimental
Arm Description
Dietary intervention: moderately carbohydrate restricted diet. Parallel phase starts after study period I and the diet is followed until labor.
Arm Title
Plant-protein based diet
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Carbohydrate restricted diet
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Plant-protein based diet
Intervention Description
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)
Primary Outcome Measure Information:
Title
Mother: The percentage of time spent within the gestational diabetes glucose target range (<7,8 mmol/l) in cross-over phase
Description
Measured with FreeStyle®Libre, Continuous Glucose Monitoring system
Time Frame
Study period I: during a 3 day intervention-diet period within gestational weeks 24-28
Title
Mother: The percentage of time spent within the gestational diabetes glucose target range (<7,8 mmol/l)
Description
Measured with FreeStyle®Libre, Continuous Glucose Monitoring system
Time Frame
Study period II: during a 14 day period within gestational weeks 34-36
Title
Child: Neonatal body fat%
Description
Neonatal body fat%; Measured with PEA POD Cosmed® Infant Body Composition Assessment system
Time Frame
one measure within 0-2 days after birth of the child
Secondary Outcome Measure Information:
Title
Mother: Glycaemic variability in crossover phase
Description
Measured with FreeStyle®Libre, Continuous Glucose Monitoring system
Time Frame
Study period I: during a 3 day intervention-diet period within gestational weeks 24-28
Title
Mother: Glycaemic variability
Description
Measured with FreeStyle®Libre, Continuous Glucose Monitoring system
Time Frame
Study period II: during a 14 day period within gestational weeks 34-36
Title
Percentage of participants on GDM medication
Time Frame
Up to 42 gestational weeks

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seppo Heinonen, prof
Organizational Affiliation
Head of department of obs and gyn/Helsinki University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Helsinki university central hospital
City
Helsinki
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No

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Dietary Management of Gestational Diabetes

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