- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03542071
Dietary Management of Gestational Diabetes in Obese Pregnant Women (eMOM)
October 22, 2019 updated by: Saila Koivusalo, Helsinki University Central Hospital
Effects of a Standardized Dietary Intake on Metabolic Outcomes in Obese Pregnant Women With Gestational Diabetes and on Offspring Body Composition
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=50) have early gestational diabetes mellitus (diagnosed before gestational weeks 13), are obese (BMI >30 kg/m²) and 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 three two-week study periods that are carried out on approximately gestational weeks 13-14 (period I), 24-25 (period II) and 34-35 (period III).
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 participant gets at least five personal counselling sessions, 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.
Study Overview
Status
Terminated
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Helsinki, Finland
- Helsinki University Central Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Early gestational diabetes (pregnancy weeks 10-15)
- BMI ≥ 30 kg/m2
- Pregnancy confirmed with ultrasound screening
Exclusion Criteria:
- Multiparous 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 study
- Factors hampering communication (e.g. lack of Finnish skills)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Carbohydrate restricted diet
Dietary intervention: moderately carbohydrate restricted diet.
Parallel phase starts after study period I and the diet is followed until labor.
|
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)
|
Experimental: Plant-protein based diet
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.
|
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 55 E%; fat 25 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)
|
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)
Time Frame: Study period II: during a 14 day period within gestational weeks 23-26
|
Measured with FreeStyle®Libre, Continuous Glucose Monitoring system
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Study period II: during a 14 day period within gestational weeks 23-26
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Mother: The percentage of time spent within the gestational diabetes glucose target range (<7,8 mmol/l)
Time Frame: Study period III: during a 14 day period within gestational weeks 33-36
|
Measured with FreeStyle®Libre, Continuous Glucose Monitoring system
|
Study period III: during a 14 day period within gestational weeks 33-36
|
Child: Neonatal body fat%
Time Frame: one measure within 0-2 days after birth of the child
|
Neonatal body fat%; Measured with PEA POD Cosmed® Infant Body Composition Assessment system
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one measure within 0-2 days after birth of the child
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Secondary 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
Time Frame: Study period I: during a 3 day intervention-diet period within gestational weeks 12-15
|
Measured with FreeStyle®Libre, Continuous Glucose Monitoring system
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Study period I: during a 3 day intervention-diet period within gestational weeks 12-15
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Mother: Glycaemic variability in crossover phase
Time Frame: Study period I: during a 3 day intervention-diet period within gestational weeks 12-15
|
Measured with FreeStyle®Libre, Continuous Glucose Monitoring system
|
Study period I: during a 3 day intervention-diet period within gestational weeks 12-15
|
Mother: Glycaemic variability
Time Frame: Study period II: during a 14 day period within gestational weeks 23-26
|
Measured with FreeStyle®Libre, Continuous Glucose Monitoring system
|
Study period II: during a 14 day period within gestational weeks 23-26
|
Mother: Glycaemic variability
Time Frame: Study period III: during a 14 day period within gestational weeks 33-36
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Measured with FreeStyle®Libre, Continuous Glucose Monitoring system
|
Study period III: during a 14 day period within gestational weeks 33-36
|
Percentage of participants on GDM medication
Time Frame: Up to 42 gestational weeks
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Up to 42 gestational weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Seppo Heinonen, prof, Head of department of obst et gyn / Helsinki Unversity Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 20, 2018
Primary Completion (Actual)
March 23, 2019
Study Completion (Actual)
March 23, 2019
Study Registration Dates
First Submitted
April 3, 2018
First Submitted That Met QC Criteria
May 30, 2018
First Posted (Actual)
May 31, 2018
Study Record Updates
Last Update Posted (Actual)
October 23, 2019
Last Update Submitted That Met QC Criteria
October 22, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUS/1792/2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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