Diabetes, GestationaleMOMNCT03542071
Dietary Management of Gestational Diabetes in Obese Pregnant Women
A study testing Carbohydrate restricted diet and Plant-protein based diet in people with Diabetes, Gestational and Dietary Modification, run by Helsinki University Central Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Diabetes, Gestational, Dietary Modification, Tissue Glucose
- What is being tested?
- Carbohydrate restricted diet and Plant-protein based diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteFinland
- Study dates
- 20 Jul 2018to 23 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Early gestational diabetes (pregnancy weeks 10-15)
- BMI ≥ 30 kg/m2
- Pregnancy confirmed with ultrasound screening
Who cannot join
- 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
Show all 9Show fewer
- Drug or alcohol abuse
- Psychiatric illness which affects participation in study
- Factors hampering communication (e.g. lack of Finnish skills)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Diabetes, Gestational, Dietary Modification, Tissue Glucose, Body Composition, Birth Weight
- Being tested
- Carbohydrate restricted diet, Plant-protein based diet
- Medical subject headings
- Diabetes, Gestational, Birth Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrate restricted dietOther
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)
Plant-protein based dietOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Carbohydrate restricted diet | Experimental | Dietary intervention: moderately carbohydrate restricted diet. Parallel phase starts after study period I and the diet is followed until labor. Receives: Other: Carbohydrate restricted diet |
| Plant-protein based diet | Experimental | 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. Receives: Other: Plant-protein based diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Study period II: during a 14 day period within gestational weeks 23-26
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
Measured: Study period III: during a 14 day period within gestational weeks 33-36
Child: Neonatal body fat%
Neonatal body fat%; Measured with PEA POD Cosmed® Infant Body Composition Assessment system
Measured: one measure within 0-2 days after birth of the child
Secondary outcomes (5)
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
Measured: Study period I: during a 3 day intervention-diet period within gestational weeks 12-15
Mother: Glycaemic variability in crossover phase
Measured with FreeStyle®Libre, Continuous Glucose Monitoring system
Measured: Study period I: during a 3 day intervention-diet period within gestational weeks 12-15
Mother: Glycaemic variability
Measured with FreeStyle®Libre, Continuous Glucose Monitoring system
Measured: Study period II: during a 14 day period within gestational weeks 23-26
Mother: Glycaemic variability
Measured with FreeStyle®Libre, Continuous Glucose Monitoring system
Measured: Study period III: during a 14 day period within gestational weeks 33-36
Percentage of participants on GDM medication
Measured: Up to 42 gestational weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start20 Jul 2018
- Primary completion23 Mar 2019
- Study completion23 Mar 2019
Why it stopped: The study protocol was changed because of too few eligible participants. A registration with revised protocol can be found by ClinicalTrials.gov ID NCT03681054.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes, GestationalStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki, Aalto University, Finnish Institute for Health and Welfare, City of Helsinki, UKK Institute
- Responsible party
- Principal investigator, Saila Koivusalo, Helsinki University Central Hospital
- Investigators
- Seppo Heinonen, prof, Study director, Head of department of obst et gyn / Helsinki Unversity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03542071
- Sponsor's protocol ID
- HUS/1792/2016
- Acronym
- eMOM
- Status last verified
- Oct 2019
- First submitted
- 3 Apr 2018
- Last updated
- 23 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Standardized Dietary Intake on Metabolic Outcomes in Obese Pregnant Women With Gestational Diabetes and on Offspring Body Composition
- ClinicalTrials.gov ID
- NCT03542071
- Acronym / sponsor ID
- eMOM / HUS/1792/2016
- Conditions
- Diabetes, Gestational, Dietary Modification, Tissue Glucose, Body Composition, Birth Weight
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study protocol was changed because of too few eligible participants. A registration with revised protocol can be found by ClinicalTrials.gov ID NCT03681054.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- University of Helsinki, Aalto University, Finnish Institute for Health and Welfare, City of Helsinki, UKK Institute
- Study start
- 20 Jul 2018 (actual)
- Primary completion
- 23 Mar 2019 (actual)
- Study completion
- 23 Mar 2019 (actual)
- First posted
- 31 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbohydrate restricted diet | Experimental | Other: Carbohydrate restricted dietDietary intervention: moderately carbohydrate restricted diet. Parallel phase starts after study period I and the diet is followed until labor. |
| Plant-protein based diet | Experimental | Other: Plant-protein based dietDietary 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Early gestational diabetes (pregnancy weeks 10-15)
- BMI ≥ 30 kg/m2
- Pregnancy confirmed with ultrasound screening
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbohydrate restricted dietThe 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) | Other | Carbohydrate restricted diet |
| Plant-protein based dietThe 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) | Other | Plant-protein based diet |
Primary outcome
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
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
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
5 secondary outcomes
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
Mother: Glycaemic variability in crossover phase
Time frame: 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
Mother: Glycaemic variability
Time frame: 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
Results and safety
The study was stopped early (reason given: The study protocol was changed because of too few eligible participants. A registration with revised protocol can be found by ClinicalTrials.gov ID NCT03681054.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seppo Heinonen, prof study director
Head of department of obst et gyn / Helsinki Unversity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbohydrate restricted diet and Plant-protein based diet in people with Diabetes, Gestational and Dietary Modification, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study protocol was changed because of too few eligible participants. A registration with revised protocol can be found by ClinicalTrials.gov ID NCT03681054.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2019.