Helsinki University Hospital
Helsinki, 00029, Finland
NCT Number: NCT04714762
The overall aim of the eMOM GDM-project is to develop and evaluate a novel system to clinical decision making and patient behavior change in treatment of GDM, combining diet, physical activity, sleep, heart rate (e.g. stress), and glucose monitoring within a single system (the eMOM GDM application), and linking the developed application tool for the normal health care system in a new way.
In this second phase of the project, the effect of eMOM GDM application on maternal and neonatal outcomes will be evaluated in a randomized controlled study design. The follow-up study continues until 3 months postpartum.
This study is active but is not currently recruiting participants.
18 year–45 year
Female
Interventional
Not applicable
Helsinki, 00029, Finland
200 women with gestational diabetes will be randomized into the intervention and the control group at gestational week (GW) 24-28.
Participants in the intervention group will use the eMOM GDM -application one week/month until delivery.
The participants in the intervention and the control group visit study nurse 3 times in study period (at GW 24-28 and GW 35-37 and 3 months postpartum).
Both groups also receive regular antenatal care in maternity clinics and hospitals.
Maternal measurements at enrollment, and at 35-37 GW (both groups):
Measurements at Birth:
Maternal measurements at 3 months postpartum:
Protocol only for the intervention group
The application includes:
Data from the sensors
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants in the intervention group will use the eMOM GDM -application one week/month.
eMOM GDM application includes:
The sensors can be worn and the application used during the whole pregnancy (if a mother is interested in)
Time frame: from gestational weeks 24-28 to gestational weeks 35-37
change in fasting glucose measured by Huslab (laboratory measurement)
Time frame: from gestational weeks 24-28 up to delivery
Measured with Contour Next One
Time frame: from gestational weeks 24-28 up to delivery
Measured with Contour Next One
Time frame: from gestational weeks 24-28 up to delivery
Measured with Contour Next One
Time frame: weight measured at gestational weeks 24-28 and at 35-37 and collected from antenatal card during whole pregnancy and up to delivery
Measured with Seca Mod 8787041649 (scale) and registered from antenatal card
Time frame: weight measured at 3 months postpartum
Measured with Seca Mod 8787041649 (scale)
Time frame: at gestational weeks 24-28, 35-37 and at 3 months postpartum
Measured with the accelerometers UKK RM42 and Firstbeat Bodyguard 2
Time frame: at gestational weeks 24-28), 35-37 and at 3 months postpartum
Measured with a questionnaire (food frequencey questionnaire, FFQ) concerning participant's diet during previous month. FFQ contains questions about the frequency (number of times per day, week, or month) and the amount of foods consumed in units of common serving sizes. Nutritional quality of total diet is assessed based on calculated daily consumption of foods and intake of nutrients. Better nutritional quality is related to e.g. higher intake of fruits and vegetables, wholegrain cereals, fiber and unsaturated fat, and lower intake of added sugar and saturated fat.
Time frame: one measure within 0-3 days after birth of the child
Measured with PEA POD Cosmed
Time frame: at gestational weeks 24-28 and 35-37
Measured with a motivation questionnaire (TSRQ and PCS). Minimum value is 1 and maximum 5. The higher score means higher autonomous motivation to manage GDM.
Time frame: up to 42 gestational weeks
Percentage of participants need for metformin treatment
Time frame: up to 42 gestational weeks
Percentage of participants need for insulin treatment
Time frame: one measure at birth
Newborn birth weight and macrosomia (birthweight >4kg)
Time frame: within a week from birth
Percentage of neonatal hypoglycemia requiring intravenous glucose
Time frame: one measure at birth
Percentage of newborn with birthweight percentile > + 2 SD
Time frame: gestational weeks 24-28, gestational weeks 35-37, 3 months postpartum
Change in HOMA-IR measured by Huslab (laboratory measurement), calculated as: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5.
Time frame: 3 months postpartum
2-hour blood glucose levels measured with OGTT (75g)
Time frame: gestational weeks 24-28, gestational weeks 35-37, 3 months postpartum
Calculated based on dedicated HRV-based algorithm by Firstbeat. Defined as percentages.
Time frame: gestational weeks 24-28, 3 months postpartum
Costs of the intervention and treatment in healthcare. Defined as €/participant.
Helsinki University Central Hospital
Other
eHealth in Treatment of Gestational Diabetes - eMOM GDM -Study (Phase 2)
Acronym: eMOMGDM
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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