Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
200 participants
INTERVENTIONAL
2021-03-10
2026-12-31
Brief Summary
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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.
Detailed Description
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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):
* Laboratory tests: fp-gluc, HbA1c, fp-insu, lipids, hs-CRP
* Fingertips glucose values from glucose meter (belong to normal antenatal care)
* Fasting blood samples for future analyses
* Weight, height, blood pressure (from the antenatal registry and study visits)
* Questionnaires: background (only at enrollment), diet (food frequency questionnaire), depression (EPDS), motivation (TSRQ+PCS), quality of life (15D)
* Physical activity and sedentary behavior with the hip-worn triaxial accelerometer (UKK RM 42)
* Physical activity and heart rate with Firstbeat Bodyguard
Measurements at Birth:
* Cord blood sample
* Placental weight
* Offspring birthweight, height, body composition (PEA POD Cosmed®)
Maternal measurements at 3 months postpartum:
* Laboratory tests: fp-gluc, HbA1c, fp-insu, lipids, hs-CRP
* fp-gluc, 2h postprandial value, as measured during oral glucose tolerance test (OGTT)
* Fasting blood samples for future analyses
* Firstbeat Bodyguard 2 measurement (3 days)
* Depression questionnaire (EPDS)
* Diet questionnaire (FFQ)
Protocol only for the intervention group
\- eMOM GDM application: use: 1 application week + 3 normal care weeks repeatedly until delivery
The application includes:
1. continuous glucose monitor (CGM)
* fingertips glucose calibration according to CGM protocol (twice per day with Medtronic)
2. diet (digital food tracker)
* 3 days during one application week
* For ensuring the quality of food record a researcher will phone interview the participant based on her recordings. This is done after each recording period.
3. heartrate, stress and physical activity with the wrist-worn activity tracker (Vivosmart 3)
4. weight measured once a week
Data from the sensors
* Data from users' input to the application
* Technology acceptance questionnaire (UTAUT) after every application week
* Usability questionnaire, after four weeks usage of the eMOM GDM application
* Semi-structured interview
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Intervention (eMOM GDM application)
Participants in the intervention group will use the eMOM GDM -application one week/month. The participants will also receive regular antenatal care in maternity clinics and hospitals. In addition they will meet a study nurse three times during study period (at GW 24-28, at GW 35-37 and 3 mo postpartum).
eMOM GDM application
Participants in the intervention group will use the eMOM GDM -application one week/month.
eMOM GDM application includes:
* continuous glucose monitor (CGM, Medtronic)
* diet (digital food tracker) (min 3 days during one application week)
* heartrate, stress and physical activity with the wrist-worn activity tracker (Vivosmart 3)
* weight measured once a week
The sensors can be worn and the application used during the whole pregnancy (if a mother is interested in)
Control
Participants in the control group will meet a study nurse 3 times during study period (at GW 24-28, at GW 35-37 and 3 mo postpartum). They also receive regular antenatal care in maternity clinics and hospitals.
No interventions assigned to this group
Interventions
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eMOM GDM application
Participants in the intervention group will use the eMOM GDM -application one week/month.
eMOM GDM application includes:
* continuous glucose monitor (CGM, Medtronic)
* diet (digital food tracker) (min 3 days during one application week)
* heartrate, stress and physical activity with the wrist-worn activity tracker (Vivosmart 3)
* weight measured once a week
The sensors can be worn and the application used during the whole pregnancy (if a mother is interested in)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* use of medication that influences glucose metabolism (such as continuous therapy with oral corticosteroids or metformin)
* multiple pregnancy
* physical disability
* current substance abuse
* severe psychiatric disorder (that complicates participation to the study)
* significant difficulty in cooperating (e.g. inadequate Finnish language skills)
18 Years
45 Years
FEMALE
Yes
Sponsors
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University of Helsinki
OTHER
Aalto University
OTHER
UKK Institute
OTHER
Tampere University
OTHER
Finnish Institute for Health and Welfare
OTHER_GOV
Fujitsu
UNKNOWN
Elisa Oyj
UNKNOWN
Business Finland
OTHER
Helsinki University Central Hospital
OTHER
Responsible Party
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Saila Koivusalo
MD Adjunct prof
Locations
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Helsinki University Hospital
Helsinki, , Finland
Countries
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References
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Maattanen S, Koivusalo S, Ylinen H, Heinonen S, Kyto M. The Effect of a Mobile App (eMOM) on Self-Discovery and Psychological Factors in Persons With Gestational Diabetes: Mixed Methods Study. JMIR Mhealth Uhealth. 2025 Jun 4;13:e60855. doi: 10.2196/60855.
Kyto M, Markussen LT, Marttinen P, Jacucci G, Niinisto S, Virtanen SM, Korhonen TE, Sievanen H, Vaha-Ypya H, Korhonen I, Heinonen S, Koivusalo SB. Comprehensive self-tracking of blood glucose and lifestyle with a mobile application in the management of gestational diabetes: a study protocol for a randomised controlled trial (eMOM GDM study). BMJ Open. 2022 Nov 7;12(11):e066292. doi: 10.1136/bmjopen-2022-066292.
Other Identifiers
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HUS/2165/2018-Phase 2
Identifier Type: -
Identifier Source: org_study_id