gezonde zwangerschap healthy child-bearing
Conditions
Interventions
The intervention in this study will consist of the use of do-it-yourself
devices and sample collection kits for self-monitoring health parameters in an
at-home setting.
The included devices are an
Sponsors
TNO
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Pregnant between 12-18 weeks at the start of the study; 2. Women must be able to speak, write and read in Dutch; 3. Healthy as assessed by the Health and Lifestyle questionnaire (P9624 F02); 4. Body mass index: - BMI 18,5 - 25 for the lean group - BMI * 30 for the obese group; 5. Able to use self-monitoring devices; 6. Voluntary participation; 7. Having given written informed consent; 8. Willing to comply with study procedures; 9. Willingness to share pseudonymised data on measured health parameters with external parties that provide the measuring devices (including MijnEetmeter, Moves and NRC) for reasons of synchronisation with the study database; 10. Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data by TNO; 11. Have internet access at home; 12. Subjects should own a Smartphone that runs either a recent version of iOS or Android.
Exclusion criteria
Exclusion criteria: 1. Use of concomitant medication; 2. Having a history of medical or surgical events that may significantly affect the study outcome, including physical limitations or cardio-vascular events; 3. Having a (history of a) medical condition that might significantly affect the study outcome as judged by the principal investigator and health and life style questionnaire. This includes diabetes type 1 or 2, gastrointestinal dysfunction, diseases related to inflammation, or a psychiatric disorder; 4. Hypertension: systolic blood pressure >160 mmHg, diastolic blood pressure >90 mmHg; 5. Having a pacemaker; 6. Previous pregnancy with medical issues (e.g. pre-eclampsia); 7. Reported slimming or medically prescribed diet; 8. Physical, mental or practical limitations in using computerized systems; 9. Alcohol consumption > 14 units (drinks)/week; 10. Smoking; 11. Reported unexplained weight loss or gain of > 2 kg in the three months prior to the pre-study screening / pregnancy; 12. Recent blood donation (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We will evaluate the feasibility of DIY-studies with pregnant women by the percentage of complete datasets. This should be at least 80% for each participant. Besides, the percentage of useful datasets for each individual device, questionnaire or test should be at least 80% to be considered eligible for do-it-yourself studies (compliance). Capability of and burden for participants of the use of DIY tools will be assessed with a questionnaire and potentially an extra evaluation during the closing visit with the researcher (Spaarne Hospital). This will encompass questions on how often the devices are used, the context in which the device is used, the satisfaction of the user with the device and the effects of the device on user behaviour. | — |
Secondary
| Measure | Time frame |
|---|---|
| We will also focus on determining differences in health parameters over time driven by overweight. This will be done by comparing the measured health parameters of lean with obese pregnant women and by comparing these data with health outcomes of mother and child (as measured by the midwife). Additionally, we will apply a network biology approach to identify clusters of correlating maternal health parameters and oral and intestinal microbiota composition parameters. The included health parameters are body weight (BW), physical activity (PA), food intake (FI), GPS-location, fasting plasma glucose (FPG), glucose response profile, insulin/c-peptide response profile, total cholesterol (TC) and triglycerides (TG), blood pressure (heart rate, systolic blood pressure and diastolic blood pressure), cognition, faecal and salivary microbiota composition, blood biomarkers (including but not restricted to fatty acids and HbA1c) and cortisol. The subjects will also fill out online-questionnaires vitality (Vita-16) and sleep (Groninger Sleep Scale) and VAS Health Scale at four to five moments during the study (W16, W24, W32, W40 and optional in W52). At W40-52 women will be asked to fill out two questionnaire on acceptable and desirable health measurements on their babies (for the follow-up study). Finally, in this study also measures by the midwife/gynaecologist during control visits will be included in the study database as reference value for healthy development of mother and child during pregnancy. Measures of the mother during the control visits (8-10 weeks, 20 weeks, 30 weeks) that will be included are weight, blood pressure, blood glucose and HbA1c. Measures of the child that will be included are the measures done during the echoes (20-weeks and other if applicable) by the midwife. These echo-forms include the following data: CRL (Crown, Rump, Length), BPD (Bipariëtale Diameter), HC (head circumference), TCD (Trans Cerebellair Diameter), AC (abd | — |
Countries
Netherlands
Outcome results
None listed