NL-OMON44770
Recruiting
Not Applicable
DIY health monitoring and simulation of health in pregnant women: a pilot study - oPTiMuM (PreganT Moms Measure)
TNO0 sites40 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- gezonde zwangerschap
- Sponsor
- TNO
- Enrollment
- 40
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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;
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;
Outcomes
Primary Outcomes
Not specified
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