DIY health monitoring and simulation of health in pregnant women: a pilot study - oPTiMuM (PreganT Moms Measure)

TNO0 个研究点目标入组 40 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•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.

•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 (<1 month prior to the start of the study);
•13. Not willing to give up blood donation during the study;
•14. Personnel of TNO and their partner.

发起方

TNO