[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100250315":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":15,"centralContacts":10,"locations":20,"responsibleParty":33,"collaborators":37,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":47,"sex":48,"minAge":10,"maxAge":10,"enrollmentInfo":49,"targetDuration":10,"studyType":52,"phases":10,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":62,"whyStopped":63,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},{"fullName":5,"class":6},"TNO","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Obese pregnant women",null,"20 obese pregnant women (BMI ≥ 30)",{"label":13,"type":10,"description":14,"interventionNames":10},"Lean pregnant women","20 lean pregnant women (BMI 18,5 - 25)",[16],{"name":17,"affiliation":18,"role":19},"Marlies A van Houten, Dr.","Spaarne Gasthuis","PRINCIPAL_INVESTIGATOR",[21],{"facility":18,"status":10,"city":22,"state":23,"zip":24,"country":25,"countryCode":26,"cosmosGeoPoint":27,"geoPoint":32,"contacts":10},"Hoofddorp","North Holland","2134 TM","Netherlands","NL",{"type":28,"coordinates":29},"Point",[30,31],4.68889,52.3025,{"lat":31,"lon":30},{"type":34,"investigatorFullName":35,"investigatorTitle":36,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","W.J. Pasman","Consultant Clinical Trials",[38],{"name":18,"class":6},"100250315","pregnant-moms-measure---do-it-yourself-health-monitoring-and-simulation-of-health-in-pregnant-women-100250315",false,"NCT02537145","PregnanT Moms Measure - Do-It-Yourself Health Monitoring and Simulation of Health in Pregnant Women","Do-It-Yourself Health Monitoring and Simulation of Health in Pregnant Women - Pilot Study","oPTiMuM","Inclusion Criteria:\n\n1. Pregnant between 12-15 weeks at the start of the study;\n2. Healthy as assessed by the Health and Lifestyle questionnaire (P9624 F02);\n3. Body mass index:\n\n   * BMI 18,5 - 25 for the lean group\n   * BMI ≥ 30 for the obese group;\n4. Able to use self-monitoring devices;\n5. Voluntary participation;\n6. Having given written informed consent;\n7. Willing to comply with study procedures;\n8. 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;\n9. Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data by TNO;\n10. Have internet access at home;\n11. Subjects should own a Smartphone with Bluetooth that runs either a recent version of iOS or Android.\n\nExclusion Criteria:\n\n1. Use of concomitant medication;\n2. Having a history of medical or surgical events that may significantly affect the study outcome, including physical limitations or cardio-vascular events;\n3. 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;\n4. Hypertension: systolic blood pressure \\>160 mmHg, diastolic blood pressure \\>90 mmHg;\n5. Having a pacemaker;\n6. Previous pregnancy with medical issues (e.g. pre-eclampsia);\n7. Reported slimming or medically prescribed diet;\n8. Physical, mental or practical limitations in using computerized systems;\n9. Alcohol consumption \\> 14 units (drinks)\u002Fweek;\n10. Smoking;\n11. Reported unexplained weight loss or gain of \\> 2 kg in the three months prior to the pre-study screening \u002F pregnancy;\n12. Recent blood donation (\\\u003C1 month prior to the start of the study);\n13. Not willing to give up blood donation during the study;\n14. Personnel of TNO and their partner.",true,"FEMALE",{"count":50,"type":51},16,"ACTUAL","OBSERVATIONAL","The aim of this pilot study is to determine the feasibility of Do-It-Yourself studies in pregnant women to detect changes in health parameters by assessing compliance and user experiences of participants. Besides, the measured health will be analysed to increase insight in physiological development in pregnant women.",[55,56],"Pregnancy","Obesity",[58,59,60,61],"compliance","do-it-yourself methodology","pilot","human microbiome","TERMINATED","Not enough obese subjects could be recruited.","2018-09-04",{"date":66,"type":51},"2018-09-06",{"date":68,"type":51},"2015-09",{"date":70,"type":51},"2017-12",{"name":35,"class":6},1]