DIY health monitoring and simulation of health in pregnant women: a pilot study

Recruiting

• Conditions: gezonde zwangerschap; healthy child-bearing; healthy pregnancy

• Registration Number: NL-OMON44770
• Lead Sponsor: TNO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 40

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

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.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>We will evaluate the feasibility of DIY-studies with pregnant women by the<br /><br>percentage of complete datasets. This should be at least 80% for each<br /><br>participant. Besides, the percentage of useful datasets for each individual<br /><br>device, questionnaire or test should be at least 80% to be considered eligible<br /><br>for do-it-yourself studies (compliance).<br /><br><br /><br>Capability of and burden for participants of the use of DIY tools will be<br /><br>assessed with a questionnaire and potentially an extra evaluation during the<br /><br>closing visit with the researcher (Spaarne Hospital). This will encompass<br /><br>questions on how often the devices are used, the context in which the device is<br /><br>used, the satisfaction of the user with the device and the effects of the<br /><br>device on user behaviour. </p><br>