PregnanT Moms Measure - Do-It-Yourself Health Monitoring and Simulation of Health in Pregnant Women

NCT ID: NCT02537145

Last Updated: 2018-09-06

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 16 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2017-12-31

Brief Summary

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.

Detailed Description

The study is designed as an open, parallel, do-it-yourself, explorative, two-group study. Subjects are women who are pregnant for approximately 3 months at the start of the study. Subjects will be included between week 12 and 15 of their pregnancy (T=-1). Week 16 is the start of the study (T=0). In the first group obese pregnant women (BMI ≥ 30) will be included; the second group will consist of lean pregnant women (BMI 18,5 - 25).

The women will be requested to assess physiological parameters at regular intervals from three months pregnancy until giving birth (week 40). The assessment after giving birth, until three months after giving birth (total study duration of approximately nine months), is optional.

Health parameters are known to be subject to change in pregnant women; the self-monitoring devices should be able to show these changes. Included subjects will be provided with the do-it-yourself devices, manuals and the study protocol. During the nine-month study, the subjects will use these do-it-yourself devices to self-monitor multiple health parameters in an at-home setting. They will be reminded to perform these tests via SMS. There are two frequency intervals defined (two week interval and eight week interval).

Conditions

Pregnancy; Obesity

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Obese pregnant women

20 obese pregnant women (BMI ≥ 30)

No interventions assigned to this group

Lean pregnant women

20 lean pregnant women (BMI 18,5 - 25)

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Pregnant between 12-15 weeks at the start of the study;

2. Healthy as assessed by the Health and Lifestyle questionnaire (P9624 F02);

3. Body mass index:

• BMI 18,5 - 25 for the lean group
• BMI ≥ 30 for the obese group;

4. Able to use self-monitoring devices;

5. Voluntary participation;

6. Having given written informed consent;

7. Willing to comply with study procedures;

8. 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;

9. Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data by TNO;

10. Have internet access at home;

11. Subjects should own a Smartphone with Bluetooth 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.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Spaarne Gasthuis

OTHER

Sponsor Role: collaborator

W.J. Pasman

OTHER

Sponsor Role: lead

Responsible Party

W.J. Pasman

Consultant Clinical Trials

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Marlies A van Houten, Dr.

Role: PRINCIPAL_INVESTIGATOR

Spaarne Gasthuis

Locations

Spaarne Gasthuis

Hoofddorp, North Holland, Netherlands

Countries

Netherlands

Other Identifiers

P9624

Identifier Type: -

Identifier Source: org_study_id