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

Terminated

• Conditions: Pregnancy; Obesity

• Registration Number: NCT02537145
• Lead Sponsor: W.J. Pasman

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).

Study Timeline

• Study First Submitted: 2015-08-28
• Study First Submitted QC: 2015-08-28
• Study Start: 2015-09
• Study First Posted: 2015-09-01
• Primary Completion: 2017-07
• Study Completion: 2017-12
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-04
• Last Update Posted: 2018-09-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 16

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
compliance (percentage of complete datasets)	end of study (3 months after giving birth)	as a measure of the potential of DIY-monitoring in pregnant women
Capability of and burden for participants of the use of DIY tools	end of study (3 months after giving birth)	as assessed by a questionnaire on user-experience with do-it-yourself devices in an at-home setting

Secondary Outcome Measures

Name	Time	Method
physical activity (calories burned, minutes of physical activity, number of steps)	at enrollment (between w12-15 of pregnancy), baseline (w16 of pregnancy), w18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40 of pregnancy; optionally after delivery in w42, 44, 46, 48, 50, 52	participants continuously wear the activity tracker during the day for the whole week in each of the above mentioned measurement-weeks
Cholesterol (total cholesterol, HDL, LDL, triglycerides, cholesterol/HDL-ratio)	at enrollment (between w12-15 of pregnancy), baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52	measured using a do-it-yourself cholesterol meter
oral glucose tolerance test (glucose, insulin, c-peptide)	baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52	in week 16 the test will be done in a clinical setting; the other tests will be done at home by the participants
fecal and salivary microbiota composition	at enrollment (between w12-15 of pregnancy), baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally also in w18, 27 and 36, and after delivery in w44, 48 and 52	using do-it-yourself sample collection kits (at home by participants; samples will be send to the lab)
fasting blood glucose	at enrollment (between w12-15 of pregnancy), baseline (w16 of pregnancy), w18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40 of pregnancy; optionally after delivery in w42, 44, 46, 48, 50, 52	as measured using a do-it-yourself glucose meter after an overnight fast
GPS location	measured continuously during the entire study	measured with an app that will be installed on the Smartphone of the participant at enrollment in the study
cortisol in hair	at the end of the study (3 months after delivery; week 52)	measured by taking a hair sample that is send to the lab
body weight	at enrollment (between w12-15 of pregnancy), baseline (w16 of pregnancy), w18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40 of pregnancy; optionally after delivery in w42, 44, 46, 48, 50, 52	as measured by a smart-scale
food intake as measured by a web-application	at enrollment (between w12-15 of pregnancy), baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52	in each measurement week, participants will register their food intake on two week days and one weekend day
blood pressure (diastolic, systolic, heart rate)	at enrollment (between w12-15 of pregnancy), baseline (w16 of pregnancy), w18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40 of pregnancy; optionally after delivery in w42, 44, 46, 48, 50, 52	as measured with a do-it-yourself blood pressure meter
dried blood spots for HbA1c, fatty acids and blood biomarkers	at enrollment (between w12-15 of pregnancy), baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52	do-it-yourself using finger-prick and blood spot collection cards that can be send to the lab.
cognition	at enrollment (between w12-15 of pregnancy), baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52	using online cognition tests (on a study portal)
Vita16 - vitality questionnaire	at enrollment (between w12-15 of pregnancy), baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52	online; can be accessed via the study portal
visual analogue scales for general health	at enrollment (between w12-15 of pregnancy), baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52	online; can be accessed via the study portal
Groninger Sleep Scale	at enrollment (between w12-15 of pregnancy), baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52	online; can be accessed via the study portal

Trial Locations

Locations (1)

Spaarne Gasthuis; 🇳🇱 Hoofddorp, Noord Holland, Netherlands