Primary Objective: To determine the feasibility of DIY studies in pregnant women to detect changes in health parameters, by:a. assessing the compliance of participants with the study protocol (number of complete total datasets as well as per…
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Brief title
Condition
- Other condition
Synonym
Health condition
gezonde zwangerschap
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
We will evaluate the feasibility of DIY-studies with pregnant women by the
percentage of complete datasets. This should be at least 80% for each
participant. Besides, the percentage of useful datasets for each individual
device, questionnaire or test should be at least 80% to be considered eligible
for do-it-yourself studies (compliance).
Capability of and burden for participants of the use of DIY tools will be
assessed with a questionnaire and potentially an extra evaluation during the
closing visit with the researcher (Spaarne Hospital). This will encompass
questions on how often the devices are used, the context in which the device is
used, the satisfaction of the user with the device and the effects of the
device on user behaviour.
Secondary outcome
We will also focus on determining differences in health parameters over time
driven by overweight. This will be done by comparing the measured health
parameters of lean with obese pregnant women and by comparing these data with
health outcomes of mother and child (as measured by the midwife).
Additionally, we will apply a network biology approach to identify clusters of
correlating maternal health parameters and oral and intestinal microbiota
composition parameters.
The included health parameters are body weight (BW), physical activity (PA),
food intake (FI), GPS-location, fasting plasma glucose (FPG), glucose response
profile, insulin/c-peptide response profile, total cholesterol (TC) and
triglycerides (TG), blood pressure (heart rate, systolic blood pressure and
diastolic blood pressure), cognition, faecal and salivary microbiota
composition, blood biomarkers (including but not restricted to fatty acids and
HbA1c) and cortisol.
The subjects will also fill out online-questionnaires vitality (Vita-16) and
sleep (Groninger Sleep Scale) and VAS Health Scale at four to five moments
during the study (W16, W24, W32, W40 and optional in W52). At W40-52 women will
be asked to fill out two questionnaire on acceptable and desirable health
measurements on their babies (for the follow-up study).
Finally, in this study also measures by the midwife/gynaecologist during
control visits will be included in the study database as reference value for
healthy development of mother and child during pregnancy. Measures of the
mother during the control visits (8-10 weeks, 20 weeks, 30 weeks) that will be
included are weight, blood pressure, blood glucose and HbA1c.
Measures of the child that will be included are the measures done during the
echoes (20-weeks and other if applicable) by the midwife. These echo-forms
include the following data: CRL (Crown, Rump, Length), BPD (Bipariëtale
Diameter), HC (head circumference), TCD (Trans Cerebellair Diameter), AC
(abdominal circumference), EFW (estimated fetal weight), heart and
heart-action, location of the placenta, Vrw (amniotic), tractus
gastro-intestinalis, tractus uro-genitalis, abdominal wall, thorax shape, CNS
(central nervous system), face. Additionally, birth weight, apgar score,
delivery term, length and type of labour (natural delivery or caesarean
section) will be included.
Background summary
The 1,000 days from the start of a woman*s pregnancy until her child*s 2nd
birthday offer a unique window of opportunity to shape healthier and more
prosperous futures for the child. An important part of these first 1,000 days
of life is the pregnancy itself. Impaired health states in pregnant women are
associated with negative pregnancy outcomes as well as with negative health
outcomes for both mother and child. It has been well established that pregnant
women are motivated towards a healthy diet and lifestyle when provided
appropriate advice. To optimally align advice on a healthy life style and diet
and to the individual, it is key to empower the individual to monitor its own
health. Smartphone apps, Quantified Self devices and self-tests give
individuals the opportunity to measure several aspects of health with
increasing accuracy, like food intake, body weight, blood pressure and physical
activity. The data that is garnered through the use of Do-It-Yourself tools can
be used to identify relations between health parameters during pregnancy on the
one hand, and to empower pregnant women to make healthy life style choices on
the other hand.
Study objective
Primary Objective:
To determine the feasibility of DIY studies in pregnant women to detect changes
in health parameters, by:
a. assessing the compliance of participants with the study protocol (number of
complete total datasets as well as per measurement)
b. assessing the capability of and burden for participants of the use of these
DIY tools (user experiences)
Secondary Objective(s):
Besides assessing the feasibility of do-it-yourself research in pregnant women,
we have underlying scientific objectives. Since this is a pilot study, these
objectives are of a more exploratory nature:
- To identify the integrated differences in physiological development between
obese (BMI * 30) and lean (BMI 18,5 - 25) pregnant women and their effects on
the health status of the baby
- To gain insight in the usability of do-it-yourself monitoring for early
detection of deviations in health parameters
- To test the hypothesis that the gut and saliva microbiota composition differs
in obese (BMI * 30) pregnant women compared with normal-weight (BMI 18,5 - 25)
pregnant women and is further associated with physiological development during
pregnancy.
Study design
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 18 of
their pregnancy. Week 16-18 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; and optionally until
three months after giving birth (total study duration of approximately six and
optionally nine months).
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 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 notifications on the tablet. There are two
frequency intervals defined (two week interval and eight week interval).
Intervention
The intervention in this study will consist of the use of do-it-yourself
devices and sample collection kits for self-monitoring health parameters in an
at-home setting.
The included devices are an activity tracker (Activ8), a blood pressure monitor
(Medisana MTX), a blood glucose meter (Medisana MediTouch 2), a smart scale
(FitBit Aria), a cholesterol meter (Mission Cholesterol 3-1 meter) and a
centimetre.
The do-it-yourself sample collection kits that will be used, include saliva,
urine, faeces, smell identification, bitter taste, hair and dry blood spot
sampling kits. The do-it-yourself questionnaires include the VAS score, POMS,
Vita-16, physical performance, Sleep and Inquisit tests.
Subjects will be supplied with these devices and kits upon inclusion in the
pilot study.
Devices have to be handed in again at the end of the study. Additionally,
subjects will be given access to a food intake application Mijn Eetmeter.
Study burden and risks
Data collection will be primarily based on *do-it-yourself* non-invasive or
minimally invasive methods. These data will be delivered by the participant to
their online portal. For some health parameters, participants will send their
samples to labs for analysis; in this case, the lab will be responsible for
uploading the data to the portal. We do not foresee any health risks in using
the do-it-yourself methods for measuring health parameters. All methods have
been used in previous studies and most are commercially available, and are
therefore, with normal use, considered safe. Data of the study will be uploaded
to the online NRC portal by an account created for the study-participant.
Personal data and research data are stored in separate databases. Research data
is stored pseudonymized, such that researchers that analyze the data cannot
connect data to an individual.
Utrechtseweg 48
Zeist 3704 HE
NL
Utrechtseweg 48
Zeist 3704 HE
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL52707.094.15 |