PregnancyoPTiMuMNCT02537145
PregnanT Moms Measure - Do-It-Yourself Health Monitoring and Simulation of Health in Pregnant Women
An observational study of Pregnancy and Obesity, run by W.J. Pasman at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- How many people
- 16 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2015to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population consists of 40 women who are between 12 and 15 weeks pregnant at the time of inclusion in the study. In this study, two groups will be compared: 20 obese pregnant women (BMI ≥ 30) and 20 lean pregnant women (BMI 18,5 - 25). All pregnant women will be from Dutch descent (Dutch nationality and culture).
Who may be able to join
- Pregnant between 12-15 weeks at the start of the study;
- Healthy as assessed by the Health and Lifestyle questionnaire (P9624 F02);
- Body mass index:
- BMI 18,5 - 25 for the lean group
- BMI ≥ 30 for the obese group;
- Able to use self-monitoring devices;
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- Voluntary participation;
- Having given written informed consent;
- Willing to comply with study procedures;
- 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;
- Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data by TNO;
- Have internet access at home;
- Subjects should own a Smartphone with Bluetooth that runs either a recent version of iOS or Android.
Who cannot join
- Use of concomitant medication;
- Having a history of medical or surgical events that may significantly affect the study outcome, including physical limitations or cardio-vascular events;
- 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;
- Hypertension: systolic blood pressure >160 mmHg, diastolic blood pressure >90 mmHg;
- Having a pacemaker;
- Previous pregnancy with medical issues (e.g. pre-eclampsia);
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- Reported slimming or medically prescribed diet;
- Physical, mental or practical limitations in using computerized systems;
- Alcohol consumption > 14 units (drinks)/week;
- Smoking;
- Reported unexplained weight loss or gain of > 2 kg in the three months prior to the pre-study screening / pregnancy;
- Recent blood donation (<1 month prior to the start of the study);
- Not willing to give up blood donation during the study;
- Personnel of TNO and their partner.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Do-It-Yourself Health Monitoring and Simulation of Health in Pregnant Women - Pilot Study
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.
Read the 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).
- Keywords
- compliance, do-it-yourself methodology, pilot, human microbiome
- Medical subject headings
- Obesity, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Obese pregnant women | 20 obese pregnant women (BMI ≥ 30) | |
| Lean pregnant women | 20 lean pregnant women (BMI 18,5 - 25) |
What is being measured
The primary outcome is the main question the study is designed to answer.
compliance (percentage of complete datasets)
as a measure of the potential of DIY-monitoring in pregnant women
Measured: end of study (3 months after giving birth)
Capability of and burden for participants of the use of DIY tools
as assessed by a questionnaire on user-experience with do-it-yourself devices in an at-home setting
Measured: end of study (3 months after giving birth)
Secondary outcomes (15)
fasting blood glucose
as measured using a do-it-yourself glucose meter after an overnight fast
Measured: 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
body weight
as measured by a smart-scale
Measured: 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
physical activity (calories burned, minutes of physical activity, number of steps)
participants continuously wear the activity tracker during the day for the whole week in each of the above mentioned measurement-weeks
Measured: 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
blood pressure (diastolic, systolic, heart rate)
as measured with a do-it-yourself blood pressure meter
Measured: 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
GPS location
measured with an app that will be installed on the Smartphone of the participant at enrollment in the study
Measured: measured continuously during the entire study
Cholesterol (total cholesterol, HDL, LDL, triglycerides, cholesterol/HDL-ratio)
measured using a do-it-yourself cholesterol meter
Measured: at enrollment (between w12-15 of pregnancy), baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52
oral glucose tolerance test (glucose, insulin, c-peptide)
in week 16 the test will be done in a clinical setting; the other tests will be done at home by the participants
Measured: baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52
fecal and salivary microbiota composition
using do-it-yourself sample collection kits (at home by participants; samples will be send to the lab)
Measured: 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
dried blood spots for HbA1c, fatty acids and blood biomarkers
do-it-yourself using finger-prick and blood spot collection cards that can be send to the lab.
Measured: at enrollment (between w12-15 of pregnancy), baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52
cortisol in hair
measured by taking a hair sample that is send to the lab
Measured: at the end of the study (3 months after delivery; week 52)
food intake as measured by a web-application
in each measurement week, participants will register their food intake on two week days and one weekend day
Measured: at enrollment (between w12-15 of pregnancy), baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52
cognition
using online cognition tests (on a study portal)
Measured: at enrollment (between w12-15 of pregnancy), baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52
Groninger Sleep Scale
online; can be accessed via the study portal
Measured: at enrollment (between w12-15 of pregnancy), baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52
Vita16 - vitality questionnaire
online; can be accessed via the study portal
Measured: at enrollment (between w12-15 of pregnancy), baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52
visual analogue scales for general health
online; can be accessed via the study portal
Measured: at enrollment (between w12-15 of pregnancy), baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionJul 2017
- Study completionDec 2017
Why it stopped: Not enough obese subjects could be recruited.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- W.J. Pasman
- Sponsor type
- University, hospital or other
- Collaborators
- Spaarne Gasthuis
- Responsible party
- Sponsor-investigator, W.J. Pasman, TNO
- Investigators
- Marlies A van Houten, Dr., Principal investigator, Spaarne Gasthuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02537145
- Sponsor's protocol ID
- P9624
- Acronym
- oPTiMuM
- Status last verified
- Sep 2018
- First submitted
- 28 Aug 2015
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do-It-Yourself Health Monitoring and Simulation of Health in Pregnant Women - Pilot Study
- ClinicalTrials.gov ID
- NCT02537145
- Acronym / sponsor ID
- oPTiMuM / P9624
- Keywords
- compliance, do-it-yourself methodology, pilot, human microbiome
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Not enough obese subjects could be recruited.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- W.J. PasmanUniversity, hospital or other
- Collaborators
- Spaarne Gasthuis
- Study start
- Sep 2015 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 1 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese pregnant women | – | –20 obese pregnant women (BMI ≥ 30) |
| Lean pregnant women | – | –20 lean pregnant women (BMI 18,5 - 25) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of 40 women who are between 12 and 15 weeks pregnant at the time of inclusion in the study. In this study, two groups will be compared: 20 obese pregnant women (BMI ≥ 30) and 20 lean pregnant women (BMI 18,5 - 25). All pregnant women will be from Dutch descent (Dutch nationality and culture).
Key inclusion criteria (13 listed)
- Pregnant between 12-15 weeks at the start of the study;
- Healthy as assessed by the Health and Lifestyle questionnaire (P9624 F02);
- Body mass index:
- Able to use self-monitoring devices;
- Voluntary participation;
Key exclusion criteria (14 listed)
- Use of concomitant medication;
- Having a history of medical or surgical events that may significantly affect the study outcome, including physical limitations or cardio-vascular events;
- 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;
- Hypertension: systolic blood pressure >160 mmHg, diastolic blood pressure >90 mmHg;
- Having a pacemaker;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
compliance (percentage of complete datasets)
Time frame: 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
Time frame: 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
15 secondary outcomes
fasting blood glucose
Time frame: 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
body weight
Time frame: 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
physical activity (calories burned, minutes of physical activity, number of steps)
Time frame: 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
blood pressure (diastolic, systolic, heart rate)
Time frame: 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
GPS location
Time frame: measured continuously during the entire study
Cholesterol (total cholesterol, HDL, LDL, triglycerides, cholesterol/HDL-ratio)
Time frame: at enrollment (between w12-15 of pregnancy), baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52
oral glucose tolerance test (glucose, insulin, c-peptide)
Time frame: baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52
fecal and salivary microbiota composition
Time frame: 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
dried blood spots for HbA1c, fatty acids and blood biomarkers
Time frame: at enrollment (between w12-15 of pregnancy), baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52
cortisol in hair
Time frame: at the end of the study (3 months after delivery; week 52)
food intake as measured by a web-application
Time frame: at enrollment (between w12-15 of pregnancy), baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52
cognition
Time frame: at enrollment (between w12-15 of pregnancy), baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52
Groninger Sleep Scale
Time frame: at enrollment (between w12-15 of pregnancy), baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52
Vita16 - vitality questionnaire
Time frame: at enrollment (between w12-15 of pregnancy), baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52
visual analogue scales for general health
Time frame: at enrollment (between w12-15 of pregnancy), baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52
Results and safety
The study was stopped early (reason given: Not enough obese subjects could be recruited.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marlies A van Houten, Dr. principal investigator
Spaarne Gasthuis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Obesity, run by W.J. Pasman at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Not enough obese subjects could be recruited.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compliance (percentage of complete datasets) (time frame: end of study (3 months after giving birth)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2018.