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

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ClinicalTrials.gov Identifier: NCT02537145
Recruitment Status : Active, not recruiting
First Posted : September 1, 2015
Last Update Posted : October 11, 2017
Sponsor:
Collaborator:
Spaarne Gasthuis
Information provided by (Responsible Party):
W.J. Pasman, TNO

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.

Condition or disease
Pregnancy Obesity

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 Type : Observational
Estimated Enrollment : 16 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Do-It-Yourself Health Monitoring and Simulation of Health in Pregnant Women - Pilot Study
Actual Study Start Date : September 2015
Actual Primary Completion Date : July 2017
Estimated Study Completion Date : December 2017

Group/Cohort
Obese pregnant women
20 obese pregnant women (BMI ≥ 30)
Lean pregnant women
20 lean pregnant women (BMI 18,5 - 25)



Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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 ]
    as measured using a do-it-yourself glucose meter after an overnight fast

  2. 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 ]
    as measured by a smart-scale

  3. 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 ]
    participants continuously wear the activity tracker during the day for the whole week in each of the above mentioned measurement-weeks

  4. 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 ]
    as measured with a do-it-yourself blood pressure meter

  5. GPS location [ Time Frame: 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

  6. 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 ]
    measured using a do-it-yourself cholesterol meter

  7. oral glucose tolerance test (glucose, insulin, c-peptide) [ Time Frame: 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

  8. 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 ]
    using do-it-yourself sample collection kits (at home by participants; samples will be send to the lab)

  9. 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 ]
    do-it-yourself using finger-prick and blood spot collection cards that can be send to the lab.

  10. cortisol in hair [ Time Frame: at the end of the study (3 months after delivery; week 52) ]
    measured by taking a hair sample that is send to the lab

  11. 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 ]
    in each measurement week, participants will register their food intake on two week days and one weekend day

  12. cognition [ Time Frame: 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)

  13. 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 ]
    online; can be accessed via the study portal

  14. 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 ]
    online; can be accessed via the study portal

  15. 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 ]
    online; can be accessed via the study portal


Biospecimen Retention:   Samples With DNA

Finger-prick-blood for dried blood spots will be performed for oral glucose tolerance tests (insuline/c-peptide response profile) and determining protein and lipid metabolism as well as HbA1c.

Finger-prick-blood for measurement of glucose and cholesterol using do-it-yourself devices.

Saliva and fecal samples for determining gut and oral microbiota (bacteria) by DNA sequencing of bacterial marker genes present in fecal and saliva samples.

Hair sample for determining cortisol concentrations over time.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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).

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02537145


Locations
Netherlands
Spaarne Gasthuis
Hoofddorp, Noord Holland, Netherlands, 2134 TM
Sponsors and Collaborators
W.J. Pasman
Spaarne Gasthuis
Investigators
Principal Investigator: Marlies A van Houten, Dr. Spaarne Gasthuis

Responsible Party: W.J. Pasman, Consultant Clinical Trials, TNO
ClinicalTrials.gov Identifier: NCT02537145     History of Changes
Other Study ID Numbers: P9624
First Posted: September 1, 2015    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by W.J. Pasman, TNO:
compliance
do-it-yourself methodology
pilot
human microbiome