Clinical trial NCT02537145: PregnanT Moms Measure - Do-It-Yourself Health Monitoring and Simulation of Health in Pregnant Women
Official title: Do-It-Yourself Health Monitoring and Simulation of Health in Pregnant Women - Pilot Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pregnancy
Obesity
Keywords: compliance
do-it-yourself methodology
pilot
human microbiome
Lead sponsor: TNO
Sponsor class: OTHER
Collaborators: name: Spaarne Gasthuis
First posted: 2015-09-01
Enrollment: 16
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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).

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).

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.

Primary outcomes:
measure: compliance (percentage of complete datasets)
timeFrame: end of study (3 months after giving birth)
measure: Capability of and burden for participants of the use of DIY tools
timeFrame: end of study (3 months after giving birth)
Secondary outcomes:
measure: fasting blood glucose
timeFrame: 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
measure: body weight
timeFrame: 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
measure: physical activity (calories burned, minutes of physical activity, number of steps)
timeFrame: 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
measure: blood pressure (diastolic, systolic, heart rate)
timeFrame: 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
measure: GPS location
timeFrame: measured continuously during the entire study
measure: Cholesterol (total cholesterol, HDL, LDL, triglycerides, cholesterol/HDL-ratio)
timeFrame: at enrollment (between w12-15 of pregnancy), baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52
measure: oral glucose tolerance test (glucose, insulin, c-peptide)
timeFrame: baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52
measure: fecal and salivary microbiota composition
timeFrame: 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
measure: dried blood spots for HbA1c, fatty acids and blood biomarkers
timeFrame: at enrollment (between w12-15 of pregnancy), baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52
measure: cortisol in hair
timeFrame: at the end of the study (3 months after delivery; week 52)
measure: food intake as measured by a web-application
timeFrame: at enrollment (between w12-15 of pregnancy), baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52
measure: cognition
timeFrame: at enrollment (between w12-15 of pregnancy), baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52
measure: Groninger Sleep Scale
timeFrame: at enrollment (between w12-15 of pregnancy), baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52
measure: Vita16 - vitality questionnaire
timeFrame: at enrollment (between w12-15 of pregnancy), baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52
measure: visual analogue scales for general health
timeFrame: at enrollment (between w12-15 of pregnancy), baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52
Other outcomes:
Locations:
city: Hoofddorp
country: Netherlands
facility: Spaarne Gasthuis
state: Noord Holland
Study officials:
affiliation: Spaarne Gasthuis
name: Marlies A van Houten, Dr.
role: PRINCIPAL_INVESTIGATOR
References: