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

Obesity Clinical Trial

— oPTiMuM  

Official title:

Do-It-Yourself Health Monitoring and Simulation of Health in Pregnant Women - Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02537145
• Other study ID #: P9624
• Status: Terminated
• Start date: September 2015
• Est. completion date: December 2017

Study information

• Verified date: September 2018
• Source: TNO
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: December 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Pregnancy

Locations

Country	Name	City	State
Netherlands	Spaarne Gasthuis	Hoofddorp	Noord Holland

Sponsors (2)

Lead Sponsor	Collaborator
W.J. Pasman	Spaarne Gasthuis

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compliance (percentage of complete datasets)	as a measure of the potential of DIY-monitoring in pregnant women	end of study (3 months after giving birth)
Primary	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	end of study (3 months after giving birth)
Secondary	fasting blood glucose	as measured using a do-it-yourself glucose meter after an overnight fast	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
Secondary	body weight	as measured by a smart-scale	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
Secondary	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	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
Secondary	blood pressure (diastolic, systolic, heart rate)	as measured with a do-it-yourself blood pressure meter	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
Secondary	GPS location	measured with an app that will be installed on the Smartphone of the participant at enrollment in the study	measured continuously during the entire study
Secondary	Cholesterol (total cholesterol, HDL, LDL, triglycerides, cholesterol/HDL-ratio)	measured using a do-it-yourself cholesterol meter	at enrollment (between w12-15 of pregnancy), baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52
Secondary	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	baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52
Secondary	fecal and salivary microbiota composition	using do-it-yourself sample collection kits (at home by participants; samples will be send to the lab)	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
Secondary	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.	at enrollment (between w12-15 of pregnancy), baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52
Secondary	cortisol in hair	measured by taking a hair sample that is send to the lab	at the end of the study (3 months after delivery; week 52)
Secondary	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	at enrollment (between w12-15 of pregnancy), baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52
Secondary	cognition	using online cognition tests (on a study portal)	at enrollment (between w12-15 of pregnancy), baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52
Secondary	Groninger Sleep Scale	online; can be accessed via the study portal	at enrollment (between w12-15 of pregnancy), baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52
Secondary	Vita16 - vitality questionnaire	online; can be accessed via the study portal	at enrollment (between w12-15 of pregnancy), baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52
Secondary	visual analogue scales for general health	online; can be accessed via the study portal	at enrollment (between w12-15 of pregnancy), baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52