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

NCT02537145 | Terminated

• 1 other identifier: P9624
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy; Obesity

Keywords

compliance; do-it-yourself methodology; pilot; human microbiome

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (15)

• fasting blood glucose

  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

  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)

  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)

  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 continuously during the entire study

Study Arms (2)

Obese pregnant women

20 obese pregnant women (BMI ≥ 30)

Lean pregnant women

20 lean pregnant women (BMI 18,5 - 25)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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);
• 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.

Sponsors & Collaborators

• Spaarne Gasthuis: collaborator
• W.J. Pasman: lead

Study Sites (1)

Spaarne Gasthuis

Hoofddorp, North Holland, 2134 TM, Netherlands

Location

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.

MeSH Terms

Conditions

Obesity; Patient Compliance

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Marlies A van Houten, Dr.

  Spaarne Gasthuis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant Clinical Trials

Study Record Dates

• First Submitted: August 28, 2015
• First Posted: September 1, 2015
• Study Start: September 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: December 1, 2017
• Last Updated: September 6, 2018

Record last verified: 2018-09

Locations

NL (1)