Do-It-Yourself Health Monitoring and Simulation of Health in Pregnant Women - Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- compliance (percentage of complete datasets)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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;
- •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.
结局指标
主要结局
compliance (percentage of complete datasets)
时间窗: 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
时间窗: 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
次要结局
- 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)
- Cholesterol (total cholesterol, HDL, LDL, triglycerides, cholesterol/HDL-ratio)(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)(baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52)
- fecal and salivary microbiota composition(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)
- 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)
- GPS location(measured continuously during the entire study)
- cortisol in hair(at the end of the study (3 months after delivery; week 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)
- food intake as measured by a web-application(at enrollment (between w12-15 of pregnancy), baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52)
- 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)
- dried blood spots for HbA1c, fatty acids and blood biomarkers(at enrollment (between w12-15 of pregnancy), baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52)
- cognition(at enrollment (between w12-15 of pregnancy), baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52)
- Vita16 - vitality questionnaire(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(at enrollment (between w12-15 of pregnancy), baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52)
- Groninger Sleep Scale(at enrollment (between w12-15 of pregnancy), baseline (w16 of pregnancy), w24, 32, 40 of pregnancy; optionally after delivery in w52)
研究者
W.J. Pasman
Consultant Clinical Trials
TNO