- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05843175
Maternal ExeRcIse Timing to Optimise Postprandial Glucose in Type 1 Diabetes (MERIT1D)
Poor glycaemic control in pregnancy is a major factor leading to obstetric complications and future maternal-offspring diseases. This phenomenon is evidenced in women with type 1 diabetes (T1DM), and is worrisome since it is aggravating the disease burden of this and next generations.
Exercise is a promising tool to improve glucose control during pregnancy and thus avoid adverse consequences.
The MERIT1D study will explore when is exercise (before or after lunch) more effective to improve postprandial glycaemic control in pregnant and non-pregnant women (of reproductive age) with T1DM, and the mechanisms underlying these metabolic responses.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Poor glycaemic control in pregnancy is a major factor leading to obstetric complications and future maternal-offspring diseases (e.g., macrosomia, diabetes). This phenomenon is evidenced in women with type 1 diabetes (T1DM), and is worrisome since it is aggravating the disease burden of this and next generations. Therefore, to find strategies aimed at breaking this intergenerational cycle has become a high-priority. Exercise is a promising tool to improve short-term glycaemic responses such as postprandial glucose peaks and glucose variability, and thus reduce adverse maternal-neonatal outcomes. However, it is unknown which timing of exercise is more effective to optimise postprandial glycaemic control in pregnant women with T1DM, and non-pregnant women (of reproductive age) with T1DM. The mechanisms underlying these benefits in T1DM and pregnancy are also to be established.
The MERIT1D project will unravel which timing of exercise (before or after a meal at lunchtime) is more effective to optimise postprandial glycaemic control in pregnant and non-pregnant women with T1DM, and the mechanisms underlying these metabolic responses. Ten pregnant women with T1DM and ten non-pregnant women with T1DM will be involved in this randomised controlled crossover trial.
Pregnant women at gestational week 16 and 35 (experimental phases 1 and 2, respectively), and non-pregnant peers once after recruitment (experimental phase 1), will undergo 3 experimental conditions within 10 days (random order): pre-meal exercise, post-meal exercise, and non-exercise meal.
Each experimental phase will entail participants attending 4 times to the research centre. Therefore, pregnant women will come to the research centre for a total of 8 study visits, while non-pregnant women will come only to 4 study visits. The acute exercise stimulus will consist of a well-controlled submaximal walking test. The standardised meal provided will consist of a mixed milkshake equivalent to the 35 % of their resting energy expenditure, being made up of approximately 45% carbohydrates, 35% fat, and 20% proteins. Postprandial glycaemic responses will be continuously monitored using last-generation glucose monitoring systems during the 10-day period. Immunometabolic markers (e.g., lipids, cytokines) will be determined in maternal blood and placenta samples.
The MERIT1D study will contribute to the understanding of exercise timing in T1DM and pregnancy, and its underlying mechanisms. This will translate into a better clinical prediction, diagnosis, prognosis and treatment of glycaemic dysregulations, and into more effective exercise programmes for pregnant and non-pregnant women with T1DM.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mireille NM van Poppel, Prof.
- Phone Number: +43 (0)316 380 - 1022
- Email: mireille.van-poppel@uni-graz.at
Study Contact Backup
- Name: Pedro Acosta Manzano, PhD
- Email: pedro.acosta-manzano@uni-graz.at
Study Locations
-
-
Styria
-
Graz, Styria, Austria, 8010
- Recruiting
- University of Graz
-
Contact:
- Pedro Acosta Manzano, PhD
- Email: pedro.acosta-manzano@uni-graz.at
-
Contact:
- Mireille NM Van Poppel, Prof.
- Phone Number: +43 (0)316 380 - 1022; 2335
- Email: mireille.van-poppel@uni-graz.at
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Pregnant women and non-pregnant women with T1DM aged 20-40 years
- Having a BMI of 18-29.9 kg/m2 at pre-pregnancy (pregnant women) or recruitment (non-pregnant)
- Clinical diagnosis of T1DM, or/and multiple daily insulin injections for >1 year, and/or using insulin pump therapy (open-loop).
- Willingness to provide informed consent to participate in the MERIT1D study.
- Being able to read and speak German, English or Spanish well enough to completely understand the instructions, provide informed consent and conduct the experimental procedures.
Exclusion Criteria:
- Having poor glycaemic control HbA1c>10% (86 mmol/mol).
- Recurrent severe hypoglycaemia; hospitalisation for diabetic ketoacidosis during the last year.
- Women who smoke or drink alcohol frequently, or require complex diets.
- Having polycystic ovarian syndrome, poorly controlled asthma/allergy, uncontrolled thyroid diseases or hypertension, diabetic ketoacidosis, hepatitis B, hepatitis C, HIV.
- Having severe autoimmune/immunodeficiency, macrovascular, renal, or neuromuscular disease, or severe retinopathy or neuropathy.
- Having any other cardiovascular, pulmonary, orthopaedic, neurologic, psychiatric, or terminal disease, or any other acute/chronic disorder that, in the opinion of the local clinician/researcher, would preclude participation and successful completion of the protocol, or that would directly influence the study results.
- Use of any medication (e.g., steroids), that, in the opinion of local clinician/researcher, would negatively impact or mitigate full participation and completion, or could influence the study results.
- Any condition that would interfere with compliance or the results, as judged by the Investigator
- Pregnant women: having multiple pregnancy
- Pregnant women: evidence of incompetent cervix, ruptured membranes, placenta previa, foetal malformation, or foetal death.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pregnant women with type 1 diabetes
Participants will undergo 3 experimental conditions in random order at week of gestation 16 and 35 (experimental phases 1 and 2): pre-meal exercise, post-meal exercise, and non-exercise meal.
|
Pre-meal exercise: 1º milkshake intake + 2º exercise test Post-meal exercise: 1º exercise test + 2º milkshake intake Non-exercise meal: Only milkshake intake |
Experimental: Non-pregnant women with type 1 diabetes
Participants will undergo 3 experimental conditions in random order after recruitment (experimental phase 1): pre-meal exercise, post-meal exercise, and non-exercise meal.
|
Pre-meal exercise: 1º milkshake intake + 2º exercise test Post-meal exercise: 1º exercise test + 2º milkshake intake Non-exercise meal: Only milkshake intake |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of time spent in the euglycemic range for the 24 hours after each experimental condition
Time Frame: assessed in the study phase 1 (10 days) - at visit nº 2, 3, 4 (3 days, 24 hours/day)
|
|
assessed in the study phase 1 (10 days) - at visit nº 2, 3, 4 (3 days, 24 hours/day)
|
Percentage of time spent in the euglycemic range for the 24 hours after each experimental condition
Time Frame: assessed in the study phase 2 (only pregnant women, 10 days) - at visit nº 6, 7, 8 (3 days, 24 h/day)
|
|
assessed in the study phase 2 (only pregnant women, 10 days) - at visit nº 6, 7, 8 (3 days, 24 h/day)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of time spent in hypoglycemia for the 24 hours after each experimental condition
Time Frame: assessed in the study phase 1 (10 days) - at visit nº 2, 3, 4 (3 days, 24 hours/day)
|
|
assessed in the study phase 1 (10 days) - at visit nº 2, 3, 4 (3 days, 24 hours/day)
|
Percentage of time spent in hypoglycemia for the 24 hours after each experimental condition
Time Frame: assessed in the study phase 2 (only pregnant women, 10 days) - at visit nº 6, 7, 8 (3 days, 24 h/day)
|
|
assessed in the study phase 2 (only pregnant women, 10 days) - at visit nº 6, 7, 8 (3 days, 24 h/day)
|
Percentage of time spent in hyperglycemia for the 24 hours after each experimental condition
Time Frame: assessed in the study phase 1 (10 days) - at visit nº 2, 3, 4 (3 days, 24 hours/day)
|
|
assessed in the study phase 1 (10 days) - at visit nº 2, 3, 4 (3 days, 24 hours/day)
|
Percentage of time spent in hyperglycemia for the 24 hours after each experimental condition
Time Frame: assessed in the study phase 2 (only pregnant women, 10 days) - at visit nº 6, 7, 8 (3 days, 24 h/day)
|
|
assessed in the study phase 2 (only pregnant women, 10 days) - at visit nº 6, 7, 8 (3 days, 24 h/day)
|
Differences in postprandial glucose levels 1-, 2-, and 4-hours post-experiment
Time Frame: assessed in the study phase 1 (10 days) - at visit nº 2, 3, 4 (3 days, 4 h/day)
|
Within-change in glucose values (mmol/L) from pre-experiment (before starting exercise/meal testing) to post-experiment (i.e., 1-, 2-, and 4-hours after starting exercise/meal intake) in each experimental day
|
assessed in the study phase 1 (10 days) - at visit nº 2, 3, 4 (3 days, 4 h/day)
|
Differences in postprandial glucose levels 1-, 2-, and 4-hours post-experiment
Time Frame: assessed in the study phase 2 (only pregnant women, 10 days) - at visit nº 6, 7, 8 (3 days, 4 h/day)
|
Within-change in glucose values (mmol/L) from pre-experiment (before starting exercise/meal testing) to post-experiment (i.e., 1-, 2-, and 4-hours after starting exercise/meal intake) in each experimental day
|
assessed in the study phase 2 (only pregnant women, 10 days) - at visit nº 6, 7, 8 (3 days, 4 h/day)
|
Number of hypoglycaemic events for the 24 hours after each experimental condition
Time Frame: assessed in the study phase 1 (10 days) - at visit nº 2, 3, 4 (3 days, 24 hours/day)
|
|
assessed in the study phase 1 (10 days) - at visit nº 2, 3, 4 (3 days, 24 hours/day)
|
Number of hypoglycaemic events for the 24 hours after each experimental condition
Time Frame: assessed in the study phase 2 (only pregnant women, 10 days) - at visit nº 6, 7, 8 (3 days, 24 h/day)
|
|
assessed in the study phase 2 (only pregnant women, 10 days) - at visit nº 6, 7, 8 (3 days, 24 h/day)
|
Number of hyperglycaemic events for the 24 hours after each experimental condition
Time Frame: assessed in the study phase 1 (10 days) - at visit nº 2, 3, 4 (3 days, 24 hours/day)
|
|
assessed in the study phase 1 (10 days) - at visit nº 2, 3, 4 (3 days, 24 hours/day)
|
Number of hyperglycaemic events for the 24 hours after each experimental condition
Time Frame: assessed in the study phase 2 (only pregnant women, 10 days) - at visit nº 6, 7, 8 (3 days, 24 h/day)
|
|
assessed in the study phase 2 (only pregnant women, 10 days) - at visit nº 6, 7, 8 (3 days, 24 h/day)
|
Percentage of time spent in nocturnal euglycemia within each experimental day
Time Frame: assessed in the study phase 1 (10 days) - at visit nº 2, 3, 4 (3 days, 00:00 am - 05:59 am)
|
|
assessed in the study phase 1 (10 days) - at visit nº 2, 3, 4 (3 days, 00:00 am - 05:59 am)
|
Percentage of time spent in nocturnal euglycemia within each experimental day
Time Frame: assessed in the study phase 2 (only pregnant women, 10 days) - at visit nº 6, 7, 8 (3 days, 00:00 am - 05:59 am )
|
|
assessed in the study phase 2 (only pregnant women, 10 days) - at visit nº 6, 7, 8 (3 days, 00:00 am - 05:59 am )
|
Percentage of time spent in diurnal euglycemia within each experimental day
Time Frame: assessed in the study phase 1 (10 days) - at visit nº 2, 3, 4 (3 days, 6.00 am - 23:59 am)
|
|
assessed in the study phase 1 (10 days) - at visit nº 2, 3, 4 (3 days, 6.00 am - 23:59 am)
|
Percentage of time spent in diurnal euglycemia within each experimental day
Time Frame: assessed in the study phase 2 (only pregnant women, 10 days) - at visit nº 6, 7, 8 (3 days, 6.00 am - 23:59 am)
|
|
assessed in the study phase 2 (only pregnant women, 10 days) - at visit nº 6, 7, 8 (3 days, 6.00 am - 23:59 am)
|
Area under the curve of glycaemic exposure
Time Frame: assessed in the study phase 1 (10 days) - at visit nº 2, 3, 4 (3 days, 8 hours/day)
|
Area under the curve of glycaemic exposure during the 2, 4 and 8 hours after meal intake at each experimental condition.
|
assessed in the study phase 1 (10 days) - at visit nº 2, 3, 4 (3 days, 8 hours/day)
|
Area under the curve of glycaemic exposure
Time Frame: assessed in the study phase 2 (only pregnant women, 10 days) - at visit nº 6, 7, 8 (3 days, 8 h/day)
|
Area under the curve of glycaemic exposure during the 2, 4 and 8 hours after meal intake at each experimental condition.
|
assessed in the study phase 2 (only pregnant women, 10 days) - at visit nº 6, 7, 8 (3 days, 8 h/day)
|
Glycaemic variability (standard deviation)
Time Frame: assessed in the study phase 1 (10 days) - at visit nº 2, 3, 4 (3 days, 24 hours/day)
|
Standard deviation (SD) of the mean continuous glucose monitoring levels over the 24 hours after each experimental condition
|
assessed in the study phase 1 (10 days) - at visit nº 2, 3, 4 (3 days, 24 hours/day)
|
Glycaemic variability (standard deviation)
Time Frame: assessed in the study phase 2 (only pregnant women, 10 days) - at visit nº 6, 7, 8 (3 days, 24 h/day)
|
Standard deviation (SD) of the mean continuous glucose monitoring levels over the 24 hours after each experimental condition
|
assessed in the study phase 2 (only pregnant women, 10 days) - at visit nº 6, 7, 8 (3 days, 24 h/day)
|
Glycaemic variability (coefficient of variation)
Time Frame: assessed in the study phase 1 (10 days) - at visit nº 2, 3, 4 (3 days, 24 hours/day)
|
Coefficient of variation of glucose levels over the 24 hours after each experimental condition
|
assessed in the study phase 1 (10 days) - at visit nº 2, 3, 4 (3 days, 24 hours/day)
|
Glycaemic variability (coefficient of variation)
Time Frame: assessed in the study phase 2 (only pregnant women, 10 days) - at visit nº 6, 7, 8 (3 days, 24 h/day)
|
Coefficient of variation of glucose levels over the 24 hours after each experimental condition
|
assessed in the study phase 2 (only pregnant women, 10 days) - at visit nº 6, 7, 8 (3 days, 24 h/day)
|
Maternal glucose metabolism
Time Frame: assessed in the phase 1 (10 days) - at visit nº 2, 3, 4 (3 days, 3 h/day)
|
Fasting and post-experiment blood samples will be collected using venous puncture in the antecubital vein.
Metabolic markers related to the glucose-insulin axis will be analysed (i.e., glucose, insulin, C-peptide and HbA1c).
|
assessed in the phase 1 (10 days) - at visit nº 2, 3, 4 (3 days, 3 h/day)
|
Maternal glucose metabolism
Time Frame: assessed in the phase 2 (only pregnant women, 10 days) - at visit nº 6, 7, 8 (3 days, 3 h/day)
|
Fasting and post-experiment blood samples will be collected using venous puncture in the antecubital vein.
Metabolic markers related to the glucose-insulin axis will be analysed (i.e., glucose, insulin, C-peptide and HbA1c).
|
assessed in the phase 2 (only pregnant women, 10 days) - at visit nº 6, 7, 8 (3 days, 3 h/day)
|
Maternal lipid profile
Time Frame: assessed in the phase 1 (10 days) - at visit nº 2, 3, 4 (3 days, 3 h/day)
|
Fasting and post-experiment blood samples will be collected using venous puncture in the antecubital vein.
Metabolic markers related to the lipid profile will be analysed (i.e., total cholesterol, high-density lipoprotein (HDL) cholesterol, LDL-cholesterol, triglycerides and free fatty acids).
|
assessed in the phase 1 (10 days) - at visit nº 2, 3, 4 (3 days, 3 h/day)
|
Maternal lipid profile
Time Frame: assessed in the phase 2 (only pregnant women, 10 days) - at visit nº 6, 7, 8 (3 days, 3 h/day)
|
Fasting and post-experiment blood samples will be collected using venous puncture in the antecubital vein.
Metabolic markers related to the lipid profile will be analysed (i.e., total cholesterol, high-density lipoprotein (HDL) cholesterol, LDL-cholesterol, triglycerides and free fatty acids).
|
assessed in the phase 2 (only pregnant women, 10 days) - at visit nº 6, 7, 8 (3 days, 3 h/day)
|
Maternal inflammatory markers
Time Frame: assessed in the phase 1 (10 days) - at visit nº 2, 3, 4 (3 days, 3 h/day)
|
Fasting and post-experiment blood samples will be collected using venous puncture in the antecubital vein.
Metabolic markers related to inflammatory-immunological responses will be analysed (e.g., IL-6, IL-8, IL-1β, TNFα, C-reactive protein, IFNγ)
|
assessed in the phase 1 (10 days) - at visit nº 2, 3, 4 (3 days, 3 h/day)
|
Maternal inflammatory markers
Time Frame: assessed in the phase 2 (only pregnant women, 10 days) - at visit nº 6, 7, 8 (3 days, 3 h/day)
|
Fasting and post-experiment blood samples will be collected using venous puncture in the antecubital vein.
Metabolic markers related to inflammatory-immunological responses will be analysed (e.g., IL-6, IL-8, IL-1β, TNFα, C-reactive protein, IFNγ)
|
assessed in the phase 2 (only pregnant women, 10 days) - at visit nº 6, 7, 8 (3 days, 3 h/day)
|
Placenta weight
Time Frame: assessed at birth - 30 minutes
|
Placenta weight (grams)
|
assessed at birth - 30 minutes
|
Placenta biopsies
Time Frame: collected at birth - 1 hour
|
Eight biopsies will be collected, four on the maternal site and four on the fetal side.
Relevant placental proteins (growth factors and cytokines) related to insulin signalling, glucose metabolism, and inflammation will be analysed (e.g., GM-CSF, GCSF, MCP1, TNF-α, IL-6, EGF, IFN-γ, IL-8, IL-10, IL-1β).
|
collected at birth - 1 hour
|
Neonate weight
Time Frame: assessed at birth - 5 minutes
|
Neonate weight (grams)
|
assessed at birth - 5 minutes
|
Placenta efficiency
Time Frame: estimated after birth - 3 minutes
|
Neonate weight divided by placenta weight
|
estimated after birth - 3 minutes
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Placenta completeness
Time Frame: assessed at birth - 20 minutes
|
The number of present and missing cotyledons and velamentous vessels will be examined visually in all the quadrants.
|
assessed at birth - 20 minutes
|
Neonate height
Time Frame: assessed at birth - 5 minutes
|
Neonate height (cm)
|
assessed at birth - 5 minutes
|
Neonate ponderal index
Time Frame: estimated after birth - 3 minutes
|
Neonate weight/height ratio: 100 x weight / (Height)3
|
estimated after birth - 3 minutes
|
Neonate anthropometrics
Time Frame: assessed at birth - 10 minutes
|
Neonate head and abdomen circumference (cm).
These circumferences will be measured using a stretch-resistant measuring tape.
|
assessed at birth - 10 minutes
|
Neonate Apgar score
Time Frame: assessed at birth - 5 minutes
|
Neonate Apgar score (1-10).
The higher score is indicative of a better health status of the newborn after birth
|
assessed at birth - 5 minutes
|
Small for gestational age
Time Frame: assessed after birth - 5 minutes
|
Newborns will be diagnosed as small for gestational age newborns if their birth weight is lower than the 10th percentile for their gestational age
|
assessed after birth - 5 minutes
|
Large for gestational age
Time Frame: assessed after birth - 5 minutes
|
Newborns will be diagnosed as large for gestational age newborns if their birth weight is greater than the 90th percentile for their gestational age
|
assessed after birth - 5 minutes
|
Physical fitness (muscle strenght)
Time Frame: assessed in the phase 1, at visit nº 1 (10 minutes)
|
Upper body muscle strength will be measured by the handgrip strength test.
|
assessed in the phase 1, at visit nº 1 (10 minutes)
|
Physical fitness (muscle strenght)
Time Frame: assessed in the phase 2 (only pregnant women), at visit nº 5 (10 minutes)
|
Upper body muscle strength will be measured by the handgrip strength test.
|
assessed in the phase 2 (only pregnant women), at visit nº 5 (10 minutes)
|
Physical fitness (flexibility)
Time Frame: assessed in the phase 1, at visit nº 1 (10 minutes)
|
Upper body flexibility will be assessed by the back scratch test, measuring the distance or overlap between the middle fingers of both hands behind the back.
|
assessed in the phase 1, at visit nº 1 (10 minutes)
|
Physical fitness (flexibility)
Time Frame: assessed in the phase 2 (only pregnant women), at visit nº 5 (10 minutes)
|
Upper body flexibility will be assessed by the back scratch test, measuring the distance or overlap between the middle fingers of both hands behind the back.
|
assessed in the phase 2 (only pregnant women), at visit nº 5 (10 minutes)
|
Physical fitness (cardiorespiratory fitness)
Time Frame: assessed in the phase 1, at visit nº 1 (30 minutes)
|
Cardiorespiratory fitness will be assessed using a submaximal walking treadmill test while recording gas exchange data (breath by breath system).
|
assessed in the phase 1, at visit nº 1 (30 minutes)
|
Physical fitness (cardiorespiratory fitness)
Time Frame: assessed in the phase 2 (only pregnant women), at visit nº 5 (30 minutes)
|
Cardiorespiratory fitness will be assessed using a submaximal walking treadmill test while recording gas exchange data (breath by breath system).
|
assessed in the phase 2 (only pregnant women), at visit nº 5 (30 minutes)
|
Resting energy expenditure
Time Frame: assessed in the phase 1, at visit nº 1 (2 hours)
|
Gas exchange will be measured breath by breath using a portable gas analyser
|
assessed in the phase 1, at visit nº 1 (2 hours)
|
Physical activity
Time Frame: assessed in the phase 1 - 10 continuous days
|
Physical activity levels will be measured with triaxial accelerometry.
|
assessed in the phase 1 - 10 continuous days
|
Physical activity
Time Frame: assessed in the phase 2 (only pregnant women) - 10 continuous days
|
Physical activity levels will be measured with triaxial accelerometry.
|
assessed in the phase 2 (only pregnant women) - 10 continuous days
|
Vital signs (systolic and diastolic blood pressure)
Time Frame: assessed in the phase 1, at visit nº 1 (15 minutes)
|
Systolic and diastolic blood pressure (mmHg) will be assessed twice using an upper arm digital sphygmomanometer with women seated, relaxed and not talking.
|
assessed in the phase 1, at visit nº 1 (15 minutes)
|
Vital signs (systolic and diastolic blood pressure)
Time Frame: assessed in the phase 2 (only pregnant women), at visit nº 5 (15 minutes)
|
Systolic and diastolic blood pressure (mmHg) will be assessed twice using an upper arm digital sphygmomanometer with women seated, relaxed and not talking.
|
assessed in the phase 2 (only pregnant women), at visit nº 5 (15 minutes)
|
Vital signs (resting heart rate)
Time Frame: assessed in the phase 1, at visit nº 1 (15 minutes)
|
Resting heart rate (beats per minute) will be assessed twice using an upper arm digital sphygmomanometer with women seated, relaxed and not talking.
|
assessed in the phase 1, at visit nº 1 (15 minutes)
|
Vital signs (resting heart rate)
Time Frame: assessed in the phase 2 (only pregnant women), at visit nº 5 (15 minutes)
|
Resting heart rate (beats per minute) will be assessed twice using an upper arm digital sphygmomanometer with women seated, relaxed and not talking.
|
assessed in the phase 2 (only pregnant women), at visit nº 5 (15 minutes)
|
Initial anamnesis (sociodemographic and clinical information)
Time Frame: assessed in the phase 1, at visit nº 1 (40 minutes)
|
Relevant information from the patients will be collected by the physicians who will ask them, and by an initial questionnaire prepared by the researchers (e.g., age, educational level, occupational status, medications, diseases, etc.).
|
assessed in the phase 1, at visit nº 1 (40 minutes)
|
Sleep quality (questionnaire)
Time Frame: assessed in the phase 1, at visit nº 1 (20 minutes)
|
The sleep quality will be assessed using a validated questionnaire, the Pittsburgh Sleep Quality Index questionnaire (PSQI).
Higher scores indicate worse sleep quality (0-21).
|
assessed in the phase 1, at visit nº 1 (20 minutes)
|
Sleep quality (questionnaire)
Time Frame: assessed in the phase 2 (only pregnant women), at visit nº 5 (20minutes)
|
The sleep quality will be assessed using a validated questionnaire, the Pittsburgh Sleep Quality Index questionnaire (PSQI).
Higher scores indicate worse sleep quality (0-21).
|
assessed in the phase 2 (only pregnant women), at visit nº 5 (20minutes)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mireille NM van Poppel, Prof., University of Graz
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11954 (DAIDS-ES Registry Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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