Circadian Rhythm Sleep Disorder, Jet Lag TypeNCT05700136
Factors Associated With Infant Circadian Rhythm, Growth, and Temperament
An observational study of Circadian Rhythm Sleep Disorder, Jet Lag Type, run by UCSI University at 10 sites in Malaysia.
Trial summary
The goal of this observational study is to learn about the role of modifiable factors affecting infant circadian rhythm so that recommendations can be made for better health outcomes for the mother and infant. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 19 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Circadian Rhythm Sleep Disorder, Jet Lag Type
- What is being tested?
- MOMENT
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 216 participants
- Where
- 10 sitesMalaysia
- Study dates
- 24 Feb 2022to 31 Mar 2024
- How long will I take part?
- 9 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study population is pregnant women in third trimester from Kuala Lumpur, Malaysia. Pregnancy is a crucial timing where the nutrient intake of the mother contributes to the development of the child. Circadian rhythm during pregnancy may experience a change in phase as the cortisol release increases throughout pregnancy. While Malaysia faces the double burden of stunting and overweight among children, modernization has also caused various health consequences through circadian rhythm disruption, mainly by exposure to light at night and limited natural light exposure. Hence, pregnant women in Malaysia urban areas were studied.
Who may be able to join
- Healthy pregnant women with no comorbidities before or during pregnancy
- Malaysian aged 18-39 years old
- Literate in English and Malay language
- Single pregnancy
Who cannot join
- Physically disabled
- Smoke cigarette and drinks alcohol during pregnancy
- On steroid medication
- Infants with any deformities or congenital diagnosis.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Malaysia10 sites, 7 recruiting
- Active, not recruiting
Klinik Kesihatan Segambut
Kuala Lumpur, 51200
- Recruiting
Klinik Kesihatan Metro Prima
Kuala Lumpur, 52100
Nor Aishah, 60326887333
Ee Yin Kok
- Active, not recruiting
Klinik Kesihatan Cheras Makmur
Kuala Lumpur, 56000
- Recruiting
Klinik Kesihatan Kuchai Ent Park
Kuala Lumpur, 57100
Nor Aishah, 60326887333
Satvinder Kaur
- Recruiting
Klinik Kesihatan Salak Selatan
Kuala Lumpur, 57100
Nor Aishah, 60326887333
Ee Yin Kok
- Active, not recruiting
Klinik Kesihatan Pantai Indah
Kuala Lumpur, 59000
- Recruiting
Klinik Kesihatan Putrajaya Presint 11
Putrajaya, 62000
Nor Aishah, 60322687333
Satvinder Kaur
- Recruiting
Klinik Kesihatan Putrajaya Presint 14
Putrajaya, 62000
Nor Aishah, 60322687333
Satvinder Kaur
- Recruiting
Klinik Kesihatan Putrajaya Presint 18
Putrajaya, 62000
Nor Aishah, 60322687333
Satvinder Kaur
- Recruiting
Klinik Kesihatan Putrajaya Presint 9
Putrajaya, 62000
Nor Aishsh, 60322687333
Satvinder Kaur
About this study
Official title: Prenatal and Postnatal Factors Associated With Infant Circadian Rhythm, Growth, and Temperament
The goal of this observational study is to learn about the role of modifiable factors affecting infant circadian rhythm so that recommendations can be made for better health outcomes for the mother and infant. The main questions it aims to answer are:
- What is the association of prenatal and postnatal maternal circadian clock with infant's circadian clock at 3 months?
- What is the association of birth outcomes, maternal factors, and environmental factors with infant circadian clock at 3 months?
- What is the role of infant circadian clock on infant growth and temperament at 6 months of age?
Participants will complete a set of questionnaires and provide saliva samples during third trimester of pregnancy and at 3 months after birth of infant.
Read the detailed description
Circadian rhythm is the body's internal clock that synchronizes the body's physiological functions according to the 24-hour sleep-wake cycle. An individual establishes a circadian rhythm 3 months after birth, which is a progressive phase that involves regulating hormones such as cortisol and melatonin. According to previous studies, the synchronization of circadian rhythm between mother-infant pairs have been found to be beneficial in the growth and development of the child by regulating a 24-hour sleep-wake cycle. However, circadian disruption may cause excessive maternal cortisol which can be transferred to the fetus through the placenta during pregnancy and cause growth retardation. Growth faltering during infancy is associated with increased risks of morbidity from infections and chronic diseases in later life. Therefore, it is important to study the relationship between maternal circadian rhythm with synchronization of infant circadian rhythm as it may be one of the potential factors which affects the growth and development of the child.
On the other hand, infant temperament is affected by the maternal and infant circadian rhythm and may also be a predictor to mood disorders such as depression and anxiety. A systematic review reported that high cortisol levels during third trimester of pregnancy is associated with higher emotional reactivity and more difficult temperament infants. Other than the biological factors determining infant temperament, maternal psychological wellbeing during and after pregnancy is also an important element. It has been found that elevated maternal stress was associated with negative infant temperament, resulting in decreased sleep quality of the infant. Negative infant temperament may be a predictor to disordered eating behaviors and growth development. As infant temperament is an important factor in determining growth and development, the risk factors to negative temperament should be studied.
This study aims to determine the role of prenatal and postnatal factors with the infant circadian rhythm and its relationship with infant growth and temperament at 6 months. This study also includes the validation of the Chrononutrition Profile Questionnaire (CPQ) among pregnant women. Through the validation of CPQ, future research about chrononutrition behaviors and eating misalignment can be conducted to replace food record. The design of this study is a prospective observational cohort study. Data will be collected during 3rd trimester of pregnancy, whereas follow-up data on birth outcomes will be collected at birth. At 3 months after birth, data on maternal and infant circadian rhythm will be assessed, then data on growth and development will be collected at 6 months after birth. Data collection is elicited through a properly designed and validated questionnaire namely Chrononutrition Profile Questionnaire (CPQ), Harvard Light Exposure Assessment (H-LEA), sun exposure habits, Morningness-Eveningness Questionnaire (MEQ), Positive and Negative Affect Schedule (PANAS), Pittsburgh Sleep Quality Index (PSQI), and Edinburgh Postnatal Depression Scale (EDPS). Meanwhile, anthropometric data such as gestational weight gain and birth outcomes are gathered from clinic record. In addition, data on infant sleep, feeding, behavior, and light exposure will be collected using Brief Infant Sleep Questionnaire (BISQ), infant feeding log, Baby Eating Behavior Questionnaire (BEBQ), Infant Behavior Questionnaire- Revised (IBQ-R), and infant light exposure log sheet. Cortisol levels will be determined using salivary cortisol method where maternal and infant saliva samples are collected at 3 time points: upon awakening, noon (10:00 to 12:00), and evening (19:30 to 21:00). Understanding the potential factors affecting infant circadian rhythm offers new insights in understanding modern lifestyle factors and its association with fetal programming, infant growth, and development.
- Being tested
- MOMENT
- Keywords
- Circadian rhythm, Chrononutrition, Pregnancy, Infant, Eating misalignment, Light exposure
- Medical subject headings
- Jet Lag Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOMENTBehavioural
Prenatal and postnatal factors including maternal, environment, and infant circadian rhythm were studied to determine its effect on infant growth and temperament.
| Study group | Role | What they receive |
|---|---|---|
| MOMENT cohort | The cohort will be recruited at third trimester of pregnancy and required to fill up questionnaires and complete saliva collection. We will then follow up with the cohort at 3 months after birth to collect follow up data of the mother and infant. Lastly, we will collect growth outcomes of the infant at 6 months. Receives: Behavioral: MOMENT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant growth in height
Infant growth is determined by measuring the height (in centimeters) and height for age
Measured: Birth to 6 months
Infant growth in weight
Infant growth is determined by measuring the weight (in kiligrams) and weight for age
Measured: Birth to 6 months
Infant growth in head circumference
Infant growth is determined by measuring the head circumference (in centimeters)
Measured: Birth to 6 months
Infant temperament
Infant temperament is determined by completing the Infant Behavior Questionnaire- Revised version (IBQ-R)
Measured: 6 months after birth
Secondary outcomes (1)
Infant circadian rhythm
Infant circadian rhythm is determined by charting the cortisol rhythms that were tested using saliva samples
Measured: 3 months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start24 Feb 2022
- Primary completion30 Nov 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Circadian Rhythm Sleep Disorder, Jet Lag TypeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 216 participants (estimated)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- UCSI University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Satvinder Kaur, UCSI University
- Investigators
- Lionel Lian Aun In, Study director, UCSI University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05700136
- Sponsor's protocol ID
- RSCH ID-21-01830-S1K
- Status last verified
- Jan 2023
- First submitted
- 5 Jan 2023
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kok EY, Kaur S, Mohd Shukri NH, Abdul Razak N, Takahashi M. Development, validation, and reliability of the Chrononutrition Profile Questionnaire-Pregnancy (CPQ-P). BMC Pregnancy Childbirth. 2024 Mar 23;24(1):217. doi: 10.1186/s12884-024-06403-4.
PubMed 38521925
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prenatal and Postnatal Factors Associated With Infant Circadian Rhythm, Growth, and Temperament
- ClinicalTrials.gov ID
- NCT05700136
- Acronym / sponsor ID
- RSCH ID-21-01830-S1K
- Keywords
- Circadian rhythm, Chrononutrition, Pregnancy, Infant, Eating misalignment, Light exposure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- UCSI UniversityUniversity, hospital or other
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn about the role of modifiable factors affecting infant circadian rhythm so that recommendations can be made for better health outcomes for the mother and infant. The main questions it aims to answer are:
- What is the association of prenatal and postnatal maternal circadian clock with infant's circadian clock at 3 months?
- What is the association of birth outcomes, maternal factors, and environmental factors with infant circadian clock at 3 months?
- What is the role of infant circadian clock on infant growth and temperament at 6 months of age?
Participants will complete a set of questionnaires and provide saliva samples during third trimester of pregnancy and at 3 months after birth of infant.
Detailed description
Circadian rhythm is the body's internal clock that synchronizes the body's physiological functions according to the 24-hour sleep-wake cycle. An individual establishes a circadian rhythm 3 months after birth, which is a progressive phase that involves regulating hormones such as cortisol and melatonin. According to previous studies, the synchronization of circadian rhythm between mother-infant pairs have been found to be beneficial in the growth and development of the child by regulating a 24-hour sleep-wake cycle. However, circadian disruption may cause excessive maternal cortisol which can be transferred to the fetus through the placenta during pregnancy and cause growth retardation. Growth faltering during infancy is associated with increased risks of morbidity from infections and chronic diseases in later life. Therefore, it is important to study the relationship between maternal circadian rhythm with synchronization of infant circadian rhythm as it may be one of the potential factors which affects the growth and development of the child.
On the other hand, infant temperament is affected by the maternal and infant circadian rhythm and may also be a predictor to mood disorders such as depression and anxiety. A systematic review reported that high cortisol levels during third trimester of pregnancy is associated with higher emotional reactivity and more difficult temperament infants. Other than the biological factors determining infant temperament, maternal psychological wellbeing during and after pregnancy is also an important element. It has been found that elevated maternal stress was associated with negative infant temperament, resulting in decreased sleep quality of the infant. Negative infant temperament may be a predictor to disordered eating behaviors and growth development. As infant temperament is an important factor in determining growth and development, the risk factors to negative temperament should be studied.
This study aims to determine the role of prenatal and postnatal factors with the infant circadian rhythm and its relationship with infant growth and temperament at 6 months. This study also includes the validation of the Chrononutrition Profile Questionnaire (CPQ) among pregnant women. Through the validation of CPQ, future research about chrononutrition behaviors and eating misalignment can be conducted to replace food record. The design of this study is a prospective observational cohort study. Data will be collected during 3rd trimester of pregnancy, whereas follow-up data on birth outcomes will be collected at birth. At 3 months after birth, data on maternal and infant circadian rhythm will be assessed, then data on growth and development will be collected at 6 months after birth. Data collection is elicited through a properly designed and validated questionnaire namely Chrononutrition Profile Questionnaire (CPQ), Harvard Light Exposure Assessment (H-LEA), sun exposure habits, Morningness-Eveningness Questionnaire (MEQ), Positive and Negative Affect Schedule (PANAS), Pittsburgh Sleep Quality Index (PSQI), and Edinburgh Postnatal Depression Scale (EDPS). Meanwhile, anthropometric data such as gestational weight gain and birth outcomes are gathered from clinic record. In addition, data on infant sleep, feeding, behavior, and light exposure will be collected using Brief Infant Sleep Questionnaire (BISQ), infant feeding log, Baby Eating Behavior Questionnaire (BEBQ), Infant Behavior Questionnaire- Revised (IBQ-R), and infant light exposure log sheet. Cortisol levels will be determined using salivary cortisol method where maternal and infant saliva samples are collected at 3 time points: upon awakening, noon (10:00 to 12:00), and evening (19:30 to 21:00). Understanding the potential factors affecting infant circadian rhythm offers new insights in understanding modern lifestyle factors and its association with fetal programming, infant growth, and development.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 9 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MOMENT cohort | – | Behavioral: MOMENTThe cohort will be recruited at third trimester of pregnancy and required to fill up questionnaires and complete saliva collection. We will then follow up with the cohort at 3 months after birth to collect follow up data of the mother and infant. Lastly, we will collect growth outcomes of the infant at 6 months. |
Who may qualify
- Ages
- 19 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population is pregnant women in third trimester from Kuala Lumpur, Malaysia. Pregnancy is a crucial timing where the nutrient intake of the mother contributes to the development of the child. Circadian rhythm during pregnancy may experience a change in phase as the cortisol release increases throughout pregnancy. While Malaysia faces the double burden of stunting and overweight among children, modernization has also caused various health consequences through circadian rhythm disruption, mainly by exposure to light at night and limited natural light exposure. Hence, pregnant women in Malaysia urban areas were studied.
Key inclusion criteria (4 listed)
- Healthy pregnant women with no comorbidities before or during pregnancy
- Malaysian aged 18-39 years old
- Literate in English and Malay language
- Single pregnancy
Key exclusion criteria (4 listed)
- Physically disabled
- Smoke cigarette and drinks alcohol during pregnancy
- On steroid medication
- Infants with any deformities or congenital diagnosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOMENTPrenatal and postnatal factors including maternal, environment, and infant circadian rhythm were studied to determine its effect on infant growth and temperament. | Behavioural | MOMENT cohort |
Primary outcome
Infant growth in height
Time frame: Birth to 6 months
Infant growth is determined by measuring the height (in centimeters) and height for age
Infant growth in weight
Time frame: Birth to 6 months
Infant growth is determined by measuring the weight (in kiligrams) and weight for age
Infant growth in head circumference
Time frame: Birth to 6 months
Infant growth is determined by measuring the head circumference (in centimeters)
Infant temperament
Time frame: 6 months after birth
Infant temperament is determined by completing the Infant Behavior Questionnaire- Revised version (IBQ-R)
1 secondary outcome
Infant circadian rhythm
Time frame: 3 months after birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Derived from this study: PubMed 38521925Kok EY, Kaur S, Mohd Shukri NH, Abdul Razak N, Takahashi M. Development, validation, and reliability of the Chrononutrition Profile Questionnaire-Pregnancy (CPQ-P). BMC Pregnancy Childbirth. 2024 Mar 23;24(1):217. doi: 10.1186/s12884-024-06403-4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lionel Lian Aun In study director
UCSI University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Circadian Rhythm Sleep Disorder, Jet Lag Type, run by UCSI University at 10 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Satvinder Kaur (60162029941, satvinderkaur@ucsiuniversity.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant growth in height (time frame: Birth to 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05700136, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.