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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
What is being tested?
MOMENT
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
  • Klinik Kesihatan Segambut

    Kuala Lumpur, 51200

    Active, not recruiting
  • Klinik Kesihatan Metro Prima

    Kuala Lumpur, 52100

    Nor Aishah, 60326887333

    Ee Yin Kok

    Recruiting
  • Klinik Kesihatan Cheras Makmur

    Kuala Lumpur, 56000

    Active, not 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

    Recruiting
  • Klinik Kesihatan Pantai Indah

    Kuala Lumpur, 59000

    Active, not 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

    Recruiting

Other trials in Malaysia

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:

  1. What is the association of prenatal and postnatal maternal circadian clock with infant's circadian clock at 3 months?
  2. What is the association of birth outcomes, maternal factors, and environmental factors with infant circadian clock at 3 months?
  3. 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 groups in NCT05700136
Study groupRoleWhat they receive
MOMENT cohortThe 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.

  1. Infant growth in height

    Infant growth is determined by measuring the height (in centimeters) and height for age

    Measured: Birth to 6 months

  2. Infant growth in weight

    Infant growth is determined by measuring the weight (in kiligrams) and weight for age

    Measured: Birth to 6 months

  3. Infant growth in head circumference

    Infant growth is determined by measuring the head circumference (in centimeters)

    Measured: Birth to 6 months

  4. Infant temperament

    Infant temperament is determined by completing the Infant Behavior Questionnaire- Revised version (IBQ-R)

    Measured: 6 months after birth

Secondary outcomes (1)
  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.

  1. First posted26 Jan 2023
  2. Study start24 Feb 2022
  3. Primary completion30 Nov 2023 (estimated)
  4. Study completion31 Mar 2024 (estimated)

Resources

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
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

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.

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