Factors Associated With Infant Circadian Rhythm, Growth, and Temperament
NCT ID: NCT05700136
Last Updated: 2023-01-26
Study Results
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Basic Information
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UNKNOWN
216 participants
OBSERVATIONAL
2022-02-24
2024-03-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
MOMENT
Prenatal and postnatal factors including maternal, environment, and infant circadian rhythm were studied to determine its effect on infant growth and temperament.
Interventions
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MOMENT
Prenatal and postnatal factors including maternal, environment, and infant circadian rhythm were studied to determine its effect on infant growth and temperament.
Eligibility Criteria
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Inclusion Criteria
* Malaysian aged 18-39 years old
* Literate in English and Malay language
* Single pregnancy
Exclusion Criteria
* Smoke cigarette and drinks alcohol during pregnancy
* On steroid medication
* Infants with any deformities or congenital diagnosis.
19 Years
39 Years
FEMALE
Yes
Sponsors
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UCSI University
OTHER
Responsible Party
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Satvinder Kaur
Dr
Principal Investigators
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Lionel Lian Aun In
Role: STUDY_DIRECTOR
UCSI University
Locations
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Klinik Kesihatan Segambut
Kuala Lumpur, , Malaysia
Klinik Kesihatan Metro Prima
Kuala Lumpur, , Malaysia
Klinik Kesihatan Cheras Makmur
Kuala Lumpur, , Malaysia
Klinik Kesihatan Kuchai Ent Park
Kuala Lumpur, , Malaysia
Klinik Kesihatan Salak Selatan
Kuala Lumpur, , Malaysia
Klinik Kesihatan Pantai Indah
Kuala Lumpur, , Malaysia
Klinik Kesihatan Putrajaya Presint 11
Putrajaya, , Malaysia
Klinik Kesihatan Putrajaya Presint 14
Putrajaya, , Malaysia
Klinik Kesihatan Putrajaya Presint 18
Putrajaya, , Malaysia
Klinik Kesihatan Putrajaya Presint 9
Putrajaya, , Malaysia
Countries
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Central Contacts
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Facility Contacts
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Nor Aishah
Role: primary
Nor Aishah
Role: primary
Nor Aishah
Role: primary
Nor Aishah
Role: primary
Nor Aishah
Role: primary
Nor Aishah
Role: primary
Nor Aishsh
Role: primary
References
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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.
Other Identifiers
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RSCH ID-21-01830-S1K
Identifier Type: -
Identifier Source: org_study_id
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