Factors Associated With Infant Circadian Rhythm, Growth, and Temperament

NCT05700136 | Unknown

• 1 other identifier: RSCH ID-21-01830-S1K
• Study Type: observational
• Target: 216
• Locations: 1 country
• Sites: 10

Brief 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. 1.What is the association of prenatal and postnatal maternal circadian clock with infant's circadian clock at 3 months?
2. 2.What is the association of birth outcomes, maternal factors, and environmental factors with infant circadian clock at 3 months?
3. 3.What is the role of infant circadian clock on infant growth and temperament at 6 months of age?

Conditions

Circadian Rhythm Sleep Disorder, Jet Lag Type

Keywords

Circadian rhythm; Chrononutrition; Pregnancy; Infant; Eating misalignment; Light exposure

Outcome Measures

Primary Outcomes (4)

• Infant growth in height

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

  Birth to 6 months

• Infant growth in weight

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

  Birth to 6 months

• Infant growth in head circumference

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

  Birth to 6 months

• Infant temperament

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

  6 months after birth

Secondary Outcomes (1)

• Infant circadian rhythm

  3 months after birth

Study Arms (1)

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.

Behavioral: MOMENT

Interventions

MOMENT BEHAVIORAL

Prenatal and postnatal factors including maternal, environment, and infant circadian rhythm were studied to determine its effect on infant growth and temperament.

MOMENT cohort

Eligibility Criteria

• Age: 19 Years - 39 Years
• Gender Eligibility Details: This study is done among pregnant women only. Hence, only females were recruited in this study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Healthy pregnant women with no comorbidities before or during pregnancy
• Malaysian aged 18-39 years old
• Literate in English and Malay language
• Single pregnancy

You may not qualify if:

• Physically disabled
• Smoke cigarette and drinks alcohol during pregnancy
• On steroid medication
• Infants with any deformities or congenital diagnosis.

Sponsors & Collaborators

• UCSI University: lead

Study Sites (10)

Klinik Kesihatan Segambut

Kuala Lumpur, 51200, Malaysia

ACTIVE NOT RECRUITING

Klinik Kesihatan Metro Prima

Kuala Lumpur, 52100, Malaysia

RECRUITING

Klinik Kesihatan Cheras Makmur

Kuala Lumpur, 56000, Malaysia

ACTIVE NOT RECRUITING

Klinik Kesihatan Kuchai Ent Park

Kuala Lumpur, 57100, Malaysia

RECRUITING

Klinik Kesihatan Salak Selatan

Kuala Lumpur, 57100, Malaysia

RECRUITING

Klinik Kesihatan Pantai Indah

Kuala Lumpur, 59000, Malaysia

ACTIVE NOT RECRUITING

Klinik Kesihatan Putrajaya Presint 11

Putrajaya, 62000, Malaysia

RECRUITING

Klinik Kesihatan Putrajaya Presint 14

Putrajaya, 62000, Malaysia

RECRUITING

Klinik Kesihatan Putrajaya Presint 18

Putrajaya, 62000, Malaysia

RECRUITING

Klinik Kesihatan Putrajaya Presint 9

Putrajaya, 62000, Malaysia

RECRUITING

Related Publications (1)

• 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.

  PMID: 38521925 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva samples were collected at third trimester and three months after birth for both mother and infant. Samples were analyzed to determine cortisol rhythm.

MeSH Terms

Conditions

Jet Lag Syndrome

Condition Hierarchy (Ancestors)

Chronobiology Disorders; Nervous System Diseases; Sleep Disorders, Circadian Rhythm; Dyssomnias; Sleep Wake Disorders; Travel-Related Illness; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Lionel Lian Aun In

  UCSI University

  STUDY DIRECTOR

Central Study Contacts

Satvinder Kaur

CONTACT

60162029941; satvinderkaur@ucsiuniversity.edu.my

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: January 26, 2023
• Study Start: February 24, 2022
• Primary Completion: November 30, 2023
• Study Completion: March 31, 2024
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

MY (10)