Clinical trial NCT01174875: Growing Up in Singapore Towards Healthy Outcomes
Official title: Developmental Pathways to Health and Disease: Metabolic, Neurodevelopmental and Related Outcomes
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Metabolic Diseases
Neurological and Mental Health Conditions
Genetic Predisposition
Skin Condition
Environmental Exposure
Socioeconomic Factors
Psychology, Social
Keywords: Epigenetics
Development
Metabolic
Neurodevelopment
Cohort Study
Birth Cohort
Longitudinal Study
Pregnancy
Growth
Developmental Origins of Health and Disease
DOHaD
Epidemiology
Maternal Health
Infant Health
Child Health
Health Outcomes
Postnatal Exposure
Perinatal Exposure
Environmental Factors
Nutrition
Genetics
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
Collaborators: name: KK Women's and Children's Hospital
name: Institute for Human Development and Potential (IHDP), Singapore
name: National University of Singapore
First posted: 2010-08-04
Enrollment: 1247
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women attending their first-trimester antenatal visit at public maternity units in KKH and NUH, along with their children born from the indexed pregnancy.

Brief summary: This study aims to examine the role of genetic and epigenetic factors, maternal nutrition, lifestyle, emotional health, and other environmental factors in pregnancy or postpartum period that can influence future maternal risk of metabolic and mental wellness, including body weight changes. The study will recruit women in early pregnancy and later follow their children after birth, tracking both the mother and child until the child reaches at least 20 years of age.

Detailed description: The dramatic emergence of non-communicable diseases (NCDs) in Asia has coincided with the rapid socioeconomic and nutritional transition taking place in the region, with the prevalence of diabetes rising five-fold in Singapore in less than four decades. One unique aspect of the epidemic has been the significant ethnic differences in predisposition to diabetes among Asians and in the ethnic variation between BMI and the risk of developing insulin resistance, a precursor to type 2 diabetes. Apart from genetic factors, dietary, lifestyle and cultural factors might have influenced the developmental programming through effects on the mechanisms associated with developmental plasticity. A center piece of this study is to examine how epigenetic changes at birth both reflects past developmental influences and, in association with other factors, influences future trajectories of development and its relationship to NCDs. Also factors active during childhood - especially the first 1000 days of life - will be focused upon. The longitudinal GUSTO birth cohort study allows us to examine associations among genetic, environmental and lifestyle interactions in the three distinct ethnic groups, Chinese, Malays and Indians, present in the Singaporean population. Participants have been followed up for their pregnancy outcome, fetal growth and offspring development. In continuation of this research, participants will continue to be followed up through their adolescence phase from the age of 10 to 20 years.

Data will be collected through questionnaires and measurements.

* Questionnaires may be related to socioeconomic factors, healthcare expenses, diet, medical history, behaviour, cognition, lifestyle, sleep, health status, social-emotion factors, and home environment.
* Body measurements such as height, weight, blood pressure, body composition analysis involving bioelectrical impedance analysis (BIA), grip strength.
* Dental examination
* Child pubertal assessments
* Skin clinical assessment and digital photography for assessment of acne presence and severity
* Collection of samples such as blood, buccal swabs, saliva, hair, urine, stool, oral specimen such as exfoliated milk teeth, dental plaque and tongue biofilms

Eligibility criteria: Inclusion Criteria of Mother Participants:

* Women 18 years and above
* Pregnant women attending the first visit (\< 14 weeks GA) at the maternity units of KKH and NUH
* Singapore citizens or Singapore Permanent Residents
* Currently resident in mainland Singapore
* Intention to eventually deliver in KKH or NUH
* Intention to reside in Singapore for the next 5 years
* Intention to donate cord, cord blood and placenta
* The fetus should be racially homogenous with both sets of grandparents of the same ethnicity

Exclusion Criteria of Mother Participants:

* Women whose pregnancies end in miscarriages will be excluded
* Pregnant women on chemotherapy
* Exclude women with significant medical conditions e.g. Type 1 diabetes mellitus, psychosis etc.
* Exclude women on certain medications - e.g. psychotropic drugs.
* Mixed marriages will be excluded

Babies born from these mothers will be invited to participate and followed up until the child is at least 20 years of age.

Primary outcomes:
measure: Roles of fetal, developmental and epigenetic factors in pathways to disease
timeFrame: Perinatal
Secondary outcomes:
measure: Influence of prenatal and early postnatal factors on child health
timeFrame: During pregnancy and infancy period
measure: Effect of factors in pregnancy and early postpartum period on maternal health
timeFrame: During pregnancy and postpartum period
measure: Influence genetic and epigenetics factors in combination with lifestyle on child health
timeFrame: Childhood and Adolescence up to age 20
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: National University Health System
name: Yap Seng Chong
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Wu Y, Lin X, Lim IY, Chen L, Teh AL, MacIsaac JL, Tan KH, Kobor MS, Chong YS, Gluckman PD, Karnani N. Analysis of two birth tissues provides new insights into the epigenetic landscape of neonates born preterm. Clin Epigenetics. 2019 Feb 11;11(1):26. doi: 10.1186/s13148-018-0599-4.
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