NCT03531658

Brief Summary

We aim to test the following primary hypothesis that nutrition, lifestyle, and maternal emotional health prior to pregnancy and/or during the first trimester alter the expression of metabolic or neurodevelopmental endophenotypes with accompanying effects on the epigenome/transcriptome of the offspring.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,054

participants targeted

Target at P75+ for all trials

Timeline
44mo left

Started Feb 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Feb 2015Dec 2029

Study Start

First participant enrolled

February 27, 2015

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

August 27, 2017

Completed
9 months until next milestone

First Posted

Study publicly available on registry

May 22, 2018

Completed
11.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

June 18, 2025

Status Verified

March 1, 2025

Enrollment Period

14.8 years

First QC Date

August 27, 2017

Last Update Submit

June 13, 2025

Conditions

Keywords

Cohort StudyBirth CohortLongitudinal StudyPregnancyGrowthDevelopmental Origins of Health and DiseaseDOHaDEpidemiologyMaternal HealthInfant HealthChild HealthHealth OutcomesPostnatal ExposurePerinatal ExposureEnvironmental FactorsNutritionGenetics

Outcome Measures

Primary Outcomes (2)

  • Offspring adiposity

    Offspring adiposity (total and percentage fat mass) measured by skinfold calipers, air-displacement plethysmography, quantitative magnetic resonance (QMR), Bioelectrical Impedance Analysis (BIA), and Magnetic resonance imaging (MRI).

    From birth until 9 years of age

  • Offspring neurocognitive and behavioural development

    Offspring neurocognitive and behavioural development measured by questionnaires, behavioural tasks and brain MRI.

    From 3-12 months up till 9 years of age

Secondary Outcomes (39)

  • Duration of gestation

    Up to 42 weeks, between estimated date of conception based on ultrasound scan and date of delivery

  • Fetal growth measured by ultrasound scan

    Up to 30 weeks, between 6-36 weeks of gestation

  • Offspring body weight measured by calibrated weighing scale

    From birth until 9 years of age

  • Offspring pubertal assessment

    From 7 until 9 years of age

  • Offspring growth trajectories

    From birth until 9 years of age

  • +34 more secondary outcomes

Other Outcomes (2)

  • Offspring health obtained from questionnaires and clinical documents

    From birth until 9 years of age

  • Maternal health obtained from questionnaires and clinical documents

    Between preconception, pregnancy and 9 years postpartum

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy women aged between 18 and 35 who are actively planning to conceive within a 1-year time frame upon recruitment, and later along with their children born from the indexed pregnancy.

You may qualify if:

  • Women aged 18-35 years
  • Intention to reside in Singapore for the next 5 years
  • Chinese, Malay, Indian or any combinations of these 3 ethnic groups
  • Planning to conceive within 1 year
  • Able to provide written, informed consent

You may not qualify if:

  • Have been actively trying to conceive for more than 18 months
  • Currently pregnant
  • Assisted fertility, apart from those taking clomiphene alone in the past 1 month
  • Established pre-existing diabetes (type 1 or type 2)
  • Oral or implanted contraception, or with an IUCD in situ in the past 1 month
  • On systemic steroids in the past 1 month
  • On anticonvulsants in the past 1 month
  • On HIV or Hepatitis B or C medication in the past 1 month
  • Not becoming pregnant after more than 12 months from recruitment
  • Eventual multiple pregnancies
  • Pregnancy complications such as miscarriages, ectopic pregnancy, still birth
  • The partners of the women will also be invited to participate in the study. Babies born from these mothers will be followed up until the child is 9 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KK Women's and Children's Hospital

Singapore, Singapore

Location

Related Publications (9)

  • Loo EXL, Soh SE, Loy SL, Ng S, Tint MT, Chan SY, Huang JY, Yap F, Tan KH, Chern BSM, Tan HH, Meaney MJ, Karnani N, Godfrey KM, Lee YS, Chan JKY, Gluckman PD, Chong YS, Shek LP, Eriksson JG; S-PRESTO Study Group; Chia A, Fogel AM, Goh AEN, Chu AHY, Rifkin-Graboi A, Qiu A, Lee BW, Cheon BK, Vaz C, Henry CJ, Forde CG, Chi C, Koh DXP, Phua DY, Loh DNL, Quah EPL, Tham EH, Law ECN, Magkos F, Mueller-Riemenschneider F, Yeo GSH, Yong HEJ, Chen HY, Tan HH, Pan H, Bever HPSV, Tan HM, Aris IBM, Tay J, Chan JKY, Xu J, Yoong JS, Eriksson JG, Choo JTL, Bernard JY, Huang JY, Lai JS, Tan KML, Godfrey KM, Kwek KYC, McCrickerd K, Narasimhan K, Chong KW, Lee KJ, Chen L, Ling LH, Chen LW, Daniel LM, Shek LP, Fortier MV, Chong MF, Chua MC, Leow MK, Kee MZL, Gong M, Tint MT, Michael N, Lek N, Teoh OH, Mishra P, Li QLJ, Velan SS, Ang SB, Cai S, Goh SH, Lim SB, Tsotsi S, Hsu SC, Toh SES, Sadananthan SA, Tan TH, Yew TW, Gupta V, Rajadurai VS, Han WM, Pang WW, Yuan WL, Zhu Y, Cheung YB, Chan YH, Cheng ZR. Cohort profile: Singapore Preconception Study of Long-Term Maternal and Child Outcomes (S-PRESTO). Eur J Epidemiol. 2021 Jan;36(1):129-142. doi: 10.1007/s10654-020-00697-2. Epub 2020 Nov 21.

    PMID: 33222050BACKGROUND
  • Chu AHY, Padmapriya N, Tan SL, Goh CMJL, Chong YS, Shek LP, Tan KH, Gluckman PD, Yap FKP, Lee YS, Loy SL, Chan JKY, Godfrey KM, Eriksson JG, Chan SY, Bernard JY, Muller-Riemenschneider F. Preconception to postpartum accelerometry-based 24-hour movement behaviors: a prospective cohort study. BMC Public Health. 2026 Jan 7. doi: 10.1186/s12889-025-26034-4. Online ahead of print.

  • Ku CW, Chan HG, Sia AL, Huang C, Quek J, Cheung YB, Tan KML, Lai JS, Godfrey KM, Chan JKY, Yap F, Loy SL. One-carbon metabolism, insulin resistance, and fecundability in a Singapore prospective preconception cohort study. Am J Clin Nutr. 2025 Jul;122(1):335-343. doi: 10.1016/j.ajcnut.2025.04.035. Epub 2025 May 5.

  • Chen L, Mir SA, Bendt AK, Chua EWL, Narasimhan K, Tan KM, Loy SL, Tan KH, Shek LP, Chan J, Yap F, Meaney MJ, Chan SY, Chong YS, Gluckman PD, Eriksson JG, Karnani N, Wenk MR. Plasma lipidomic profiling reveals metabolic adaptations to pregnancy and signatures of cardiometabolic risk: a preconception and longitudinal cohort study. BMC Med. 2023 Feb 13;21(1):53. doi: 10.1186/s12916-023-02740-x.

  • Li LJ, Du R, Loy SL, Chong YS, Chan JKY, Wong TY, Eriksson JG, Huang Z, Zhang C. Retinal microvasculature and risk of spontaneous abortion in multiethnic Southeast Asian women. Fertil Steril. 2022 Oct;118(4):748-757. doi: 10.1016/j.fertnstert.2022.06.033. Epub 2022 Aug 16.

  • Lim SX, Loy SL, Colega MT, Lai JS, Godfrey KM, Lee YS, Tan KH, Yap F, Shek LP, Chong YS, Eriksson JG, Chan JKY, Chan SY, Chong MF. Prepregnancy adherence to plant-based diet indices and exploratory dietary patterns in relation to fecundability. Am J Clin Nutr. 2022 Feb 9;115(2):559-569. doi: 10.1093/ajcn/nqab344.

  • Huang L, Loy SL, Chen WQ, Eriksson JG, Chong YS, Huang Z, Chan JKY, Wong TY, Kramer M, Zhang C, Li LJ. Retinal microvasculature and time to pregnancy in a multi-ethnic pre-conception cohort in Singapore. Hum Reprod. 2021 Oct 18;36(11):2935-2947. doi: 10.1093/humrep/deab197.

  • Lim SX, Colega MT, M Ayob MN, Robinson SM, Godfrey KM, Bernard JY, Lee YS, Tan KH, Yap F, Shek LP, Chong YS, Eriksson JG, Chan JK, Chan SY, Chong MF. Identification and reproducibility of dietary patterns assessed with a FFQ among women planning pregnancy. Public Health Nutr. 2021 Jun;24(9):2437-2446. doi: 10.1017/S1368980021001178. Epub 2021 Mar 22.

  • Loy SL, Ku CW, Lai AEQ, Choo XH, Ho AHM, Cheung YB, Godfrey KM, Chong YS, Gluckman PD, Shek LP, Tan KH, Yap FKP, Chan SY, Chan JKY. Plasma glycemic measures and fecundability in a Singapore preconception cohort study. Fertil Steril. 2021 Jan;115(1):138-147. doi: 10.1016/j.fertnstert.2020.07.014. Epub 2020 Oct 15.

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Human biological materials such as blood, urine, buccal swabs, saliva, hair, stool, skin microbiome, epithelial swabs (including vaginal, vulval, rectal and breast skin swabs), nasal swabs, breast milk, cord and cord blood, placental samples, subcutaneous fat samples, heel prick blood are collected prospectively from the participants (mother or child) at respective time points, upon their consent.

MeSH Terms

Conditions

Metabolic DiseasesNeurologic ManifestationsGenetic Predisposition to DiseaseSkin DiseasesDevelopmental Origins of Health and Disease

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsDisease SusceptibilityDisease AttributesPathologic ProcessesSkin and Connective Tissue DiseasesPrenatal Exposure Delayed EffectsPrenatal InjuriesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Jerry Kok Yen Chan

    KK Women's and Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

August 27, 2017

First Posted

May 22, 2018

Study Start

February 27, 2015

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

June 18, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations