NCT03803345

Brief Summary

This study aims to assess the associations of maternal food timing with glucose levels during pregnancy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

December 18, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 14, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

March 28, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2022

Completed
Last Updated

August 17, 2022

Status Verified

August 1, 2022

Enrollment Period

2.7 years

First QC Date

December 18, 2018

Last Update Submit

August 15, 2022

Conditions

Metabolic Disease

Keywords

Food timingGestational diabetes mellitusGlucose toleranceNight-eatingPregnancy outcomesSnacking

Outcome Measures

Primary Outcomes (3)

  • Maternal glucose tolerance

    Maternal glucose tolerance based on plasma glucose levels as assessed by the Oral Glucose Tolerance Test.

    Up to 4 weeks, during second trimester of pregnancy

  • Maternal night-eating pattern

    Maternal night-eating pattern as assessed by the food diary and food record app.

    Up to 4 days, during second trimester of pregnancy

  • Maternal meal and snack distribution

    Maternal meal and snack distribution as assessed by the food diary and food record app.

    Up to 4 days, during second trimester of pregnancy

Secondary Outcomes (20)

  • Maternal insulin profile

    Up to 4 weeks, during second trimester of pregnancy

  • Maternal gestational diabetes status

    up to 4 weeks, during second trimester of pregnancy

  • Maternal glycemic variability

    Up to 10 days, during second trimester of pregnancy

  • Maternal diet quality

    up to 1 month, during second trimester of pregnancy

  • Maternal type of food intake

    up to 10 weeks, during second trimester of pregnancy

  • +15 more secondary outcomes

Other Outcomes (5)

  • Maternal hypertension status

    Up to 42 weeks, during pregnancy

  • Maternal delivery outcomes

    Up to 72 hours, after delivery

  • Birth weight

    Up to 72 hours, after delivery

  • +2 more other outcomes

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women.
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy pregnant women aged 18-45 years old and at 18-21 weeks of gestation upon recruitment.

You may qualify if:

  • week's gestation
  • Singapore citizens or Singapore Permanent Residents
  • Age 18-45 years
  • Plan to follow-up for antenatal care in KK Women's and Children's Hospital
  • Intend to deliver in KK Women's and Children's Hospital
  • Provide written informed consent

You may not qualify if:

  • Type 1 or 2 diabetes
  • Diabetes in pregnancy as confirmed by oral glucose tolerance test
  • Use of medications such as anticonvulsant medications or oral steroids in the past 1 month
  • Multiple pregnancy
  • On routine night-shift work for at least 3x/week over the past 1 month
  • Known or suspected allergy to medical grade adhesives
  • Chronic kidney diseases
  • Preeclampsia
  • Eventual miscarriage or undergo termination event

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

Related Publications (2)

  • Chen YE, Ku CW, Chong MF, Yap F, Chan JKY, Loy SL, Chen LW. Associations of >1-h compared with 1-h meal timing variability (eating jetlag) with plasma glycemic parameters and continuous glucose monitoring measures among pregnant females: a prospective cohort study. Am J Clin Nutr. 2025 Jul;122(1):244-254. doi: 10.1016/j.ajcnut.2025.04.026. Epub 2025 Apr 26.

    PMID: 40294750DERIVED

  • Loy SL, Cheung YB, Chong M, Muller-Riemenschneider F, Lek N, Lee YS, Tan KH, Chern B, Yap F, Chan J. Maternal night-eating pattern and glucose tolerance during pregnancy: study protocol for a longitudinal study. BMJ Open. 2019 Oct 10;9(10):e030036. doi: 10.1136/bmjopen-2019-030036.

    PMID: 31601588DERIVED

MeSH Terms

Conditions

Metabolic DiseasesDiabetes, Gestational

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersEndocrine System Diseases

Study Officials

  • See Ling Loy, PhD

    KK Women's and Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2018

First Posted

January 14, 2019

Study Start

March 28, 2019

Primary Completion

December 24, 2021

Study Completion

March 11, 2022

Last Updated

August 17, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)