AzTrials
AzTrials

Metabolic DiseaseNCT03803345

The Association of Maternal Night-Eating Pattern With Glucose Tolerance During Pregnancy

An observational study of Metabolic Disease, run by KK Women's and Children's Hospital at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Metabolic Disease
How many people
300 participants
Where
1 siteSingapore
Study dates
28 Mar 2019to 11 Mar 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

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

Who may be able to join

  • 18-21 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

Who cannot join

  • 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
Show all 9Show fewer
  • Chronic kidney diseases
  • Preeclampsia
  • Eventual miscarriage or undergo termination event

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • KK Women's and Children's Hospital

    Singapore, Singapore, 229899

Other trials in Singapore

About this study

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

Read the detailed description

A novel line of research has emerged, suggesting that synchronizing the timing of food intake with body's circadian rhythms or day-night cycle has metabolic implications. Eating at the inappropriate time can disrupt circadian system which might induce metabolic perturbations, including glucose abnormalities. Recent evidence showed that circadian timing of eating was associated with glucose regulation in pregnant women. However, little is known about night-eating pattern during pregnancy, particularly the influence of nocturnal snacking on glycaemic control.

This cross-sectional study aims to recruit 400 pregnant women at 18-21 weeks' gestation. The investigators will assess maternal dietary intake, monitor 24-hour activity-rest pattern and light-dark exposure, and measure glucose and insulin profiles during the second trimester of pregnancy. Maternal socio-demographic status, lifestyle characteristics, health conditions and pregnancy outcomes will be asked through interview or retrieved from medical notes.

This study allows understanding the importance of circadian eating pattern, which is a modifiable behavior, in glycaemic control during pregnancy, and help to provide evidence for developing nutritional guidelines which can ameliorate metabolic health for mothers.

Keywords
Food timing, Gestational diabetes mellitus, Glucose tolerance, Night-eating, Pregnancy outcomes, Snacking
Medical subject headings
Metabolic Diseases, Diabetes, Gestational

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maternal glucose tolerance

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

    Measured: Up to 4 weeks, during second trimester of pregnancy

  2. Maternal night-eating pattern

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

    Measured: Up to 4 days, during second trimester of pregnancy

  3. Maternal meal and snack distribution

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

    Measured: Up to 4 days, during second trimester of pregnancy

Secondary outcomes (20)

  1. Maternal insulin profile

    Maternal insulin profile as assessed by the fasting insulin level.

    Measured: Up to 4 weeks, during second trimester of pregnancy

  2. Maternal gestational diabetes status

    Maternal gestational diabetes status as assessed by the Oral Glucose Tolerance Test.

    Measured: up to 4 weeks, during second trimester of pregnancy

  3. Maternal glycemic variability

    Maternal glycemic variability based on continuous glucose monitoring profile as assessed by the continuous glucose monitoring system (Freestyle Libre Pro, Abbott).

    Measured: Up to 10 days, during second trimester of pregnancy

  4. Maternal diet quality

    Maternal diet quality as assessed by the Food Frequency Questionnaire.

    Measured: up to 1 month, during second trimester of pregnancy

  5. Maternal type of food intake

    Maternal type of food intake as assessed by the food diary, food record app and Food Frequency Questionnaire.

    Measured: up to 10 weeks, during second trimester of pregnancy

  6. Maternal nutritional intake

    Maternal nutritional intake as assessed by the food diary and food record app.

    Measured: Up to 4 days, during second trimester of pregnancy

  7. Maternal eating frequency

    Maternal eating frequency as assessed by the food diary and food record app.

    Measured: Up to 4 days, during second trimester of pregnancy

  8. Maternal meal and snack regularity

    Maternal meal and snack regularity as assessed by the questionnaire based on frequency of meal/ snack delay and skipping.

    Measured: Up to 1 month, during second trimester of pregnancy

  9. Maternal physical activity

    Maternal physical activity as measured by the Actigraph accelerometer.

    Measured: Up to 10 days, during second trimester of pregnancy

  10. Maternal physical activity

    Maternal physical activity as assessed using the modified International Physical Activity Questionnaire (IPAQ).

    Measured: Up to 1 week, during second trimester of pregnancy

  11. Maternal sedentary behavior

    Maternal sedentary behavior as measured by the Actigraph accelerometer.

    Measured: Up to 10 days, during second trimester of pregnancy

  12. Maternal sedentary behavior

    Maternal sedentary behavior as assessed using the structured questionnaires based on frequency and duration of time spent in sedentary behaviour.

    Measured: Up to 1 week, during second trimester of pregnancy

  13. Maternal sleep related behavior

    Maternal sleep related behaviour as measured by the Actigraph accelerometer.

    Measured: Up to 10 days, during second trimester of pregnancy

  14. Maternal sleep related behavior

    Maternal sleep related behavior as assessed using the Pittsburgh Sleep Quality Index (PSQI) questionnaire.

    Measured: Up to 1 month, during second trimester of pregnancy

  15. Maternal light exposure

    Maternal light exposure as measured by the Actigraph accelerometer.

    Measured: Up to 10 days, during second trimester of pregnancy

  16. Maternal light exposure

    Maternal light exposure as assessed by the Harvard Light Exposure Assessment (H-LEA) questionnaire.

    Measured: Up to 1 week, during second trimester of pregnancy

  17. Maternal electronic media use before bedtime

    Maternal electronic media use before bedtime as assessed by the structured questionnaire based on frequency, duration and location of electronic device use.

    Measured: up to 1 week, during second trimester of pregnancy

  18. Maternal mood

    Maternal mood as assessed by the Depression Anxiety Stress Scale (DASS21) questionnaire.

    Measured: Up to 1 week, during second trimester of pregnancy

  19. Maternal gestational weight gain

    Maternal weight measured by calibrated weighing scale as recorded in medical notes

    Measured: Up to 42 weeks, throughout pregnancy

  20. Dietary data from food record app.

    Feasibility and validity of using food record mobile app to capture maternal dietary intake, compared with paper-based food diary.

    Measured: up to 4 days, during second trimester of pregnancy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2019
  2. Study start28 Mar 2019
  3. Primary completion24 Dec 2021
  4. Study completion11 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03803345
Sponsor's protocol ID
CIRB 2018/2529
Status last verified
Sep 2026
First submitted
18 Dec 2018
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chen YE, Ku CW, Zheng RT, Chan JKY, Yap F, Loy SL, Chen LW. Associations of Circadian-Disruptive Behaviours With Plasma Glycemic Parameters and Continuous Glucose Monitoring Measures Among Pregnant Women. Diabetes Obes Metab. 2026 Aug 25. doi: 10.1111/dom.71264. Online ahead of print.

    PubMed 42642345

  • 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.

    PubMed 40294750

  • 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.

    PubMed 31601588

Questions about this trial

What is this clinical trial studying?

An observational study of Metabolic Disease, run by KK Women's and Children's Hospital at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maternal glucose tolerance (time frame: Up to 4 weeks, during second trimester of pregnancy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03803345, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in