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

August 15, 2022 updated by: KK Women's and Children's Hospital
This study aims to assess the associations of maternal food timing with glucose levels during pregnancy.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Singapore, Singapore, 229899
        • KK Women's and Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  1. 18-21 week's gestation
  2. Singapore citizens or Singapore Permanent Residents
  3. Age 18-45 years
  4. Plan to follow-up for antenatal care in KK Women's and Children's Hospital
  5. Intend to deliver in KK Women's and Children's Hospital
  6. Provide written informed consent

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal glucose tolerance
Time Frame: Up to 4 weeks, during second trimester of pregnancy
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
Time Frame: Up to 4 days, during second trimester of pregnancy
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
Time Frame: Up to 4 days, during second trimester of pregnancy
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal insulin profile
Time Frame: Up to 4 weeks, during second trimester of pregnancy
Maternal insulin profile as assessed by the fasting insulin level.
Up to 4 weeks, during second trimester of pregnancy
Maternal gestational diabetes status
Time Frame: up to 4 weeks, during second trimester of pregnancy
Maternal gestational diabetes status as assessed by the Oral Glucose Tolerance Test.
up to 4 weeks, during second trimester of pregnancy
Maternal glycemic variability
Time Frame: Up to 10 days, during second trimester of pregnancy
Maternal glycemic variability based on continuous glucose monitoring profile as assessed by the continuous glucose monitoring system (Freestyle Libre Pro, Abbott).
Up to 10 days, during second trimester of pregnancy
Maternal diet quality
Time Frame: up to 1 month, during second trimester of pregnancy
Maternal diet quality as assessed by the Food Frequency Questionnaire.
up to 1 month, during second trimester of pregnancy
Maternal type of food intake
Time Frame: up to 10 weeks, during second trimester of pregnancy
Maternal type of food intake as assessed by the food diary, food record app and Food Frequency Questionnaire.
up to 10 weeks, during second trimester of pregnancy
Maternal nutritional intake
Time Frame: Up to 4 days, during second trimester of pregnancy
Maternal nutritional intake as assessed by the food diary and food record app.
Up to 4 days, during second trimester of pregnancy
Maternal eating frequency
Time Frame: Up to 4 days, during second trimester of pregnancy
Maternal eating frequency as assessed by the food diary and food record app.
Up to 4 days, during second trimester of pregnancy
Maternal meal and snack regularity
Time Frame: Up to 1 month, during second trimester of pregnancy
Maternal meal and snack regularity as assessed by the questionnaire based on frequency of meal/ snack delay and skipping.
Up to 1 month, during second trimester of pregnancy
Maternal physical activity
Time Frame: Up to 10 days, during second trimester of pregnancy
Maternal physical activity as measured by the Actigraph accelerometer.
Up to 10 days, during second trimester of pregnancy
Maternal physical activity
Time Frame: Up to 1 week, during second trimester of pregnancy
Maternal physical activity as assessed using the modified International Physical Activity Questionnaire (IPAQ).
Up to 1 week, during second trimester of pregnancy
Maternal sedentary behavior
Time Frame: Up to 10 days, during second trimester of pregnancy
Maternal sedentary behavior as measured by the Actigraph accelerometer.
Up to 10 days, during second trimester of pregnancy
Maternal sedentary behavior
Time Frame: Up to 1 week, during second trimester of pregnancy
Maternal sedentary behavior as assessed using the structured questionnaires based on frequency and duration of time spent in sedentary behaviour.
Up to 1 week, during second trimester of pregnancy
Maternal sleep related behavior
Time Frame: Up to 10 days, during second trimester of pregnancy
Maternal sleep related behaviour as measured by the Actigraph accelerometer.
Up to 10 days, during second trimester of pregnancy
Maternal sleep related behavior
Time Frame: Up to 1 month, during second trimester of pregnancy
Maternal sleep related behavior as assessed using the Pittsburgh Sleep Quality Index (PSQI) questionnaire.
Up to 1 month, during second trimester of pregnancy
Maternal light exposure
Time Frame: Up to 10 days, during second trimester of pregnancy
Maternal light exposure as measured by the Actigraph accelerometer.
Up to 10 days, during second trimester of pregnancy
Maternal light exposure
Time Frame: Up to 1 week, during second trimester of pregnancy
Maternal light exposure as assessed by the Harvard Light Exposure Assessment (H-LEA) questionnaire.
Up to 1 week, during second trimester of pregnancy
Maternal electronic media use before bedtime
Time Frame: up to 1 week, during second trimester of pregnancy
Maternal electronic media use before bedtime as assessed by the structured questionnaire based on frequency, duration and location of electronic device use.
up to 1 week, during second trimester of pregnancy
Maternal mood
Time Frame: Up to 1 week, during second trimester of pregnancy
Maternal mood as assessed by the Depression Anxiety Stress Scale (DASS21) questionnaire.
Up to 1 week, during second trimester of pregnancy
Maternal gestational weight gain
Time Frame: Up to 42 weeks, throughout pregnancy
Maternal weight measured by calibrated weighing scale as recorded in medical notes
Up to 42 weeks, throughout pregnancy
Dietary data from food record app.
Time Frame: up to 4 days, during second trimester of pregnancy
Feasibility and validity of using food record mobile app to capture maternal dietary intake, compared with paper-based food diary.
up to 4 days, during second trimester of pregnancy

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal hypertension status
Time Frame: Up to 42 weeks, during pregnancy
Maternal hypertension status obtained from medical notes.
Up to 42 weeks, during pregnancy
Maternal delivery outcomes
Time Frame: Up to 72 hours, after delivery
Maternal delivery outcomes obtained from medical notes.
Up to 72 hours, after delivery
Birth weight
Time Frame: Up to 72 hours, after delivery
Offspring birth weight in gram obtained from medical notes.
Up to 72 hours, after delivery
Birth length
Time Frame: Up to 72 hours, after delivery
Offspring birth length in cm obtained from medical notes.
Up to 72 hours, after delivery
Birth head circumference
Time Frame: Up to 72 hours, after delivery
Offspring birth head circumference in cm obtained from medical notes.
Up to 72 hours, after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: See Ling Loy, PhD, KK Women's and Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 28, 2019

Primary Completion (ACTUAL)

December 24, 2021

Study Completion (ACTUAL)

March 11, 2022

Study Registration Dates

First Submitted

December 18, 2018

First Submitted That Met QC Criteria

January 10, 2019

First Posted (ACTUAL)

January 14, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 17, 2022

Last Update Submitted That Met QC Criteria

August 15, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIRB 2018/2529

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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