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Completed

NCT Number: NCT03803345

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

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

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Key information

Conditions

Metabolic Disease Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

KK Women's and Children's Hospital

Singapore, 229899

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Maternal insulin profile

    Time frame: Up to 4 weeks, during second trimester of pregnancy

    Maternal insulin profile as assessed by the fasting insulin level.

  2. 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.

  3. 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).

  4. Maternal diet quality

    Time frame: up to 1 month, during second trimester of pregnancy

    Maternal diet quality as assessed by the Food Frequency Questionnaire.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Maternal physical activity

    Time frame: Up to 10 days, during second trimester of pregnancy

    Maternal physical activity as measured by the Actigraph accelerometer.

  10. 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).

  11. Maternal sedentary behavior

    Time frame: Up to 10 days, during second trimester of pregnancy

    Maternal sedentary behavior as measured by the Actigraph accelerometer.

  12. 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.

  13. 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.

  14. 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.

  15. Maternal light exposure

    Time frame: Up to 10 days, during second trimester of pregnancy

    Maternal light exposure as measured by the Actigraph accelerometer.

  16. 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.

  17. 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.

  18. 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.

  19. Maternal gestational weight gain

    Time frame: Up to 42 weeks, throughout pregnancy

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

  20. 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.

Other outcomes

  1. Maternal hypertension status

    Time frame: Up to 42 weeks, during pregnancy

    Maternal hypertension status obtained from medical notes.

  2. Maternal delivery outcomes

    Time frame: Up to 72 hours, after delivery

    Maternal delivery outcomes obtained from medical notes.

  3. Birth weight

    Time frame: Up to 72 hours, after delivery

    Offspring birth weight in gram obtained from medical notes.

  4. Birth length

    Time frame: Up to 72 hours, after delivery

    Offspring birth length in cm obtained from medical notes.

  5. Birth head circumference

    Time frame: Up to 72 hours, after delivery

    Offspring birth head circumference in cm obtained from medical notes.

Sponsors and collaborators

Lead sponsor

KK Women's and Children's Hospital

Other Gov

Collaborators

  • Duke-NUS Graduate Medical School
  • National University Hospital, Singapore
  • National University of Singapore

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jan 14, 2019
Registry last updated
Aug 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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