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

Completed

• Conditions: Metabolic Disease

• Registration Number: NCT03803345
• Lead Sponsor: KK Women's and Children's Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-12-18
• Study First Submitted QC: 2019-01-10
• Study First Posted: 2019-01-14
• Study Start: 2019-03-28
• Primary Completion: 2021-12-24
• Study Completion: 2022-03-11
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-15
• Last Update Posted: 2022-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maternal glucose tolerance	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.
Maternal night-eating pattern	Up to 4 days, during second trimester of pregnancy	Maternal night-eating pattern as assessed by the food diary and food record app.
Maternal meal and snack distribution	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 Outcome Measures

Name	Time	Method
Maternal eating frequency	Up to 4 days, during second trimester of pregnancy	Maternal eating frequency as assessed by the food diary and food record app.
Maternal meal and snack regularity	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.
Maternal glycemic variability	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).
Maternal nutritional intake	Up to 4 days, during second trimester of pregnancy	Maternal nutritional intake as assessed by the food diary and food record app.
Maternal physical activity	Up to 1 week, during second trimester of pregnancy	Maternal physical activity as assessed using the modified International Physical Activity Questionnaire (IPAQ).
Maternal sedentary behavior	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.
Maternal insulin profile	Up to 4 weeks, during second trimester of pregnancy	Maternal insulin profile as assessed by the fasting insulin level.
Maternal gestational diabetes status	up to 4 weeks, during second trimester of pregnancy	Maternal gestational diabetes status as assessed by the Oral Glucose Tolerance Test.
Maternal diet quality	up to 1 month, during second trimester of pregnancy	Maternal diet quality as assessed by the Food Frequency Questionnaire.
Maternal type of food intake	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.
Maternal sleep related behavior	Up to 1 month, during second trimester of pregnancy	Maternal sleep related behavior as assessed using the Pittsburgh Sleep Quality Index (PSQI) questionnaire.
Maternal light exposure	Up to 1 week, during second trimester of pregnancy	Maternal light exposure as assessed by the Harvard Light Exposure Assessment (H-LEA) questionnaire.
Maternal electronic media use before bedtime	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.
Maternal mood	Up to 1 week, during second trimester of pregnancy	Maternal mood as assessed by the Depression Anxiety Stress Scale (DASS21) questionnaire.
Maternal gestational weight gain	Up to 42 weeks, throughout pregnancy	Maternal weight measured by calibrated weighing scale as recorded in medical notes
Dietary data from food record app.	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.

Trial Locations

Locations (1)

KK Women's and Children's Hospital; 🇸🇬 Singapore, Singapore