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

Metabolic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03803345
• Other study ID #: CIRB 2018/2529
• Status: Completed
• Start date: March 28, 2019
• Est. completion date: March 11, 2022

Study information

• Verified date: August 2022
• Source: KK Women's and Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 11, 2022
• Est. primary completion date: December 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Disease
• Metabolic Diseases

Locations

Country	Name	City	State
Singapore	KK Women's and Children's Hospital	Singapore

Sponsors (4)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital	Duke-NUS Medical School (Singapore), National University Hospital, Singapore, National University, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maternal hypertension status	Maternal hypertension status obtained from medical notes.	Up to 42 weeks, during pregnancy
Other	Maternal delivery outcomes	Maternal delivery outcomes obtained from medical notes.	Up to 72 hours, after delivery
Other	Birth weight	Offspring birth weight in gram obtained from medical notes.	Up to 72 hours, after delivery
Other	Birth length	Offspring birth length in cm obtained from medical notes.	Up to 72 hours, after delivery
Other	Birth head circumference	Offspring birth head circumference in cm obtained from medical notes.	Up to 72 hours, after delivery
Primary	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
Primary	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
Primary	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	Maternal insulin profile	Maternal insulin profile as assessed by the fasting insulin level.	Up to 4 weeks, during second trimester of pregnancy
Secondary	Maternal gestational diabetes status	Maternal gestational diabetes status as assessed by the Oral Glucose Tolerance Test.	up to 4 weeks, during second trimester of pregnancy
Secondary	Maternal glycemic variability	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
Secondary	Maternal diet quality	Maternal diet quality as assessed by the Food Frequency Questionnaire.	up to 1 month, during second trimester of pregnancy
Secondary	Maternal type of food intake	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
Secondary	Maternal nutritional intake	Maternal nutritional intake as assessed by the food diary and food record app.	Up to 4 days, during second trimester of pregnancy
Secondary	Maternal eating frequency	Maternal eating frequency as assessed by the food diary and food record app.	Up to 4 days, during second trimester of pregnancy
Secondary	Maternal meal and snack regularity	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
Secondary	Maternal physical activity	Maternal physical activity as measured by the Actigraph accelerometer.	Up to 10 days, during second trimester of pregnancy
Secondary	Maternal physical activity	Maternal physical activity as assessed using the modified International Physical Activity Questionnaire (IPAQ).	Up to 1 week, during second trimester of pregnancy
Secondary	Maternal sedentary behavior	Maternal sedentary behavior as measured by the Actigraph accelerometer.	Up to 10 days, during second trimester of pregnancy
Secondary	Maternal sedentary behavior	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
Secondary	Maternal sleep related behavior	Maternal sleep related behaviour as measured by the Actigraph accelerometer.	Up to 10 days, during second trimester of pregnancy
Secondary	Maternal sleep related behavior	Maternal sleep related behavior as assessed using the Pittsburgh Sleep Quality Index (PSQI) questionnaire.	Up to 1 month, during second trimester of pregnancy
Secondary	Maternal light exposure	Maternal light exposure as measured by the Actigraph accelerometer.	Up to 10 days, during second trimester of pregnancy
Secondary	Maternal light exposure	Maternal light exposure as assessed by the Harvard Light Exposure Assessment (H-LEA) questionnaire.	Up to 1 week, during second trimester of pregnancy
Secondary	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.	up to 1 week, during second trimester of pregnancy
Secondary	Maternal mood	Maternal mood as assessed by the Depression Anxiety Stress Scale (DASS21) questionnaire.	Up to 1 week, during second trimester of pregnancy
Secondary	Maternal gestational weight gain	Maternal weight measured by calibrated weighing scale as recorded in medical notes	Up to 42 weeks, throughout pregnancy
Secondary	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.	up to 4 days, during second trimester of pregnancy