Clinical trial NCT03803345: The Association of Maternal Night-Eating Pattern With Glucose Tolerance During Pregnancy
Official title: The Association of Maternal Night-Eating Pattern With Glucose Tolerance During Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Disease
Keywords: Food timing
Gestational diabetes mellitus
Glucose tolerance
Night-eating
Pregnancy outcomes
Snacking
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
Collaborators: name: National University of Singapore
name: National University Hospital, Singapore
name: Duke-NUS Graduate Medical School
First posted: 2019-01-14
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy pregnant women aged 18-45 years old and at 18-21 weeks of gestation upon recruitment.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maternal glucose tolerance
timeFrame: Up to 4 weeks, during second trimester of pregnancy
measure: Maternal night-eating pattern
timeFrame: Up to 4 days, during second trimester of pregnancy
measure: Maternal meal and snack distribution
timeFrame: Up to 4 days, during second trimester of pregnancy
Secondary outcomes:
measure: Maternal insulin profile
timeFrame: Up to 4 weeks, during second trimester of pregnancy
measure: Maternal gestational diabetes status
timeFrame: up to 4 weeks, during second trimester of pregnancy
measure: Maternal glycemic variability
timeFrame: Up to 10 days, during second trimester of pregnancy
measure: Maternal diet quality
timeFrame: up to 1 month, during second trimester of pregnancy
measure: Maternal type of food intake
timeFrame: up to 10 weeks, during second trimester of pregnancy
measure: Maternal nutritional intake
timeFrame: Up to 4 days, during second trimester of pregnancy
measure: Maternal eating frequency
timeFrame: Up to 4 days, during second trimester of pregnancy
measure: Maternal meal and snack regularity
timeFrame: Up to 1 month, during second trimester of pregnancy
measure: Maternal physical activity
timeFrame: Up to 10 days, during second trimester of pregnancy
measure: Maternal physical activity
timeFrame: Up to 1 week, during second trimester of pregnancy
measure: Maternal sedentary behavior
timeFrame: Up to 10 days, during second trimester of pregnancy
measure: Maternal sedentary behavior
timeFrame: Up to 1 week, during second trimester of pregnancy
measure: Maternal sleep related behavior
timeFrame: Up to 10 days, during second trimester of pregnancy
measure: Maternal sleep related behavior
timeFrame: Up to 1 month, during second trimester of pregnancy
measure: Maternal light exposure
timeFrame: Up to 10 days, during second trimester of pregnancy
measure: Maternal light exposure
timeFrame: Up to 1 week, during second trimester of pregnancy
measure: Maternal electronic media use before bedtime
timeFrame: up to 1 week, during second trimester of pregnancy
measure: Maternal mood
timeFrame: Up to 1 week, during second trimester of pregnancy
measure: Maternal gestational weight gain
timeFrame: Up to 42 weeks, throughout pregnancy
measure: Dietary data from food record app.
timeFrame: up to 4 days, during second trimester of pregnancy
Other outcomes:
measure: Maternal hypertension status
timeFrame: Up to 42 weeks, during pregnancy
measure: Maternal delivery outcomes
timeFrame: Up to 72 hours, after delivery
measure: Birth weight
timeFrame: Up to 72 hours, after delivery
measure: Birth length
timeFrame: Up to 72 hours, after delivery
measure: Birth head circumference
timeFrame: Up to 72 hours, after delivery
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: See Ling Loy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.