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

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

Detailed Description
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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.

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

Conditions
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Metabolic Disease

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal insulin profile | Maternal insulin profile as assessed by the fasting insulin level. | Up to 4 weeks, during second trimester of pregnancy | 
| 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 | 
| 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 | 
| Maternal diet quality | Maternal diet quality as assessed by the Food Frequency Questionnaire. | up to 1 month, during second trimester of pregnancy | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Maternal physical activity | Maternal physical activity as measured by the Actigraph accelerometer. | Up to 10 days, during second trimester of pregnancy | 
| 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 | 
| Maternal sedentary behavior | Maternal sedentary behavior as measured by the Actigraph accelerometer. | Up to 10 days, during second trimester of pregnancy | 
| 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 | 
| Maternal sleep related behavior | Maternal sleep related behaviour as measured by the Actigraph accelerometer. | Up to 10 days, during second trimester of pregnancy | 
| 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 | 
| Maternal light exposure | Maternal light exposure as measured by the Actigraph accelerometer. | Up to 10 days, during second trimester of pregnancy | 
| 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 | 
| 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 | 
| Maternal mood | 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 | Maternal weight measured by calibrated weighing scale as recorded in medical notes | Up to 42 weeks, throughout pregnancy | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Food timing, Gestational diabetes mellitus, Glucose tolerance, Night-eating, Pregnancy outcomes, Snacking