- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03803345
The Association of Maternal Night-Eating Pattern With Glucose Tolerance During Pregnancy
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Singapore, Singapore, 229899
- KK Women's and Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal glucose tolerance
Time Frame: Up to 4 weeks, during second trimester of pregnancy
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Maternal glucose tolerance based on plasma glucose levels as assessed by the Oral Glucose Tolerance Test.
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Up to 4 weeks, during second trimester of pregnancy
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Maternal night-eating pattern
Time Frame: Up to 4 days, during second trimester of pregnancy
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Maternal night-eating pattern as assessed by the food diary and food record app.
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Up to 4 days, during second trimester of pregnancy
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Maternal meal and snack distribution
Time Frame: Up to 4 days, during second trimester of pregnancy
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Maternal meal and snack distribution as assessed by the food diary and food record app.
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Up to 4 days, during second trimester of pregnancy
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal insulin profile
Time Frame: Up to 4 weeks, during second trimester of pregnancy
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Maternal insulin profile as assessed by the fasting insulin level.
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Up to 4 weeks, during second trimester of pregnancy
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Maternal gestational diabetes status
Time Frame: up to 4 weeks, during second trimester of pregnancy
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Maternal gestational diabetes status as assessed by the Oral Glucose Tolerance Test.
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up to 4 weeks, during second trimester of pregnancy
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Maternal glycemic variability
Time Frame: Up to 10 days, during second trimester of pregnancy
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Maternal glycemic variability based on continuous glucose monitoring profile as assessed by the continuous glucose monitoring system (Freestyle Libre Pro, Abbott).
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Up to 10 days, during second trimester of pregnancy
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Maternal diet quality
Time Frame: up to 1 month, during second trimester of pregnancy
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Maternal diet quality as assessed by the Food Frequency Questionnaire.
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up to 1 month, during second trimester of pregnancy
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Maternal type of food intake
Time Frame: up to 10 weeks, during second trimester of pregnancy
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Maternal type of food intake as assessed by the food diary, food record app and Food Frequency Questionnaire.
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up to 10 weeks, during second trimester of pregnancy
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Maternal nutritional intake
Time Frame: Up to 4 days, during second trimester of pregnancy
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Maternal nutritional intake as assessed by the food diary and food record app.
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Up to 4 days, during second trimester of pregnancy
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Maternal eating frequency
Time Frame: Up to 4 days, during second trimester of pregnancy
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Maternal eating frequency as assessed by the food diary and food record app.
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Up to 4 days, during second trimester of pregnancy
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Maternal meal and snack regularity
Time Frame: Up to 1 month, during second trimester of pregnancy
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Maternal meal and snack regularity as assessed by the questionnaire based on frequency of meal/ snack delay and skipping.
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Up to 1 month, during second trimester of pregnancy
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Maternal physical activity
Time Frame: Up to 10 days, during second trimester of pregnancy
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Maternal physical activity as measured by the Actigraph accelerometer.
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Up to 10 days, during second trimester of pregnancy
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Maternal physical activity
Time Frame: Up to 1 week, during second trimester of pregnancy
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Maternal physical activity as assessed using the modified International Physical Activity Questionnaire (IPAQ).
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Up to 1 week, during second trimester of pregnancy
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Maternal sedentary behavior
Time Frame: Up to 10 days, during second trimester of pregnancy
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Maternal sedentary behavior as measured by the Actigraph accelerometer.
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Up to 10 days, during second trimester of pregnancy
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Maternal sedentary behavior
Time Frame: Up to 1 week, during second trimester of pregnancy
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Maternal sedentary behavior as assessed using the structured questionnaires based on frequency and duration of time spent in sedentary behaviour.
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Up to 1 week, during second trimester of pregnancy
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Maternal sleep related behavior
Time Frame: Up to 10 days, during second trimester of pregnancy
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Maternal sleep related behaviour as measured by the Actigraph accelerometer.
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Up to 10 days, during second trimester of pregnancy
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Maternal sleep related behavior
Time Frame: Up to 1 month, during second trimester of pregnancy
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Maternal sleep related behavior as assessed using the Pittsburgh Sleep Quality Index (PSQI) questionnaire.
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Up to 1 month, during second trimester of pregnancy
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Maternal light exposure
Time Frame: Up to 10 days, during second trimester of pregnancy
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Maternal light exposure as measured by the Actigraph accelerometer.
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Up to 10 days, during second trimester of pregnancy
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Maternal light exposure
Time Frame: Up to 1 week, during second trimester of pregnancy
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Maternal light exposure as assessed by the Harvard Light Exposure Assessment (H-LEA) questionnaire.
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Up to 1 week, during second trimester of pregnancy
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Maternal electronic media use before bedtime
Time Frame: up to 1 week, during second trimester of pregnancy
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Maternal electronic media use before bedtime as assessed by the structured questionnaire based on frequency, duration and location of electronic device use.
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up to 1 week, during second trimester of pregnancy
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Maternal mood
Time Frame: Up to 1 week, during second trimester of pregnancy
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Maternal mood as assessed by the Depression Anxiety Stress Scale (DASS21) questionnaire.
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Up to 1 week, during second trimester of pregnancy
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Maternal gestational weight gain
Time Frame: Up to 42 weeks, throughout pregnancy
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Maternal weight measured by calibrated weighing scale as recorded in medical notes
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Up to 42 weeks, throughout pregnancy
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Dietary data from food record app.
Time Frame: up to 4 days, during second trimester of pregnancy
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Feasibility and validity of using food record mobile app to capture maternal dietary intake, compared with paper-based food diary.
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up to 4 days, during second trimester of pregnancy
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal hypertension status
Time Frame: Up to 42 weeks, during pregnancy
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Maternal hypertension status obtained from medical notes.
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Up to 42 weeks, during pregnancy
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Maternal delivery outcomes
Time Frame: Up to 72 hours, after delivery
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Maternal delivery outcomes obtained from medical notes.
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Up to 72 hours, after delivery
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Birth weight
Time Frame: Up to 72 hours, after delivery
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Offspring birth weight in gram obtained from medical notes.
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Up to 72 hours, after delivery
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Birth length
Time Frame: Up to 72 hours, after delivery
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Offspring birth length in cm obtained from medical notes.
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Up to 72 hours, after delivery
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Birth head circumference
Time Frame: Up to 72 hours, after delivery
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Offspring birth head circumference in cm obtained from medical notes.
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Up to 72 hours, after delivery
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: See Ling Loy, PhD, KK Women's and Children's Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIRB 2018/2529
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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