Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03803345
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : February 20, 2020
Sponsor:
Collaborators:
National University, Singapore
National University Hospital, Singapore
Duke-NUS Medical School (Singapore)
Information provided by (Responsible Party):
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.

Condition or disease
Metabolic Disease

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: The Association of Maternal Night-Eating Pattern With Glucose Tolerance During Pregnancy
Actual Study Start Date : March 28, 2019
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Maternal glucose tolerance [ Time Frame: 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.

  2. Maternal night-eating pattern [ Time Frame: Up to 4 days, during second trimester of pregnancy ]
    Maternal night-eating pattern as assessed by the food diary and food record app.

  3. Maternal meal and snack distribution [ Time Frame: 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 :
  1. Maternal insulin profile [ Time Frame: Up to 4 weeks, during second trimester of pregnancy ]
    Maternal insulin profile as assessed by the fasting insulin level.

  2. Maternal gestational diabetes status [ Time Frame: up to 4 weeks, during second trimester of pregnancy ]
    Maternal gestational diabetes status as assessed by the Oral Glucose Tolerance Test.

  3. Maternal glycemic variability [ Time Frame: 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).

  4. Maternal diet quality [ Time Frame: up to 1 month, during second trimester of pregnancy ]
    Maternal diet quality as assessed by the Food Frequency Questionnaire.

  5. Maternal type of food intake [ Time Frame: 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.

  6. Maternal nutritional intake [ Time Frame: Up to 4 days, during second trimester of pregnancy ]
    Maternal nutritional intake as assessed by the food diary and food record app.

  7. Maternal eating frequency [ Time Frame: Up to 4 days, during second trimester of pregnancy ]
    Maternal eating frequency as assessed by the food diary and food record app.

  8. Maternal meal and snack regularity [ Time Frame: 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.

  9. Maternal physical activity [ Time Frame: Up to 10 days, during second trimester of pregnancy ]
    Maternal physical activity as measured by the Actigraph accelerometer.

  10. Maternal physical activity [ Time Frame: Up to 1 week, during second trimester of pregnancy ]
    Maternal physical activity as assessed using the modified International Physical Activity Questionnaire (IPAQ).

  11. Maternal sedentary behavior [ Time Frame: Up to 10 days, during second trimester of pregnancy ]
    Maternal sedentary behavior as measured by the Actigraph accelerometer.

  12. Maternal sedentary behavior [ Time Frame: 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.

  13. Maternal sleep related behavior [ Time Frame: Up to 10 days, during second trimester of pregnancy ]
    Maternal sleep related behaviour as measured by the Actigraph accelerometer.

  14. Maternal sleep related behavior [ Time Frame: Up to 1 month, during second trimester of pregnancy ]
    Maternal sleep related behavior as assessed using the Pittsburgh Sleep Quality Index (PSQI) questionnaire.

  15. Maternal light exposure [ Time Frame: Up to 10 days, during second trimester of pregnancy ]
    Maternal light exposure as measured by the Actigraph accelerometer.

  16. Maternal light exposure [ Time Frame: Up to 1 week, during second trimester of pregnancy ]
    Maternal light exposure as assessed by the Harvard Light Exposure Assessment (H-LEA) questionnaire.

  17. Maternal electronic media use before bedtime [ Time Frame: 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.

  18. Maternal mood [ Time Frame: Up to 1 week, during second trimester of pregnancy ]
    Maternal mood as assessed by the Depression Anxiety Stress Scale (DASS21) questionnaire.

  19. Maternal gestational weight gain [ Time Frame: Up to 42 weeks, throughout pregnancy ]
    Maternal weight measured by calibrated weighing scale as recorded in medical notes

  20. Dietary data from food record app. [ Time Frame: 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.


Other Outcome Measures:
  1. Maternal hypertension status [ Time Frame: Up to 42 weeks, during pregnancy ]
    Maternal hypertension status obtained from medical notes.

  2. Maternal delivery outcomes [ Time Frame: Up to 72 hours, after delivery ]
    Maternal delivery outcomes obtained from medical notes.

  3. Birth weight [ Time Frame: Up to 72 hours, after delivery ]
    Offspring birth weight in gram obtained from medical notes.

  4. Birth length [ Time Frame: Up to 72 hours, after delivery ]
    Offspring birth length in cm obtained from medical notes.

  5. Birth head circumference [ Time Frame: Up to 72 hours, after delivery ]
    Offspring birth head circumference in cm obtained from medical notes.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women.
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy pregnant women aged 18-45 years old and at 18-21 weeks of gestation upon recruitment.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03803345


Contacts
Layout table for location contacts
Contact: Dora Xin Ping Gan 65 6394 7254 dora.gan.xin.p@kkh.com.sg

Locations
Layout table for location information
Singapore
KK Women's and Children's Hospital Recruiting
Singapore, Singapore, 229899
Principal Investigator: See Ling Loy, PhD         
Sponsors and Collaborators
KK Women's and Children's Hospital
National University, Singapore
National University Hospital, Singapore
Duke-NUS Medical School (Singapore)
Investigators
Layout table for investigator information
Principal Investigator: See Ling Loy, PhD KK Women's and Children's Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: KK Women's and Children's Hospital
ClinicalTrials.gov Identifier: NCT03803345    
Other Study ID Numbers: CIRB 2018/2529
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by KK Women's and Children's Hospital:
Food timing
Gestational diabetes mellitus
Glucose tolerance
Night-eating
Pregnancy outcomes
Snacking
Additional relevant MeSH terms:
Layout table for MeSH terms
Metabolic Diseases