<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03803345</url>
  </required_header>
  <id_info>
    <org_study_id>CIRB 2018/2529</org_study_id>
    <nct_id>NCT03803345</nct_id>
  </id_info>
  <brief_title>The Association of Maternal Night-Eating Pattern With Glucose Tolerance During Pregnancy</brief_title>
  <official_title>The Association of Maternal Night-Eating Pattern With Glucose Tolerance During Pregnancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KK Women's and Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National University of Singapore</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National University Hospital, Singapore</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Duke-NUS Medical School (Singapore)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>KK Women's and Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to assess the associations of maternal food timing with glucose levels during&#xD;
      pregnancy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A novel line of research has emerged, suggesting that synchronizing the timing of food intake&#xD;
      with body's circadian rhythms or day-night cycle has metabolic implications. Eating at the&#xD;
      inappropriate time can disrupt circadian system which might induce metabolic perturbations,&#xD;
      including glucose abnormalities. Recent evidence showed that circadian timing of eating was&#xD;
      associated with glucose regulation in pregnant women. However, little is known about&#xD;
      night-eating pattern during pregnancy, particularly the influence of nocturnal snacking on&#xD;
      glycaemic control.&#xD;
&#xD;
      This cross-sectional study aims to recruit 400 pregnant women at 18-21 weeks' gestation. The&#xD;
      investigators will assess maternal dietary intake, monitor 24-hour activity-rest pattern and&#xD;
      light-dark exposure, and measure glucose and insulin profiles during the second trimester of&#xD;
      pregnancy. Maternal socio-demographic status, lifestyle characteristics, health conditions&#xD;
      and pregnancy outcomes will be asked through interview or retrieved from medical notes.&#xD;
&#xD;
      This study allows understanding the importance of circadian eating pattern, which is a&#xD;
      modifiable behavior, in glycaemic control during pregnancy, and help to provide evidence for&#xD;
      developing nutritional guidelines which can ameliorate metabolic health for mothers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 28, 2019</start_date>
  <completion_date type="Actual">March 11, 2022</completion_date>
  <primary_completion_date type="Actual">December 24, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Maternal glucose tolerance</measure>
    <time_frame>Up to 4 weeks, during second trimester of pregnancy</time_frame>
    <description>Maternal glucose tolerance based on plasma glucose levels as assessed by the Oral Glucose Tolerance Test.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maternal night-eating pattern</measure>
    <time_frame>Up to 4 days, during second trimester of pregnancy</time_frame>
    <description>Maternal night-eating pattern as assessed by the food diary and food record app.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maternal meal and snack distribution</measure>
    <time_frame>Up to 4 days, during second trimester of pregnancy</time_frame>
    <description>Maternal meal and snack distribution as assessed by the food diary and food record app.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maternal insulin profile</measure>
    <time_frame>Up to 4 weeks, during second trimester of pregnancy</time_frame>
    <description>Maternal insulin profile as assessed by the fasting insulin level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal gestational diabetes status</measure>
    <time_frame>up to 4 weeks, during second trimester of pregnancy</time_frame>
    <description>Maternal gestational diabetes status as assessed by the Oral Glucose Tolerance Test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal glycemic variability</measure>
    <time_frame>Up to 10 days, during second trimester of pregnancy</time_frame>
    <description>Maternal glycemic variability based on continuous glucose monitoring profile as assessed by the continuous glucose monitoring system (Freestyle Libre Pro, Abbott).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal diet quality</measure>
    <time_frame>up to 1 month, during second trimester of pregnancy</time_frame>
    <description>Maternal diet quality as assessed by the Food Frequency Questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal type of food intake</measure>
    <time_frame>up to 10 weeks, during second trimester of pregnancy</time_frame>
    <description>Maternal type of food intake as assessed by the food diary, food record app and Food Frequency Questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal nutritional intake</measure>
    <time_frame>Up to 4 days, during second trimester of pregnancy</time_frame>
    <description>Maternal nutritional intake as assessed by the food diary and food record app.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal eating frequency</measure>
    <time_frame>Up to 4 days, during second trimester of pregnancy</time_frame>
    <description>Maternal eating frequency as assessed by the food diary and food record app.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal meal and snack regularity</measure>
    <time_frame>Up to 1 month, during second trimester of pregnancy</time_frame>
    <description>Maternal meal and snack regularity as assessed by the questionnaire based on frequency of meal/ snack delay and skipping.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal physical activity</measure>
    <time_frame>Up to 10 days, during second trimester of pregnancy</time_frame>
    <description>Maternal physical activity as measured by the Actigraph accelerometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal physical activity</measure>
    <time_frame>Up to 1 week, during second trimester of pregnancy</time_frame>
    <description>Maternal physical activity as assessed using the modified International Physical Activity Questionnaire (IPAQ).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal sedentary behavior</measure>
    <time_frame>Up to 10 days, during second trimester of pregnancy</time_frame>
    <description>Maternal sedentary behavior as measured by the Actigraph accelerometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal sedentary behavior</measure>
    <time_frame>Up to 1 week, during second trimester of pregnancy</time_frame>
    <description>Maternal sedentary behavior as assessed using the structured questionnaires based on frequency and duration of time spent in sedentary behaviour.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal sleep related behavior</measure>
    <time_frame>Up to 10 days, during second trimester of pregnancy</time_frame>
    <description>Maternal sleep related behaviour as measured by the Actigraph accelerometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal sleep related behavior</measure>
    <time_frame>Up to 1 month, during second trimester of pregnancy</time_frame>
    <description>Maternal sleep related behavior as assessed using the Pittsburgh Sleep Quality Index (PSQI) questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal light exposure</measure>
    <time_frame>Up to 10 days, during second trimester of pregnancy</time_frame>
    <description>Maternal light exposure as measured by the Actigraph accelerometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal light exposure</measure>
    <time_frame>Up to 1 week, during second trimester of pregnancy</time_frame>
    <description>Maternal light exposure as assessed by the Harvard Light Exposure Assessment (H-LEA) questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal electronic media use before bedtime</measure>
    <time_frame>up to 1 week, during second trimester of pregnancy</time_frame>
    <description>Maternal electronic media use before bedtime as assessed by the structured questionnaire based on frequency, duration and location of electronic device use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal mood</measure>
    <time_frame>Up to 1 week, during second trimester of pregnancy</time_frame>
    <description>Maternal mood as assessed by the Depression Anxiety Stress Scale (DASS21) questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal gestational weight gain</measure>
    <time_frame>Up to 42 weeks, throughout pregnancy</time_frame>
    <description>Maternal weight measured by calibrated weighing scale as recorded in medical notes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary data from food record app.</measure>
    <time_frame>up to 4 days, during second trimester of pregnancy</time_frame>
    <description>Feasibility and validity of using food record mobile app to capture maternal dietary intake, compared with paper-based food diary.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Maternal hypertension status</measure>
    <time_frame>Up to 42 weeks, during pregnancy</time_frame>
    <description>Maternal hypertension status obtained from medical notes.</description>
  </other_outcome>
  <other_outcome>
    <measure>Maternal delivery outcomes</measure>
    <time_frame>Up to 72 hours, after delivery</time_frame>
    <description>Maternal delivery outcomes obtained from medical notes.</description>
  </other_outcome>
  <other_outcome>
    <measure>Birth weight</measure>
    <time_frame>Up to 72 hours, after delivery</time_frame>
    <description>Offspring birth weight in gram obtained from medical notes.</description>
  </other_outcome>
  <other_outcome>
    <measure>Birth length</measure>
    <time_frame>Up to 72 hours, after delivery</time_frame>
    <description>Offspring birth length in cm obtained from medical notes.</description>
  </other_outcome>
  <other_outcome>
    <measure>Birth head circumference</measure>
    <time_frame>Up to 72 hours, after delivery</time_frame>
    <description>Offspring birth head circumference in cm obtained from medical notes.</description>
  </other_outcome>
  <enrollment type="Actual">300</enrollment>
  <condition>Metabolic Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy pregnant women aged 18-45 years old and at 18-21 weeks of gestation upon&#xD;
        recruitment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18-21 week's gestation&#xD;
&#xD;
          2. Singapore citizens or Singapore Permanent Residents&#xD;
&#xD;
          3. Age 18-45 years&#xD;
&#xD;
          4. Plan to follow-up for antenatal care in KK Women's and Children's Hospital&#xD;
&#xD;
          5. Intend to deliver in KK Women's and Children's Hospital&#xD;
&#xD;
          6. Provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Type 1 or 2 diabetes&#xD;
&#xD;
          2. Diabetes in pregnancy as confirmed by oral glucose tolerance test&#xD;
&#xD;
          3. Use of medications such as anticonvulsant medications or oral steroids in the past 1&#xD;
             month&#xD;
&#xD;
          4. Multiple pregnancy&#xD;
&#xD;
          5. On routine night-shift work for at least 3x/week over the past 1 month&#xD;
&#xD;
          6. Known or suspected allergy to medical grade adhesives&#xD;
&#xD;
          7. Chronic kidney diseases&#xD;
&#xD;
          8. Preeclampsia&#xD;
&#xD;
          9. Eventual miscarriage or undergo termination event&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Pregnant women.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>See Ling Loy, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>KK Women's and Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>KK Women's and Children's Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>229899</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>August 15, 2022</last_update_submitted>
  <last_update_submitted_qc>August 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Food timing</keyword>
  <keyword>Gestational diabetes mellitus</keyword>
  <keyword>Glucose tolerance</keyword>
  <keyword>Night-eating</keyword>
  <keyword>Pregnancy outcomes</keyword>
  <keyword>Snacking</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03803345
org study id: CIRB 2018/2529
nct id: NCT03803345
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to assess the associations of maternal food timing with glucose levels during
      pregnancy.
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.
observational model: Other
time perspective: Prospective
measure: Maternal glucose tolerance
time frame: Up to 4 weeks, during second trimester of pregnancy
description: Maternal glucose tolerance based on plasma glucose levels as assessed by the Oral Glucose Tolerance Test.
measure: Maternal night-eating pattern
time frame: Up to 4 days, during second trimester of pregnancy
description: Maternal night-eating pattern as assessed by the food diary and food record app.
measure: Maternal meal and snack distribution
time frame: Up to 4 days, during second trimester of pregnancy
description: Maternal meal and snack distribution as assessed by the food diary and food record app.
measure: Maternal insulin profile
time frame: Up to 4 weeks, during second trimester of pregnancy
description: Maternal insulin profile as assessed by the fasting insulin level.
measure: Maternal gestational diabetes status
time frame: up to 4 weeks, during second trimester of pregnancy
description: Maternal gestational diabetes status as assessed by the Oral Glucose Tolerance Test.
measure: Maternal glycemic variability
time frame: Up to 10 days, during second trimester of pregnancy
description: Maternal glycemic variability based on continuous glucose monitoring profile as assessed by the continuous glucose monitoring system (Freestyle Libre Pro, Abbott).
measure: Maternal diet quality
time frame: up to 1 month, during second trimester of pregnancy
description: Maternal diet quality as assessed by the Food Frequency Questionnaire.
measure: Maternal type of food intake
time frame: up to 10 weeks, during second trimester of pregnancy
description: Maternal type of food intake as assessed by the food diary, food record app and Food Frequency Questionnaire.
measure: Maternal nutritional intake
time frame: Up to 4 days, during second trimester of pregnancy
description: Maternal nutritional intake as assessed by the food diary and food record app.
measure: Maternal eating frequency
time frame: Up to 4 days, during second trimester of pregnancy
description: Maternal eating frequency as assessed by the food diary and food record app.
measure: Maternal meal and snack regularity
time frame: Up to 1 month, during second trimester of pregnancy
description: Maternal meal and snack regularity as assessed by the questionnaire based on frequency of meal/ snack delay and skipping.
measure: Maternal physical activity
time frame: Up to 10 days, during second trimester of pregnancy
description: Maternal physical activity as measured by the Actigraph accelerometer.
measure: Maternal physical activity
time frame: Up to 1 week, during second trimester of pregnancy
description: Maternal physical activity as assessed using the modified International Physical Activity Questionnaire (IPAQ).
measure: Maternal sedentary behavior
time frame: Up to 10 days, during second trimester of pregnancy
description: Maternal sedentary behavior as measured by the Actigraph accelerometer.
measure: Maternal sedentary behavior
time frame: Up to 1 week, during second trimester of pregnancy
description: Maternal sedentary behavior as assessed using the structured questionnaires based on frequency and duration of time spent in sedentary behaviour.
measure: Maternal sleep related behavior
time frame: Up to 10 days, during second trimester of pregnancy
description: Maternal sleep related behaviour as measured by the Actigraph accelerometer.
measure: Maternal sleep related behavior
time frame: Up to 1 month, during second trimester of pregnancy
description: Maternal sleep related behavior as assessed using the Pittsburgh Sleep Quality Index (PSQI) questionnaire.
measure: Maternal light exposure
time frame: Up to 10 days, during second trimester of pregnancy
description: Maternal light exposure as measured by the Actigraph accelerometer.
measure: Maternal light exposure
time frame: Up to 1 week, during second trimester of pregnancy
description: Maternal light exposure as assessed by the Harvard Light Exposure Assessment (H-LEA) questionnaire.
measure: Maternal electronic media use before bedtime
time frame: up to 1 week, during second trimester of pregnancy
description: Maternal electronic media use before bedtime as assessed by the structured questionnaire based on frequency, duration and location of electronic device use.
measure: Maternal mood
time frame: Up to 1 week, during second trimester of pregnancy
description: Maternal mood as assessed by the Depression Anxiety Stress Scale (DASS21) questionnaire.
measure: Maternal gestational weight gain
time frame: Up to 42 weeks, throughout pregnancy
description: Maternal weight measured by calibrated weighing scale as recorded in medical notes
measure: Dietary data from food record app.
time frame: up to 4 days, during second trimester of pregnancy
description: Feasibility and validity of using food record mobile app to capture maternal dietary intake, compared with paper-based food diary.
measure: Maternal hypertension status
time frame: Up to 42 weeks, during pregnancy
description: Maternal hypertension status obtained from medical notes.
measure: Maternal delivery outcomes
time frame: Up to 72 hours, after delivery
description: Maternal delivery outcomes obtained from medical notes.
measure: Birth weight
time frame: Up to 72 hours, after delivery
description: Offspring birth weight in gram obtained from medical notes.
measure: Birth length
time frame: Up to 72 hours, after delivery
description: Offspring birth length in cm obtained from medical notes.
measure: Birth head circumference
time frame: Up to 72 hours, after delivery
description: Offspring birth head circumference in cm obtained from medical notes.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Pregnant women.
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: See Ling Loy, PhD
role: Principal Investigator
affiliation: KK Women's and Children's Hospital
facility: 
country: Singapore
responsible party type: Sponsor
mesh term: Metabolic Diseases
sharing ipd: No