<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/NCT03803072</url>
  </required_header>
  <id_info>
    <org_study_id>2018/2271</org_study_id>
    <nct_id>NCT03803072</nct_id>
  </id_info>
  <brief_title>A Novel Diet Approach to Combat Gestational Diabetes</brief_title>
  <official_title>A Novel Diet Approach to Combat Gestational Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norwegian University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>St. Olavs Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Norwegian University of Science and Technology</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is an urgent need to implement novel diet approaches to combat the increasing rates of&#xD;
      gestational diabetes mellitus (GDM). The primary aim of this study is to establish the&#xD;
      feasibility of time-restricted eating in pregnancy, to prepare for future larger controlled&#xD;
      trials in this research project to determine the efficacy of time-restricted eating in women&#xD;
      at risk of GDM. Expectations:&#xD;
&#xD;
        1. Women who have an increased risk of GDM will be able to adhere to time reduced eating&#xD;
           during pregnancy.&#xD;
&#xD;
        2. Time reduced eating will improve short-term glycemic control in pregnancy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 18, 2019</start_date>
  <completion_date type="Actual">March 15, 2023</completion_date>
  <primary_completion_date type="Actual">March 13, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in average time-window for energy intake</measure>
    <time_frame>Change between baseline (pre-intervention) time-window for energy intake to average time-window for energy intake during the 5-week intervention period</time_frame>
    <description>Average daily time-window for energy intake will be registered through log books.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Weekly adherence rates for time restricted eating (TRE)</measure>
    <time_frame>Weekly measures throughout the 5 week period of TRE intervention</time_frame>
    <description>The number of days per week that the participants are able to adhere to TRE, as calculated as weekly average of days with a time-window ≤ 10 hours</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Perceived barriers to the protocol assessed with an unstructured interview</measure>
    <time_frame>Weekly phone calls to participants in TRE group during the 5-week intervention period and after 6 weeks</time_frame>
    <description>Participants will be asked about which barriers they perceived as challenging regarding keeping to a TRE schedule and if they have strategies to overcome these barriers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective appetite sensations assessed by Visual Analogue Scales</measure>
    <time_frame>Once weekly throughout 6 weeks, on a weekday.</time_frame>
    <description>Paper line scales 100 mm on scales for Hunger (&quot;How hungry are you&quot;: From &quot;Not at all&quot; = 0 on the scale to &quot;Extremely. As hungry as I have ever felt&quot; =100 on the scale, Fullness (From &quot;Not at all&quot; = 0 on the scale to &quot;Extremely. As full as I have ever felt&quot; = 100 on the scale, Satiety (&quot;How satiated are you&quot; From &quot;Not at all&quot; =0 on the scale to &quot;Extremely&quot; =100 on the scale, Desire to eat (&quot;How strong is your desire to eat&quot; From &quot;Very weak. Extremely low&quot; = 0 on the scale to &quot;Very strong. Extremely high&quot; = 100 on the scale and Prospective consumption (quantity) (&quot;How much do you think you could (or would want to) eat right now?&quot; From &quot;Nothing at all&quot; = 0 on the scale to &quot;A very large amount&quot; = 100 on the scale. Scales will be filled in in the morning, before dinner and at bedtime.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change between baseline and post-intervention in fasting glucose</measure>
    <time_frame>6 weeks</time_frame>
    <description>Post-intervention fasting glucose minus pre-intervention fasting glucose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change between baseline and post-intervention in postprandial glucose</measure>
    <time_frame>6 weeks</time_frame>
    <description>Blood glucose levels 120 minutes after ingestion of 75 g glucose (oral glucose tolerance test)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change between baseline and post-intervention in fasting insulin</measure>
    <time_frame>6 weeks</time_frame>
    <description>Circulating insulin levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change between baseline and post-intervention in postprandial insulin</measure>
    <time_frame>6 weeks</time_frame>
    <description>Circulating insulin levels 120 minutes after ingestion of 75 g glucose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change between baseline and post-intervention blood pressure</measure>
    <time_frame>6 weeks</time_frame>
    <description>Diastolic and systolic blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change between baseline and post-intervention body mass</measure>
    <time_frame>6 weeks</time_frame>
    <description>Body mass in kg.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in total cholesterol</measure>
    <time_frame>6 weeks</time_frame>
    <description>Total cholesterol measured in blood</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in triglycerides</measure>
    <time_frame>6 weeks</time_frame>
    <description>Triglycerides measured in blood</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HDL cholesterol</measure>
    <time_frame>6 weeks</time_frame>
    <description>HDL cholesterol measured in blood</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in LDL cholesterol</measure>
    <time_frame>6 weeks</time_frame>
    <description>LDL cholesterol measured in blood</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HbA1c</measure>
    <time_frame>6 weeks</time_frame>
    <description>HbA1c measured in blood</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Continuous glucose monitoring</measure>
    <time_frame>6 weeks</time_frame>
    <description>Interstitial glucose measurements</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change between baseline and post-intervention fat mass</measure>
    <time_frame>6 weeks</time_frame>
    <description>Fat mass in kg and percent of body mass</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change between baseline and post-intervention muscle mass</measure>
    <time_frame>6 weeks</time_frame>
    <description>Muscle mass in kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change between baseline and post-intervention visceral fat area</measure>
    <time_frame>6 weeks</time_frame>
    <description>Visceral fat area in squared cm.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Diabetes, Gestational</condition>
  <arm_group>
    <arm_group_label>Time restricted eating (TRE)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>prolonging the duration of fasting between the last evening meal and the first meal of the next day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard care. Will receive a booklet about physical activity recommendations and healthy eating in pregnancy</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>time restricted eating (TRE)</intervention_name>
    <description>Participants will attend a face-to-face meeting with the researchers at the last day of the first week of data collection (habitual diet and physical activity period) where they will be counselled to consume all food and fluid within a 8-10 h time window of their choice starting no later than 09.00 h for five weeks. During the intervention period, they will be counselled by weekly phone calls to provide encouragement, support and monitoring to improve adherence to the TRE window.</description>
    <arm_group_label>Time restricted eating (TRE)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  carrying one singleton live foetus&#xD;
&#xD;
          -  in pregnancy week 12-30&#xD;
&#xD;
          -  having at least one risk factor for gestational diabetes mellitus (GDM) according to&#xD;
             Norwegian guidelines for GDM screening: pre-pregnancy BMI &gt; 25 kg/m2, GDM in previous&#xD;
             pregnancy, primiparae aged &gt; 25 years, first degree relative with diabetes mellitus,&#xD;
             Asian or African ethnicity, previous delivery of new-born &gt; 4.5 kg&#xD;
&#xD;
          -  understand written and spoken Norwegian language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  habitual eating window &lt; 12 hours&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Øystein Risa, phd</last_name>
    <role>Study Director</role>
    <affiliation>Department of circulation and medical imaging, NTNU</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St Olavs Hospital</name>
      <address>
        <city>Trondheim</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>March 2023</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>March 15, 2023</last_update_submitted>
  <last_update_submitted_qc>March 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Exercise therapy</keyword>
  <keyword>Diet</keyword>
  <keyword>Prevention and control</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes, Gestational</mesh_term>
    <mesh_term>Diabetes Mellitus</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/NCT03803072
org study id: 2018/2271
nct id: NCT03803072
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
There is an urgent need to implement novel diet approaches to combat the increasing rates of
      gestational diabetes mellitus (GDM). The primary aim of this study is to establish the
      feasibility of time-restricted eating in pregnancy, to prepare for future larger controlled
      trials in this research project to determine the efficacy of time-restricted eating in women
      at risk of GDM. Expectations:

        1. Women who have an increased risk of GDM will be able to adhere to time reduced eating
           during pregnancy.

        2. Time reduced eating will improve short-term glycemic control in pregnancy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in average time-window for energy intake
time frame: Change between baseline (pre-intervention) time-window for energy intake to average time-window for energy intake during the 5-week intervention period
description: Average daily time-window for energy intake will be registered through log books.
measure: Weekly adherence rates for time restricted eating (TRE)
time frame: Weekly measures throughout the 5 week period of TRE intervention
description: The number of days per week that the participants are able to adhere to TRE, as calculated as weekly average of days with a time-window ≤ 10 hours
measure: Perceived barriers to the protocol assessed with an unstructured interview
time frame: Weekly phone calls to participants in TRE group during the 5-week intervention period and after 6 weeks
description: Participants will be asked about which barriers they perceived as challenging regarding keeping to a TRE schedule and if they have strategies to overcome these barriers.
measure: Subjective appetite sensations assessed by Visual Analogue Scales
time frame: Once weekly throughout 6 weeks, on a weekday.
description: Paper line scales 100 mm on scales for Hunger ("How hungry are you": From "Not at all" = 0 on the scale to "Extremely. As hungry as I have ever felt" =100 on the scale, Fullness (From "Not at all" = 0 on the scale to "Extremely. As full as I have ever felt" = 100 on the scale, Satiety ("How satiated are you" From "Not at all" =0 on the scale to "Extremely" =100 on the scale, Desire to eat ("How strong is your desire to eat" From "Very weak. Extremely low" = 0 on the scale to "Very strong. Extremely high" = 100 on the scale and Prospective consumption (quantity) ("How much do you think you could (or would want to) eat right now?" From "Nothing at all" = 0 on the scale to "A very large amount" = 100 on the scale. Scales will be filled in in the morning, before dinner and at bedtime.
measure: Change between baseline and post-intervention in fasting glucose
time frame: 6 weeks
description: Post-intervention fasting glucose minus pre-intervention fasting glucose
measure: Change between baseline and post-intervention in postprandial glucose
time frame: 6 weeks
description: Blood glucose levels 120 minutes after ingestion of 75 g glucose (oral glucose tolerance test)
measure: Change between baseline and post-intervention in fasting insulin
time frame: 6 weeks
description: Circulating insulin levels
measure: Change between baseline and post-intervention in postprandial insulin
time frame: 6 weeks
description: Circulating insulin levels 120 minutes after ingestion of 75 g glucose.
measure: Change between baseline and post-intervention blood pressure
time frame: 6 weeks
description: Diastolic and systolic blood pressure
measure: Change between baseline and post-intervention body mass
time frame: 6 weeks
description: Body mass in kg.
measure: Change in total cholesterol
time frame: 6 weeks
description: Total cholesterol measured in blood
measure: Change in triglycerides
time frame: 6 weeks
description: Triglycerides measured in blood
measure: Change in HDL cholesterol
time frame: 6 weeks
description: HDL cholesterol measured in blood
measure: Change in LDL cholesterol
time frame: 6 weeks
description: LDL cholesterol measured in blood
measure: Change in HbA1c
time frame: 6 weeks
description: HbA1c measured in blood
measure: Continuous glucose monitoring
time frame: 6 weeks
description: Interstitial glucose measurements
measure: Change between baseline and post-intervention fat mass
time frame: 6 weeks
description: Fat mass in kg and percent of body mass
measure: Change between baseline and post-intervention muscle mass
time frame: 6 weeks
description: Muscle mass in kg
measure: Change between baseline and post-intervention visceral fat area
time frame: 6 weeks
description: Visceral fat area in squared cm.
arm group label: Time restricted eating (TRE)
arm group type: Experimental
description: prolonging the duration of fasting between the last evening meal and the first meal of the next day
arm group label: control
arm group type: No Intervention
description: Standard care. Will receive a booklet about physical activity recommendations and healthy eating in pregnancy
intervention type: Behavioral
intervention name: time restricted eating (TRE)
description: Participants will attend a face-to-face meeting with the researchers at the last day of the first week of data collection (habitual diet and physical activity period) where they will be counselled to consume all food and fluid within a 8-10 h time window of their choice starting no later than 09.00 h for five weeks. During the intervention period, they will be counselled by weekly phone calls to provide encouragement, support and monitoring to improve adherence to the TRE window.
arm group label: Time restricted eating (TRE)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Øystein Risa, phd
role: Study Director
affiliation: Department of circulation and medical imaging, NTNU
facility: 
country: Norway
responsible party type: Sponsor
mesh term: Diabetes, Gestational
mesh term: Diabetes Mellitus
sharing ipd: No