<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/NCT03828812</url>
  </required_header>
  <id_info>
    <org_study_id>YM104136E</org_study_id>
    <nct_id>NCT03828812</nct_id>
  </id_info>
  <brief_title>Temporal Patterns of Diet and the Changes in Body Composition and Blood Pressure</brief_title>
  <official_title>Temporal Patterns of Diet and the Changes in Body Composition and Blood Pressure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Yang Ming University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Yang Ming University</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>
      The study includes two parts: 1) an observational study examines the association of meal&#xD;
      frequency, meal timing, and meal regularity with short-term changes in blood pressure and&#xD;
      body composition; 2) a randomized controlled intervention examines the influence of&#xD;
      recommendation of increase breakfast frequency and decrease nighttime snacking on 1-year&#xD;
      changes in blood pressure and body composition.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2015</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">October 31, 2018</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>Body weight</measure>
    <time_frame>1 year</time_frame>
    <description>Body weight in kilogram</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Standing height</measure>
    <time_frame>1 year</time_frame>
    <description>Height in meters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body fat%</measure>
    <time_frame>1 year</time_frame>
    <description>Bioimpedance method (TANITA BC-418)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body mass index</measure>
    <time_frame>1 year</time_frame>
    <description>Weight and height will be combined to report BMI in kg/m^2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Systolic blood pressure</measure>
    <time_frame>1 year</time_frame>
    <description>Measured in mmHg (Microlife BP 3MS1-4K)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diastolic blood pressure</measure>
    <time_frame>1 year</time_frame>
    <description>Measured in mmHg (Microlife BP 3MS1-4K)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of breakfast per week</measure>
    <time_frame>1 year</time_frame>
    <description>Self-report food frequency questionnaire(0-7 days/week)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of nighttime snacking per week</measure>
    <time_frame>1 year</time_frame>
    <description>Self-report food frequency questionnaire(0-7 days/week)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Sleep quality score</measure>
    <time_frame>1 year</time_frame>
    <description>Pittsburgh Sleep Questionnaire(0-21 points): The higher scores, the worse sleep quality</description>
  </other_outcome>
  <other_outcome>
    <measure>Mood status</measure>
    <time_frame>1 year</time_frame>
    <description>Depression, Anxiety, Stress Scale (DASS): The higher scores, the worse moods</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">125</enrollment>
  <condition>Body Composition</condition>
  <condition>Blood Pressure</condition>
  <condition>Mealtimes</condition>
  <arm_group>
    <arm_group_label>Breakfast promotion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Receiving the recommendation of daily breakfast</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nighttime snack reduction</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Receiving the recommendation of reducing nighttime snack frequency</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Breakfast promotion + nighttime snack reduction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receiving the recommendation of daily breakfast + reducing nighttime snack frequency</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Breakfast promotion</intervention_name>
    <description>Recommendation of having breakfast daily</description>
    <arm_group_label>Breakfast promotion</arm_group_label>
    <arm_group_label>Breakfast promotion + nighttime snack reduction</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Nighttime snack reduction</intervention_name>
    <description>Recommendation of reducing frequency of nighttime snacking</description>
    <arm_group_label>Breakfast promotion + nighttime snack reduction</arm_group_label>
    <arm_group_label>Nighttime snack reduction</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Adult&#xD;
&#xD;
          -  Willing to participate&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Being pregnant&#xD;
&#xD;
          -  hemodialysis patients&#xD;
&#xD;
          -  clinical diagnosis of cardiovascular diseases&#xD;
&#xD;
          -  clinical diagnosis of cancer&#xD;
&#xD;
          -  clinical diagnosis of dementia&#xD;
&#xD;
          -  clinical diagnosis of eating disorders&#xD;
&#xD;
          -  having metal orthopedic implants&#xD;
&#xD;
          -  having pacemaker implanted&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hsin-Jen Chen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Yang Ming University</affiliation>
  </overall_official>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>June 23, 2020</last_update_submitted>
  <last_update_submitted_qc>June 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Yang Ming University</investigator_affiliation>
    <investigator_full_name>Hsin-Jen Chen</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03828812
org study id: YM104136E
nct id: NCT03828812
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The study includes two parts: 1) an observational study examines the association of meal
      frequency, meal timing, and meal regularity with short-term changes in blood pressure and
      body composition; 2) a randomized controlled intervention examines the influence of
      recommendation of increase breakfast frequency and decrease nighttime snacking on 1-year
      changes in blood pressure and body composition.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Body weight
time frame: 1 year
description: Body weight in kilogram
measure: Standing height
time frame: 1 year
description: Height in meters
measure: Body fat%
time frame: 1 year
description: Bioimpedance method (TANITA BC-418)
measure: Body mass index
time frame: 1 year
description: Weight and height will be combined to report BMI in kg/m^2
measure: Systolic blood pressure
time frame: 1 year
description: Measured in mmHg (Microlife BP 3MS1-4K)
measure: Diastolic blood pressure
time frame: 1 year
description: Measured in mmHg (Microlife BP 3MS1-4K)
measure: Frequency of breakfast per week
time frame: 1 year
description: Self-report food frequency questionnaire(0-7 days/week)
measure: Frequency of nighttime snacking per week
time frame: 1 year
description: Self-report food frequency questionnaire(0-7 days/week)
measure: Sleep quality score
time frame: 1 year
description: Pittsburgh Sleep Questionnaire(0-21 points): The higher scores, the worse sleep quality
measure: Mood status
time frame: 1 year
description: Depression, Anxiety, Stress Scale (DASS): The higher scores, the worse moods
arm group label: Breakfast promotion
arm group type: Active Comparator
description: Receiving the recommendation of daily breakfast
arm group label: Nighttime snack reduction
arm group type: Active Comparator
description: Receiving the recommendation of reducing nighttime snack frequency
arm group label: Breakfast promotion + nighttime snack reduction
arm group type: Experimental
description: Receiving the recommendation of daily breakfast + reducing nighttime snack frequency
intervention type: Behavioral
intervention name: Breakfast promotion
description: Recommendation of having breakfast daily
arm group label: Breakfast promotion
arm group label: Breakfast promotion + nighttime snack reduction
intervention type: Behavioral
intervention name: Nighttime snack reduction
description: Recommendation of reducing frequency of nighttime snacking
arm group label: Breakfast promotion + nighttime snack reduction
arm group label: Nighttime snack reduction
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hsin-Jen Chen, PhD
role: Principal Investigator
affiliation: National Yang Ming University
responsible party type: Principal Investigator
investigator affiliation: National Yang Ming University
investigator full name: Hsin-Jen Chen
investigator title: Assistant Professor
sharing ipd: Undecided