<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/NCT02249611</url>
  </required_header>
  <id_info>
    <org_study_id>NSC 102-2314-B-006 -004 -MY2</org_study_id>
    <nct_id>NCT02249611</nct_id>
  </id_info>
  <brief_title>Application of MT in Subjects With Overweight/Metabolic Abnormality---RCT</brief_title>
  <official_title>Application of Mobile Physical Activity Promotion Tool in Subjects With Overweight/Metabolic Abnormality---randomised Control Trial of Efficacy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cheng-Kung University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Cheng-Kung University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The subjects will be recruited from July 1, 2014 until the participants enough. Interviewing&#xD;
      for research purpose explication and informed consent will be collected before the study is&#xD;
      executed. In the first 3 months, subjects of group A will use the mobile physical activity&#xD;
      promotion tool (MT), receive professional personal counseling, and individualized reminding&#xD;
      message (intervention) once a week. In the last 3 months, they will receive standard care&#xD;
      (control) which is in support of behavioral and educational recommendations in diet control,&#xD;
      increased physical activity, less smoking and drinking, deal with pressure, and regular&#xD;
      health examination (based on the booklet of metabolic syndrome prevention which is edited by&#xD;
      Health Promotion Administration, Ministry of Health and Welfare, Taiwan). Subjects of group B&#xD;
      will begin with an initial 3 months control period of standard care only, and the&#xD;
      intervention program will be conducted for last 3 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      RCT with a crossover design will present in this study and take place during a 6-month&#xD;
      period. Participants will be randomly allocated to two groups applying a randomized block&#xD;
      technique and matching with different age and sex. The subjects will be recruited from July&#xD;
      1, 2014 until the participants enough. Interviewing for research purpose explication and&#xD;
      informed consent will be collected before the study is executed. Physical activity amount&#xD;
      (including mild, moderate and vigorous physical activity), cardio-respiratory fitness&#xD;
      (including three minutes of stair-climbing and a minute sit-up), physiological indicators&#xD;
      (blood pressure, weight, waist circumference, and body composition), metabolic and&#xD;
      biochemical indicators (including glucose level, lipid profile etc.), and the questionnaire&#xD;
      of psychological health and quality of life will be recorded at the first visit. And then&#xD;
      subjects will be followed after 12 weeks and 24 weeks. Additionally, diet record compliance&#xD;
      will be recorded for 12 weeks.&#xD;
&#xD;
      In the first 3 months, subjects of group A will use the mobile physical activity promotion&#xD;
      tool (MT), receive professional personal counseling, and individualized reminding message&#xD;
      (intervention) once a week. In the last 3 months, they will receive standard care (control)&#xD;
      which is in support of behavioral and educational recommendations in diet control, increased&#xD;
      physical activity, less smoking and drinking, deal with pressure, and regular health&#xD;
      examination (based on the booklet of metabolic syndrome prevention which is edited by Health&#xD;
      Promotion Administration, Ministry of Health and Welfare, Taiwan). Subjects of group B will&#xD;
      begin with an initial 3 months control period of standard care only, and the intervention&#xD;
      program will be conducted for last 3 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Increase physical activity</measure>
    <time_frame>6 months</time_frame>
    <description>Measurement by mobile activity sensor system and the questionnaire of International Physical Activity Questionnaires (IPAQ) short form, and evaluate by counts/minute</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Increase physical fitness</measure>
    <time_frame>6 months</time_frame>
    <description>Measurement by examination of physical fitness.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>executive performance of participants</measure>
    <time_frame>6 months</time_frame>
    <description>physiological indicators and other metabolic and biochemical indicators, the questionnaire of psychological health, and WHO health related quality of life to evaluate executive performance of participants</description>
  </other_outcome>
  <other_outcome>
    <measure>diet record compliance</measure>
    <time_frame>3 months</time_frame>
    <description>Measurement by records of web survey</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Overweight</condition>
  <condition>Metabolic Abnormality</condition>
  <arm_group>
    <arm_group_label>MT and life counseling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>To improve physical activity, body composition, physiological parameters and quality of life by using MT (mobile physical activity promotion tool) and lifestyle counseling in diet control, increased physical activity, less smoking and drinking, deal with pressure, and regular health examination will be conducted for 3 months in intervention periods.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Lifestyle counseling in diet control, increased physical activity, less smoking and drinking, deal with pressure, and regular health examination based on the booklet of metabolic syndrome prevention which is edited by Health Promotion Administration, Ministry of Health and Welfare in Taiwan only once in this period (3 months).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mobile physical activity promotion tool</intervention_name>
    <description>Mobile activity sensor&#xD;
Smartphone with APP&#xD;
Interactional webpage of internet&#xD;
Evidence based health information&#xD;
Individualized reminding messages according to the data from activity recording system&#xD;
Personal counseling from professional personnel</description>
    <arm_group_label>MT and life counseling</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard care</intervention_name>
    <description>Counseling on lifestyles with health education material</description>
    <arm_group_label>Standard care</arm_group_label>
    <other_name>Counseling on lifestyles</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Body Mass Index (BMI) ≥ 24kgw/m2,&#xD;
&#xD;
          -  Waist circumference, male≥ 90cm, female≥ 80cm,&#xD;
&#xD;
          -  Systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85mmHg,&#xD;
&#xD;
          -  Fast plasma glucose ≥ 100mg/dL,&#xD;
&#xD;
          -  High-density lipoprotein cholesterol (HDL-C): male&lt;40 mg/dL, female&lt;50 mg/dL,&#xD;
&#xD;
          -  Triglyceride ≥ 150 mg/dL.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  can't use computer, internet, and smartphone,&#xD;
&#xD;
          -  is pregnant, within 6 months after delivery and on breastfeeding,&#xD;
&#xD;
          -  is exercise-intolerance.&#xD;
&#xD;
          -  use the relevant drugs for weight reduction, cardiovascular diseases, hypertension,&#xD;
             diabetes and dyslipidemia.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yi Ching Yang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Family Medicine, College of Medicine, National Cheng Kung University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Cheng Kung University</name>
      <address>
        <city>Tainan</city>
        <zip>701</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>October 7, 2015</last_update_submitted>
  <last_update_submitted_qc>October 7, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 9, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Cheng-Kung University Hospital</investigator_affiliation>
    <investigator_full_name>Yi-Ching Yang</investigator_full_name>
    <investigator_title>MD, professor</investigator_title>
  </responsible_party>
  <keyword>Physical activity</keyword>
  <keyword>mobile activity sensor and feedback system</keyword>
  <keyword>self-management of health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Congenital Abnormalities</mesh_term>
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <!-- 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/NCT02249611
org study id: NSC 102-2314-B-006 -004 -MY2
nct id: NCT02249611
lead sponsor: 
has dmc: Yes
The subjects will be recruited from July 1, 2014 until the participants enough. Interviewing
      for research purpose explication and informed consent will be collected before the study is
      executed. In the first 3 months, subjects of group A will use the mobile physical activity
      promotion tool (MT), receive professional personal counseling, and individualized reminding
      message (intervention) once a week. In the last 3 months, they will receive standard care
      (control) which is in support of behavioral and educational recommendations in diet control,
      increased physical activity, less smoking and drinking, deal with pressure, and regular
      health examination (based on the booklet of metabolic syndrome prevention which is edited by
      Health Promotion Administration, Ministry of Health and Welfare, Taiwan). Subjects of group B
      will begin with an initial 3 months control period of standard care only, and the
      intervention program will be conducted for last 3 months.
RCT with a crossover design will present in this study and take place during a 6-month
      period. Participants will be randomly allocated to two groups applying a randomized block
      technique and matching with different age and sex. The subjects will be recruited from July
      1, 2014 until the participants enough. Interviewing for research purpose explication and
      informed consent will be collected before the study is executed. Physical activity amount
      (including mild, moderate and vigorous physical activity), cardio-respiratory fitness
      (including three minutes of stair-climbing and a minute sit-up), physiological indicators
      (blood pressure, weight, waist circumference, and body composition), metabolic and
      biochemical indicators (including glucose level, lipid profile etc.), and the questionnaire
      of psychological health and quality of life will be recorded at the first visit. And then
      subjects will be followed after 12 weeks and 24 weeks. Additionally, diet record compliance
      will be recorded for 12 weeks.

      In the first 3 months, subjects of group A will use the mobile physical activity promotion
      tool (MT), receive professional personal counseling, and individualized reminding message
      (intervention) once a week. In the last 3 months, they will receive standard care (control)
      which is in support of behavioral and educational recommendations in diet control, increased
      physical activity, less smoking and drinking, deal with pressure, and regular health
      examination (based on the booklet of metabolic syndrome prevention which is edited by Health
      Promotion Administration, Ministry of Health and Welfare, Taiwan). Subjects of group B will
      begin with an initial 3 months control period of standard care only, and the intervention
      program will be conducted for last 3 months.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Increase physical activity
time frame: 6 months
description: Measurement by mobile activity sensor system and the questionnaire of International Physical Activity Questionnaires (IPAQ) short form, and evaluate by counts/minute
measure: Increase physical fitness
time frame: 6 months
description: Measurement by examination of physical fitness.
measure: executive performance of participants
time frame: 6 months
description: physiological indicators and other metabolic and biochemical indicators, the questionnaire of psychological health, and WHO health related quality of life to evaluate executive performance of participants
measure: diet record compliance
time frame: 3 months
description: Measurement by records of web survey
arm group label: MT and life counseling
arm group type: Experimental
description: To improve physical activity, body composition, physiological parameters and quality of life by using MT (mobile physical activity promotion tool) and lifestyle counseling in diet control, increased physical activity, less smoking and drinking, deal with pressure, and regular health examination will be conducted for 3 months in intervention periods.
arm group label: Standard care
arm group type: Active Comparator
description: Lifestyle counseling in diet control, increased physical activity, less smoking and drinking, deal with pressure, and regular health examination based on the booklet of metabolic syndrome prevention which is edited by Health Promotion Administration, Ministry of Health and Welfare in Taiwan only once in this period (3 months).
intervention type: Device
intervention name: Mobile physical activity promotion tool
description: Mobile activity sensor
Smartphone with APP
Interactional webpage of internet
Evidence based health information
Individualized reminding messages according to the data from activity recording system
Personal counseling from professional personnel
arm group label: MT and life counseling
intervention type: Other
intervention name: Standard care
description: Counseling on lifestyles with health education material
arm group label: Standard care
other name: Counseling on lifestyles
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: No
last name: Yi Ching Yang, MD
role: Principal Investigator
affiliation: Department of Family Medicine, College of Medicine, National Cheng Kung University
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: National Cheng-Kung University Hospital
investigator full name: Yi-Ching Yang
investigator title: MD, professor
mesh term: Congenital Abnormalities
mesh term: Overweight