xml: <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/NCT06022549</url>
    </required_header>
    <id_info>
      <org_study_id>202301HM003</org_study_id>
      <nct_id>NCT06022549</nct_id>
    </id_info>
    <brief_title>Effects of mHealth Message on Metabolic Syndrome and Bone Loss of HIV Infected Persons in Taiwan</brief_title>
    <official_title>Effects of mHealth Message on Metabolic Syndrome and Bone Loss of HIV Infected Persons in Taiwan</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Taiwan University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Taiwan 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>
        With improved AIDS treatment leading to extended survival, HIV-infected individuals face a&#xD;
        higher metabolic syndrome incidence. This study aims to determine the prevalence of Non-AIDS&#xD;
        related Comorbidities (NARC) in HIV-infected individuals. Using purposive and snowball&#xD;
        sampling, the cross-sectional survey targets 400 HIV-infected individuals aged 40 and above.&#xD;
        Data collection includes demographics, physical activity, nutrition, depression, and&#xD;
        physiological measurements. Analyzing the data through statistical tests and structural&#xD;
        equation modeling, the study aims to provide precise care recommendations for preventive&#xD;
        medicine and healthy aging in this population.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        With the success of treatment, the survival period of Acquired immunodeficiency syndrome&#xD;
        (AIDS) patients is prolonged. Compared with non-HIV-infected persons of the same age,&#xD;
        HIV-infected persons have a relatively higher incidence of metabolic syndrome (MS). The main&#xD;
        purpose of this study is to estimate the prevalence of common Non-AIDS related Comorbidities&#xD;
        (NARC) among HIV-infected persons This study is a cross-sectional survey, purposive and&#xD;
        snowball sampling will be applied. The recruitment information is released through channels&#xD;
        such as AIDS case managers, AIDS non-government organizations, and social networks of&#xD;
        HIV-infected people all around Taiwan. The expected sample size is 400 HIV-infected persons&#xD;
        over the age of 40, after signing a written consent form, a test will be conducted, including&#xD;
        the collection of demographic data, questionnaire data collection with physical activity&#xD;
        scale, mini-nutrition assessment scale, and depression self-test scale, and measurement of&#xD;
        physiological parameters using instruments including a gripper, body composition meter,&#xD;
        sphygmomanometer, blood glucose, and lipid monitor, tape measure. The Chi-square test and&#xD;
        independent sample T-test are used to compare the differences in the categorical and&#xD;
        continuous data of each variable, and the structural equation model is used to conduct path&#xD;
        analysis of the research framework. The research results can be used as precise care&#xD;
        recommendations for the development of preventive medicine and healthy aging for HIV-infected&#xD;
        persons.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Mini Nutritional Assessment</measure>
      <time_frame>1 year</time_frame>
      <description>The points of this assessment is from 0 to 30. The points over 23.5 mean normal nutritional status, 17~23.5 points mean at risk of malnutrition, less 7 points mean malnourished.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>International Physical Activity Questionnaire</measure>
      <time_frame>1 year</time_frame>
      <description>It is a self-administered survey used to assess an individual's physical activity levels. It aims to measure the amount of physical activity a person engages in across various domains of life, including work, transportation, household chores, and leisure time.&#xD;
  The IPAQ typically asks participants about the duration and frequency of their physical activities in the past seven days. The MET-minutes per week score is calculated by multiplying the minutes spent in each activity intensity level by the MET value associated with that activity and then summing these values across all activities.&#xD;
  The interpretation of MET-minutes per week is as follows:&#xD;
  Low activity: Below 600 MET-minutes per week Moderate activity: 600 to 3000 MET-minutes per week High activity: More than 3000 MET-minutes per week</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient Health Questionnaire-9</measure>
      <time_frame>1 year</time_frame>
      <description>The Patient Health Questionnaire-9 (PHQ-9) is a self-report assessment tool commonly used to screen and measure the severity of depression symptoms in individuals. It consists of 9 items or questions, each assessing different aspects of depression such as mood, energy level, and concentration.&#xD;
  The PHQ-9 scores each item on a scale from 0 (not at all) to 3 (nearly every day), with a maximum total score of 27. Higher scores on the PHQ-9 indicate more severe depressive symptoms, while lower scores suggest milder or no depressive symptoms.</description>
    </primary_outcome>
    <enrollment type="Anticipated">400</enrollment>
    <condition>Hiv</condition>
    <eligibility>
      <study_pop>
        <textblock>
          HIV-infected persons over the age of 40&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  HIV-infected persons over the age of 40&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          -&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>PIAO-YI CHIOU, doctoral</last_name>
      <role>Study Director</role>
      <affiliation>National Taiwan University, College of Medicine, School of Nursing</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>PIAO-YI CHIOU, doctoral</last_name>
      <phone>+886-2-23123456</phone>
      <phone_ext>88427</phone_ext>
      <email>piaoyi@ntu.edu.tw</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>National Taiwan University</investigator_affiliation>
      <investigator_full_name>Piao-Yi Chiou</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>HIV-infected persons</keyword>
    <keyword>Metabolic syndrome</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Metabolic Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06022549
  org study id: 202301HM003
  nct id: NCT06022549
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  With improved AIDS treatment leading to extended survival, HIV-infected individuals face a
        higher metabolic syndrome incidence. This study aims to determine the prevalence of Non-AIDS
        related Comorbidities (NARC) in HIV-infected individuals. Using purposive and snowball
        sampling, the cross-sectional survey targets 400 HIV-infected individuals aged 40 and above.
        Data collection includes demographics, physical activity, nutrition, depression, and
        physiological measurements. Analyzing the data through statistical tests and structural
        equation modeling, the study aims to provide precise care recommendations for preventive
        medicine and healthy aging in this population.
  With the success of treatment, the survival period of Acquired immunodeficiency syndrome
        (AIDS) patients is prolonged. Compared with non-HIV-infected persons of the same age,
        HIV-infected persons have a relatively higher incidence of metabolic syndrome (MS). The main
        purpose of this study is to estimate the prevalence of common Non-AIDS related Comorbidities
        (NARC) among HIV-infected persons This study is a cross-sectional survey, purposive and
        snowball sampling will be applied. The recruitment information is released through channels
        such as AIDS case managers, AIDS non-government organizations, and social networks of
        HIV-infected people all around Taiwan. The expected sample size is 400 HIV-infected persons
        over the age of 40, after signing a written consent form, a test will be conducted, including
        the collection of demographic data, questionnaire data collection with physical activity
        scale, mini-nutrition assessment scale, and depression self-test scale, and measurement of
        physiological parameters using instruments including a gripper, body composition meter,
        sphygmomanometer, blood glucose, and lipid monitor, tape measure. The Chi-square test and
        independent sample T-test are used to compare the differences in the categorical and
        continuous data of each variable, and the structural equation model is used to conduct path
        analysis of the research framework. The research results can be used as precise care
        recommendations for the development of preventive medicine and healthy aging for HIV-infected
        persons.
  observational model: Case-Only
  time perspective: Cross-Sectional
  measure: Mini Nutritional Assessment
  time frame: 1 year
  description: The points of this assessment is from 0 to 30. The points over 23.5 mean normal nutritional status, 17~23.5 points mean at risk of malnutrition, less 7 points mean malnourished.
  measure: International Physical Activity Questionnaire
  time frame: 1 year
  description: It is a self-administered survey used to assess an individual's physical activity levels. It aims to measure the amount of physical activity a person engages in across various domains of life, including work, transportation, household chores, and leisure time.
  The IPAQ typically asks participants about the duration and frequency of their physical activities in the past seven days. The MET-minutes per week score is calculated by multiplying the minutes spent in each activity intensity level by the MET value associated with that activity and then summing these values across all activities.
  The interpretation of MET-minutes per week is as follows:
  Low activity: Below 600 MET-minutes per week Moderate activity: 600 to 3000 MET-minutes per week High activity: More than 3000 MET-minutes per week
  measure: Patient Health Questionnaire-9
  time frame: 1 year
  description: The Patient Health Questionnaire-9 (PHQ-9) is a self-report assessment tool commonly used to screen and measure the severity of depression symptoms in individuals. It consists of 9 items or questions, each assessing different aspects of depression such as mood, energy level, and concentration.
  The PHQ-9 scores each item on a scale from 0 (not at all) to 3 (nearly every day), with a maximum total score of 27. Higher scores on the PHQ-9 indicate more severe depressive symptoms, while lower scores suggest milder or no depressive symptoms.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: N/A
  healthy volunteers: No
  last name: PIAO-YI CHIOU, doctoral
  role: Study Director
  affiliation: National Taiwan University, College of Medicine, School of Nursing
  last name: PIAO-YI CHIOU, doctoral
  phone: +886-2-23123456
  phone ext: 88427
  email: piaoyi@ntu.edu.tw
  responsible party type: Principal Investigator
  investigator affiliation: National Taiwan University
  investigator full name: Piao-Yi Chiou
  investigator title: Associate Professor
  mesh term: Metabolic Syndrome
  sharing ipd: Undecided