<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/NCT03261895</url>
  </required_header>
  <id_info>
    <org_study_id>NIHaW</org_study_id>
    <nct_id>NCT03261895</nct_id>
  </id_info>
  <brief_title>Effectiveness of a Nurse-led Integrative Health and Wellness Programme Among Newly Diagnosed Type 2 Diabetes Patients</brief_title>
  <acronym>NIHaW</acronym>
  <official_title>Effectiveness of a Nurse-led Integrative Health and Wellness (NIHaW) Programme on Behavioural, Psychosocial and Biomedical Outcomes Among Individuals With Newly Diagnosed Type 2 Diabetes: A Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</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 randomized controlled trial aims to investigate the effectiveness of an integrative&#xD;
      medicine (traditional Chinese medicine and western medicine) based structured education&#xD;
      programme for newly diagnosed type 2 diabetes patients. The theoretical frame of this study&#xD;
      is based on the health belief model and self efficacy theory. The hypotheses of this study&#xD;
      are: 1) Participants in the intervention group will have higher level of self-management&#xD;
      behaviour after intervention compared to participants in the control group; 2) Participants&#xD;
      in the intervention group will have better diabetes knowledge after intervention compared to&#xD;
      participants in the control group; 3) Participants in the intervention group will have higher&#xD;
      level of self-efficacy after intervention compared to participants in the control group; 4)&#xD;
      Participants in the intervention group will be less depressed after intervention compared to&#xD;
      participants in the control group; 5) Participants in the intervention group will have better&#xD;
      QOL after intervention compared to participants in the control group; 6) Participants in the&#xD;
      intervention group will gain greater reduction in HbA1c after intervention compared to&#xD;
      participants in the control group; 7) Participants in the intervention group will gain&#xD;
      greater reduction in fasting blood glucose after intervention compared to participants in the&#xD;
      control group; 8) Participants in the intervention group will gain greater reduction in BP&#xD;
      after intervention compared to participants in the control group; 9) Participants in the&#xD;
      intervention group will gain greater reduction in BMI after intervention compared to&#xD;
      participants in the control group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 4, 2017</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</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>Supportive Care</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Self-management</measure>
    <time_frame>Baseline (T0)</time_frame>
    <description>self-management refers to the efforts patients actively take to appropriately manage their daily life in order to gain optimal disease control, health status, and quality of life. Self-management was measured using the Summary of Diabetes Self-Care Activities (SDSCA) in this study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-management</measure>
    <time_frame>Immediately post-intervention (T1)</time_frame>
    <description>self-management refers to the efforts patients actively take to appropriately manage their daily life in order to gain optimal disease control, health status, and quality of life. Self-management was measured using the Summary of Diabetes Self-Care Activities (SDSCA) in this study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-management</measure>
    <time_frame>Three months post-intervention (T2)</time_frame>
    <description>self-management refers to the efforts patients actively take to appropriately manage their daily life in order to gain optimal disease control, health status, and quality of life. Self-management was measured using the Summary of Diabetes Self-Care Activities (SDSCA) in this study.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">128</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nurse-led Integrative health and wellness programme</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>usual diabetes care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Nurse-led Integrative health and wellness programme</intervention_name>
    <description>Participants in the intervention group will go through a eight-session structured education programme. The education programme was designed by incorporating the evidences of diabetes care from the western medicine and the philosophy of traditional Chinese medicine.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  individuals diagnosed with type 2 diabetes in the preceding six months&#xD;
&#xD;
          -  individuals aged ≥ 18 years&#xD;
&#xD;
          -  individuals who were permanent residents of Xi'an City, China&#xD;
&#xD;
          -  individuals without mental disorders&#xD;
&#xD;
          -  individuals who were voluntary to participate in the study&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  individuals with a terminal illness&#xD;
&#xD;
          -  individuals who were physically disabled&#xD;
&#xD;
          -  individuals who were taking part in other studies&#xD;
&#xD;
          -  individuals with aural or visual problems&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xingfeng YU</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Xi'an Jiaotong University</name>
      <address>
        <city>Xi'an</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Xi'an Jiaotong University</name>
      <address>
        <city>Xi'an</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Shaanxi Provincial People's Hospital</name>
      <address>
        <city>Xi'an</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xi'an Central Hospital</name>
      <address>
        <city>Xi'an</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>July 18, 2018</last_update_submitted>
  <last_update_submitted_qc>July 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>YU Xingfeng</investigator_full_name>
    <investigator_title>Graduate Assistant</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</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/NCT03261895
org study id: NIHaW
nct id: NCT03261895
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This randomized controlled trial aims to investigate the effectiveness of an integrative
      medicine (traditional Chinese medicine and western medicine) based structured education
      programme for newly diagnosed type 2 diabetes patients. The theoretical frame of this study
      is based on the health belief model and self efficacy theory. The hypotheses of this study
      are: 1) Participants in the intervention group will have higher level of self-management
      behaviour after intervention compared to participants in the control group; 2) Participants
      in the intervention group will have better diabetes knowledge after intervention compared to
      participants in the control group; 3) Participants in the intervention group will have higher
      level of self-efficacy after intervention compared to participants in the control group; 4)
      Participants in the intervention group will be less depressed after intervention compared to
      participants in the control group; 5) Participants in the intervention group will have better
      QOL after intervention compared to participants in the control group; 6) Participants in the
      intervention group will gain greater reduction in HbA1c after intervention compared to
      participants in the control group; 7) Participants in the intervention group will gain
      greater reduction in fasting blood glucose after intervention compared to participants in the
      control group; 8) Participants in the intervention group will gain greater reduction in BP
      after intervention compared to participants in the control group; 9) Participants in the
      intervention group will gain greater reduction in BMI after intervention compared to
      participants in the control group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Investigator, Outcomes Assessor)
measure: Self-management
time frame: Baseline (T0)
description: self-management refers to the efforts patients actively take to appropriately manage their daily life in order to gain optimal disease control, health status, and quality of life. Self-management was measured using the Summary of Diabetes Self-Care Activities (SDSCA) in this study.
measure: Self-management
time frame: Immediately post-intervention (T1)
description: self-management refers to the efforts patients actively take to appropriately manage their daily life in order to gain optimal disease control, health status, and quality of life. Self-management was measured using the Summary of Diabetes Self-Care Activities (SDSCA) in this study.
measure: Self-management
time frame: Three months post-intervention (T2)
description: self-management refers to the efforts patients actively take to appropriately manage their daily life in order to gain optimal disease control, health status, and quality of life. Self-management was measured using the Summary of Diabetes Self-Care Activities (SDSCA) in this study.
arm group label: Intervention group
arm group type: Experimental
description: Nurse-led Integrative health and wellness programme
arm group label: control group
arm group type: No Intervention
description: usual diabetes care
intervention type: Behavioral
intervention name: Nurse-led Integrative health and wellness programme
description: Participants in the intervention group will go through a eight-session structured education programme. The education programme was designed by incorporating the evidences of diabetes care from the western medicine and the philosophy of traditional Chinese medicine.
arm group label: Intervention group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Xingfeng YU
role: Principal Investigator
affiliation: Chinese University of Hong Kong
facility: 
facility: 
facility: 
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: YU Xingfeng
investigator title: Graduate Assistant
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2