<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/NCT03821220</url>
  </required_header>
  <id_info>
    <org_study_id>0201-17-COM2</org_study_id>
    <nct_id>NCT03821220</nct_id>
  </id_info>
  <brief_title>Improving Physical Activity Levels in the Arabic- Speaking Residents of East Jerusalem With Prediabetes</brief_title>
  <official_title>Improving Physical Activity Levels in the Arabic- Speaking Residents of East Jerusalem With Prediabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clalit Health Services</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hebrew University of Jerusalem</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Clalit Health Services</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 three-arm clinical trial aims to improve levels of physical activity among Arabic-&#xD;
      speaking residents of East Jerusalem with prediabetes. Levels of daily physical activity&#xD;
      (assessed through activity trackers), dietary habits and self-assessed health will be&#xD;
      compared between patients that receive only the activity tracker and written information&#xD;
      (group A), receive the activity tracker, written information and a personalized physical&#xD;
      activity prescription (group B), and those that receive in addition also intensive follow-up&#xD;
      with motivational interview by physician assistants and a dietitian (group C)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a three-arm clinical trial studying the effect of providing activity trackers with&#xD;
      intensive motivational interview by trained physician assistants, and dietitian counselling,&#xD;
      on the levels of daily physical activity among Arabic- speaking residents of East Jerusalem&#xD;
      with prediabetes from Clalit Health Services. In addition, this study will also assess&#xD;
      healthy dietary changes, and self assessed health and quality of life.&#xD;
&#xD;
      The study will compare three groups (total 375, each group 125):&#xD;
&#xD;
      Group A - will receive activity trackers and written educational handouts in addition to&#xD;
      their usual care.&#xD;
&#xD;
      Group B - will receive all of group A intervention components and also a personalized&#xD;
      physical activity prescription.&#xD;
&#xD;
      Group C - will receive all of group B components and also intensive motivational interview&#xD;
      support by trained physician assistants (3 sessions), and dietitian support (two sessions).&#xD;
&#xD;
      Each participant will be followed-up for six months, with data collection occurring at&#xD;
      baseline, three months and six months. Data collection will include average weekly steps,&#xD;
      blood pressure, anthropometric measurements, routine blood tests (including fasting glucose,&#xD;
      HbA1C, and lipid profile), physical activity survey, Mediterranean dietary habits survey,&#xD;
      Food Frequency Questionnaire, and quality of life survey.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 15, 2019</start_date>
  <completion_date type="Anticipated">August 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">February 15, 2021</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>Physical activity level assessed through average weekly steps</measure>
    <time_frame>six months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fasting glucose levels</measure>
    <time_frame>six months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HbA1C levels</measure>
    <time_frame>six months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Mass Index</measure>
    <time_frame>six months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipid profile</measure>
    <time_frame>six months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>six months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Energy intake 500&lt; kcal/d &lt;6000 kcal/d</measure>
    <time_frame>Six months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist circumference</measure>
    <time_frame>six months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fat intake 15 &lt;gram/day&lt;200</measure>
    <time_frame>six months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Protein intake 10&lt;gram/day&lt;300</measure>
    <time_frame>six months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Iron intake 0&lt;mg/day&lt;50</measure>
    <time_frame>six months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Folic acid intake 15&lt; μg/day&lt;3000</measure>
    <time_frame>six months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vitamin A intake 20&lt; μg RAE/day&lt;2500</measure>
    <time_frame>six months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vitamin C intake 0&lt;mg/day&lt;2500</measure>
    <time_frame>six months</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">375</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive an activity tracker and written information for pre-diabetic, on top of their usual care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive an activity tracker, written information for pre-diabetic, and personalized physical activity prescription, on top of their usual care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive an activity tracker, written information for pre-diabetic, personalized physical activity prescription, three sessions of motivational interview support from trained physician assistants, and two session of dietitian support, on top of their usual care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Motivational Interview support and Dietitian support</intervention_name>
    <description>Three sessions of a structured motivational support intervention. Each patient will be required to set a SMART physical activity personal objective. The sessions will cover possible barriers and facilitators, enhancing self-efficacy, and feedback. In addition two sessions with a dietitian to discuss ways to improve current health habits.</description>
    <arm_group_label>Group C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Activity tracker plus usual care</intervention_name>
    <description>Each patient will receive their own activity tracker (vivofit 3) with instructions on use, in addition to usual care, and written handouts for pre-diabetic patients.</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_label>Group C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Personalized physical activity prescription</intervention_name>
    <description>Each patient will receive a personalized prescription of recommended physical activity including type of activity, duration and frequency.</description>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_label>Group C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Pre-diabetes patients - Impaired fasting glucose at least twice between 100-125 mg/dL in&#xD;
        the two years prior to the study; or HbA1C 5.7%-6.4% twice in the two years prior to the&#xD;
        study; or one test of fasting glucose of 100-125 mg/dL, and one test of HbA1C between&#xD;
        5.7%-6.4% in the two years prior to the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Diabetes including a doctor's diagnosis based on a medical file or a recurrence of&#xD;
             fasting blood glucose values above 126 mg/dL in the year preceding the study or a&#xD;
             glucose value greater than 200 mg/dL in the year prior to the study or HbA1C above&#xD;
             6.5%&#xD;
&#xD;
          2. Treatment with diabetes drugs other than metformin, as prescribed in the medical file&#xD;
             with regular or chronic medications&#xD;
&#xD;
          3. Artificial lower limbs or inability to walk normally (eg: stroke with plegia)&#xD;
&#xD;
          4. Chronic obstructive pulmonary disease&#xD;
&#xD;
          5. Known heart disease (with impaired exercise tolerance)&#xD;
&#xD;
          6. Pregnancy&#xD;
&#xD;
          7. Medical conditions:&#xD;
&#xD;
               -  a cardiac event/ Transient ischemic attack in the last year&#xD;
&#xD;
               -  Cerebrovascular attack with residual impairment&#xD;
&#xD;
               -  Surgery that required hospitalization in the last year&#xD;
&#xD;
               -  Injury to lower limbs that prevents regular walking&#xD;
&#xD;
               -  Malignancy excluding skin cancer small cell carcinoma or basal cell carcinoma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amnon Lahad, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clalit</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Amnon Lahad, MD</last_name>
    <phone>972-52-3293484</phone>
    <email>amnonl@ekmd.huji.ac.il</email>
  </overall_contact>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 27, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>February 3, 2019</last_update_submitted>
  <last_update_submitted_qc>February 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Clalit Health Services</investigator_affiliation>
    <investigator_full_name>Prof. Amnon Lahad</investigator_full_name>
    <investigator_title>Director of Medical Quality unit and Chairman department of Family Medicine, Clalit Health Services, Jerusalem district</investigator_title>
  </responsible_party>
  <keyword>Activity tracker; Arab population; Physical Activity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prediabetic State</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual participant data will not be shared</ipd_description>
  </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/NCT03821220
org study id: 0201-17-COM2
nct id: NCT03821220
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This three-arm clinical trial aims to improve levels of physical activity among Arabic-
      speaking residents of East Jerusalem with prediabetes. Levels of daily physical activity
      (assessed through activity trackers), dietary habits and self-assessed health will be
      compared between patients that receive only the activity tracker and written information
      (group A), receive the activity tracker, written information and a personalized physical
      activity prescription (group B), and those that receive in addition also intensive follow-up
      with motivational interview by physician assistants and a dietitian (group C)
This is a three-arm clinical trial studying the effect of providing activity trackers with
      intensive motivational interview by trained physician assistants, and dietitian counselling,
      on the levels of daily physical activity among Arabic- speaking residents of East Jerusalem
      with prediabetes from Clalit Health Services. In addition, this study will also assess
      healthy dietary changes, and self assessed health and quality of life.

      The study will compare three groups (total 375, each group 125):

      Group A - will receive activity trackers and written educational handouts in addition to
      their usual care.

      Group B - will receive all of group A intervention components and also a personalized
      physical activity prescription.

      Group C - will receive all of group B components and also intensive motivational interview
      support by trained physician assistants (3 sessions), and dietitian support (two sessions).

      Each participant will be followed-up for six months, with data collection occurring at
      baseline, three months and six months. Data collection will include average weekly steps,
      blood pressure, anthropometric measurements, routine blood tests (including fasting glucose,
      HbA1C, and lipid profile), physical activity survey, Mediterranean dietary habits survey,
      Food Frequency Questionnaire, and quality of life survey.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Physical activity level assessed through average weekly steps
time frame: six months
measure: Fasting glucose levels
time frame: six months
measure: HbA1C levels
time frame: six months
measure: Body Mass Index
time frame: six months
measure: Lipid profile
time frame: six months
measure: Blood pressure
time frame: six months
measure: Energy intake 500< kcal/d <6000 kcal/d
time frame: Six months
measure: Waist circumference
time frame: six months
measure: Fat intake 15 <gram/day<200
time frame: six months
measure: Protein intake 10<gram/day<300
time frame: six months
measure: Iron intake 0<mg/day<50
time frame: six months
measure: Folic acid intake 15< μg/day<3000
time frame: six months
measure: Vitamin A intake 20< μg RAE/day<2500
time frame: six months
measure: Vitamin C intake 0<mg/day<2500
time frame: six months
arm group label: Group A
arm group type: Active Comparator
description: Patients will receive an activity tracker and written information for pre-diabetic, on top of their usual care.
arm group label: Group B
arm group type: Active Comparator
description: Patients will receive an activity tracker, written information for pre-diabetic, and personalized physical activity prescription, on top of their usual care.
arm group label: Group C
arm group type: Active Comparator
description: Patients will receive an activity tracker, written information for pre-diabetic, personalized physical activity prescription, three sessions of motivational interview support from trained physician assistants, and two session of dietitian support, on top of their usual care.
intervention type: Behavioral
intervention name: Motivational Interview support and Dietitian support
description: Three sessions of a structured motivational support intervention. Each patient will be required to set a SMART physical activity personal objective. The sessions will cover possible barriers and facilitators, enhancing self-efficacy, and feedback. In addition two sessions with a dietitian to discuss ways to improve current health habits.
arm group label: Group C
intervention type: Behavioral
intervention name: Activity tracker plus usual care
description: Each patient will receive their own activity tracker (vivofit 3) with instructions on use, in addition to usual care, and written handouts for pre-diabetic patients.
arm group label: Group A
arm group label: Group B
arm group label: Group C
intervention type: Behavioral
intervention name: Personalized physical activity prescription
description: Each patient will receive a personalized prescription of recommended physical activity including type of activity, duration and frequency.
arm group label: Group B
arm group label: Group C
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: No
last name: Amnon Lahad, MD
role: Principal Investigator
affiliation: Clalit
last name: Amnon Lahad, MD
phone: 972-52-3293484
email: amnonl@ekmd.huji.ac.il
responsible party type: Principal Investigator
investigator affiliation: Clalit Health Services
investigator full name: Prof. Amnon Lahad
investigator title: Director of Medical Quality unit and Chairman department of Family Medicine, Clalit Health Services, Jerusalem district
mesh term: Prediabetic State
sharing ipd: No
ipd description: Individual participant data will not be shared