<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/NCT01666938</url>
  </required_header>
  <id_info>
    <org_study_id>CSE-1410/2011</org_study_id>
    <nct_id>NCT01666938</nct_id>
  </id_info>
  <brief_title>Telephone Counselling to Promote Physical Activity in Diabetes Mellitus People</brief_title>
  <official_title>The Use of a Telephone Counselling as a Strategy to Promote Physical Activity in Diabetes Mellitus People</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the effects of phone counselling support as a&#xD;
      strategy to increase physical activity in people with diabetes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">November 2012</completion_date>
  <primary_completion_date type="Actual">September 2012</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>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>level of physical activity</measure>
    <time_frame>four months</time_frame>
    <description>It was used the international physical activity questionnaire (IPAQ) to classify the level of physical activity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Metabolic Control</measure>
    <time_frame>Four Months</time_frame>
    <description>Body Mass Index&#xD;
Waist Circumference&#xD;
Mean Systolic Blood Pressure&#xD;
Mean Diastolic Blood Pressure&#xD;
Fasting Glucose&#xD;
Low Density Lipoprotein (LDL)&#xD;
High Density Lipoprotein&#xD;
Total Cholesterol&#xD;
Triglycerides&#xD;
Glycated Hemoglobin</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Diabetes Education Group &amp; Telephone counseling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This step was done for four months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Telephone counseling about physical activity</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This step was done for four months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diabetes Education Group</intervention_name>
    <description>Diabetes Education Group: Diabetes Education for four month, one time per week.</description>
    <arm_group_label>Diabetes Education Group &amp; Telephone counseling</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Telephone Counseling</intervention_name>
    <description>Telephone counseling: 12 phone calls for four months about physical activity. During the first and second month, was done four phone calls each month. During the third and fourth month, was done two phone calls per month.</description>
    <arm_group_label>Diabetes Education Group &amp; Telephone counseling</arm_group_label>
    <arm_group_label>Telephone counseling about physical activity</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of type 2 diabetes mellitus&#xD;
&#xD;
          -  age between 18 and 80 years&#xD;
&#xD;
          -  both sexes&#xD;
&#xD;
          -  medical recommendation for physical activity&#xD;
&#xD;
          -  ability to listen and answer questions&#xD;
&#xD;
          -  have cell phone and/or residential&#xD;
&#xD;
          -  be registered the Center for Family Health 03 in 2012&#xD;
&#xD;
          -  People should also produce higher frequency than 75% stake in the proposed activities&#xD;
             Diabetes Education Group and telephone counseling&#xD;
&#xD;
        Exclusion Criteria: People who do not attend the criteria for inclusion.&#xD;
&#xD;
          -  did not have clinical diagnosis of type 2 diabetes mellitus&#xD;
&#xD;
          -  did not have age between 18 and 80 years&#xD;
&#xD;
          -  did not have medical recommendation for physical activity&#xD;
&#xD;
          -  did not have ability to listen and answer questions&#xD;
&#xD;
          -  did not have cell phone and/or residential&#xD;
&#xD;
          -  do not be registered the Center for Family Health 03 in 2012&#xD;
&#xD;
          -  People who did not participate in 75% of the activities of the Group proposed the&#xD;
             Diabetes Education and telephone counseling&#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>Gabriel Guidorizzi Zanetti, graduated</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Sao Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Family Health 03</name>
      <address>
        <city>Ribeirao Preto</city>
        <state>Sao Paulo</state>
        <zip>14051-297</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>March 2013</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <last_update_submitted>March 23, 2013</last_update_submitted>
  <last_update_submitted_qc>March 23, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 26, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Gabriel Guidorizzi Zanetti</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Diabetes Mellitus</keyword>
  <keyword>Telephone</keyword>
  <keyword>Physical activity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</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/NCT01666938
org study id: CSE-1410/2011
nct id: NCT01666938
lead sponsor: 
The purpose of this study is to investigate the effects of phone counselling support as a
      strategy to increase physical activity in people with diabetes.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: level of physical activity
time frame: four months
description: It was used the international physical activity questionnaire (IPAQ) to classify the level of physical activity
measure: Metabolic Control
time frame: Four Months
description: Body Mass Index
Waist Circumference
Mean Systolic Blood Pressure
Mean Diastolic Blood Pressure
Fasting Glucose
Low Density Lipoprotein (LDL)
High Density Lipoprotein
Total Cholesterol
Triglycerides
Glycated Hemoglobin
arm group label: Diabetes Education Group & Telephone counseling
arm group type: Experimental
description: This step was done for four months.
arm group label: Telephone counseling about physical activity
arm group type: Active Comparator
description: This step was done for four months.
intervention type: Other
intervention name: Diabetes Education Group
description: Diabetes Education Group: Diabetes Education for four month, one time per week.
arm group label: Diabetes Education Group & Telephone counseling
intervention type: Other
intervention name: Telephone Counseling
description: Telephone counseling: 12 phone calls for four months about physical activity. During the first and second month, was done four phone calls each month. During the third and fourth month, was done two phone calls per month.
arm group label: Diabetes Education Group & Telephone counseling
arm group label: Telephone counseling about physical activity
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Gabriel Guidorizzi Zanetti, graduated
role: Principal Investigator
affiliation: University of Sao Paulo
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Gabriel Guidorizzi Zanetti
investigator title: Principal Investigator
mesh term: Diabetes Mellitus