<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/NCT01671293</url>
  </required_header>
  <id_info>
    <org_study_id>FONIS SA10I20017</org_study_id>
    <nct_id>NCT01671293</nct_id>
  </id_info>
  <brief_title>Multicomponent Telecare Model for Supporting Prediabetes Patients</brief_title>
  <acronym>MTELECAREP</acronym>
  <official_title>Remote Care Model for Supporting Prediabetes Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pontificia Universidad Catolica de Chile</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Fund for Research and Development in Health, Chile</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Corporación Municipal de Educación, Salud y Recreación de La Florida</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Pontificia Universidad Catolica de Chile</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether a multi-component remote care model&#xD;
      (telephone-based) is effective to achieve the modification of unhealthy eating practices and&#xD;
      increase physical activity in adults who have prediabetes and over-weight/obesity. The&#xD;
      effectiveness of the remote care model will be determined with respect to the mentioned&#xD;
      practices as well as anthropometric parameters (Waist circumference and Weight) and clinical&#xD;
      parameters (Fasting Glucose, Triglycerides, Total Cholesterol) which are sensitive to changes&#xD;
      in these habits. The counseling intervention is the core of the multi-component tele-care&#xD;
      model, which also includes counseling-through text messages, supply of Educational material&#xD;
      and self-monitoring equipment (pedometers and measuring tape for patients to check their&#xD;
      waist circumference).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      International data report that the population with prediabetes is approximately twice the&#xD;
      population with Diabetes Mellitus type 2 (DM2) both in the U.S. and Latin America. Given&#xD;
      prediabetes estimated prevalence in Chile (8 to 15%) and considering the high risk for&#xD;
      developing DM2 that prediabetic people present, as well as the high cost associated with&#xD;
      treating this disease and its consequences, it is essential to look for strategies to prevent&#xD;
      and/or delay this process. People under 45 years who are overweight and have altered glucose&#xD;
      tolerance test constitute a population who is at high risk for developing DM2 (MINSAL, 2009).&#xD;
      It has been shown that weight loss and increase of moderate physical activity reduces by 58%&#xD;
      the risk of developing DM2 (The Diabetes Prevention Program Research Group, 2002), however,&#xD;
      at primary care, people who are informed of having prediabetes usually present no access to&#xD;
      the available services to support them in the process of changing behaviors that are at the&#xD;
      core of this condition.&#xD;
&#xD;
      This study aims to design, implement and evaluate a multi-component remote care model to&#xD;
      support people with prediabetes who are overweight or obese, at self-management of their risk&#xD;
      behaviors of unhealthy diet and physical inactivity. This study seeks to determine whether&#xD;
      remote care interventions aimed at overweight or obese people with prediabetes, carried out&#xD;
      by professionals trained in motivational interviewing, behavior change theories and support&#xD;
      health decision-making, with knowledge of prediabetes and effective interventions for coping&#xD;
      are effective for: a) Increase participants knowledge about the risks of this condition and&#xD;
      how to prevent them b) Provide effective support that results in an increase in daily&#xD;
      physical activity c) Provide effective support to ensure change in their eating habits d)&#xD;
      Achieve reduction in clinical parameters values of glucose, cholesterol and triglycerides e)&#xD;
      Attain decrease in the anthropometric parameters body weight and waist circumference&#xD;
      (associated with the modification of the unwanted habits).&#xD;
&#xD;
      The counseling intervention is the core of the multi-component remote care model, which also&#xD;
      includes counseling through text messages, the purveyance of educational material, and&#xD;
      self-monitoring equipment (pedometers and measuring tape for patients to check their waist&#xD;
      circumference). The calls are made by professionals working at health centers who have been&#xD;
      trained to apply theories on behavioral change and decision-making. Phone counseling are&#xD;
      conducted at least once a month. Three different types of counseling are included: (a)&#xD;
      Welcome: aimed at exploring the factors that promote behavioral change and the goals that the&#xD;
      patient must reach to deal with prediabetes; (b) Follow-up: aimed at accompanying the patient&#xD;
      and/or monitoring the attainment of goals associated with the desired behavioral change, (c)&#xD;
      Completion: for closing the intervention process, reinforcing achievements, and inviting the&#xD;
      patient to maintain the behavioral changes made. Short Message Service (SMS) counseling is&#xD;
      aimed at providing information and encouraging the patient to change his/her behavior in&#xD;
      terms of nutrition and physical activity. Messages are sent weekly and are related to the&#xD;
      topics referred to in counseling sessions. The educational material and equipment&#xD;
      --respectively-- seek to provide additional information and foster the habit of&#xD;
      self-monitoring progress and/or reversions in the change process.&#xD;
&#xD;
      A randomized clinical study was designed, including a sample of 70 (both groups) people&#xD;
      diagnosed with prediabetes and altered BMI, registered in 5 primary care centers in the La&#xD;
      Florida commune, Santiago, Chile. The intervention will last 6 months. The control group will&#xD;
      receive usual care from health centers consisting of an indication of physical activity and&#xD;
      healthy eating recommendations, as well as referral to Dietitian if appropriate, an&#xD;
      invitation to participate in educational activities at health centers and periodic inspection&#xD;
      appointments. Apart from the usual care provided in health centers, the intervention group&#xD;
      will also receive the four components of the remote care model. Pre and post intervention&#xD;
      measurements will be applied. At the end of the intervention (after post-measurement) control&#xD;
      group participants will be invited to participate in an educational workshop to improve&#xD;
      eating practices and physical activity, and will receive educational materials generated by&#xD;
      this project, thus ensuring the principle of equity in the project's development. For the&#xD;
      intervention group, the program is expected to lead to increased knowledge on prediabetes,&#xD;
      increment in physical activity, improvement of clinical and anthropometric parameters as well&#xD;
      as of eating habits, all of these are non expected results for the control group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Weight Parameter</measure>
    <time_frame>baseline and post intervention (6 -9 months after the first phone counseling session)</time_frame>
    <description>Patient's weight wil be measured in kilograms using scales.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Self Report of Physical Activity</measure>
    <time_frame>baseline and post intervention (6 -9 months after the first phone counseling session)</time_frame>
    <description>The level of physical activity reported by participants is measured using the Rapid Assessment Physical Activity Scale (RAPA; Tolpolski et al., 2006), in its version adapted for Chile. This instrument is made up by 9 dichotomous questions, which point to a physical activity level corresponding to the following categories: sedentary, under-active, under-active regular-light activities, under-active regular, and active, depending on the frequency and intensity of the physical activity done. The instrument adaptation process of the instrument is conducted as part of the present study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Fasting Glucose</measure>
    <time_frame>baseline and post intervention (6 -9 months after the first phone counseling session)</time_frame>
    <description>Fasting Glucose will be measured through a blood sample. The samples will be processed by the Municipal Laboratory (Laboratorio Comunal), following the standard procedures established by their protocols:&#xD;
Method:Colorimetric - Hexokinase / Glucose 6-phosphate-DH. UV. Equipment: Siemens Dimension RXL. Normal Range: 70-100 mg/dL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Triglycerides</measure>
    <time_frame>baseline and post intervention (6 -9 months after the first phone counseling session)</time_frame>
    <description>It will be measured through a blood sample. The samples will be processed by the Municipal Laboratory (Laboratorio Comunal), following the standard procedures established by their protocols:&#xD;
Method:Colorimetric - GPO/PAP blank glycerol. Equipment: Siemens Dimension RXL. Normal Range: ≤ 150 mg/dL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Total Cholesterol</measure>
    <time_frame>baseline and post intervention (6 -9 months after the first phone counseling session)</time_frame>
    <description>It will be measured through a blood sample. The samples will be processed by the Municipal Laboratory (Laboratorio Comunal), following the standard procedures established by their protocols:&#xD;
Method: Colorimetric - CHOD/PAP.Equipment: Siemens Dimension RXL. Normal Range: ≤ 200 mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Self Report of Dietary Practices</measure>
    <time_frame>baseline and post intervention (6 -9 months after the first phone counseling session)</time_frame>
    <description>The dietary practices reported by the participants will be measured with an instrument designed with this purpose in mind as part of the present study. The instrument is constituted by 17 items aimed at measuring the frequency of healthy and unhealthy eating. It was constructed on the basis of items present in the Diabetes Self Care Activities Measure (Toobert, Hampson, &amp; Glasgow, 2000) and of others created by the Stanford Patient Education Research Center. Some of these items were used to measure dietary practices in Chilean populations diagnosed with Diabetes Mellitus (Lange et al., 2010)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Baseline in Knowledge About Prediabetes</measure>
    <time_frame>baseline and post intervention (6 -9 months after the first phone counseling session)</time_frame>
    <description>A self-report questionnaire was developed to measure patients' knowledge about prediabetes, the risk factors for its appearance, and its treatment (or management). Is is made up by 18 items in which the person must say whether the statement presented is true or false. In addition, the instrument measures the subjective perception of the risk of developing diabetes (one item).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Baseline in Waist Circumference</measure>
    <time_frame>baseline and post intervention (6 -9 months after the first phone counseling session)</time_frame>
    <description>Participants' waist circumference will be measured in centimeters using a measuring tape. The circumference will be measured at the highest part of the iliac crest (The Canadian Physical Activity, Fitness and Lifestyle approach, 2010)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Prediabetic State</condition>
  <condition>Glucose Intolerance</condition>
  <arm_group>
    <arm_group_label>Multicomponent remote care model</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A remote intervention based on counseling (telephone-based).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Usual care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Multicomponent remote care model</intervention_name>
    <description>A remote intervention based on counseling (telephone-based) was implemented. This counseling intervention is the core of the multi-component model, which also includes counseling through text messages, the purveyance of educational material, and self-monitoring equipment (pedometer &amp; waist circumference measuring tape). The phone counseling is made by health centers professionals who have been trained to apply theories on behavioral change and decision-making. Phone counseling is conducted at least once a month. Messages are sent weekly and are related to the topics referred to in phone counseling sessions. The educational material and equipment -respectively- seek to provide additional information and foster the habit of self-monitoring progress and/or reversions in the change process.</description>
    <arm_group_label>Multicomponent remote care model</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <description>Usual care from health centers consisting of medical indication of physical activity and healthy eating recommendations, as well as referral to Dietitian if appropriate, an invitation to participate in educational activities at health centers and periodic inspection appointments</description>
    <arm_group_label>Usual care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Prediabetes diagnosis&#xD;
&#xD;
          -  25- 34 Body Mass Index&#xD;
&#xD;
          -  cellphone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Fasting blood glucose ≥ 126 (at the beginning of the intervention).&#xD;
&#xD;
          -  Terminal chronic diseases&#xD;
&#xD;
          -  Major cardiovascular problems (ie: angina pectoris, myocardial infarction,&#xD;
             cerebrovascular accident)&#xD;
&#xD;
          -  Severe psychiatric pathology&#xD;
&#xD;
          -  Presence of another pathology which, for the doctor assessing the patient (at the&#xD;
             beginning of the intervention), can be a contraindications to participate in the&#xD;
             program.&#xD;
&#xD;
          -  be pregnant&#xD;
&#xD;
          -  To belong to private health system (called ISAPRE).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janet Carola Pérez Ewert</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pontificia Universidad Catolica de Chile</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centro de Salud Santa Amalia</name>
      <address>
        <city>Santiago</city>
        <state>Región Metropolitana</state>
        <zip>8250403</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Salud Familiar Villa O'Higgins</name>
      <address>
        <city>Santiago</city>
        <state>Región Metropolitana</state>
        <zip>8260558</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Salud Familiar Fernando Maffioletti-Alvo</name>
      <address>
        <city>Santiago</city>
        <state>Región Metropolitana</state>
        <zip>8301588</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Salud Familiar Los Quillayes</name>
      <address>
        <city>Santiago</city>
        <state>Región Metropolitana</state>
        <zip>8310695</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Salud Familiar Los Castaños</name>
      <address>
        <city>Santiago</city>
        <state>Región Metropolitanta</state>
        <zip>8270041</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Chile</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>August 20, 2012</study_first_submitted>
  <study_first_submitted_qc>August 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 23, 2012</study_first_posted>
  <results_first_submitted>January 7, 2015</results_first_submitted>
  <results_first_submitted_qc>June 25, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">June 30, 2015</results_first_posted>
  <last_update_submitted>June 25, 2015</last_update_submitted>
  <last_update_submitted_qc>June 25, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 30, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prediabetic State</mesh_term>
    <mesh_term>Glucose Intolerance</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Multicomponent Remote Care Model</title>
          <description>Multicomponent remote care model: A remote intervention based on counseling (telephone-based) was implemented. This counseling intervention is the core of the multi-component model, which also includes counseling through text messages, the purveyance of educational material, and self-monitoring equipment (pedometer and measuring tape to check waist circumference). The phone counseling was made by professionals working at health centers who have been trained to apply theories on behavioral change and decision-making. A Mean of 5 phone counseling calls were done by participant. Messages were sent weekly and are related to the topics referred to in phone counseling sessions. The educational material and equipment -respectively- sought to provide additional information and foster the habit of self-monitoring progress and/or reversions in the change process.</description>
        </group>
        <group group_id="P2">
          <title>Usual Care</title>
          <description>Usual care from health centers consisting of medical indication of physical activity and healthy eating recommendations, as well as referral to Dietitian if appropriate, an invitation to participate in educational activities at health centers and periodic inspection appointments.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
                <participants group_id="P2" count="34"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Multicomponent Remote Care Model</title>
          <description>Multicomponent remote care model: A remote intervention based on counseling (telephone-based) was implemented. This counseling intervention is the core of the multi-component model, which also includes counseling through text messages, the purveyance of educational material, and self-monitoring equipment (pedometer and measuring tape to check waist circumference). The phone counseling was made by professionals working at health centers who have been trained to apply theories on behavioral change and decision-making. A Mean of 5 phone counseling calls were done by participant. Messages were sent weekly and are related to the topics referred to in phone counseling sessions. The educational material and equipment -respectively- sought to provide additional information and foster the habit of self-monitoring progress and/or reversions in the change process.</description>
        </group>
        <group group_id="B2">
          <title>Usual Care</title>
          <description>Usual care from health centers consisting of medical indication of physical activity and healthy eating recommendations, as well as referral to Dietitian if appropriate, an invitation to participate in educational activities at health centers and periodic inspection appointments.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="36"/>
            <count group_id="B2" value="34"/>
            <count group_id="B3" value="70"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50.78" spread="8.46"/>
                    <measurement group_id="B2" value="54.88" spread="8.59"/>
                    <measurement group_id="B3" value="52.77" spread="8.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Chile</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Weight Parameter</title>
        <description>Patient's weight wil be measured in kilograms using scales.</description>
        <time_frame>baseline and post intervention (6 -9 months after the first phone counseling session)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Multicomponent Remote Care Model</title>
            <description>Multicomponent remote care model: A remote intervention based on counseling (telephone-based) was implemented. This counseling intervention is the core of the multi-component model, which also includes counseling through text messages, the purveyance of educational material, and self-monitoring equipment (pedometer and measuring tape to check waist circumference). The phone counseling was made by professionals working at health centers who have been trained to apply theories on behavioral change and decision-making. A Mean of 5 phone counseling calls were done by participant. Messages were sent weekly and are related to the topics referred to in phone counseling sessions. The educational material and equipment -respectively- sought to provide additional information and foster the habit of self-monitoring progress and/or reversions in the change process.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care from health centers consisting of medical indication of physical activity and healthy eating recommendations, as well as referral to Dietitian if appropriate, an invitation to participate in educational activities at health centers and periodic inspection appointments.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Weight Parameter</title>
          <description>Patient's weight wil be measured in kilograms using scales.</description>
          <units>kilograms</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-.58" spread="2.98"/>
                    <measurement group_id="O2" value="-.18" spread="2.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Self Report of Physical Activity</title>
        <description>The level of physical activity reported by participants is measured using the Rapid Assessment Physical Activity Scale (RAPA; Tolpolski et al., 2006), in its version adapted for Chile. This instrument is made up by 9 dichotomous questions, which point to a physical activity level corresponding to the following categories: sedentary, under-active, under-active regular-light activities, under-active regular, and active, depending on the frequency and intensity of the physical activity done. The instrument adaptation process of the instrument is conducted as part of the present study.</description>
        <time_frame>baseline and post intervention (6 -9 months after the first phone counseling session)</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Fasting Glucose</title>
        <description>Fasting Glucose will be measured through a blood sample. The samples will be processed by the Municipal Laboratory (Laboratorio Comunal), following the standard procedures established by their protocols:&#xD;
Method:Colorimetric - Hexokinase / Glucose 6-phosphate-DH. UV. Equipment: Siemens Dimension RXL. Normal Range: 70-100 mg/dL.</description>
        <time_frame>baseline and post intervention (6 -9 months after the first phone counseling session)</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Triglycerides</title>
        <description>It will be measured through a blood sample. The samples will be processed by the Municipal Laboratory (Laboratorio Comunal), following the standard procedures established by their protocols:&#xD;
Method:Colorimetric - GPO/PAP blank glycerol. Equipment: Siemens Dimension RXL. Normal Range: ≤ 150 mg/dL.</description>
        <time_frame>baseline and post intervention (6 -9 months after the first phone counseling session)</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Total Cholesterol</title>
        <description>It will be measured through a blood sample. The samples will be processed by the Municipal Laboratory (Laboratorio Comunal), following the standard procedures established by their protocols:&#xD;
Method: Colorimetric - CHOD/PAP.Equipment: Siemens Dimension RXL. Normal Range: ≤ 200 mg/dL</description>
        <time_frame>baseline and post intervention (6 -9 months after the first phone counseling session)</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Self Report of Dietary Practices</title>
        <description>The dietary practices reported by the participants will be measured with an instrument designed with this purpose in mind as part of the present study. The instrument is constituted by 17 items aimed at measuring the frequency of healthy and unhealthy eating. It was constructed on the basis of items present in the Diabetes Self Care Activities Measure (Toobert, Hampson, &amp; Glasgow, 2000) and of others created by the Stanford Patient Education Research Center. Some of these items were used to measure dietary practices in Chilean populations diagnosed with Diabetes Mellitus (Lange et al., 2010)</description>
        <time_frame>baseline and post intervention (6 -9 months after the first phone counseling session)</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change of Baseline in Knowledge About Prediabetes</title>
        <description>A self-report questionnaire was developed to measure patients' knowledge about prediabetes, the risk factors for its appearance, and its treatment (or management). Is is made up by 18 items in which the person must say whether the statement presented is true or false. In addition, the instrument measures the subjective perception of the risk of developing diabetes (one item).</description>
        <time_frame>baseline and post intervention (6 -9 months after the first phone counseling session)</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change of Baseline in Waist Circumference</title>
        <description>Participants' waist circumference will be measured in centimeters using a measuring tape. The circumference will be measured at the highest part of the iliac crest (The Canadian Physical Activity, Fitness and Lifestyle approach, 2010)</description>
        <time_frame>baseline and post intervention (6 -9 months after the first phone counseling session)</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>During the intervention time frame</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Multicomponent Remote Care Model</title>
          <description>Multicomponent remote care model: A remote intervention based on counseling (telephone-based) was implemented. This counseling intervention is the core of the multi-component model, which also includes counseling through text messages, the purveyance of educational material, and self-monitoring equipment (pedometer and measuring tape to check waist circumference). The phone counseling was made by professionals working at health centers who have been trained to apply theories on behavioral change and decision-making. A Mean of 5 phone counseling calls were done by participant. Messages were sent weekly and are related to the topics referred to in phone counseling sessions. The educational material and equipment -respectively- sought to provide additional information and foster the habit of self-monitoring progress and/or reversions in the change process.</description>
        </group>
        <group group_id="E2">
          <title>Usual Care</title>
          <description>Usual care from health centers consisting of medical indication of physical activity and healthy eating recommendations, as well as referral to Dietitian if appropriate, an invitation to participate in educational activities at health centers and periodic inspection appointments.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>falls</sub_title>
                <description>falls during physical activity</description>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>J. Carola Pérez Ewert</name_or_title>
      <organization>Universidad del Desarrollo</organization>
      <phone>5623279875</phone>
      <email>janetperez@udd.cl</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01671293
org study id: FONIS SA10I20017
nct id: NCT01671293
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to determine whether a multi-component remote care model
      (telephone-based) is effective to achieve the modification of unhealthy eating practices and
      increase physical activity in adults who have prediabetes and over-weight/obesity. The
      effectiveness of the remote care model will be determined with respect to the mentioned
      practices as well as anthropometric parameters (Waist circumference and Weight) and clinical
      parameters (Fasting Glucose, Triglycerides, Total Cholesterol) which are sensitive to changes
      in these habits. The counseling intervention is the core of the multi-component tele-care
      model, which also includes counseling-through text messages, supply of Educational material
      and self-monitoring equipment (pedometers and measuring tape for patients to check their
      waist circumference).
International data report that the population with prediabetes is approximately twice the
      population with Diabetes Mellitus type 2 (DM2) both in the U.S. and Latin America. Given
      prediabetes estimated prevalence in Chile (8 to 15%) and considering the high risk for
      developing DM2 that prediabetic people present, as well as the high cost associated with
      treating this disease and its consequences, it is essential to look for strategies to prevent
      and/or delay this process. People under 45 years who are overweight and have altered glucose
      tolerance test constitute a population who is at high risk for developing DM2 (MINSAL, 2009).
      It has been shown that weight loss and increase of moderate physical activity reduces by 58%
      the risk of developing DM2 (The Diabetes Prevention Program Research Group, 2002), however,
      at primary care, people who are informed of having prediabetes usually present no access to
      the available services to support them in the process of changing behaviors that are at the
      core of this condition.

      This study aims to design, implement and evaluate a multi-component remote care model to
      support people with prediabetes who are overweight or obese, at self-management of their risk
      behaviors of unhealthy diet and physical inactivity. This study seeks to determine whether
      remote care interventions aimed at overweight or obese people with prediabetes, carried out
      by professionals trained in motivational interviewing, behavior change theories and support
      health decision-making, with knowledge of prediabetes and effective interventions for coping
      are effective for: a) Increase participants knowledge about the risks of this condition and
      how to prevent them b) Provide effective support that results in an increase in daily
      physical activity c) Provide effective support to ensure change in their eating habits d)
      Achieve reduction in clinical parameters values of glucose, cholesterol and triglycerides e)
      Attain decrease in the anthropometric parameters body weight and waist circumference
      (associated with the modification of the unwanted habits).

      The counseling intervention is the core of the multi-component remote care model, which also
      includes counseling through text messages, the purveyance of educational material, and
      self-monitoring equipment (pedometers and measuring tape for patients to check their waist
      circumference). The calls are made by professionals working at health centers who have been
      trained to apply theories on behavioral change and decision-making. Phone counseling are
      conducted at least once a month. Three different types of counseling are included: (a)
      Welcome: aimed at exploring the factors that promote behavioral change and the goals that the
      patient must reach to deal with prediabetes; (b) Follow-up: aimed at accompanying the patient
      and/or monitoring the attainment of goals associated with the desired behavioral change, (c)
      Completion: for closing the intervention process, reinforcing achievements, and inviting the
      patient to maintain the behavioral changes made. Short Message Service (SMS) counseling is
      aimed at providing information and encouraging the patient to change his/her behavior in
      terms of nutrition and physical activity. Messages are sent weekly and are related to the
      topics referred to in counseling sessions. The educational material and equipment
      --respectively-- seek to provide additional information and foster the habit of
      self-monitoring progress and/or reversions in the change process.

      A randomized clinical study was designed, including a sample of 70 (both groups) people
      diagnosed with prediabetes and altered BMI, registered in 5 primary care centers in the La
      Florida commune, Santiago, Chile. The intervention will last 6 months. The control group will
      receive usual care from health centers consisting of an indication of physical activity and
      healthy eating recommendations, as well as referral to Dietitian if appropriate, an
      invitation to participate in educational activities at health centers and periodic inspection
      appointments. Apart from the usual care provided in health centers, the intervention group
      will also receive the four components of the remote care model. Pre and post intervention
      measurements will be applied. At the end of the intervention (after post-measurement) control
      group participants will be invited to participate in an educational workshop to improve
      eating practices and physical activity, and will receive educational materials generated by
      this project, thus ensuring the principle of equity in the project's development. For the
      intervention group, the program is expected to lead to increased knowledge on prediabetes,
      increment in physical activity, improvement of clinical and anthropometric parameters as well
      as of eating habits, all of these are non expected results for the control group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change From Baseline in Weight Parameter
time frame: baseline and post intervention (6 -9 months after the first phone counseling session)
description: Patient's weight wil be measured in kilograms using scales.
measure: Change From Baseline in Self Report of Physical Activity
time frame: baseline and post intervention (6 -9 months after the first phone counseling session)
description: The level of physical activity reported by participants is measured using the Rapid Assessment Physical Activity Scale (RAPA; Tolpolski et al., 2006), in its version adapted for Chile. This instrument is made up by 9 dichotomous questions, which point to a physical activity level corresponding to the following categories: sedentary, under-active, under-active regular-light activities, under-active regular, and active, depending on the frequency and intensity of the physical activity done. The instrument adaptation process of the instrument is conducted as part of the present study.
measure: Change From Baseline in Fasting Glucose
time frame: baseline and post intervention (6 -9 months after the first phone counseling session)
description: Fasting Glucose will be measured through a blood sample. The samples will be processed by the Municipal Laboratory (Laboratorio Comunal), following the standard procedures established by their protocols:
Method:Colorimetric - Hexokinase / Glucose 6-phosphate-DH. UV. Equipment: Siemens Dimension RXL. Normal Range: 70-100 mg/dL.
measure: Change From Baseline in Triglycerides
time frame: baseline and post intervention (6 -9 months after the first phone counseling session)
description: It will be measured through a blood sample. The samples will be processed by the Municipal Laboratory (Laboratorio Comunal), following the standard procedures established by their protocols:
Method:Colorimetric - GPO/PAP blank glycerol. Equipment: Siemens Dimension RXL. Normal Range: ≤ 150 mg/dL.
measure: Change From Baseline in Total Cholesterol
time frame: baseline and post intervention (6 -9 months after the first phone counseling session)
description: It will be measured through a blood sample. The samples will be processed by the Municipal Laboratory (Laboratorio Comunal), following the standard procedures established by their protocols:
Method: Colorimetric - CHOD/PAP.Equipment: Siemens Dimension RXL. Normal Range: ≤ 200 mg/dL
measure: Change From Baseline in Self Report of Dietary Practices
time frame: baseline and post intervention (6 -9 months after the first phone counseling session)
description: The dietary practices reported by the participants will be measured with an instrument designed with this purpose in mind as part of the present study. The instrument is constituted by 17 items aimed at measuring the frequency of healthy and unhealthy eating. It was constructed on the basis of items present in the Diabetes Self Care Activities Measure (Toobert, Hampson, & Glasgow, 2000) and of others created by the Stanford Patient Education Research Center. Some of these items were used to measure dietary practices in Chilean populations diagnosed with Diabetes Mellitus (Lange et al., 2010)
measure: Change of Baseline in Knowledge About Prediabetes
time frame: baseline and post intervention (6 -9 months after the first phone counseling session)
description: A self-report questionnaire was developed to measure patients' knowledge about prediabetes, the risk factors for its appearance, and its treatment (or management). Is is made up by 18 items in which the person must say whether the statement presented is true or false. In addition, the instrument measures the subjective perception of the risk of developing diabetes (one item).
measure: Change of Baseline in Waist Circumference
time frame: baseline and post intervention (6 -9 months after the first phone counseling session)
description: Participants' waist circumference will be measured in centimeters using a measuring tape. The circumference will be measured at the highest part of the iliac crest (The Canadian Physical Activity, Fitness and Lifestyle approach, 2010)
arm group label: Multicomponent remote care model
arm group type: Experimental
description: A remote intervention based on counseling (telephone-based).
arm group label: Usual care
arm group type: Active Comparator
description: Usual care.
intervention type: Behavioral
intervention name: Multicomponent remote care model
description: A remote intervention based on counseling (telephone-based) was implemented. This counseling intervention is the core of the multi-component model, which also includes counseling through text messages, the purveyance of educational material, and self-monitoring equipment (pedometer & waist circumference measuring tape). The phone counseling is made by health centers professionals who have been trained to apply theories on behavioral change and decision-making. Phone counseling is conducted at least once a month. Messages are sent weekly and are related to the topics referred to in phone counseling sessions. The educational material and equipment -respectively- seek to provide additional information and foster the habit of self-monitoring progress and/or reversions in the change process.
arm group label: Multicomponent remote care model
intervention type: Other
intervention name: Usual care
description: Usual care from health centers consisting of medical indication of physical activity and healthy eating recommendations, as well as referral to Dietitian if appropriate, an invitation to participate in educational activities at health centers and periodic inspection appointments
arm group label: Usual care
criteria: 
gender: All
minimum age: 20 Years
maximum age: 64 Years
healthy volunteers: No
last name: Janet Carola Pérez Ewert
role: Principal Investigator
affiliation: Pontificia Universidad Catolica de Chile
facility: 
facility: 
facility: 
facility: 
facility: 
country: Chile
responsible party type: Sponsor
mesh term: Prediabetic State
mesh term: Glucose Intolerance
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 