<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/NCT02991079</url>
  </required_header>
  <id_info>
    <org_study_id>GRS 1276/B/16</org_study_id>
    <nct_id>NCT02991079</nct_id>
  </id_info>
  <brief_title>Effectiveness of a Multifactorial Intervention to Improve Diet and Physical Activity in Diabetics From Primary Care</brief_title>
  <official_title>Effectiveness of a Multifactorial Intervention to Improve Diet and Physical Activity in Diabetic Patients From Primary Care: A Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundacion para la Investigacion y Formacion en Ciencias de la Salud</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Castilla-León Health Service</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundacion para la Investigacion y Formacion en Ciencias de la Salud</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 is a randomized, clinical trial aimed at diabetics between 25-70 years (with no&#xD;
      cardiovascular disease) selected at urban primary care health clinics in Salamanca (Spain).&#xD;
      It is aimed at assessing the effects of adding an ICT (information and communication&#xD;
      technology) tool, developed for the Smartphone application and group activities of healthy&#xD;
      food and cardio-health rides in support of behavioral and educational recommendations in the&#xD;
      increased physical activity and adaption to the Mediterranean dietary pattern.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective:&#xD;
&#xD;
      The main objective of this study is to evaluate the effect of adding a multifactorial&#xD;
      intervention (ICT tool for Smartphone, cardio-health rides and a standardized advice about&#xD;
      eating habits) to the usual care in the increase of the physical activity, in order to reach&#xD;
      the international recommendations and in the Increased adherence to the Mediterranean diet in&#xD;
      type 2 diabetic patients. Secondary objectives will be to evaluate the effect of intervention&#xD;
      in improving dietary patterns, cardiovascular risk factors and metabolic control.&#xD;
&#xD;
      Design and setting:&#xD;
&#xD;
      A randomised controlled clinical trial, with two parallel groups, aimed at assessing the&#xD;
      effects of adding an ICT tool and group activities on healthy food and cardio-health rides&#xD;
      (intervention), in support of behavioral and educational recommendations (control) in the&#xD;
      increased physical activity and adaption to the Mediterranean dietary pattern.&#xD;
&#xD;
      Study setting:&#xD;
&#xD;
      Primary Care Health Area of Salamanca in the Research Unit of La Alamedilla, belonging to the&#xD;
      Spanish Network for Preventive Activities and Health Promotion (redIAPP) and Salamanca&#xD;
      Institute for Biomedical Research (IBSAL).&#xD;
&#xD;
      Study population:&#xD;
&#xD;
      200 patients with Diabetes Mellitus Type 2, aged between 25-70 years, of both sexes, who meet&#xD;
      selection criteria and signed informed consent.&#xD;
&#xD;
      Each participant will make three visits: baseline, three and twelve months post-intervention.&#xD;
&#xD;
      Measuring the effect of the intervention:&#xD;
&#xD;
      The validated 14-point Mediterranean Diet Adherence Screener, the International Physical&#xD;
      Activity Questionnaire (IPAQ), pedometer, laboratory values including glucose and&#xD;
      glycosylated hemoglobin, and quality of life questionnaire (SF -12).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">March 28, 2018</completion_date>
  <primary_completion_date type="Actual">March 17, 2018</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adherence to the Mediterranean diet using the validated 14-point Mediterranean Diet Adherence Screener</measure>
    <time_frame>1 year</time_frame>
    <description>Principal endpoint of alimentation, will be measured using the validated 14-point Mediterranean Diet Adherence Screener.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-reported physical activity measured by the International Physical Activity Questionary - Short Form</measure>
    <time_frame>1 year</time_frame>
    <description>Measured by the International Physical Activity Questionary - Short Form</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Increase physical activity measurement by pedometer</measure>
    <time_frame>1 year</time_frame>
    <description>Measurement by pedometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HbA1c</measure>
    <time_frame>1 year</time_frame>
    <description>Measurement by laboratory test sampling</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting Plasma Glucose</measure>
    <time_frame>1 year</time_frame>
    <description>Measurement by laboratory test sampling</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life measured by SF-12 test</measure>
    <time_frame>1 year</time_frame>
    <description>Measurement by SF-12 test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular risk factors measured by Framingham Risk Score</measure>
    <time_frame>1 year</time_frame>
    <description>Measurement by Framingham Risk Score</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Control: Lifestyle counseling</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Counseling on physical activity and Mediterranean diet.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Add for three months a smartphone with an app (EVIDENT) to improve alimentation and physical activity, five cardio-health rides and feeding workshop.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intervention group</intervention_name>
    <description>Smartphone with APP (EVIDENT) for 3 months, cardio-health rides and feeding workshop.&#xD;
Counseling on physical activity and Mediterranean diet.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control: Lifestyle counseling</intervention_name>
    <description>Conseling on physical activity and nutrition (intervention)</description>
    <arm_group_label>Control: Lifestyle counseling</arm_group_label>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects with Diabetes Mellitus Type 2 since 25 to 70 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Older than 70 years are excluded, due to difficulties in the use of ICTs.&#xD;
&#xD;
          -  History of cardiovascular events (acute myocardial infarction, stroke, etc).&#xD;
&#xD;
          -  Diagnosis of clinically demonstrable neurological and/or neuropsychological disease.&#xD;
&#xD;
          -  Muscular-skeletal pathology that inhibit mobility.&#xD;
&#xD;
          -  Those with any other circumstance that the investigators consider could interfere with&#xD;
             the study procedures.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Primary Care Research Unit - The Alamedilla Center for Health</name>
      <address>
        <city>Salamanca</city>
        <zip>37003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>December 9, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>April 23, 2018</last_update_submitted>
  <last_update_submitted_qc>April 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Food Habits</keyword>
  <keyword>Health education</keyword>
  <keyword>Physical activity</keyword>
  <keyword>Information and Communication Technologies</keyword>
  <!-- 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/NCT02991079
org study id: GRS 1276/B/16
nct id: NCT02991079
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a randomized, clinical trial aimed at diabetics between 25-70 years (with no
      cardiovascular disease) selected at urban primary care health clinics in Salamanca (Spain).
      It is aimed at assessing the effects of adding an ICT (information and communication
      technology) tool, developed for the Smartphone application and group activities of healthy
      food and cardio-health rides in support of behavioral and educational recommendations in the
      increased physical activity and adaption to the Mediterranean dietary pattern.
Objective:

      The main objective of this study is to evaluate the effect of adding a multifactorial
      intervention (ICT tool for Smartphone, cardio-health rides and a standardized advice about
      eating habits) to the usual care in the increase of the physical activity, in order to reach
      the international recommendations and in the Increased adherence to the Mediterranean diet in
      type 2 diabetic patients. Secondary objectives will be to evaluate the effect of intervention
      in improving dietary patterns, cardiovascular risk factors and metabolic control.

      Design and setting:

      A randomised controlled clinical trial, with two parallel groups, aimed at assessing the
      effects of adding an ICT tool and group activities on healthy food and cardio-health rides
      (intervention), in support of behavioral and educational recommendations (control) in the
      increased physical activity and adaption to the Mediterranean dietary pattern.

      Study setting:

      Primary Care Health Area of Salamanca in the Research Unit of La Alamedilla, belonging to the
      Spanish Network for Preventive Activities and Health Promotion (redIAPP) and Salamanca
      Institute for Biomedical Research (IBSAL).

      Study population:

      200 patients with Diabetes Mellitus Type 2, aged between 25-70 years, of both sexes, who meet
      selection criteria and signed informed consent.

      Each participant will make three visits: baseline, three and twelve months post-intervention.

      Measuring the effect of the intervention:

      The validated 14-point Mediterranean Diet Adherence Screener, the International Physical
      Activity Questionnaire (IPAQ), pedometer, laboratory values including glucose and
      glycosylated hemoglobin, and quality of life questionnaire (SF -12).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Adherence to the Mediterranean diet using the validated 14-point Mediterranean Diet Adherence Screener
time frame: 1 year
description: Principal endpoint of alimentation, will be measured using the validated 14-point Mediterranean Diet Adherence Screener.
measure: Self-reported physical activity measured by the International Physical Activity Questionary - Short Form
time frame: 1 year
description: Measured by the International Physical Activity Questionary - Short Form
measure: Increase physical activity measurement by pedometer
time frame: 1 year
description: Measurement by pedometer.
measure: HbA1c
time frame: 1 year
description: Measurement by laboratory test sampling
measure: Fasting Plasma Glucose
time frame: 1 year
description: Measurement by laboratory test sampling
measure: Quality of life measured by SF-12 test
time frame: 1 year
description: Measurement by SF-12 test
measure: Cardiovascular risk factors measured by Framingham Risk Score
time frame: 1 year
description: Measurement by Framingham Risk Score
arm group label: Control: Lifestyle counseling
arm group type: Active Comparator
description: Counseling on physical activity and Mediterranean diet.
arm group label: Intervention group
arm group type: Experimental
description: Add for three months a smartphone with an app (EVIDENT) to improve alimentation and physical activity, five cardio-health rides and feeding workshop.
intervention type: Other
intervention name: Intervention group
description: Smartphone with APP (EVIDENT) for 3 months, cardio-health rides and feeding workshop.
Counseling on physical activity and Mediterranean diet.
arm group label: Intervention group
intervention type: Other
intervention name: Control: Lifestyle counseling
description: Conseling on physical activity and nutrition (intervention)
arm group label: Control: Lifestyle counseling
arm group label: Intervention group
criteria: 
gender: All
minimum age: 25 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Spain
responsible party type: Sponsor