<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/NCT03001583</url>
  </required_header>
  <id_info>
    <org_study_id>GRUCO_2016</org_study_id>
    <nct_id>NCT03001583</nct_id>
  </id_info>
  <brief_title>Clinical Trial Comparing Two Health Education Programs for Obese Patients (HEPO-TRIAL)</brief_title>
  <official_title>Clinical Trial Comparing Two Health Education Programs for Obese Patients: Groups With Health Education Plus Cooking Program vs. Only Education Without Cooking</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal</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>
      Clinical trial comparing two health education programs for obese patients in order to achieve&#xD;
      a substantial and beneficial weight loss, using mediterranean diet. Patients will be&#xD;
      allocated to two groups, one will receive education in diet and lifestyle, and the other one&#xD;
      the same plus cooking lessons. The intervention period is for 6 months with monthly visits&#xD;
      and phone and email contacts in between. An extension observation period of two years is also&#xD;
      planned with 6 months contacts in our clinic, also with phone and email contact available.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eligibility: obese patients attending our center. Exclusion criteria: previous dietary or&#xD;
      anti-obesity drugs treatments, previous bariatric surgery, eating disorders, desire for&#xD;
      short-term bariatric surgery, active neoplasia, end stage kidney or liver disease, food&#xD;
      allergies or celiac disease.&#xD;
&#xD;
      Sample Size: a total of 260 patients (130 patients in each group) are needed for α=0.05 and&#xD;
      1-ß=0.8, to reach a difference of a 5% in weight loss between both groups, with a maximum of&#xD;
      a 30% dropouts.&#xD;
&#xD;
      Intervention: structured health education program of Mediterranean diet and lifestyle changes&#xD;
      with cooking lessons in monthly sessions, with the aid of phone and email contacts during an&#xD;
      induction phase of 6 months, followed by an extension period of 18 months.&#xD;
&#xD;
      Control: same strategy without the cooking lessons. Primary outcome: weight loss in %&#xD;
      Secondary outcomes: reversal in obesity associated comorbidities and quality of life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The investigators hadn't got funding to support the study&#xD;
  </why_stopped>
  <start_date type="Actual">October 30, 2019</start_date>
  <completion_date type="Anticipated">October 2021</completion_date>
  <primary_completion_date type="Anticipated">October 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Weight loss</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Weight loss</measure>
    <time_frame>Visits at 12, 18 and 24 months (to complete a total study time period of 24 months)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Education Program with cooking lessons</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Structured education program of mediterranean diet and lifestyle changes with cooking lessons delivered in monthly visits for an induction phase of 6 months, with an extension period of up to two years.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Education without cooking</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Structured education program of mediterranean diet and lifestyle changes WITHOUT cooking lessons delivered in monthly visits for an induction phase of 6 months, with an extension period of up to two years.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Education program with cooking lessons</intervention_name>
    <description>Structured education program of mediterranean diet and lifestyle changes with cooking lessons delivered in monthly visits for an induction phase of 6 months, with an extension period of up to two years.</description>
    <arm_group_label>Education Program with cooking lessons</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Education program WITHOUT cooking lessons</intervention_name>
    <description>Structured education program of mediterranean diet and lifestyle changes WITHOUT cooking lessons delivered in monthly visits for an induction phase of 6 months, with an extension period of up to two years.</description>
    <arm_group_label>Education without cooking</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Obese patients attending our center&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous dietary or pharmacologic treatment for obesity, previous bariatric surgery,&#xD;
             desired bariatric surgery in the short-term, eating disorders, end-stage kidney or&#xD;
             liver disease, active neoplasia, food allergies, celiac disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>February 4, 2020</last_update_submitted>
  <last_update_submitted_qc>February 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mediterranean diet</keyword>
  <keyword>weight loss</keyword>
  <keyword>type 2 diabetes</keyword>
  <keyword>education program</keyword>
  <keyword>cooking</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/NCT03001583
org study id: GRUCO_2016
nct id: NCT03001583
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Clinical trial comparing two health education programs for obese patients in order to achieve
      a substantial and beneficial weight loss, using mediterranean diet. Patients will be
      allocated to two groups, one will receive education in diet and lifestyle, and the other one
      the same plus cooking lessons. The intervention period is for 6 months with monthly visits
      and phone and email contacts in between. An extension observation period of two years is also
      planned with 6 months contacts in our clinic, also with phone and email contact available.
Eligibility: obese patients attending our center. Exclusion criteria: previous dietary or
      anti-obesity drugs treatments, previous bariatric surgery, eating disorders, desire for
      short-term bariatric surgery, active neoplasia, end stage kidney or liver disease, food
      allergies or celiac disease.

      Sample Size: a total of 260 patients (130 patients in each group) are needed for α=0.05 and
      1-ß=0.8, to reach a difference of a 5% in weight loss between both groups, with a maximum of
      a 30% dropouts.

      Intervention: structured health education program of Mediterranean diet and lifestyle changes
      with cooking lessons in monthly sessions, with the aid of phone and email contacts during an
      induction phase of 6 months, followed by an extension period of 18 months.

      Control: same strategy without the cooking lessons. Primary outcome: weight loss in %
      Secondary outcomes: reversal in obesity associated comorbidities and quality of life.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Weight loss
time frame: 6 months
measure: Weight loss
time frame: Visits at 12, 18 and 24 months (to complete a total study time period of 24 months)
arm group label: Education Program with cooking lessons
arm group type: Experimental
description: Structured education program of mediterranean diet and lifestyle changes with cooking lessons delivered in monthly visits for an induction phase of 6 months, with an extension period of up to two years.
arm group label: Education without cooking
arm group type: Active Comparator
description: Structured education program of mediterranean diet and lifestyle changes WITHOUT cooking lessons delivered in monthly visits for an induction phase of 6 months, with an extension period of up to two years.
intervention type: Behavioral
intervention name: Education program with cooking lessons
description: Structured education program of mediterranean diet and lifestyle changes with cooking lessons delivered in monthly visits for an induction phase of 6 months, with an extension period of up to two years.
arm group label: Education Program with cooking lessons
intervention type: Behavioral
intervention name: Education program WITHOUT cooking lessons
description: Structured education program of mediterranean diet and lifestyle changes WITHOUT cooking lessons delivered in monthly visits for an induction phase of 6 months, with an extension period of up to two years.
arm group label: Education without cooking
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
responsible party type: Sponsor