<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/NCT03749772</url>
  </required_header>
  <id_info>
    <org_study_id>PMAFI14/12-2</org_study_id>
    <nct_id>NCT03749772</nct_id>
  </id_info>
  <brief_title>Cognitive Therapy Plus Dietary Intervention for Obesity Treatment</brief_title>
  <acronym>COGNI-OB</acronym>
  <official_title>Effectiveness of a Cognitive Training Therapy for Overweight/Obesity Treatment: A Randomized Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Católica San Antonio de Murcia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Católica San Antonio de Murcia</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 randomized clinical trial was carried out from January 2017 to December 2017 at the&#xD;
      facilities of the Catholic University of Murcia. Written informed consent was required from&#xD;
      each patient. The protocols of the present clinical trial follow the CONSORT standards. To&#xD;
      measure the impact of cognitive training on weight loss in overweight / obese subjects, a&#xD;
      double-blind study (de facto masking) was designed.&#xD;
&#xD;
      Both the participants and the statistical assessors were unaware of the study hypothesis.&#xD;
      Participants were unaware of treatments and possible assignments between groups, and only&#xD;
      those subjects who were randomly assigned to the cognitive training group were informed that&#xD;
      such training was part of dietary therapy.&#xD;
&#xD;
      The principal investigator of the present study (J.J.H.M.) carried out the randomization,&#xD;
      with the assistance of the Microsoft Excell program, with the help of a macro designed in&#xD;
      Visual Basic® for that purpose.&#xD;
&#xD;
      The randomization divided the subjects into two groups, as they were treated with a&#xD;
      hypocaloric diet plus 12 nutrition education sessions (CONTROL group) or a group that were&#xD;
      treated with a hypocaloric diet plus 12 sessions of cognitive training (COGNITIVE group).&#xD;
&#xD;
      In order to obtain a similar size in both groups, a randomization in blocks with a 1: 1&#xD;
      allocation ratio was performed.&#xD;
&#xD;
      Cognitive performance measures were performed before and after training. One week before the&#xD;
      beginning of the cognitive and dietary intervention, the participants performed a series of&#xD;
      cognitive tests. After 12 weeks of both dietary and cognitive intervention, participants were&#xD;
      reexamined to measure performance on neurocognitive tests.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2016</start_date>
  <completion_date type="Actual">February 28, 2017</completion_date>
  <primary_completion_date type="Actual">December 21, 2016</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>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Randomization was performed by the principal investigator. The interventions were carried out individually, so the participants were unaware of the existence of another study arms.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Total weight loss percentage</measure>
    <time_frame>12 weeks</time_frame>
    <description>Percentage of weight loss from baseline measurement to the end-of-treatment weight, calculated as (baseline weight - weight at week 12)/baseline weight * 100</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Overweight and Obesity</condition>
  <arm_group>
    <arm_group_label>Cognitive</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants of the COGNITIVE group performed cognitive training during 12 sessions during the 3 months of hypocaloric treatment. The training was carried out with the PC game Brain Exercise TM (Bandai Namco Games Ltd.). The participants made a total of 12 practice exercises, which implies approximately 30 minutes of duration per session.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>As a control group, we used nutrition education sessions of approximately the same duration (30 min) where we simply reinforced the knowledge that was already provided during the sessions with the patient, such as concepts about the balanced diet, nutrient composition and micronutrients, etc. The objective of this control group was to avoid the effect of time with the researcher.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Training</intervention_name>
    <description>The intervention was carried out with the PC game Brain Exercise TM (Bandai Namco Games Ltd.). Participants held the training sessions on an HP 250 G3 Notebook PC (Windows 10), with a 15-inch screen, and a resolution of 1366x768x40 Hz. The performance achieved by each participant in each session was recorded to analyze the evolution of the subjects. The participants made a total of 12 practice exercises, which implies approximately 30 minutes of duration per session.</description>
    <arm_group_label>Cognitive</arm_group_label>
    <other_name>Cognitive Rehabilitation Therapy</other_name>
    <other_name>Executive Function Training</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Present a BMI&gt; 27 kg / m2, and want to be part of the study voluntarily&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subjects with diabetes mellitus type 2&#xD;
&#xD;
          -  subjects with a history of a cardiovascular event (acute myocardial infarction,&#xD;
             intermittent claudication, etc.)&#xD;
&#xD;
          -  subjects with kidney or liver failure or some other significant pathology (cancer)&#xD;
&#xD;
          -  subjects under pharmacological treatment that could affect body weight (corticoids,&#xD;
             thyroxine, etc.)&#xD;
&#xD;
          -  subjects who were on a diet or had been on a diet at least 6 months before their&#xD;
             participation in the study were also excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>November 20, 2018</last_update_submitted>
  <last_update_submitted_qc>November 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Católica San Antonio de Murcia</investigator_affiliation>
    <investigator_full_name>Juan Jose Hernández Morante</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>obesity, cognitive therapy, executive function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Overweight</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/NCT03749772
org study id: PMAFI14/12-2
nct id: NCT03749772
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This randomized clinical trial was carried out from January 2017 to December 2017 at the
      facilities of the Catholic University of Murcia. Written informed consent was required from
      each patient. The protocols of the present clinical trial follow the CONSORT standards. To
      measure the impact of cognitive training on weight loss in overweight / obese subjects, a
      double-blind study (de facto masking) was designed.

      Both the participants and the statistical assessors were unaware of the study hypothesis.
      Participants were unaware of treatments and possible assignments between groups, and only
      those subjects who were randomly assigned to the cognitive training group were informed that
      such training was part of dietary therapy.

      The principal investigator of the present study (J.J.H.M.) carried out the randomization,
      with the assistance of the Microsoft Excell program, with the help of a macro designed in
      Visual Basic® for that purpose.

      The randomization divided the subjects into two groups, as they were treated with a
      hypocaloric diet plus 12 nutrition education sessions (CONTROL group) or a group that were
      treated with a hypocaloric diet plus 12 sessions of cognitive training (COGNITIVE group).

      In order to obtain a similar size in both groups, a randomization in blocks with a 1: 1
      allocation ratio was performed.

      Cognitive performance measures were performed before and after training. One week before the
      beginning of the cognitive and dietary intervention, the participants performed a series of
      cognitive tests. After 12 weeks of both dietary and cognitive intervention, participants were
      reexamined to measure performance on neurocognitive tests.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: Randomization was performed by the principal investigator. The interventions were carried out individually, so the participants were unaware of the existence of another study arms.
measure: Total weight loss percentage
time frame: 12 weeks
description: Percentage of weight loss from baseline measurement to the end-of-treatment weight, calculated as (baseline weight - weight at week 12)/baseline weight * 100
arm group label: Cognitive
arm group type: Experimental
description: The participants of the COGNITIVE group performed cognitive training during 12 sessions during the 3 months of hypocaloric treatment. The training was carried out with the PC game Brain Exercise TM (Bandai Namco Games Ltd.). The participants made a total of 12 practice exercises, which implies approximately 30 minutes of duration per session.
arm group label: Control
arm group type: No Intervention
description: As a control group, we used nutrition education sessions of approximately the same duration (30 min) where we simply reinforced the knowledge that was already provided during the sessions with the patient, such as concepts about the balanced diet, nutrient composition and micronutrients, etc. The objective of this control group was to avoid the effect of time with the researcher.
intervention type: Behavioral
intervention name: Cognitive Training
description: The intervention was carried out with the PC game Brain Exercise TM (Bandai Namco Games Ltd.). Participants held the training sessions on an HP 250 G3 Notebook PC (Windows 10), with a 15-inch screen, and a resolution of 1366x768x40 Hz. The performance achieved by each participant in each session was recorded to analyze the evolution of the subjects. The participants made a total of 12 practice exercises, which implies approximately 30 minutes of duration per session.
arm group label: Cognitive
other name: Cognitive Rehabilitation Therapy
other name: Executive Function Training
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Universidad Católica San Antonio de Murcia
investigator full name: Juan Jose Hernández Morante
investigator title: Professor
mesh term: Obesity
mesh term: Overweight