<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/NCT03833791</url>
  </required_header>
  <id_info>
    <org_study_id>TESIS-OBESITICS-2018</org_study_id>
    <nct_id>NCT03833791</nct_id>
  </id_info>
  <brief_title>Effect of Different Physical Programs on the Body Composition of Adult Men and Women With an Initial Body Fat &gt;25% and &gt;30%, Respectively.</brief_title>
  <official_title>Effect of the Prescription of Physical Activity on the Fat, Muscle Mass, and Body Weight of Overweight or Adult Men and Women: Randomized Clinical Trial of 6 Month Duration.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de Córdoba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad de Córdoba</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>
      Compare the Effect of Different Physical Programs on the Body Composition of Adult Women and&#xD;
      Men With a Total Body Fat Percentage ≥ 30 % at the Beginning of the Test or BMI ≥25&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Weight loss by exercise can be frequently deceptive. The focus continues to be centred around&#xD;
      total body weight and body mass index (BMI), despite the fact that body fat and fat-free mass&#xD;
      are the indicators that represent the greatest risk in the comorbidity associated with&#xD;
      obesity. Body weight per se cannot be considered to be reliable; however, its quality can be&#xD;
      justified, when measured together with the loss in body fat and the maintenance or increase&#xD;
      in fat-free mass.&#xD;
&#xD;
      The purpose of the study is compare the effect of different physical programs (FA) on the&#xD;
      body composition (BC) of adult women with a total body fat percentage ≥ 30 % and adult men&#xD;
      with a BMI ≥25 at the beginning of the test.&#xD;
&#xD;
      Participants (n=220, women = 110, men = 110) will be recruited through outpatient from&#xD;
      private clinics in Cádiz, Andalucía, Spain, as well as through community presentations.&#xD;
      Overweight or obese and sedentary women and men will be randomly assigned into three groups&#xD;
      according to different levels of AF. 21 of the participants will be assigned to the sedentary&#xD;
      control group (METs &lt;2.9), 20 in a group of moderate AF (METs 3-5.9), and 19 will be assigned&#xD;
      to the group of intense AF (METs &gt;6).&#xD;
&#xD;
      For 6 months, all of the women shall follow the same diet with an identical distribution of&#xD;
      macronutrients. There will be a weekly check up of weight, fat, body water and muscle mass&#xD;
      for all of them.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Actual">June 1, 2019</completion_date>
  <primary_completion_date type="Actual">December 15, 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>Other</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes from baseline BMI.</measure>
    <time_frame>At baseline (0 years) and followed for 2 years</time_frame>
    <description>Baseline mean BMI values will be measured and compared at 3, 6, 12 and 24 months. BMI will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes from baseline Fatty mass.</measure>
    <time_frame>At baseline (0 years) and followed for 2 years</time_frame>
    <description>Baseline mean Fatty mass values will be measured and compared at 3, 6, 12 and 24 months. Fatty mass will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale. Fatty mass is measured as a percentage.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes from baseline Free-fatty mass.</measure>
    <time_frame>At baseline (0 years) and followed for 2 years</time_frame>
    <description>Baseline mean Free-fatty mass values will be measured and compared at 3, 6, 12 and 24 months. Free-fatty mass will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale. Fatty mass is measured as a percentage.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes from baseline Muscular Mass.</measure>
    <time_frame>At baseline (0 years) and followed for 2 years</time_frame>
    <description>Baseline mean Muscular Mass values will be measured and compared at 3, 6, 12 and 24 months. Muscular Mass will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale. Fatty mass is measured as a Kg.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes from baseline Corporal Water .</measure>
    <time_frame>At baseline (0 years) and followed for 2 years</time_frame>
    <description>Baseline mean Corporal Water values will be measured and compared at 3, 6, 12 and 24 months. Corporal Water will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale. Fatty mass is measured as a Kg.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence to dietary pattern will be also measured through personal interview</measure>
    <time_frame>At baseline (0 years) and followed for 2 years</time_frame>
    <description>Participants will be subjected for an intervention based on nutritional (control group) and physical education (two intervention arms) during 24 months. Partial measures will be also taken every week. In the end of the trial, changes in dietary patterns will be measured comparing means differences between baselines, 3, 6, 12 and 24 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence to physical activity patterns will be also measured through IPAQ (International Physical Activity Questionnaire).</measure>
    <time_frame>At baseline (0 years) and followed for 2 years</time_frame>
    <description>Participants will be subjected for an intervention based on nutritional (control group) and physical education (two intervention arms) during 24 months. Partial measures will be also taken every week. In the end of the trial, changes in physical activity will be measured comparing means differences between baselines, 3, 6, 12 and 24 months.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">220</enrollment>
  <condition>Overweight</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Control Group (CON)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>education and modifying diet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Moderate physical activity Group (PAM)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>education, modifying diet and physical activity prescription</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intensity physical activity Group (PAI)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>education, modifying diet and physical activity prescription</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>education and modifying diet</intervention_name>
    <description>The control group maintains a sedentary lifestyle and is only subjected to follow a hypocaloric diet</description>
    <arm_group_label>Control Group (CON)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>education, modifying diet and physical activity prescription</intervention_name>
    <description>One group, in addition to fulfilling a hypocaloric diet identical to the control group, is subjected to prescribe moderate physical activity.&#xD;
Other group, in addition to fulfilling a hypocaloric diet identical to the control and moderate group, is subjected to prescribe intense activity.</description>
    <arm_group_label>Intensity physical activity Group (PAI)</arm_group_label>
    <arm_group_label>Moderate physical activity Group (PAM)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Having a body fat percentage &gt;30&#xD;
&#xD;
          -  Having a BMI &gt;25&#xD;
&#xD;
          -  Being sedentary and&#xD;
&#xD;
          -  Have not been submitted to a restrictive diet in the 6 months preceding this study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Suffered from type 2 diabetes or renal conditions&#xD;
&#xD;
          -  Being pregnancy or attempt at pregnancy,&#xD;
&#xD;
          -  Being in a maternal lactation period,&#xD;
&#xD;
          -  Being underage&#xD;
&#xD;
          -  Undergoing antidepressant pharmacological treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alberto Hernández-Reyes</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad de Córdoba</affiliation>
  </overall_official>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>January 20, 2021</last_update_submitted>
  <last_update_submitted_qc>January 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad de Córdoba</investigator_affiliation>
    <investigator_full_name>Alberto Hernández de los Reyes</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>obesity</keyword>
  <keyword>Physical Activity</keyword>
  <keyword>fat mass</keyword>
  <keyword>fat free mass</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03833791
org study id: TESIS-OBESITICS-2018
nct id: NCT03833791
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Compare the Effect of Different Physical Programs on the Body Composition of Adult Women and
      Men With a Total Body Fat Percentage ≥ 30 % at the Beginning of the Test or BMI ≥25
Weight loss by exercise can be frequently deceptive. The focus continues to be centred around
      total body weight and body mass index (BMI), despite the fact that body fat and fat-free mass
      are the indicators that represent the greatest risk in the comorbidity associated with
      obesity. Body weight per se cannot be considered to be reliable; however, its quality can be
      justified, when measured together with the loss in body fat and the maintenance or increase
      in fat-free mass.

      The purpose of the study is compare the effect of different physical programs (FA) on the
      body composition (BC) of adult women with a total body fat percentage ≥ 30 % and adult men
      with a BMI ≥25 at the beginning of the test.

      Participants (n=220, women = 110, men = 110) will be recruited through outpatient from
      private clinics in Cádiz, Andalucía, Spain, as well as through community presentations.
      Overweight or obese and sedentary women and men will be randomly assigned into three groups
      according to different levels of AF. 21 of the participants will be assigned to the sedentary
      control group (METs <2.9), 20 in a group of moderate AF (METs 3-5.9), and 19 will be assigned
      to the group of intense AF (METs >6).

      For 6 months, all of the women shall follow the same diet with an identical distribution of
      macronutrients. There will be a weekly check up of weight, fat, body water and muscle mass
      for all of them.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Investigator)
measure: Changes from baseline BMI.
time frame: At baseline (0 years) and followed for 2 years
description: Baseline mean BMI values will be measured and compared at 3, 6, 12 and 24 months. BMI will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale.
measure: Changes from baseline Fatty mass.
time frame: At baseline (0 years) and followed for 2 years
description: Baseline mean Fatty mass values will be measured and compared at 3, 6, 12 and 24 months. Fatty mass will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale. Fatty mass is measured as a percentage.
measure: Changes from baseline Free-fatty mass.
time frame: At baseline (0 years) and followed for 2 years
description: Baseline mean Free-fatty mass values will be measured and compared at 3, 6, 12 and 24 months. Free-fatty mass will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale. Fatty mass is measured as a percentage.
measure: Changes from baseline Muscular Mass.
time frame: At baseline (0 years) and followed for 2 years
description: Baseline mean Muscular Mass values will be measured and compared at 3, 6, 12 and 24 months. Muscular Mass will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale. Fatty mass is measured as a Kg.
measure: Changes from baseline Corporal Water .
time frame: At baseline (0 years) and followed for 2 years
description: Baseline mean Corporal Water values will be measured and compared at 3, 6, 12 and 24 months. Corporal Water will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale. Fatty mass is measured as a Kg.
measure: Adherence to dietary pattern will be also measured through personal interview
time frame: At baseline (0 years) and followed for 2 years
description: Participants will be subjected for an intervention based on nutritional (control group) and physical education (two intervention arms) during 24 months. Partial measures will be also taken every week. In the end of the trial, changes in dietary patterns will be measured comparing means differences between baselines, 3, 6, 12 and 24 months.
measure: Adherence to physical activity patterns will be also measured through IPAQ (International Physical Activity Questionnaire).
time frame: At baseline (0 years) and followed for 2 years
description: Participants will be subjected for an intervention based on nutritional (control group) and physical education (two intervention arms) during 24 months. Partial measures will be also taken every week. In the end of the trial, changes in physical activity will be measured comparing means differences between baselines, 3, 6, 12 and 24 months.
arm group label: Control Group (CON)
arm group type: Active Comparator
description: education and modifying diet
arm group label: Moderate physical activity Group (PAM)
arm group type: Experimental
description: education, modifying diet and physical activity prescription
arm group label: Intensity physical activity Group (PAI)
arm group type: Experimental
description: education, modifying diet and physical activity prescription
intervention type: Behavioral
intervention name: education and modifying diet
description: The control group maintains a sedentary lifestyle and is only subjected to follow a hypocaloric diet
arm group label: Control Group (CON)
intervention type: Behavioral
intervention name: education, modifying diet and physical activity prescription
description: One group, in addition to fulfilling a hypocaloric diet identical to the control group, is subjected to prescribe moderate physical activity.
Other group, in addition to fulfilling a hypocaloric diet identical to the control and moderate group, is subjected to prescribe intense activity.
arm group label: Intensity physical activity Group (PAI)
arm group label: Moderate physical activity Group (PAM)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Alberto Hernández-Reyes
role: Principal Investigator
affiliation: Universidad de Córdoba
responsible party type: Principal Investigator
investigator affiliation: Universidad de Córdoba
investigator full name: Alberto Hernández de los Reyes
investigator title: Principal Investigator
mesh term: Overweight
sharing ipd: No