<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/NCT03269513</url>
  </required_header>
  <id_info>
    <org_study_id>UNISC</org_study_id>
    <nct_id>NCT03269513</nct_id>
  </id_info>
  <brief_title>OBESITY IN SCHOOLCHILDREN OF BASIC EDUCATION - Phase III 2017</brief_title>
  <official_title>OBESITY IN SCHOOLCHILDREN OF BASIC EDUCATION: a Study Interdisciplinary Intervention - Phase III</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Santa Cruz do Sul</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Santa Cruz do Sul</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The study aims to evaluate the possible effects of an exercise program, nutritional and&#xD;
      psychological, postural orientation and guidance of oral health on body composition, physical&#xD;
      activity levels and lifestyle, physical fitness and health and motor performance, the factors&#xD;
      risk of cardiovascular disease, eating habits, the cognition levels, the psychological&#xD;
      profile, the body posture of children and adolescent with overweight and obesity, considering&#xD;
      the presence of risk genotype associated with the development of obesity. In addition,&#xD;
      identify the effects of orientation for oral health on the quality of life and healthy oral&#xD;
      habits.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">August 23, 2017</start_date>
  <completion_date type="Anticipated">December 8, 2017</completion_date>
  <primary_completion_date type="Anticipated">November 23, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from body mass index (BMI) at 3 months</measure>
    <time_frame>Baseline and 3 months.</time_frame>
    <description>Weight and height will be evaluated early in the morning in a fasting state, with the student wearing light clothing and shoes. The BMI will be classified as normal BMI, overweight or obesity.The BMI will be classified according to the percentage curves of the Centers for Disease Control and Prevention / National Center for Health Statistics (CDC/NCHS) (2010) according to gender and age, considering the low weight (&lt;p5), normal weight (p5 and &lt;p85), overweight (p 85 and &lt;p 95) and obesity (p 95).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from the percentage of body fat at 3 months</measure>
    <time_frame>Baseline and 3 months.</time_frame>
    <description>To measure body fat percentage (BF%), a Lange (Beta Technology Incorporated) compass will be used to measure triceps and subscapular skinfolds. The equation of Slaughter et al. (1998) will be applied, and data will be classified according to Lonman's data, as mentioned by Heyward and Stolarczyk (2000).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from the waist circumference (WC) at 3 months</measure>
    <time_frame>Baseline and 3 months.</time_frame>
    <description>Waist circumference (WC) was measured with an inelastic tape, using the narrowest part of the trunk between the ribs and the iliac crest and the hip at the greater trochanter level as references. The subjects were then classified according to Taylor et al. (2000), defining the normal circumference percentile as &lt;80 and obesity percentile as &gt;80 according to gender and age.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Obesity</condition>
  <condition>Overweight</condition>
  <condition>Adolescent Obesity</condition>
  <condition>Exercise</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adolescent Obesity&#xD;
The exercise program, nutritional counseling and oral health will last for five to three months and will be held in the gym and rooms of the University of Santa Cruz do Sul (UNISC).&#xD;
The sessions will last two hours (one hour of physical exercise and the second time divided into nutritional counseling, postural, psychological and oral) with a frequency of three times a week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Physical Exercise</intervention_name>
    <description>The sessions will last two hours (one hour of physical exercise and the second time divided into nutritional counseling, postural, psychological and oral) with a frequency of three times a week.</description>
    <arm_group_label>Intervention group</arm_group_label>
    <other_name>Nutritional counseling</other_name>
    <other_name>Psychological counseling</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The official signing the informed consent and informed;&#xD;
&#xD;
          -  The student with 12 years or older must sign the consent term;&#xD;
&#xD;
          -  Age range: 10 to 17;&#xD;
&#xD;
          -  Gender: male and female;&#xD;
&#xD;
          -  No contraindications for blood collection;&#xD;
&#xD;
          -  No distinction in relation to social class, ethnicity or color;&#xD;
&#xD;
          -  To have a BMI greater than 85th percentile;&#xD;
&#xD;
          -  Do not be participating in any other exercise program and dietary intervention;&#xD;
&#xD;
          -  Participate in the clarification meetings on the project, when the head of the student&#xD;
             is committed to the project, the following: a) assume responsibility for bringing to&#xD;
             the UNISC (building 42) and refer to their home, the participant student of this&#xD;
             study, both in the days of assessment (testing and completion of the data collection&#xD;
             instruments), as in the days of intervention: 2nd, 4th and 6th fairs, from 14h to 16h,&#xD;
             including 15 minutes in advance to the host, call and guidance students;&#xD;
&#xD;
          -  Participate in intervention sessions during the period of 2 hours daily, the&#xD;
             established days, following the guidelines given by the coordination of the project&#xD;
             and the professionals of Physical Education, Nutrition, Psychology, Pharmacy,&#xD;
             Physiotherapy, Medicine, Nursing and / or another area of health / education that can&#xD;
             contribute to achieving the objectives of the intervention project;&#xD;
&#xD;
          -  Participate in the assessments and reassessments as protocols established by the&#xD;
             project.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Students who submit a frequency less than 70% stake in the intervention;&#xD;
&#xD;
          -  Students who present contraindication to the practice of physical activity during the&#xD;
             program implementation period;&#xD;
&#xD;
          -  Students who choose not to continue with the treatment of intervention proposed by the&#xD;
             program;&#xD;
&#xD;
          -  Be in possession of any kind of illness, abnormality or health problem such as:&#xD;
&#xD;
               -  Hypertension untreated, Kidney diseases, Cardiac disorders, chronic renal&#xD;
                  failure, genetic diseases that have congenital malformations and mental&#xD;
                  retardation as Turner syndrome, Klinefelter syndrome and Down syndrome or&#xD;
                  cognitive impairment. And do not be carrying transmitted diseases vertically&#xD;
                  (from mother to child) with anatomical deformations caused by the interference of&#xD;
                  the pathogenic agent in the development process, as Congenital Toxoplasmosis&#xD;
                  (hydrocephalus, cerebral calcification, mental retardation, acute myocarditis,&#xD;
                  retinochoroiditis, strabismus, microphthalmia ), Rubella Syndrome, congenital&#xD;
                  (deafness, congenital cataracts, heart defects, microcephaly and mental&#xD;
                  retardation) congenital Syphilis (bone deformities, keratitis, deafness and&#xD;
                  mental retardation), cytomegalovirus infection congenital (microcephaly,&#xD;
                  intracranial calcifications and sensorineural deafness), because these subjects&#xD;
                  they need special care medical and/or service people trained for the specific&#xD;
                  purposes.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Miria S Burgos, Dra</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade de Santa Cruz do Sul</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universidade de Santa Cruz do Sul</name>
      <address>
        <city>Santa Cruz do Sul</city>
        <state>Rio Grande do Sul</state>
        <zip>96815900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>August 30, 2017</last_update_submitted>
  <last_update_submitted_qc>August 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Santa Cruz do Sul</investigator_affiliation>
    <investigator_full_name>Miria Suzana Burgos</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Pediatric Obesity</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/NCT03269513
org study id: UNISC
nct id: NCT03269513
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study aims to evaluate the possible effects of an exercise program, nutritional and
      psychological, postural orientation and guidance of oral health on body composition, physical
      activity levels and lifestyle, physical fitness and health and motor performance, the factors
      risk of cardiovascular disease, eating habits, the cognition levels, the psychological
      profile, the body posture of children and adolescent with overweight and obesity, considering
      the presence of risk genotype associated with the development of obesity. In addition,
      identify the effects of orientation for oral health on the quality of life and healthy oral
      habits.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Change from body mass index (BMI) at 3 months
time frame: Baseline and 3 months.
description: Weight and height will be evaluated early in the morning in a fasting state, with the student wearing light clothing and shoes. The BMI will be classified as normal BMI, overweight or obesity.The BMI will be classified according to the percentage curves of the Centers for Disease Control and Prevention / National Center for Health Statistics (CDC/NCHS) (2010) according to gender and age, considering the low weight (<p5), normal weight (p5 and <p85), overweight (p 85 and <p 95) and obesity (p 95).
measure: Change from the percentage of body fat at 3 months
time frame: Baseline and 3 months.
description: To measure body fat percentage (BF%), a Lange (Beta Technology Incorporated) compass will be used to measure triceps and subscapular skinfolds. The equation of Slaughter et al. (1998) will be applied, and data will be classified according to Lonman's data, as mentioned by Heyward and Stolarczyk (2000).
measure: Change from the waist circumference (WC) at 3 months
time frame: Baseline and 3 months.
description: Waist circumference (WC) was measured with an inelastic tape, using the narrowest part of the trunk between the ribs and the iliac crest and the hip at the greater trochanter level as references. The subjects were then classified according to Taylor et al. (2000), defining the normal circumference percentile as <80 and obesity percentile as >80 according to gender and age.
arm group label: Intervention group
arm group type: Experimental
description: Adolescent Obesity
The exercise program, nutritional counseling and oral health will last for five to three months and will be held in the gym and rooms of the University of Santa Cruz do Sul (UNISC).
The sessions will last two hours (one hour of physical exercise and the second time divided into nutritional counseling, postural, psychological and oral) with a frequency of three times a week.
arm group label: Control group
arm group type: No Intervention
intervention type: Behavioral
intervention name: Physical Exercise
description: The sessions will last two hours (one hour of physical exercise and the second time divided into nutritional counseling, postural, psychological and oral) with a frequency of three times a week.
arm group label: Intervention group
other name: Nutritional counseling
other name: Psychological counseling
criteria: 
gender: All
minimum age: 10 Years
maximum age: 17 Years
healthy volunteers: No
last name: Miria S Burgos, Dra
role: Principal Investigator
affiliation: Universidade de Santa Cruz do Sul
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Santa Cruz do Sul
investigator full name: Miria Suzana Burgos
investigator title: Principal Investigator
mesh term: Obesity
mesh term: Overweight
mesh term: Pediatric Obesity