xml: <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/NCT05966259</url>
    </required_header>
    <id_info>
      <org_study_id>39508720.6.0000.5149</org_study_id>
      <nct_id>NCT05966259</nct_id>
    </id_info>
    <brief_title>Management of Childhood Obesity</brief_title>
    <official_title>Management of Childhood Obesity in the Context of Primary Health Care: an Intensive Multi-level Intervention</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Adaliene Versiani M. Ferreira</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Conselho Nacional de Desenvolvimento Científico e Tecnológico</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Fundacion MAPFRE</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Federal University of Minas Gerais</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>
        The significant increase in the prevalence of obesity can also be attributed to various&#xD;
        social changes, in which the environment (political, economic, social, cultural), and not&#xD;
        only the individual and his choices, takes a strategic place in the analysis of the problem&#xD;
        and proposed interventions. The food environment can influence the choice and consumption of&#xD;
        foods that promote obesity, such as ultra-processed foods (UPA). It is suggested that to&#xD;
        intervene to effectively change behavior and eating habits, intensive interventions are&#xD;
        needed that consider multiple levels that include the family, school, and community rather&#xD;
        than one-off interventions that may not be effective in changing behavior and lifestyle.&#xD;
        Regarding the family environment, parents or guardians can assist in the adoption of&#xD;
        obesity-related behavioral patterns. It is known that the context of Primary Health Care&#xD;
        (PHC) is ideal for actions to prevent diseases and promote children's health, since the PHC&#xD;
        professional team is closest to the reality of life of the child, family, and community. We&#xD;
        emphasize the importance of this study from the perspective of treatment of childhood&#xD;
        obesity, in order to generate scientific evidence and practical subsidies for the&#xD;
        implementation of interventions focused not only on the individual, but also in the context&#xD;
        of the Unified Health System (SUS). The hypothesis of the study is that there will be a&#xD;
        decrease in the consumption of ultra-processed foods (UPA) among children, aged 6 to 10&#xD;
        years, living with obesity and who are treated in primary health care. In addition to&#xD;
        encouraging healthy habits such as physical activity and the consumption of in natura and&#xD;
        minimally processed foods. The management of childhood obesity is one of the priority topics&#xD;
        on the national agenda of SUS's food, nutrition, and health promotion policies.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 11, 2023</start_date>
    <completion_date type="Anticipated">July 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2024</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>
      <intervention_model_description>Intervention Group: intensive multilevel intervention, with a minimum of 26 contact hours, for a period of 5 months. The children will be re-evaluated in the eighth month (three months after intervention) and in the eleventh month (six months after intervention). The monthly activities were composed of four weekly contacts: Individual Attendance, Food and Nutrition Education (at home), Group Food and Nutrition Education in the basic health unit and Telephone monitoring. There will be five monthly themes: food, physical activity, sedentary behavior, sleep, and mental health. The children in the Control Group were followed in a similar way, observing the activities so that they did not exceed 26 hours of contact, during the 5 months.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Consumption of ultra-processed foods</measure>
      <time_frame>After 5 months</time_frame>
      <description>10% reduction in consumption of ultra-processed foods</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>BMI Z score by age</measure>
      <time_frame>After completion of the study (12 months)</time_frame>
      <description>Reduce and/or maintain BMI Z score by age</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">78</enrollment>
    <condition>Childhood Obesity</condition>
    <condition>Pediatric Obesity</condition>
    <arm_group>
      <arm_group_label>Intervention Group- Intensive Multilevel Intervention</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Intervention Group: intensive multilevel intervention, with a minimum of 26 contact hours, for a period of 5 months. The children will be re-evaluated in the eighth month (three months after intervention) and in the eleventh month (six months after intervention). The monthly activities were composed of four weekly contacts: Individual Attendance, Food and Nutrition Education (at home), Group Food and Nutrition Education in the basic health unit and Telephone monitoring. There will be five monthly themes: food, physical activity, sedentary behavior, sleep, and mental health.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>The children in the Control Group were followed in a similar way, observing the activities so that they did not exceed 26 hours of contact, during the 5 months.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Intervention Group- Intensive Multilevel Intervention</intervention_name>
      <description>intensive multilevel intervention, with a minimum of 26 contact hours, for a period of 5 months. The children will be re-evaluated in the eighth month (three months after intervention) and in the eleventh month (six months after intervention). The monthly activities were composed of four weekly contacts: Individual Attendance, Food and Nutrition Education (at home), Group Food and Nutrition Education in the basic health unit and Telephone monitoring. There will be five monthly themes: food, physical activity, sedentary behavior, sleep, and mental health.</description>
      <arm_group_label>Intervention Group- Intensive Multilevel Intervention</arm_group_label>
      <other_name>Intensive Multilevel Intervention</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Control Group</intervention_name>
      <description>The children in the Control Group were followed in a similar way, observing the activities so that they did not exceed 26 hours of contact, during the 5 months.</description>
      <arm_group_label>Control Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  child classified as obesity by values equal to or greater than z-score +2 for BMI/age&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  children with severe mental disorders&#xD;
  &#xD;
            -  children on weight loss medication and with comorbidities associated with obesity&#xD;
  &#xD;
            -  children participating in any diet and physical activity program for weight&#xD;
               loss/maintenance&#xD;
  &#xD;
            -  parents/guardians who do not agree to participate and do not sign the informed consent&#xD;
               form&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Years</minimum_age>
      <maximum_age>10 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Larissa L Mendes, Doctor</last_name>
      <role>Principal Investigator</role>
      <affiliation>UFMG</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Larissa L Mendes, Doctor</last_name>
      <phone>+55 31 9687-7827</phone>
      <email>larissa.mendesloures@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Universidade Federal de Minas Gerais</name>
        <address>
          <city>Belo Horizonte</city>
          <state>Minas Gerais</state>
          <zip>30130100</zip>
          <country>Brazil</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Larissa L Mendes, Doctor</last_name>
        <phone>+55 31 9687-7827</phone>
        <email>larissa.mendesloures@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Brazil</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Federal University of Minas Gerais</investigator_affiliation>
      <investigator_full_name>Adaliene Versiani M. Ferreira</investigator_full_name>
      <investigator_title>Doctor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Obesity</mesh_term>
      <mesh_term>Pediatric Obesity</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05966259
  org study id: 39508720.6.0000.5149
  nct id: NCT05966259
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The significant increase in the prevalence of obesity can also be attributed to various
        social changes, in which the environment (political, economic, social, cultural), and not
        only the individual and his choices, takes a strategic place in the analysis of the problem
        and proposed interventions. The food environment can influence the choice and consumption of
        foods that promote obesity, such as ultra-processed foods (UPA). It is suggested that to
        intervene to effectively change behavior and eating habits, intensive interventions are
        needed that consider multiple levels that include the family, school, and community rather
        than one-off interventions that may not be effective in changing behavior and lifestyle.
        Regarding the family environment, parents or guardians can assist in the adoption of
        obesity-related behavioral patterns. It is known that the context of Primary Health Care
        (PHC) is ideal for actions to prevent diseases and promote children's health, since the PHC
        professional team is closest to the reality of life of the child, family, and community. We
        emphasize the importance of this study from the perspective of treatment of childhood
        obesity, in order to generate scientific evidence and practical subsidies for the
        implementation of interventions focused not only on the individual, but also in the context
        of the Unified Health System (SUS). The hypothesis of the study is that there will be a
        decrease in the consumption of ultra-processed foods (UPA) among children, aged 6 to 10
        years, living with obesity and who are treated in primary health care. In addition to
        encouraging healthy habits such as physical activity and the consumption of in natura and
        minimally processed foods. The management of childhood obesity is one of the priority topics
        on the national agenda of SUS's food, nutrition, and health promotion policies.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Intervention Group: intensive multilevel intervention, with a minimum of 26 contact hours, for a period of 5 months. The children will be re-evaluated in the eighth month (three months after intervention) and in the eleventh month (six months after intervention). The monthly activities were composed of four weekly contacts: Individual Attendance, Food and Nutrition Education (at home), Group Food and Nutrition Education in the basic health unit and Telephone monitoring. There will be five monthly themes: food, physical activity, sedentary behavior, sleep, and mental health. The children in the Control Group were followed in a similar way, observing the activities so that they did not exceed 26 hours of contact, during the 5 months.
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Consumption of ultra-processed foods
  time frame: After 5 months
  description: 10% reduction in consumption of ultra-processed foods
  measure: BMI Z score by age
  time frame: After completion of the study (12 months)
  description: Reduce and/or maintain BMI Z score by age
  arm group label: Intervention Group- Intensive Multilevel Intervention
  arm group type: Other
  description: Intervention Group: intensive multilevel intervention, with a minimum of 26 contact hours, for a period of 5 months. The children will be re-evaluated in the eighth month (three months after intervention) and in the eleventh month (six months after intervention). The monthly activities were composed of four weekly contacts: Individual Attendance, Food and Nutrition Education (at home), Group Food and Nutrition Education in the basic health unit and Telephone monitoring. There will be five monthly themes: food, physical activity, sedentary behavior, sleep, and mental health.
  arm group label: Control Group
  arm group type: Other
  description: The children in the Control Group were followed in a similar way, observing the activities so that they did not exceed 26 hours of contact, during the 5 months.
  intervention type: Other
  intervention name: Intervention Group- Intensive Multilevel Intervention
  description: intensive multilevel intervention, with a minimum of 26 contact hours, for a period of 5 months. The children will be re-evaluated in the eighth month (three months after intervention) and in the eleventh month (six months after intervention). The monthly activities were composed of four weekly contacts: Individual Attendance, Food and Nutrition Education (at home), Group Food and Nutrition Education in the basic health unit and Telephone monitoring. There will be five monthly themes: food, physical activity, sedentary behavior, sleep, and mental health.
  arm group label: Intervention Group- Intensive Multilevel Intervention
  other name: Intensive Multilevel Intervention
  intervention type: Other
  intervention name: Control Group
  description: The children in the Control Group were followed in a similar way, observing the activities so that they did not exceed 26 hours of contact, during the 5 months.
  arm group label: Control Group
  criteria: 
  gender: All
  minimum age: 6 Years
  maximum age: 10 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Larissa L Mendes, Doctor
  role: Principal Investigator
  affiliation: UFMG
  last name: Larissa L Mendes, Doctor
  phone: +55 31 9687-7827
  email: larissa.mendesloures@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Brazil
  responsible party type: Sponsor-Investigator
  investigator affiliation: Federal University of Minas Gerais
  investigator full name: Adaliene Versiani M. Ferreira
  investigator title: Doctor
  mesh term: Obesity
  mesh term: Pediatric Obesity