<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/NCT02228447</url>
  </required_header>
  <id_info>
    <org_study_id>FSP_14</org_study_id>
    <nct_id>NCT02228447</nct_id>
  </id_info>
  <brief_title>Healthy Habits, Healthy Girls Preventing Unhealthy Weight Gain</brief_title>
  <official_title>Healthy Habits, Healthy Girls: a Intervention Program for Adolescent Girls From Disadvantaged Backgrounds</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the impact of a multicomponent school-based&#xD;
      intervention based on Bandura's Social Cognitive Theory targeting healthy eating and physical&#xD;
      activity for high school adolescent girls from low-income communities in the city of São&#xD;
      Paulo, Brazil.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The &quot;Healthy Habits, Healthy Girls&quot; is a 6-month multi-component school-based intervention&#xD;
      developed in reference to Social Cognitive Theory and includes: (1) enhanced physical&#xD;
      education classes (2x/week and delivered by a Physical Education teacher), (2)&#xD;
      break/lunch-time physical activity sessions (the participating girls will encourage younger&#xD;
      girls to make Physical Activity during break and/or lunch-time. This session will only happen&#xD;
      after 3 months of enhanced Physical Education classes, so the girls will be able to pass&#xD;
      their knowledge for the others), (3) Nutrition and Physical Activity handbooks with 10 health&#xD;
      messages (lessons to be done at home and their family); (4) 4 Parent newsletters; (5) Food&#xD;
      and Physical Activity diaries for self-monitoring; (6) text-messages using a group&#xD;
      application for more interaction and social support; and (7) 10 weekly Nutrition and Physical&#xD;
      Activity key messages (delivered by a Nutrition and Dietetics Bachelor degree and/or Physical&#xD;
      Education teacher during break). The intervention will be evaluated using a randomised&#xD;
      controlled trial in 10 public schools in the city of São Paulo, Brazil (5 control and 5&#xD;
      intervention) and based on the 10 weekly key messages: (1) eat fruit and vegetables daily;&#xD;
      (2) Do Physical Activity respecting your limits; (3) Eat a healthy breakfast every day; (4)&#xD;
      Do Physical Activity with your family and friends; (5) Control the portion size you eat&#xD;
      during meals - and sit while you are eating; (6) Reduce your sitting time during school&#xD;
      break, after the school period and on the weekends; (7) Have less &quot;junk food&quot; for&#xD;
      meals/snacks and munch less; (8) Identify the excuses for not practicing PA; (9) Drink water&#xD;
      and substitute sodas and artificial juices for water, homemade natural fruit juices and&#xD;
      coconut water, and; (10)Make family meals.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>February 2014</start_date>
  <completion_date type="Anticipated">February 2015</completion_date>
  <primary_completion_date type="Actual">August 2014</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>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Body Mass Index</measure>
    <time_frame>1 year</time_frame>
    <description>Weight will be measured to the nearest 0.1kg without shoes, in light clothes using a portable digital scale and height was recorded to the nearest 0.1cm using a portable stadiometer. BMI was calculated using the standard equation (weight [kg]/height [m2]) and BMI z-score was calculated using the &quot;LMS&quot; method</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dietary intake</measure>
    <time_frame>1 year</time_frame>
    <description>Dietary intake was assessed a 49-item semi-quantitative food-frequency questionnaire (FFQ) Subjects were asked about their consumption over the previous 12-months. The frequency options ranged from &quot;Never&quot; to &quot;at least twice a day&quot; for all the items.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity level</measure>
    <time_frame>1 year</time_frame>
    <description>PA was assessed using a brief PA questionnaire that aims to evaluate the PA frequency and intensity realized in one week. The subjects should inform the number of times of light-to-vigorous intensity PA practiced for at least 30 minutes during a period of seven days (i.e., week and weekends).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sedentary behaviors</measure>
    <time_frame>1 year</time_frame>
    <description>The subjects reported the time spent during the weekdays (Monday through Friday) and weekends (Saturday and Sunday) in the following activities: watching television/videos/DVDs, using the computer for leisure activities (games and social networks), using telephone and studying, reading or doing homework.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity social-cognitive mediators</measure>
    <time_frame>1 year</time_frame>
    <description>Social cognitive scales for dietary and PA behaviors based on constructs from Social Cognitive Theory were adapted and designed for the study. Participants will complete PA scales for the following constructs: self-efficacy, intentions, family and friends support, environment perceptions (situation), behavioral strategies (self-control), outcome expectations (perceived benefits) and outcome expectancies (valued placed on benefits).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary social cognitive mediators</measure>
    <time_frame>1 year</time_frame>
    <description>Social cognitive scales for dietary behaviors based on constructs from Social Cognitive Theory were adapted and designed for the study. Participants will complete dietary scales for the following constructs: self-efficacy, intentions, family and friends support, environment perceptions (situation), behavioral strategies (self-control), outcome expectations (perceived benefits) and outcome expectancies (valued placed on benefits)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist circunference</measure>
    <time_frame>1 year</time_frame>
    <description>waist circumference will be measured to the nearest 0.1cm against the skin using a non-extensible steel tape in line with the umbilicus.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">244</enrollment>
  <condition>Overweight</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>No intervention group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will not receive any intervention during the one year of this study. Only the baseline, 6-12 months assessments (anthropometrics, PA, dietary intake, social cognitive mediators and sedentary behaviors). To prevent compensatory rivalry and resentful demoralization, the control school will be provided with a condensed version of the following 12-month assessments. The condensed version of the program will include the professional learning workshops for intervention schools and the intervention materials (i.e., nutrition and PA handbooks and PA leadership handbook).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy habits, healthy girls group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention group will receive a 6-month multicomponent intervention (i.e., enhanced physical education classes; interactive seminars; nutrition workshops; text messages; and parents newsletters) and materials (i.e., nutrition and PA handbooks; cooking books; Choreographies CDs and PA leadership handbook).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Healthy Habits, Healthy Girls Group</intervention_name>
    <description>The intervention group will receive a 6-month multicomponent intervention (i.e., enhanced physical education classes; interactive seminars; nutrition workshops; text messages; and parents newsletters) and materials (i.e., nutrition and PA handbooks; cooking books; Choreographies CDs and PA leadership handbook).</description>
    <arm_group_label>Healthy habits, healthy girls group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Adolescent girls from low-income backgrounds enrolled in high schools of the city of São&#xD;
        Paulo, Brazil.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Adolescent boys&#xD;
&#xD;
          -  Adolescents from middle and high income backgrounds&#xD;
&#xD;
          -  Pregnant&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sonia Tucunduva Philippi, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>School of Public Health University of São Paulo</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ana Carolina Barco Leme, Master</last_name>
    <role>Principal Investigator</role>
    <affiliation>School of Public Health, University of São Paulo</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ana Carolina Leme, Master</last_name>
    <phone>+551130617872</phone>
    <email>leme.acarolina@usp.br</email>
  </overall_contact>
  <location>
    <facility>
      <name>School of Public Health, University of São Paulo</name>
      <address>
        <city>São Paulo</city>
        <zip>01246-904</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sonia Tucunduva Philippi, PhD</last_name>
      <phone>+551130617872</phone>
      <email>philippi@usp.br</email>
    </contact>
    <contact_backup>
      <last_name>Ana Barco Leme, Master</last_name>
      <phone>+5511981859721</phone>
      <email>leme.acarolina@usp.br</email>
    </contact_backup>
    <investigator>
      <last_name>Ana Carolina Barco Leme, Master</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sonia Tucunduva Philippi, PHD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <last_update_submitted>August 29, 2014</last_update_submitted>
  <last_update_submitted_qc>August 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 3, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Sonia Tucunduva Philippi</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Adolescent</keyword>
  <keyword>Randomized controlled trial</keyword>
  <keyword>Eating behavior</keyword>
  <keyword>Physical Activity</keyword>
  <keyword>Sedentary lifestyle</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT02228447
org study id: FSP_14
nct id: NCT02228447
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the impact of a multicomponent school-based
      intervention based on Bandura's Social Cognitive Theory targeting healthy eating and physical
      activity for high school adolescent girls from low-income communities in the city of São
      Paulo, Brazil.
The "Healthy Habits, Healthy Girls" is a 6-month multi-component school-based intervention
      developed in reference to Social Cognitive Theory and includes: (1) enhanced physical
      education classes (2x/week and delivered by a Physical Education teacher), (2)
      break/lunch-time physical activity sessions (the participating girls will encourage younger
      girls to make Physical Activity during break and/or lunch-time. This session will only happen
      after 3 months of enhanced Physical Education classes, so the girls will be able to pass
      their knowledge for the others), (3) Nutrition and Physical Activity handbooks with 10 health
      messages (lessons to be done at home and their family); (4) 4 Parent newsletters; (5) Food
      and Physical Activity diaries for self-monitoring; (6) text-messages using a group
      application for more interaction and social support; and (7) 10 weekly Nutrition and Physical
      Activity key messages (delivered by a Nutrition and Dietetics Bachelor degree and/or Physical
      Education teacher during break). The intervention will be evaluated using a randomised
      controlled trial in 10 public schools in the city of São Paulo, Brazil (5 control and 5
      intervention) and based on the 10 weekly key messages: (1) eat fruit and vegetables daily;
      (2) Do Physical Activity respecting your limits; (3) Eat a healthy breakfast every day; (4)
      Do Physical Activity with your family and friends; (5) Control the portion size you eat
      during meals - and sit while you are eating; (6) Reduce your sitting time during school
      break, after the school period and on the weekends; (7) Have less "junk food" for
      meals/snacks and munch less; (8) Identify the excuses for not practicing PA; (9) Drink water
      and substitute sodas and artificial juices for water, homemade natural fruit juices and
      coconut water, and; (10)Make family meals.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Body Mass Index
time frame: 1 year
description: Weight will be measured to the nearest 0.1kg without shoes, in light clothes using a portable digital scale and height was recorded to the nearest 0.1cm using a portable stadiometer. BMI was calculated using the standard equation (weight [kg]/height [m2]) and BMI z-score was calculated using the "LMS" method
measure: Dietary intake
time frame: 1 year
description: Dietary intake was assessed a 49-item semi-quantitative food-frequency questionnaire (FFQ) Subjects were asked about their consumption over the previous 12-months. The frequency options ranged from "Never" to "at least twice a day" for all the items.
measure: Physical activity level
time frame: 1 year
description: PA was assessed using a brief PA questionnaire that aims to evaluate the PA frequency and intensity realized in one week. The subjects should inform the number of times of light-to-vigorous intensity PA practiced for at least 30 minutes during a period of seven days (i.e., week and weekends).
measure: Sedentary behaviors
time frame: 1 year
description: The subjects reported the time spent during the weekdays (Monday through Friday) and weekends (Saturday and Sunday) in the following activities: watching television/videos/DVDs, using the computer for leisure activities (games and social networks), using telephone and studying, reading or doing homework.
measure: Physical activity social-cognitive mediators
time frame: 1 year
description: Social cognitive scales for dietary and PA behaviors based on constructs from Social Cognitive Theory were adapted and designed for the study. Participants will complete PA scales for the following constructs: self-efficacy, intentions, family and friends support, environment perceptions (situation), behavioral strategies (self-control), outcome expectations (perceived benefits) and outcome expectancies (valued placed on benefits).
measure: Dietary social cognitive mediators
time frame: 1 year
description: Social cognitive scales for dietary behaviors based on constructs from Social Cognitive Theory were adapted and designed for the study. Participants will complete dietary scales for the following constructs: self-efficacy, intentions, family and friends support, environment perceptions (situation), behavioral strategies (self-control), outcome expectations (perceived benefits) and outcome expectancies (valued placed on benefits)
measure: Waist circunference
time frame: 1 year
description: waist circumference will be measured to the nearest 0.1cm against the skin using a non-extensible steel tape in line with the umbilicus.
arm group label: No intervention group
arm group type: No Intervention
description: The control group will not receive any intervention during the one year of this study. Only the baseline, 6-12 months assessments (anthropometrics, PA, dietary intake, social cognitive mediators and sedentary behaviors). To prevent compensatory rivalry and resentful demoralization, the control school will be provided with a condensed version of the following 12-month assessments. The condensed version of the program will include the professional learning workshops for intervention schools and the intervention materials (i.e., nutrition and PA handbooks and PA leadership handbook).
arm group label: Healthy habits, healthy girls group
arm group type: Experimental
description: The intervention group will receive a 6-month multicomponent intervention (i.e., enhanced physical education classes; interactive seminars; nutrition workshops; text messages; and parents newsletters) and materials (i.e., nutrition and PA handbooks; cooking books; Choreographies CDs and PA leadership handbook).
intervention type: Behavioral
intervention name: Healthy Habits, Healthy Girls Group
description: The intervention group will receive a 6-month multicomponent intervention (i.e., enhanced physical education classes; interactive seminars; nutrition workshops; text messages; and parents newsletters) and materials (i.e., nutrition and PA handbooks; cooking books; Choreographies CDs and PA leadership handbook).
arm group label: Healthy habits, healthy girls group
criteria: 
gender: Female
minimum age: 14 Years
maximum age: 19 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sonia Tucunduva Philippi, PhD
role: Study Chair
affiliation: School of Public Health University of São Paulo
last name: Ana Carolina Barco Leme, Master
role: Principal Investigator
affiliation: School of Public Health, University of São Paulo
last name: Ana Carolina Leme, Master
phone: +551130617872
email: leme.acarolina@usp.br
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Sonia Tucunduva Philippi
investigator title: Associate Professor
mesh term: Overweight