<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/NCT01679938</url>
  </required_header>
  <id_info>
    <org_study_id>SALUD-2009-01-114027</org_study_id>
    <nct_id>NCT01679938</nct_id>
  </id_info>
  <brief_title>A Child Care-based Obesity Prevention Intervention</brief_title>
  <official_title>Prevention of Obesity in Children: An Intervention Based on Child Care Centers Belonging to the Mexican Institute of Social Security</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Nacional de Salud Publica, Mexico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Council of Science and Technology, Mexico</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Instituto Mexicano del Seguro Social</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Harvard Pilgrim Health Care</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Instituto Nacional de Salud Publica, Mexico</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall objective is to determine the impact of comprehensive, multifaceted, child&#xD;
      care-based intervention to prevent obesity among children 2 through 5 years of age. The&#xD;
      specific aims are:&#xD;
&#xD;
        1. To determine the extent to which the intervention, compared with the control condition,&#xD;
           results in a smaller age-associated increase in body mass index (BMI) after a 6-month&#xD;
           intervention (primary outcome) and a 1-year follow-up period among children.&#xD;
&#xD;
        2. To determine the extent to which the intervention, compared with the control condition,&#xD;
           reduces the proportion of children who are obese (BMI &gt;95th percentile for age and sex).&#xD;
&#xD;
        3. To determine the extent to which the intervention, compared with the control condition,&#xD;
           results in:&#xD;
&#xD;
             1. improved dietary, physical activity and television-viewing behaviors among&#xD;
                children, specifically, reducing the consumption of sugar-sweetened beverages, high&#xD;
                calorie/low nutrient-dense snack foods, and fast food, increasing active time, and&#xD;
                reducing TV/video viewing time;&#xD;
&#xD;
             2. improved home food and activity environment, specifically, decreasing availability&#xD;
                of sugar-sweetened beverages and high calorie/low nutrient-dense snack foods, and&#xD;
                increasing parental support for healthy eating and regular physical activity;&#xD;
&#xD;
             3. improved child care center food and activity environment, specifically, increasing&#xD;
                opportunities for healthy eating and physical activity, and increasing support and&#xD;
                encouragement of children's behavior change by child care providers;&#xD;
&#xD;
        4. To assess the feasibility and acceptability of the intervention among child care&#xD;
           providers and families.&#xD;
&#xD;
      METHODS. The investigators will conduct a cluster-randomized controlled trial in 16 IMSS&#xD;
      child care centers in Mexico City. The investigators will randomly assign 8 child care&#xD;
      centers to the intervention condition and 8 to an assessment-only control condition.&#xD;
&#xD;
      Multifaceted intervention. The resulting intervention will involve four main components:&#xD;
&#xD;
        1. Training of child care providers.&#xD;
&#xD;
        2. Curriculum sessions for children.&#xD;
&#xD;
        3. Family outreach activities.&#xD;
&#xD;
        4. Maintenance activities. Outcome and process measurements. Age-associated BMI (child's),&#xD;
           changes in child's key obesity-related behaviors, changes in the child's home food and&#xD;
           activity environment, and changes in child care food and activity environment. At the&#xD;
           intervention and control child care sites, changes from baseline to one year for all&#xD;
           outcome variables will be measured.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Over the past 20 years, the prevalence of obesity in Mexico has increased dramatically among&#xD;
      individuals across the lifespan, including even the youngest populations.National data from&#xD;
      the Mexican Institute of Social Security (IMSS) population estimate that nearly 15% of&#xD;
      children aged 2 to 5 years are obese as defined by World Health Organization criteria.&#xD;
      Obesity among preschool-aged children is of serious public health concern due to its adverse&#xD;
      effects on children's physical and psychosocial well-being,and its association with obesity&#xD;
      risk in later childhood, adolescence, and young adulthood. Furthermore, because dietary and&#xD;
      activity patterns have not been firmly established, early childhood represents a critical&#xD;
      window for prevention.&#xD;
&#xD;
      Given the high number of preschool children enrolled in out-of-home child care in Mexico,&#xD;
      important opportunities exist for developing child care-based obesity prevention&#xD;
      interventions focused on promoting healthy activity and dietary behaviors among children.&#xD;
      Child care centers provide an ideal setting for a multi-level, ecologic intervention that&#xD;
      includes strategies aimed at environmental level changes within the child care center, as&#xD;
      well as individual level behavior change among the children. In addition, child care-based&#xD;
      interventions have the potential to reach out to the children's families to improve the&#xD;
      child's home food and activity environment.&#xD;
&#xD;
      Setting and study population. There are 142 IMSS child care centers in Mexico City. To allow&#xD;
      for adequate attention to details in the development of the intervention and evaluation&#xD;
      protocol and to contain costs prior to broad dissemination of the program, the investigators&#xD;
      will focus on 16 IMSS child care sites for this proposal, which together provide care for&#xD;
      approximately 450 children aged 2 to 5 years. At each IMSS child care center a team&#xD;
      consisting of a nutritionist, a nurse, an educator, and child care technicians provides the&#xD;
      daily care and education programs for the children. This extensive personnel structure&#xD;
      provides the ideal infrastructure for implementing the proposed multifaceted intervention.&#xD;
&#xD;
      Since the intervention is a primary prevention program, the investigators will make the&#xD;
      program available to all children, aged 2 to 5 years, at the child care centers, regardless&#xD;
      of their current weight status. Children with chronic conditions that limit ability to&#xD;
      measure height and weight or substantially interfere with growth, physical activity, or&#xD;
      dietary recommendations will be excluded.&#xD;
&#xD;
      Data analysis for outcome measures. Intent-to-treat analyses to compare study outcomes&#xD;
      between the intervention and control groups at post-intervention and at 6-months follow-up&#xD;
      will be used. To compare the difference the age-associated increase in body mass index (BMI)&#xD;
      among intervention and control groups (Aim 1), the mixed effects model with group (child care&#xD;
      center) as the clustering factor will be used, as recommended by several authoritative&#xD;
      sources. Similar analyses to compare the difference in prevalence of overweight (Aim 2), in&#xD;
      the children's weight-related behaviors (Aim 3a), in the children's home environment (Aim&#xD;
      3b), and in the environment of the child care center (Aim 3c) will be performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2011</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">November 2012</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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Child's age-associated Body Mass Index</measure>
    <time_frame>Change from baseline (May 2011) at one year follow-up (November 2012)</time_frame>
    <description>The investigators will measure standing height for all participants over the age of 3 years, and from 2-3 years when possible. For some participants between age 2 and 3 years requiring recumbent lengths, a recumbent board and the recumbent to standing correction factor recommended by the U.S. Centers for Disease Control and Prevention (0.8 cm)will be used.In all cases, BMI will be the ratio of weight (kg) to the square of standing height (m). Accepted definition of obese (BMI &gt;95th percentile for age and sex) and overweight (BMI 85th - 95th percentile for age and sex)will be used. All height and weight measurements will be conducted in a private area at the child care sites.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Children's home environment</measure>
    <time_frame>Change from baseline at one year follow-up.</time_frame>
    <description>To assess the home food and nutrition environment, research staff will conduct in-person surveys with parents using items from the Healthy Home Survey. The Healthy Home Survey was designed to assess key aspects of the diet and activity home environment, including availability of foods, role modeling by parents of behaviors, and parental support for healthy behaviors.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Children's key obesity-related behaviors.</measure>
    <time_frame>Change from baseline at one year of follow-up.</time_frame>
    <description>Research staff will conduct brief, in-person surveys with parents to measure children's obesity-related behaviors. The in-person surveys will include questions about the children's behaviors and the children's home dietary and activity environment and will be conducted at the child care center when parents come to pick up their children.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">640</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>primary obesity prevention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention will involve four main components:&#xD;
Training of child care providers.&#xD;
Curriculum sessions for children.&#xD;
Family outreach activities.&#xD;
Maintenance activities.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>For the control group, usual care will be provided</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>primary obesity prevention</intervention_name>
    <description>Training of child care providers.&#xD;
Curriculum sessions for children. Child care providers will facilitate 12 interactive education sessions that focus on key obesity-related behaviors.&#xD;
Family outreach activities. Child care providers and research staff will communicate behavior change messages to families through ten take-home activities focused on key obesity-related behaviors and through monthly family workshops at the child care center.&#xD;
Maintenance activities. Over the six months following the main intervention, research staff will conduct eight booster sessions for the children and one booster session for the family that will build upon activities and behavior change messages of the main intervention.</description>
    <arm_group_label>primary obesity prevention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  IMSS child care centers with at least 40 children aged 2-4 years&#xD;
&#xD;
          -  Child care center director that is willing to participate in the study and agrees to&#xD;
             be randomized to control or intervention conditions. Since the intervention is a&#xD;
             primary prevention program, the program will be available to all children, aged 2 to 4&#xD;
             years, at the child care centers, regardless of their current weight status&#xD;
&#xD;
          -  Children's parents who sign a consent form indicating their permission for their child&#xD;
             to participate in the study and their willingness to participate in the measurement&#xD;
             activities&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children with chronic conditions that limit ability to measure height and weight or&#xD;
             substantially interfere with growth, physical activity, or dietary recommendations&#xD;
             from the measurement activities&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>4 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hortensia Reyes-Morales, DrSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Instituto Nacional de Salud Publica, Mexico</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Instituto Nacional de Salud Pública</name>
      <address>
        <city>Cuernavaca</city>
        <state>Morelos</state>
        <zip>62100</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <results_reference>
    <citation>Rodriguez-Oliveros G, Haines J, Ortega-Altamirano D, Power E, Taveras EM, Gonzalez-Unzaga MA, Reyes-Morales H. Obesity determinants in Mexican preschool children: parental perceptions and practices related to feeding and physical activity. Arch Med Res. 2011 Aug;42(6):532-9. doi: 10.1016/j.arcmed.2011.10.006. Epub 2011 Oct 21.</citation>
    <PMID>22019411</PMID>
  </results_reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>August 24, 2012</study_first_submitted>
  <study_first_submitted_qc>September 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <last_update_submitted>August 20, 2018</last_update_submitted>
  <last_update_submitted_qc>August 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Instituto Nacional de Salud Publica, Mexico</investigator_affiliation>
    <investigator_full_name>Hortensia Reyes Morales</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>obesity prevention</keyword>
  <keyword>cluster-randomized controlled trial</keyword>
  <keyword>preschool-aged children</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>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/NCT01679938
org study id: SALUD-2009-01-114027
nct id: NCT01679938
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The overall objective is to determine the impact of comprehensive, multifaceted, child
      care-based intervention to prevent obesity among children 2 through 5 years of age. The
      specific aims are:

        1. To determine the extent to which the intervention, compared with the control condition,
           results in a smaller age-associated increase in body mass index (BMI) after a 6-month
           intervention (primary outcome) and a 1-year follow-up period among children.

        2. To determine the extent to which the intervention, compared with the control condition,
           reduces the proportion of children who are obese (BMI >95th percentile for age and sex).

        3. To determine the extent to which the intervention, compared with the control condition,
           results in:

             1. improved dietary, physical activity and television-viewing behaviors among
                children, specifically, reducing the consumption of sugar-sweetened beverages, high
                calorie/low nutrient-dense snack foods, and fast food, increasing active time, and
                reducing TV/video viewing time;

             2. improved home food and activity environment, specifically, decreasing availability
                of sugar-sweetened beverages and high calorie/low nutrient-dense snack foods, and
                increasing parental support for healthy eating and regular physical activity;

             3. improved child care center food and activity environment, specifically, increasing
                opportunities for healthy eating and physical activity, and increasing support and
                encouragement of children's behavior change by child care providers;

        4. To assess the feasibility and acceptability of the intervention among child care
           providers and families.

      METHODS. The investigators will conduct a cluster-randomized controlled trial in 16 IMSS
      child care centers in Mexico City. The investigators will randomly assign 8 child care
      centers to the intervention condition and 8 to an assessment-only control condition.

      Multifaceted intervention. The resulting intervention will involve four main components:

        1. Training of child care providers.

        2. Curriculum sessions for children.

        3. Family outreach activities.

        4. Maintenance activities. Outcome and process measurements. Age-associated BMI (child's),
           changes in child's key obesity-related behaviors, changes in the child's home food and
           activity environment, and changes in child care food and activity environment. At the
           intervention and control child care sites, changes from baseline to one year for all
           outcome variables will be measured.
Over the past 20 years, the prevalence of obesity in Mexico has increased dramatically among
      individuals across the lifespan, including even the youngest populations.National data from
      the Mexican Institute of Social Security (IMSS) population estimate that nearly 15% of
      children aged 2 to 5 years are obese as defined by World Health Organization criteria.
      Obesity among preschool-aged children is of serious public health concern due to its adverse
      effects on children's physical and psychosocial well-being,and its association with obesity
      risk in later childhood, adolescence, and young adulthood. Furthermore, because dietary and
      activity patterns have not been firmly established, early childhood represents a critical
      window for prevention.

      Given the high number of preschool children enrolled in out-of-home child care in Mexico,
      important opportunities exist for developing child care-based obesity prevention
      interventions focused on promoting healthy activity and dietary behaviors among children.
      Child care centers provide an ideal setting for a multi-level, ecologic intervention that
      includes strategies aimed at environmental level changes within the child care center, as
      well as individual level behavior change among the children. In addition, child care-based
      interventions have the potential to reach out to the children's families to improve the
      child's home food and activity environment.

      Setting and study population. There are 142 IMSS child care centers in Mexico City. To allow
      for adequate attention to details in the development of the intervention and evaluation
      protocol and to contain costs prior to broad dissemination of the program, the investigators
      will focus on 16 IMSS child care sites for this proposal, which together provide care for
      approximately 450 children aged 2 to 5 years. At each IMSS child care center a team
      consisting of a nutritionist, a nurse, an educator, and child care technicians provides the
      daily care and education programs for the children. This extensive personnel structure
      provides the ideal infrastructure for implementing the proposed multifaceted intervention.

      Since the intervention is a primary prevention program, the investigators will make the
      program available to all children, aged 2 to 5 years, at the child care centers, regardless
      of their current weight status. Children with chronic conditions that limit ability to
      measure height and weight or substantially interfere with growth, physical activity, or
      dietary recommendations will be excluded.

      Data analysis for outcome measures. Intent-to-treat analyses to compare study outcomes
      between the intervention and control groups at post-intervention and at 6-months follow-up
      will be used. To compare the difference the age-associated increase in body mass index (BMI)
      among intervention and control groups (Aim 1), the mixed effects model with group (child care
      center) as the clustering factor will be used, as recommended by several authoritative
      sources. Similar analyses to compare the difference in prevalence of overweight (Aim 2), in
      the children's weight-related behaviors (Aim 3a), in the children's home environment (Aim
      3b), and in the environment of the child care center (Aim 3c) will be performed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Child's age-associated Body Mass Index
time frame: Change from baseline (May 2011) at one year follow-up (November 2012)
description: The investigators will measure standing height for all participants over the age of 3 years, and from 2-3 years when possible. For some participants between age 2 and 3 years requiring recumbent lengths, a recumbent board and the recumbent to standing correction factor recommended by the U.S. Centers for Disease Control and Prevention (0.8 cm)will be used.In all cases, BMI will be the ratio of weight (kg) to the square of standing height (m). Accepted definition of obese (BMI >95th percentile for age and sex) and overweight (BMI 85th - 95th percentile for age and sex)will be used. All height and weight measurements will be conducted in a private area at the child care sites.
measure: Children's home environment
time frame: Change from baseline at one year follow-up.
description: To assess the home food and nutrition environment, research staff will conduct in-person surveys with parents using items from the Healthy Home Survey. The Healthy Home Survey was designed to assess key aspects of the diet and activity home environment, including availability of foods, role modeling by parents of behaviors, and parental support for healthy behaviors.
measure: Children's key obesity-related behaviors.
time frame: Change from baseline at one year of follow-up.
description: Research staff will conduct brief, in-person surveys with parents to measure children's obesity-related behaviors. The in-person surveys will include questions about the children's behaviors and the children's home dietary and activity environment and will be conducted at the child care center when parents come to pick up their children.
arm group label: primary obesity prevention
arm group type: Experimental
description: The intervention will involve four main components:
Training of child care providers.
Curriculum sessions for children.
Family outreach activities.
Maintenance activities.
arm group label: Control group
arm group type: No Intervention
description: For the control group, usual care will be provided
intervention type: Behavioral
intervention name: primary obesity prevention
description: Training of child care providers.
Curriculum sessions for children. Child care providers will facilitate 12 interactive education sessions that focus on key obesity-related behaviors.
Family outreach activities. Child care providers and research staff will communicate behavior change messages to families through ten take-home activities focused on key obesity-related behaviors and through monthly family workshops at the child care center.
Maintenance activities. Over the six months following the main intervention, research staff will conduct eight booster sessions for the children and one booster session for the family that will build upon activities and behavior change messages of the main intervention.
arm group label: primary obesity prevention
criteria: 
gender: All
minimum age: 2 Years
maximum age: 4 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hortensia Reyes-Morales, DrSc
role: Principal Investigator
affiliation: Instituto Nacional de Salud Publica, Mexico
facility: 
country: Mexico
citation: Rodriguez-Oliveros G, Haines J, Ortega-Altamirano D, Power E, Taveras EM, Gonzalez-Unzaga MA, Reyes-Morales H. Obesity determinants in Mexican preschool children: parental perceptions and practices related to feeding and physical activity. Arch Med Res. 2011 Aug;42(6):532-9. doi: 10.1016/j.arcmed.2011.10.006. Epub 2011 Oct 21.
PMID: 22019411
responsible party type: Principal Investigator
investigator affiliation: Instituto Nacional de Salud Publica, Mexico
investigator full name: Hortensia Reyes Morales
investigator title: Principal Investigator
mesh term: Obesity