<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/NCT01722032</url>
  </required_header>
  <id_info>
    <org_study_id>2009-05065</org_study_id>
    <nct_id>NCT01722032</nct_id>
  </id_info>
  <brief_title>USDA Healthy Caregivers/Healthy Children: A Childhood Obesity Prevention Program</brief_title>
  <acronym>HC2</acronym>
  <official_title>Healthy Caregivers/Healthy Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Miami</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Many unhealthy dietary and physical activity habits that foster the development&#xD;
      of obesity are established by the age of five. Presently, approximately 70 percent of&#xD;
      children in the United States are currently enrolled in early childcare facilities, making&#xD;
      this an ideal setting to implement and evaluate childhood obesity prevention efforts. We&#xD;
      describe here the methods for conducting an obesity prevention intervention randomized trial&#xD;
      in the child care setting.&#xD;
&#xD;
      Methods/Design: A randomized, controlled obesity prevention trial in 28 low-income,&#xD;
      ethnically diverse child care centers located throughout Miami-Dade County, FL is currently&#xD;
      being conducted over two years (2010-present) to test the efficacy of an intervention that&#xD;
      poises teachers and parents as lifestyle change agents. The Healthy Caregivers-Healthy&#xD;
      Children (HC2) program includes a curriculum focusing specifically on healthy food choices,&#xD;
      increased exercise, and role modeling. The program targets food policy changes throughout the&#xD;
      school, and via the child, caregiver, and teacher. Major outcome measures include child body&#xD;
      mass index percentile and z score, fruit and vegetable and other nutritious food intake, and&#xD;
      amount of physical activity.&#xD;
&#xD;
      Discussion: Although few attempts have been made to prevent obesity during the first years of&#xD;
      life, this period may represent the best opportunity for obesity prevention. Findings from&#xD;
      this investigation should inform both the fields of childhood obesity prevention and early&#xD;
      childhood research about the effects of an obesity prevention program housed in the childcare&#xD;
      setting. (H1) A child care center-based obesity prevention intervention program that includes&#xD;
      a teacher and parent nutritional gatekeeper and role modeling program will be more effective&#xD;
      in maintaining BMI in 3-5 year olds compared to a control group.&#xD;
&#xD;
      (H2) Role modeling (teacher and parent) will be identified as a significant mediator in&#xD;
      preventing obesity among intervention children versus controls.&#xD;
&#xD;
      (H3) A child care center-based multi-level obesity prevention intervention program will&#xD;
      improve child nutrition (increased consumption of fruits and vegetables, decreased&#xD;
      consumption of sweetened beverages) and increase physical activity level compared to a&#xD;
      control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Over one third of preschoolers were either overweight (18.4%) or obese (16.5%). The majority&#xD;
      (92%) of caregivers of an overweight/obese child inaccurately perceived that their child was&#xD;
      in a normal BMI category. Foreign-born caregivers were significantly more likely to&#xD;
      inaccurately perceive their child's BMI percentile category, versus US-born caregivers&#xD;
      (OR=0.65, 95% CI, 0.48-0.88). Specifically, those born in South America [OR=0.59. 95% CI,&#xD;
      0.36-0.98), Central America/Mexico (OR=0.59, 95% CI,0.41-0.85), and Caribbean Hispanic&#xD;
      nations [OR=0.54, 95% CI 0.35-0.83) were significantly less likely to accurately perceive&#xD;
      their child's BMI category, versus US-born caregivers.&#xD;
&#xD;
      Conclusions: The results of this study suggest that foreign-born parents of preschool-age&#xD;
      overweight/obese children in particular do not accurately perceive their child's BMI status.&#xD;
      Pediatricians and other healthcare providers serving foreign-born caregivers may consider&#xD;
      additional healthy weight counseling for these families.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2010</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">September 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>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maintenance of a Child's Body Mass Index as a result of the intervention</measure>
    <time_frame>up to two years</time_frame>
    <description>Assessment of demographic variables, anthropometrics, food insecurity and parent perception were performed. Sociodemographic variables included age and gender of the children, country of birth of parent and child, years living in the US, and parental education (highest grade completed).&#xD;
Child Health Measures:Anthropometric Variables. Assessment of body composition included height (by stadiometer), weight (by digital scale), which was converted to BMI (weight in kilograms/height in meters squared) and then to a BMI age-and sex-adjusted BMI percentile. Participants were asked to remove shoes and any heavy outer clothing prior to measurement. Weight and height measurements were collected by trained staff based on US Department of Health and Human Services (HHS) guidelines for accurate anthropomorphic measurement. Research grade stadiometers and scales were used, and were brought from site to site by the staff.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>A Parent's perception of his/her child's weight status</measure>
    <time_frame>up to two years</time_frame>
    <description>Caregiver Measures. To assess parent perception of child weight status, the child's actual weight status (determined by BMI percentile group) was compared to the caregivers' response to the question &quot;Do you consider your child to be overweight, underweight or about right weight for (his/her) age?&quot; Food insecurity was measured by the short form of the USDA's Food Security Scale. This information was obtained by means of a structured parent interview or a self-administered survey. Caregiver BMI was obtained by self reported height and weight included on the caregivers survey. Parent acculturation was measured by items from the Stephenson Acculturation Scale.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1100</enrollment>
  <condition>Childhood Obesity</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention centers' menus were modified to include more fresh fruit, fresh vegetables, low-fat (1%) or skim milk, water, less juice, and less simple carbohydrate snacks. The centers were also encouraged to incorporate fresh fruits and vegetables as often as possible for snack and meal time.&#xD;
Physical Activity. Physical activity was promoted for at least 60 minutes per day. TV viewing, watching movies and playing computer games were logged and limited to 30 minutes or less per day. Schools adopted &quot;Best-Practice Policies&quot;.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Those schools randomized to the control arm received a safety curriculum and some child care center locations received an attention control consisting of three visits from the University of Miami Safety Van which provided parents and teachers with home, car and child seat safety information. The control group received all the same pre-post measures as the intervention arms. They also received the same incentives as the intervention arms to foster involvement and ensure retention/reduce loss to follow up.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Childhood Obesity</intervention_name>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria. Centers must have met the following criteria to be included: (1) have &gt;&#xD;
        30 children ages 2-5 enrolled; (2) Serve low income families who are a part of the USDA&#xD;
        food program and SNAP eligible; (3) Reflect the ethnic distribution of the Miami-Dade&#xD;
        County Public School System (63 percent Hispanic, 19 percent African American, 18 percent&#xD;
        white); and (4) Center directors agree to participate and sign a letter of commitment.&#xD;
        Studies were excluded if they did not meet these criteria.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ruby Natale, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>October 26, 2012</study_first_submitted>
  <study_first_submitted_qc>November 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 6, 2012</study_first_posted>
  <last_update_submitted>November 2, 2012</last_update_submitted>
  <last_update_submitted_qc>November 2, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 6, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Stephanie Scott</investigator_full_name>
    <investigator_title>Assistant Research Professor</investigator_title>
  </responsible_party>
  <keyword>childhood obesity, early childhood, nutrition</keyword>
  <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>


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/NCT01722032
org study id: 2009-05065
nct id: NCT01722032
lead sponsor: 
has dmc: No
Background: Many unhealthy dietary and physical activity habits that foster the development
      of obesity are established by the age of five. Presently, approximately 70 percent of
      children in the United States are currently enrolled in early childcare facilities, making
      this an ideal setting to implement and evaluate childhood obesity prevention efforts. We
      describe here the methods for conducting an obesity prevention intervention randomized trial
      in the child care setting.

      Methods/Design: A randomized, controlled obesity prevention trial in 28 low-income,
      ethnically diverse child care centers located throughout Miami-Dade County, FL is currently
      being conducted over two years (2010-present) to test the efficacy of an intervention that
      poises teachers and parents as lifestyle change agents. The Healthy Caregivers-Healthy
      Children (HC2) program includes a curriculum focusing specifically on healthy food choices,
      increased exercise, and role modeling. The program targets food policy changes throughout the
      school, and via the child, caregiver, and teacher. Major outcome measures include child body
      mass index percentile and z score, fruit and vegetable and other nutritious food intake, and
      amount of physical activity.

      Discussion: Although few attempts have been made to prevent obesity during the first years of
      life, this period may represent the best opportunity for obesity prevention. Findings from
      this investigation should inform both the fields of childhood obesity prevention and early
      childhood research about the effects of an obesity prevention program housed in the childcare
      setting. (H1) A child care center-based obesity prevention intervention program that includes
      a teacher and parent nutritional gatekeeper and role modeling program will be more effective
      in maintaining BMI in 3-5 year olds compared to a control group.

      (H2) Role modeling (teacher and parent) will be identified as a significant mediator in
      preventing obesity among intervention children versus controls.

      (H3) A child care center-based multi-level obesity prevention intervention program will
      improve child nutrition (increased consumption of fruits and vegetables, decreased
      consumption of sweetened beverages) and increase physical activity level compared to a
      control group.
Over one third of preschoolers were either overweight (18.4%) or obese (16.5%). The majority
      (92%) of caregivers of an overweight/obese child inaccurately perceived that their child was
      in a normal BMI category. Foreign-born caregivers were significantly more likely to
      inaccurately perceive their child's BMI percentile category, versus US-born caregivers
      (OR=0.65, 95% CI, 0.48-0.88). Specifically, those born in South America [OR=0.59. 95% CI,
      0.36-0.98), Central America/Mexico (OR=0.59, 95% CI,0.41-0.85), and Caribbean Hispanic
      nations [OR=0.54, 95% CI 0.35-0.83) were significantly less likely to accurately perceive
      their child's BMI category, versus US-born caregivers.

      Conclusions: The results of this study suggest that foreign-born parents of preschool-age
      overweight/obese children in particular do not accurately perceive their child's BMI status.
      Pediatricians and other healthcare providers serving foreign-born caregivers may consider
      additional healthy weight counseling for these families.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Maintenance of a Child's Body Mass Index as a result of the intervention
time frame: up to two years
description: Assessment of demographic variables, anthropometrics, food insecurity and parent perception were performed. Sociodemographic variables included age and gender of the children, country of birth of parent and child, years living in the US, and parental education (highest grade completed).
Child Health Measures:Anthropometric Variables. Assessment of body composition included height (by stadiometer), weight (by digital scale), which was converted to BMI (weight in kilograms/height in meters squared) and then to a BMI age-and sex-adjusted BMI percentile. Participants were asked to remove shoes and any heavy outer clothing prior to measurement. Weight and height measurements were collected by trained staff based on US Department of Health and Human Services (HHS) guidelines for accurate anthropomorphic measurement. Research grade stadiometers and scales were used, and were brought from site to site by the staff.
measure: A Parent's perception of his/her child's weight status
time frame: up to two years
description: Caregiver Measures. To assess parent perception of child weight status, the child's actual weight status (determined by BMI percentile group) was compared to the caregivers' response to the question "Do you consider your child to be overweight, underweight or about right weight for (his/her) age?" Food insecurity was measured by the short form of the USDA's Food Security Scale. This information was obtained by means of a structured parent interview or a self-administered survey. Caregiver BMI was obtained by self reported height and weight included on the caregivers survey. Parent acculturation was measured by items from the Stephenson Acculturation Scale.
arm group label: Treatment
arm group type: Experimental
description: The intervention centers' menus were modified to include more fresh fruit, fresh vegetables, low-fat (1%) or skim milk, water, less juice, and less simple carbohydrate snacks. The centers were also encouraged to incorporate fresh fruits and vegetables as often as possible for snack and meal time.
Physical Activity. Physical activity was promoted for at least 60 minutes per day. TV viewing, watching movies and playing computer games were logged and limited to 30 minutes or less per day. Schools adopted "Best-Practice Policies".
arm group label: Control
arm group type: No Intervention
description: Those schools randomized to the control arm received a safety curriculum and some child care center locations received an attention control consisting of three visits from the University of Miami Safety Van which provided parents and teachers with home, car and child seat safety information. The control group received all the same pre-post measures as the intervention arms. They also received the same incentives as the intervention arms to foster involvement and ensure retention/reduce loss to follow up.
intervention type: Other
intervention name: Childhood Obesity
arm group label: Treatment
criteria: 
gender: All
minimum age: 2 Years
maximum age: 5 Years
healthy volunteers: No
last name: Ruby Natale, PhD
role: Principal Investigator
affiliation: University of Miami
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: Stephanie Scott
investigator title: Assistant Research Professor
mesh term: Obesity
mesh term: Pediatric Obesity