<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/NCT02202889</url>
  </required_header>
  <id_info>
    <org_study_id>00-52102-9696</org_study_id>
    <nct_id>NCT02202889</nct_id>
  </id_info>
  <brief_title>Improving Bone Health in Adolescence Through Targeted Behavioral Intervention</brief_title>
  <official_title>Improving Bone Health in Adolescence Through Targeted Behavioral Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Purdue University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Hawaii</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Arizona State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Nevada, Las Vegas</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Southern Illinois University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Purdue University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      School based educational intervention to educate on bone health among Hispanic, Asian or&#xD;
      non-Hispanic white girls between 10-13 years with end points of knowledge gained, calcium&#xD;
      intake and bone density in . The hypothesis was that the educational program would increase&#xD;
      knowledge, improve dairy food and calcium consumption and enhance bone health in this&#xD;
      population. A secondary hypothesis was that lactose maldigestion would be an impediment to&#xD;
      improved dairy food consumption.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A targeted behavioral intervention to improve calcium intake and bone mass was conducted at&#xD;
      middle schools in 6 states. The primary outcomes of bone mass and dietary calcium were&#xD;
      assessed among Asian, Hispanic, or non-Hispanic white girls between 10 -13 y. Lactose&#xD;
      maldigestion (LM) was determined by a breath hydrogen test (BHT). Perceived milk intolerance&#xD;
      (PMI) and calcium intake were assessed by questionnaires and bone mineral content (BMC) was&#xD;
      determined by dual energy X-ray absorptiometry (DXA). Data from 473 girls were used in a&#xD;
      multiple linear regression to examine the impact of the intervention while accounting for PMI&#xD;
      and LM and adjusting for covariates.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2000</start_date>
  <completion_date type="Actual">September 2004</completion_date>
  <primary_completion_date type="Actual">September 2004</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Bone Mineral Content</measure>
    <time_frame>18 months</time_frame>
    <description>Baseline, 12 month and 18 month bone mineral content measured</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dietary Calcium</measure>
    <time_frame>18 months</time_frame>
    <description>Dietary Calcium intake assessed by food frequency questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lactose maldigestion</measure>
    <time_frame>Baseline</time_frame>
    <description>Measured by breath hydrogen testing</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Perceived lactose intolerance</measure>
    <time_frame>Baseline</time_frame>
    <description>Measured by questionnaire</description>
  </other_outcome>
  <enrollment type="Actual">848</enrollment>
  <condition>Bone Development</condition>
  <condition>Dietary Adequacy</condition>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Adequate Calcium Today</intervention_name>
    <description>A school-randomized behavioral intervention study called the Adequate Calcium Today (ACT) project was conducted in sixth grade classrooms located in six states (Arizona, California, Hawaii, Indiana, Nevada, and Ohio).</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Middle schools within one-hour driving time of one of the designated DXA measurement sites&#xD;
        were eligible to participate in ACT if their student population had a higher proportion of&#xD;
        Asian or Hispanic students than the respective state's average. - Girls recruited for&#xD;
        evaluation measures were limited to those being at least 75% Asian, Hispanic or&#xD;
        non-Hispanic White based on the race/ethnicity of their biological parents.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>13 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dennis Savaiano, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Purdue University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Carol Boushey, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Hawaii</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Purdue University</name>
      <address>
        <city>West Lafayette</city>
        <state>Indiana</state>
        <zip>47907-2059</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>July 25, 2014</last_update_submitted>
  <last_update_submitted_qc>July 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 29, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Purdue University</investigator_affiliation>
    <investigator_full_name>Dennis A. Savaiano</investigator_full_name>
    <investigator_title>Professor and Associate Provost</investigator_title>
  </responsible_party>
  <keyword>Adolescents</keyword>
  <keyword>Bone mass</keyword>
  <keyword>Calcium</keyword>
  <keyword>Perceived milk intolerance</keyword>
  <keyword>lactose maldigestion</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcium</mesh_term>
  </intervention_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/NCT02202889
org study id: 00-52102-9696
nct id: NCT02202889
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
School based educational intervention to educate on bone health among Hispanic, Asian or
      non-Hispanic white girls between 10-13 years with end points of knowledge gained, calcium
      intake and bone density in . The hypothesis was that the educational program would increase
      knowledge, improve dairy food and calcium consumption and enhance bone health in this
      population. A secondary hypothesis was that lactose maldigestion would be an impediment to
      improved dairy food consumption.
A targeted behavioral intervention to improve calcium intake and bone mass was conducted at
      middle schools in 6 states. The primary outcomes of bone mass and dietary calcium were
      assessed among Asian, Hispanic, or non-Hispanic white girls between 10 -13 y. Lactose
      maldigestion (LM) was determined by a breath hydrogen test (BHT). Perceived milk intolerance
      (PMI) and calcium intake were assessed by questionnaires and bone mineral content (BMC) was
      determined by dual energy X-ray absorptiometry (DXA). Data from 473 girls were used in a
      multiple linear regression to examine the impact of the intervention while accounting for PMI
      and LM and adjusting for covariates.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in Bone Mineral Content
time frame: 18 months
description: Baseline, 12 month and 18 month bone mineral content measured
measure: Dietary Calcium
time frame: 18 months
description: Dietary Calcium intake assessed by food frequency questionnaire
measure: Lactose maldigestion
time frame: Baseline
description: Measured by breath hydrogen testing
measure: Perceived lactose intolerance
time frame: Baseline
description: Measured by questionnaire
intervention type: Behavioral
intervention name: Adequate Calcium Today
description: A school-randomized behavioral intervention study called the Adequate Calcium Today (ACT) project was conducted in sixth grade classrooms located in six states (Arizona, California, Hawaii, Indiana, Nevada, and Ohio).
criteria: 
gender: Female
minimum age: 10 Years
maximum age: 13 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dennis Savaiano, PhD
role: Principal Investigator
affiliation: Purdue University
last name: Carol Boushey, PhD
role: Principal Investigator
affiliation: University of Hawaii
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Purdue University
investigator full name: Dennis A. Savaiano
investigator title: Professor and Associate Provost
mesh term: Calcium