<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/NCT01698034</url>
  </required_header>
  <id_info>
    <org_study_id>H11-00943</org_study_id>
    <nct_id>NCT01698034</nct_id>
  </id_info>
  <brief_title>Volunteering and Cardiovascular Risk in Adolescents</brief_title>
  <official_title>How Volunteer Programs Affect Health and Well-being in Low-income Youth</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>William T. Grant Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>HopeLab Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Social Sciences and Humanities Research Council of Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study tested whether getting youth engaged in helping others (volunteering) would&#xD;
      benefit youth's physical health. 106 predominantly minority and low socioeconomic status&#xD;
      (SES) youth were randomized to either volunteer weekly with elementary school children in&#xD;
      after school programs or to a wait-list control group. The investigators hypothesized that&#xD;
      cardiovascular risk markers of C-reactive protein (CRP), interleukin-6 (IL-6), total&#xD;
      cholesterol, and body mass index (BMI) would be lower at post-intervention (4 months after&#xD;
      baseline) in the volunteer group compared to the control group. The investigators also&#xD;
      hypothesized that the intervention might work through pathways such as reducing negative&#xD;
      mood, improving self esteem, and increasing prosocial behaviors (empathy, altruism).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">January 2012</completion_date>
  <primary_completion_date type="Actual">January 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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Body mass index</measure>
    <time_frame>Baseline-adjusted post-intervention scores at 4 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>C-reactive protein</measure>
    <time_frame>Baseline-adjusted post-intervention scores at 4 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Interleukin-6</measure>
    <time_frame>Baseline-adjusted post-intervention scores at 4 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Cholesterol</measure>
    <time_frame>Baseline-adjusted post-intervention scores at 4 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">106</enrollment>
  <condition>Cardiovascular Risk Factors</condition>
  <arm_group>
    <arm_group_label>Volunteering</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Weekly volunteering with elementary school children in after school programs</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Wait-list control</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Volunteering</intervention_name>
    <description>Weekly volunteering with elementary school children in after school programs</description>
    <arm_group_label>Volunteering</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  10th grade high school student&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  No chronic illnesses&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic medical illness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Edith Chen</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vancouver Technical Secondary School</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5M1Y5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>October 2, 2012</last_update_submitted>
  <last_update_submitted_qc>October 2, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 4, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>volunteering</keyword>
  <keyword>cardiovascular health</keyword>
  <!-- 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/NCT01698034
org study id: H11-00943
nct id: NCT01698034
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
This study tested whether getting youth engaged in helping others (volunteering) would
      benefit youth's physical health. 106 predominantly minority and low socioeconomic status
      (SES) youth were randomized to either volunteer weekly with elementary school children in
      after school programs or to a wait-list control group. The investigators hypothesized that
      cardiovascular risk markers of C-reactive protein (CRP), interleukin-6 (IL-6), total
      cholesterol, and body mass index (BMI) would be lower at post-intervention (4 months after
      baseline) in the volunteer group compared to the control group. The investigators also
      hypothesized that the intervention might work through pathways such as reducing negative
      mood, improving self esteem, and increasing prosocial behaviors (empathy, altruism).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Body mass index
time frame: Baseline-adjusted post-intervention scores at 4 months
measure: C-reactive protein
time frame: Baseline-adjusted post-intervention scores at 4 months
measure: Interleukin-6
time frame: Baseline-adjusted post-intervention scores at 4 months
measure: Total Cholesterol
time frame: Baseline-adjusted post-intervention scores at 4 months
arm group label: Volunteering
arm group type: Experimental
description: Weekly volunteering with elementary school children in after school programs
arm group label: Control
arm group type: No Intervention
description: Wait-list control
intervention type: Behavioral
intervention name: Volunteering
description: Weekly volunteering with elementary school children in after school programs
arm group label: Volunteering
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Edith Chen
role: Principal Investigator
affiliation: Northwestern University
facility: 
country: Canada
responsible party type: Sponsor