<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/NCT03245775</url>
  </required_header>
  <id_info>
    <org_study_id>19748</org_study_id>
    <nct_id>NCT03245775</nct_id>
  </id_info>
  <brief_title>A Trial of Two Family-based Childhood Obesity Treatment Programs</brief_title>
  <official_title>A Randomized-controlled Trial to Compare the Reach, Effectiveness and Maintenance of Two Family-based Childhood Obesity Treatment Programs in a Medically Underserved Region</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Virginia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Nebraska</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Virginia Polytechnic Institute and State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Virginia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary aim is to determine the relative effectiveness in child BMI z-scores at 3, 6, and&#xD;
      12-months post baseline of iChoose+ versus Family Connections. Secondary aims are to&#xD;
      determine (1) ongoing reach, fidelity, and implementation costs, (2) community capacity for&#xD;
      implementation and sustainability, (3) relative impact on family eating/physical activity and&#xD;
      parental weight, and (4) relative adherence and potential dose response relationships.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In partnership with the Community Advisory Board and Parent Advisory Team, with a goal to&#xD;
      improve the magnitude of weight reductions and increase the likelihood of iChoose&#xD;
      sustainability in the community, the investigators propose to test iChoose+ that will (1)&#xD;
      extend iChoose to a 6-month program, followed by 12 bi-weekly maintenance telephone calls,&#xD;
      congruent with the 12-month Bright Bodies program duration, (2) formalize a Parent Health&#xD;
      Advisory model of previous iChoose families to serve as a 'peer support safety net' for new&#xD;
      program participants, and (3) deliver support calls using interactive voice response (IVR)&#xD;
      automation to reduce the burden on community stakeholder implementation. When reflecting on&#xD;
      and interpreting the outcomes of the previous planning grant, the Community Advisory Board&#xD;
      and Parent Advisory Team also identified the need to use a study design that allowed all&#xD;
      participants the opportunity to benefit and, with this in mind, to test alternative&#xD;
      family-based childhood obesity program options that improve reach within the broad Dan River&#xD;
      Region population of minority, low-income, and geographically dispersed families. Thus, the&#xD;
      Community Advisory Board and Parent Advisory Team returned to a potential option for delivery&#xD;
      that was considered earlier in the planning grant process and was rated highly for&#xD;
      scalability- Family Connections, an adaptation of Golan's Home Environmental Change model&#xD;
      that focuses exclusively on parents as the agents of change. When compared to iChoose+ (12&#xD;
      bi-weekly sessions &amp; 24 IVR calls/12 months), Family Connections has fewer sessions and fewer&#xD;
      IVR support calls over a shorter period of time (2 in-person sessions spaced one week apart &amp;&#xD;
      10 IVR calls/6 months), delivers intervention to parents only, and promotes physical&#xD;
      activity, but does not include structured exercise sessions. Still, in previous studies&#xD;
      Family Connections led to significant reductions in child weight status, though smaller in&#xD;
      magnitude than Bright Bodies, that were sustained 6-month post intervention completion.&#xD;
      Committed to the goal of allowing all participating families an opportunity to benefit from&#xD;
      study participation and the need for a sustainable family-based childhood obesity option, the&#xD;
      Community Advisory Board and Parent Advisory Team propose a comparative effectiveness trial&#xD;
      where eligible families will be randomly assigned to: (1) iChoose+ (n=87) or to (2) Family&#xD;
      Connections (n=87). Given the need to optimize program enrollment, participation, and&#xD;
      retention in each program, both iChoose+ and Family Connections will include Parent Health&#xD;
      Advisor support63-68 as refined by the Parent Advisory Team. The primary aim is to determine&#xD;
      the relative changes in child BMI z-scores at 6 months post baseline of iChoose+ versus&#xD;
      Family Connections, though additional assessments will occur at 3 and 12 months post&#xD;
      baseline. Secondary aims include (1) determine ongoing reach, fidelity, and costs of&#xD;
      implementation, (2) assess community capacity to implement and sustain childhood obesity&#xD;
      programs, (3) determine impact on family eating and physical activity and parental weight by&#xD;
      intervention, and (4) assess the adherence by intervention and potential dose response&#xD;
      relationships. The primary study hypotheses are: (a) children in both conditions will reduce&#xD;
      BMI-z scores significantly, when compared to baseline at 3, 6 and 12 months, but iChoose+&#xD;
      reductions will be significantly larger than Family Connections, (b) reach-the sample will be&#xD;
      representative of the eligible regional population on demographic and behavioral factors, (c)&#xD;
      implementation-the intervention components will be delivered with high fidelity in both&#xD;
      conditions, but costs will be lower for Family Connections, (d) maintenance-a sustainability&#xD;
      action plan will be completed to include strategies for continued delivery of iChoose+ and/or&#xD;
      Family Connections (outcome dependent), (e) parent weight, parent/child behaviors, &amp; tertiary&#xD;
      outcomes that follow the same patterns as BMI z-scores, and (f), community capacity for&#xD;
      implementing and sustaining a locally relevant FBCO treatment and maintenance program will&#xD;
      remain high over time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Anticipated">May 29, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2019</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>child BMI z-score</measure>
    <time_frame>6-months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>parent BMI</measure>
    <time_frame>6-month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>child self-reported diet, physical activity, quality of life, health literacy</measure>
    <time_frame>6-months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>child self-reported diet, physical activity, quality of life, health literacy, home environment</measure>
    <time_frame>6-months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">348</enrollment>
  <condition>Obesity, Childhood</condition>
  <arm_group>
    <arm_group_label>iChoose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12 bi-weekly sessions &amp; 24 IVR calls/12 months, 24 physical activity sessions over 6 months; delivers intervention to parents and children only</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Family Connections</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 in-person sessions spaced one week apart &amp; 10 IVR calls/6 months, promotes physical activity but does not include structured exercise sessions; delivers intervention to parents only</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>iChoose</intervention_name>
    <description>12 bi-weekly sessions &amp; 24 IVR calls/12 months, 24 physical activity sessions over 6 months; delivers intervention to parents and children only</description>
    <arm_group_label>iChoose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Family Connections</intervention_name>
    <description>2 in-person sessions spaced one week apart &amp; 10 IVR calls/6 months, promotes physical activity but does not include structured exercise sessions; delivers intervention to parents only</description>
    <arm_group_label>Family Connections</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parent/child dyads will be eligible for participation if they reside in the Dan River&#xD;
             Region&#xD;
&#xD;
               -  English speaking&#xD;
&#xD;
               -  child with a BMI percentile ranking of 85 or higher&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  children with a major cognitive impairment and parents or children with a medical&#xD;
             contraindication for moderate physical activity.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jamie M Zoellner, PhD, RD</last_name>
    <phone>434-962-4488</phone>
    <email>jz9q@virginia.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Paul A Estabrooks, PhD</last_name>
    <phone>402.559.4325</phone>
    <email>Paul.estabrooks@unmc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908-0717</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jamie M Zoellner, PhD</last_name>
      <phone>434-962-4488</phone>
      <email>jz9q@virginia.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>August 9, 2017</last_update_submitted>
  <last_update_submitted_qc>August 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Virginia</investigator_affiliation>
    <investigator_full_name>Jamie Zoellner, PhD RD</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>health disparities</keyword>
  <keyword>community-based participatory research</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>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>March 15, 2021</submitted>
    <returned>April 9, 2021</returned>
    <submitted>January 9, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03245775
org study id: 19748
nct id: NCT03245775
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The primary aim is to determine the relative effectiveness in child BMI z-scores at 3, 6, and
      12-months post baseline of iChoose+ versus Family Connections. Secondary aims are to
      determine (1) ongoing reach, fidelity, and implementation costs, (2) community capacity for
      implementation and sustainability, (3) relative impact on family eating/physical activity and
      parental weight, and (4) relative adherence and potential dose response relationships.
In partnership with the Community Advisory Board and Parent Advisory Team, with a goal to
      improve the magnitude of weight reductions and increase the likelihood of iChoose
      sustainability in the community, the investigators propose to test iChoose+ that will (1)
      extend iChoose to a 6-month program, followed by 12 bi-weekly maintenance telephone calls,
      congruent with the 12-month Bright Bodies program duration, (2) formalize a Parent Health
      Advisory model of previous iChoose families to serve as a 'peer support safety net' for new
      program participants, and (3) deliver support calls using interactive voice response (IVR)
      automation to reduce the burden on community stakeholder implementation. When reflecting on
      and interpreting the outcomes of the previous planning grant, the Community Advisory Board
      and Parent Advisory Team also identified the need to use a study design that allowed all
      participants the opportunity to benefit and, with this in mind, to test alternative
      family-based childhood obesity program options that improve reach within the broad Dan River
      Region population of minority, low-income, and geographically dispersed families. Thus, the
      Community Advisory Board and Parent Advisory Team returned to a potential option for delivery
      that was considered earlier in the planning grant process and was rated highly for
      scalability- Family Connections, an adaptation of Golan's Home Environmental Change model
      that focuses exclusively on parents as the agents of change. When compared to iChoose+ (12
      bi-weekly sessions & 24 IVR calls/12 months), Family Connections has fewer sessions and fewer
      IVR support calls over a shorter period of time (2 in-person sessions spaced one week apart &
      10 IVR calls/6 months), delivers intervention to parents only, and promotes physical
      activity, but does not include structured exercise sessions. Still, in previous studies
      Family Connections led to significant reductions in child weight status, though smaller in
      magnitude than Bright Bodies, that were sustained 6-month post intervention completion.
      Committed to the goal of allowing all participating families an opportunity to benefit from
      study participation and the need for a sustainable family-based childhood obesity option, the
      Community Advisory Board and Parent Advisory Team propose a comparative effectiveness trial
      where eligible families will be randomly assigned to: (1) iChoose+ (n=87) or to (2) Family
      Connections (n=87). Given the need to optimize program enrollment, participation, and
      retention in each program, both iChoose+ and Family Connections will include Parent Health
      Advisor support63-68 as refined by the Parent Advisory Team. The primary aim is to determine
      the relative changes in child BMI z-scores at 6 months post baseline of iChoose+ versus
      Family Connections, though additional assessments will occur at 3 and 12 months post
      baseline. Secondary aims include (1) determine ongoing reach, fidelity, and costs of
      implementation, (2) assess community capacity to implement and sustain childhood obesity
      programs, (3) determine impact on family eating and physical activity and parental weight by
      intervention, and (4) assess the adherence by intervention and potential dose response
      relationships. The primary study hypotheses are: (a) children in both conditions will reduce
      BMI-z scores significantly, when compared to baseline at 3, 6 and 12 months, but iChoose+
      reductions will be significantly larger than Family Connections, (b) reach-the sample will be
      representative of the eligible regional population on demographic and behavioral factors, (c)
      implementation-the intervention components will be delivered with high fidelity in both
      conditions, but costs will be lower for Family Connections, (d) maintenance-a sustainability
      action plan will be completed to include strategies for continued delivery of iChoose+ and/or
      Family Connections (outcome dependent), (e) parent weight, parent/child behaviors, & tertiary
      outcomes that follow the same patterns as BMI z-scores, and (f), community capacity for
      implementing and sustaining a locally relevant FBCO treatment and maintenance program will
      remain high over time.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: child BMI z-score
time frame: 6-months
measure: parent BMI
time frame: 6-month
measure: child self-reported diet, physical activity, quality of life, health literacy
time frame: 6-months
measure: child self-reported diet, physical activity, quality of life, health literacy, home environment
time frame: 6-months
arm group label: iChoose
arm group type: Experimental
description: 12 bi-weekly sessions & 24 IVR calls/12 months, 24 physical activity sessions over 6 months; delivers intervention to parents and children only
arm group label: Family Connections
arm group type: Experimental
description: 2 in-person sessions spaced one week apart & 10 IVR calls/6 months, promotes physical activity but does not include structured exercise sessions; delivers intervention to parents only
intervention type: Behavioral
intervention name: iChoose
description: 12 bi-weekly sessions & 24 IVR calls/12 months, 24 physical activity sessions over 6 months; delivers intervention to parents and children only
arm group label: iChoose
intervention type: Behavioral
intervention name: Family Connections
description: 2 in-person sessions spaced one week apart & 10 IVR calls/6 months, promotes physical activity but does not include structured exercise sessions; delivers intervention to parents only
arm group label: Family Connections
criteria: 
gender: All
minimum age: 8 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jamie M Zoellner, PhD, RD
phone: 434-962-4488
email: jz9q@virginia.edu
last name: Paul A Estabrooks, PhD
phone: 402.559.4325
email: Paul.estabrooks@unmc.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Virginia
investigator full name: Jamie Zoellner, PhD RD
investigator title: Associate Professor
mesh term: Obesity
mesh term: Pediatric Obesity
sharing ipd: Undecided
submitted: March 15, 2021
returned: April 9, 2021
submitted: January 9, 2023