<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/NCT01729910</url>
  </required_header>
  <id_info>
    <org_study_id>1R15HD054950-01A2 REVISED</org_study_id>
    <secondary_id>1R15HD054950-01A2</secondary_id>
    <nct_id>NCT01729910</nct_id>
  </id_info>
  <brief_title>Primary Care Child Obesity Intervention Targeting Parents</brief_title>
  <official_title>Primary Care Child Obesity Intervention Targeting Parents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>East Tennessee State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>East Tennessee State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Child overweight has become one of today's most important public health concerns. Engaged and&#xD;
      skilled parenting that models, values, and encourages healthy eating habits and a physically&#xD;
      active lifestyle can play a key role in childhood overweight prevention and reduction.&#xD;
      Primary care providers are well positioned to intervene with children and their parents, but&#xD;
      face many barriers in addressing child overweight. A child overweight treatment approach is&#xD;
      proposed for the primary care setting to facilitate parents' active involvement and&#xD;
      self-efficacy in promoting healthy eating habits and physical activity for their children. We&#xD;
      will test the following hypotheses: Hypothesis I (primary hypothesis): Children assigned to&#xD;
      the intervention group will improve more in weight status (measured by BMI percentile) than&#xD;
      children in the control group. Hypothesis II: Primary care providers assigned to the&#xD;
      intervention group will improve more in their competence in addressing child overweight than&#xD;
      the providers in the control group. Hypothesis III: After the intervention, parents in the&#xD;
      intervention group will have more involvement and self-efficacy in promoting healthy weight&#xD;
      for their children than parents in the control group. Hypothesis IV: Compared to the control&#xD;
      group, the intervention group will improve more in family diet and eating, physical activity&#xD;
      behaviors, as well as parental attitude and beliefs. Eighty children five to eleven years old&#xD;
      who are overweight or obese will be recruited from two pediatric and two family practice&#xD;
      clinics in southern Appalachia. Children will be randomly assigned to intervention and&#xD;
      control groups based on clinic affiliation. Parents of children in the intervention group&#xD;
      will participate in four clinic-based group sessions using the NIH We Can! curriculum&#xD;
      moderated by a trained clinic provider, two individual brief motivational interviewing visits&#xD;
      with their clinic provider, and four follow-up phone calls with the project coordinator or&#xD;
      registered dietician. Parenting behaviors and attitudes, and family eating and activity&#xD;
      habits, and children's weight status will be assessed at baseline, at the completion of the&#xD;
      intervention, and at six months after the intervention. Changes in the assessments will be&#xD;
      compared between treatment and control groups. Changes in provider and parent attitudes and&#xD;
      perceptions about this treatment approach,adherence to the program, and estimates of&#xD;
      associated time will be measured.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Specific aims of this project are: 1) to establish a primary care based and parent-mediated&#xD;
      childhood overweight intervention program based on the Chronic Care Model in the primary care&#xD;
      setting, 2) to explore the efficacy of this intervention in improving the weight status of&#xD;
      children, 3) to examine the acceptability and feasibility of the approach among primary care&#xD;
      providers and parents. Clinic providers and study personnel will be trained in the use of&#xD;
      brief motivational interviewing (brief MI) for the visits and phone calls. The American&#xD;
      Academy of Pediatrics 15-Minute Obesity Prevention Protocol will be used for individual&#xD;
      visits while the NIH We Can! curriculum and materials will be used for group visits. Parents&#xD;
      in the control group will receive the We Can! Parent Handbook and usual care. The&#xD;
      intervention is designed to facilitate efficient communication of advice about behavior&#xD;
      change, nutrition, and physical activity to parents. Partnership of primary care providers&#xD;
      with parents and use of brief intervention techniques and group visits can be a practical&#xD;
      approach. If proven to be effective, this approach can serve as an exportable model to other&#xD;
      primary care practices and will reach a large proportion of the population and have&#xD;
      far-reaching effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2009</start_date>
  <completion_date type="Actual">March 2011</completion_date>
  <primary_completion_date type="Actual">November 2010</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 body mass index percentile</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Parent report of knowledge, attitudes, perceptions, intentions, and behaviors related to eating and physical activity</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Health care provider knowledge, attitudes, and practices related to child obesity management</measure>
    <time_frame>6-12 months</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">67</enrollment>
  <condition>Overweight</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Parent education / behavioral counseling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Parents of children in the intervention group will be invited to participate in four group visits and two individual visits with their primary care provider as well as four follow-up phone calls with study personnel (project coordinator or registered dietician). Providers and study personnel will be trained in the use of the NIH We Can! curriculum for group visits and brief motivational interviewing for individual visits and follow-up phone calls.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Parents of children in the control group will receive usual care from their primary care provider as well as a copy of the NIH We Can! Parent Handbook.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Parent education / behavioral counseling</intervention_name>
    <description>Providers and study personnel will be trained in the use of the NIH We Can! curriculum for group visits and brief motivational interviewing for individual visits and follow-up phone calls. Training will be conducted by the PI and Co-Investigators using a combination of online, self-study, and face-to-face formats totally at least/approximately 8 hours. At least one project team member will attend each group visit. Specifically, the American Academy of Pediatrics 15-minute Obesity Prevention Protocol will be utilized during individual visits. The intervention is designed to take place over a period of 10-12 weeks in the primary care office.</description>
    <arm_group_label>Parent education / behavioral counseling</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <description>Parents of children in the control group will receive usual care from their primary care provider as well as a copy of the NIH We Can! Parent Handbook.</description>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI &gt;= 85th percentile&#xD;
&#xD;
          -  age 5-11 years&#xD;
&#xD;
          -  one parent or other primary care giver agrees to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  current participation in another weight management program by child or&#xD;
             parent/caregiver&#xD;
&#xD;
          -  presence of a diagnosed psychiatric/psychological disorder in the parent or child&#xD;
&#xD;
          -  presence of an underlying condition affecting weight status&#xD;
&#xD;
          -  current dietary or physical activity limitations&#xD;
&#xD;
          -  parents who do not have phone accessibility&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karen E Schetzina, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>East Tennessee State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>East Tennessee State University</name>
      <address>
        <city>Johnson City</city>
        <state>Tennessee</state>
        <zip>37614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Dalton WT 3rd, Schetzina KE, Holt N, Fulton-Robinson H, Ho AL, Tudiver F, McBee MT, Wu T. Parent-Led Activity and Nutrition (PLAN) for healthy living: design and methods. Contemp Clin Trials. 2011 Nov;32(6):882-92. doi: 10.1016/j.cct.2011.07.004. Epub 2011 Jul 18.</citation>
    <PMID>21777701</PMID>
  </reference>
  <results_reference>
    <citation>Holt N, Schetzina KE, Dalton WT 3rd, Tudiver F, Fulton-Robinson H, Wu T. Primary care practice addressing child overweight and obesity: a survey of primary care physicians at four clinics in southern Appalachia. South Med J. 2011 Jan;104(1):14-9. doi: 10.1097/SMJ.0b013e3181fc968a.</citation>
    <PMID>21119559</PMID>
  </results_reference>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>November 15, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>November 23, 2015</last_update_submitted>
  <last_update_submitted_qc>November 23, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 24, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>overweight</keyword>
  <keyword>obesity</keyword>
  <keyword>rural</keyword>
  <keyword>primary care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Overweight</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/NCT01729910
org study id: 1R15HD054950-01A2 REVISED
secondary id: 1R15HD054950-01A2
nct id: NCT01729910
lead sponsor: 
collaborator: 
has dmc: No
Child overweight has become one of today's most important public health concerns. Engaged and
      skilled parenting that models, values, and encourages healthy eating habits and a physically
      active lifestyle can play a key role in childhood overweight prevention and reduction.
      Primary care providers are well positioned to intervene with children and their parents, but
      face many barriers in addressing child overweight. A child overweight treatment approach is
      proposed for the primary care setting to facilitate parents' active involvement and
      self-efficacy in promoting healthy eating habits and physical activity for their children. We
      will test the following hypotheses: Hypothesis I (primary hypothesis): Children assigned to
      the intervention group will improve more in weight status (measured by BMI percentile) than
      children in the control group. Hypothesis II: Primary care providers assigned to the
      intervention group will improve more in their competence in addressing child overweight than
      the providers in the control group. Hypothesis III: After the intervention, parents in the
      intervention group will have more involvement and self-efficacy in promoting healthy weight
      for their children than parents in the control group. Hypothesis IV: Compared to the control
      group, the intervention group will improve more in family diet and eating, physical activity
      behaviors, as well as parental attitude and beliefs. Eighty children five to eleven years old
      who are overweight or obese will be recruited from two pediatric and two family practice
      clinics in southern Appalachia. Children will be randomly assigned to intervention and
      control groups based on clinic affiliation. Parents of children in the intervention group
      will participate in four clinic-based group sessions using the NIH We Can! curriculum
      moderated by a trained clinic provider, two individual brief motivational interviewing visits
      with their clinic provider, and four follow-up phone calls with the project coordinator or
      registered dietician. Parenting behaviors and attitudes, and family eating and activity
      habits, and children's weight status will be assessed at baseline, at the completion of the
      intervention, and at six months after the intervention. Changes in the assessments will be
      compared between treatment and control groups. Changes in provider and parent attitudes and
      perceptions about this treatment approach,adherence to the program, and estimates of
      associated time will be measured.
Specific aims of this project are: 1) to establish a primary care based and parent-mediated
      childhood overweight intervention program based on the Chronic Care Model in the primary care
      setting, 2) to explore the efficacy of this intervention in improving the weight status of
      children, 3) to examine the acceptability and feasibility of the approach among primary care
      providers and parents. Clinic providers and study personnel will be trained in the use of
      brief motivational interviewing (brief MI) for the visits and phone calls. The American
      Academy of Pediatrics 15-Minute Obesity Prevention Protocol will be used for individual
      visits while the NIH We Can! curriculum and materials will be used for group visits. Parents
      in the control group will receive the We Can! Parent Handbook and usual care. The
      intervention is designed to facilitate efficient communication of advice about behavior
      change, nutrition, and physical activity to parents. Partnership of primary care providers
      with parents and use of brief intervention techniques and group visits can be a practical
      approach. If proven to be effective, this approach can serve as an exportable model to other
      primary care practices and will reach a large proportion of the population and have
      far-reaching effects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: child body mass index percentile
time frame: 6 months
measure: Parent report of knowledge, attitudes, perceptions, intentions, and behaviors related to eating and physical activity
time frame: 6 months
measure: Health care provider knowledge, attitudes, and practices related to child obesity management
time frame: 6-12 months
arm group label: Parent education / behavioral counseling
arm group type: Experimental
description: Parents of children in the intervention group will be invited to participate in four group visits and two individual visits with their primary care provider as well as four follow-up phone calls with study personnel (project coordinator or registered dietician). Providers and study personnel will be trained in the use of the NIH We Can! curriculum for group visits and brief motivational interviewing for individual visits and follow-up phone calls.
arm group label: Usual Care
arm group type: Placebo Comparator
description: Parents of children in the control group will receive usual care from their primary care provider as well as a copy of the NIH We Can! Parent Handbook.
intervention type: Behavioral
intervention name: Parent education / behavioral counseling
description: Providers and study personnel will be trained in the use of the NIH We Can! curriculum for group visits and brief motivational interviewing for individual visits and follow-up phone calls. Training will be conducted by the PI and Co-Investigators using a combination of online, self-study, and face-to-face formats totally at least/approximately 8 hours. At least one project team member will attend each group visit. Specifically, the American Academy of Pediatrics 15-minute Obesity Prevention Protocol will be utilized during individual visits. The intervention is designed to take place over a period of 10-12 weeks in the primary care office.
arm group label: Parent education / behavioral counseling
intervention type: Behavioral
intervention name: Usual Care
description: Parents of children in the control group will receive usual care from their primary care provider as well as a copy of the NIH We Can! Parent Handbook.
arm group label: Usual Care
criteria: 
gender: All
minimum age: 5 Years
maximum age: 11 Years
healthy volunteers: No
last name: Karen E Schetzina, MD, MPH
role: Principal Investigator
affiliation: East Tennessee State University
facility: 
country: United States
citation: Dalton WT 3rd, Schetzina KE, Holt N, Fulton-Robinson H, Ho AL, Tudiver F, McBee MT, Wu T. Parent-Led Activity and Nutrition (PLAN) for healthy living: design and methods. Contemp Clin Trials. 2011 Nov;32(6):882-92. doi: 10.1016/j.cct.2011.07.004. Epub 2011 Jul 18.
PMID: 21777701
citation: Holt N, Schetzina KE, Dalton WT 3rd, Tudiver F, Fulton-Robinson H, Wu T. Primary care practice addressing child overweight and obesity: a survey of primary care physicians at four clinics in southern Appalachia. South Med J. 2011 Jan;104(1):14-9. doi: 10.1097/SMJ.0b013e3181fc968a.
PMID: 21119559
responsible party type: Sponsor
mesh term: Obesity
mesh term: Overweight
mesh term: Pediatric Obesity