<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/NCT02185248</url>
  </required_header>
  <id_info>
    <org_study_id>363990-4</org_study_id>
    <nct_id>NCT02185248</nct_id>
  </id_info>
  <brief_title>Wellness Action Plan Trial Addressing Childhood Obesity</brief_title>
  <official_title>Randomized Controlled Trial of a Wellness Action Plan to Address the Childhood Obesity Epidemic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Roohi Kharofa, MD, MPH</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical College of Wisconsin</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study was to determine the effectiveness of a novel Wellness Action&#xD;
      Plan aimed at 1) improving parent recall of diet and activity plans 2) increasing&#xD;
      follow-through with plans and 3) aiding parents in identifying their child's weight category.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diet plan recall directly after visit</measure>
    <time_frame>On day of primary visit</time_frame>
    <description>Parents are given a questionnaire which asks whether they made a diet plan with their physician for their child during the visit and whether they will attempt to follow-through with the plan made.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Activity plan recall directly after visit</measure>
    <time_frame>On day of primary visit, directly after seeing physician</time_frame>
    <description>Parents are given a questionnaire which asks whether they made an activity plan with their physician for their child during the visit and whether they will attempt to follow-through with the plan made.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diet plan recall/follow-through 1 month post visit</measure>
    <time_frame>4 weeks after primary visit</time_frame>
    <description>Parents are contacted 4 weeks after their primary visit and given a phone questionnaire which asks whether they made a diet plan with their physician for their child during the last visit and whether they can recall the plan. If parents can recall the plan, they are then asked if they followed-through with the plan (yes, no) and how successful they were with the changes (1-10 scale).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diet plan recall/follow-through 3 months post visit</measure>
    <time_frame>12 weeks after primary visit</time_frame>
    <description>Parents are contacted 12 weeks after their primary visit and given a phone questionnaire which asks whether they made a diet plan with their physician for their child during the last visit and whether they can recall the plan. If parents can recall the plan, they are then asked if they followed-through with the plan (yes, no) and how successful they were with the changes (1-10 scale).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity plan recall/follow-through 1 month post visit</measure>
    <time_frame>4 weeks after primary visit</time_frame>
    <description>Parents are contacted 4 weeks after their primary visit and given a phone questionnaire which asks whether they made an activity plan with their physician for their child during the last visit and whether they can recall the plan. If parents can recall the plan, they are then asked if they followed-through with the plan (yes, no) and how successful they were with the changes (1-10 scale).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity plan recall/follow-through 3 months post visit</measure>
    <time_frame>12 weeks after primary visit</time_frame>
    <description>Parents are contacted 12 weeks after their primary visit and given a phone questionnaire which asks whether they made an activity plan with their physician for their child during the last visit and whether they can recall the plan. If parents can recall the plan, they are then asked if they followed-through with the plan (yes, no) and how successful they were with the changes (1-10 scale).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMI category identification directly after the visit</measure>
    <time_frame>On day of primary visit</time_frame>
    <description>Parents are given a questionnaire which asks whether their physician told them their child's weight category and asks whether they can identify that category.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMI category identification 1 month post visit</measure>
    <time_frame>4 weeks after primary visit</time_frame>
    <description>Parents are contacted 4 weeks after their primary visit and given a phone questionnaire which asks whether their physician told them their child's weight category and asks whether they can identify that category.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMI category identification 3 months post visit</measure>
    <time_frame>12 weeks after primary visit</time_frame>
    <description>Parents are contacted 12 weeks after their primary visit and given a phone questionnaire which asks whether their physician told them their child's weight category and asks whether they can identify that category.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">181</enrollment>
  <condition>Childhood Obesity</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>General clinical counseling in regards to child's BMI category and necessary changes to diet and activity regimen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wellness Plan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Received a wellness action plan. The plan included a color-coded BMI chart to help parents understand their child's weight category as well as a brief action planning worksheet to help families create personalized plans around healthy diet and activity changes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Wellness Action Plan</intervention_name>
    <description>The plan included a color-coded BMI chart to help parents understand their child's weight category as well as a brief action planning worksheet to help families create personalized plans around healthy diet and activity changes.</description>
    <arm_group_label>Wellness Plan</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children between the ages of 2.5 and 14 years, regardless of baseline BMI&#xD;
&#xD;
          -  Presented for a well child visit at a pediatric clinic serving primarily&#xD;
             Medicaid-insured children in Milwaukee, Wisconsin&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients in foster care&#xD;
&#xD;
          -  Parents and patients who were non-English speaking&#xD;
&#xD;
          -  Patients who were being seen by a specialist for weight management.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Months</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John R Meurer, MD, MBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical College of Wisconsin</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Downtown Health Center</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>July 2, 2014</study_first_submitted>
  <study_first_submitted_qc>July 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>March 20, 2015</last_update_submitted>
  <last_update_submitted_qc>March 20, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 24, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Medical College of Wisconsin</investigator_affiliation>
    <investigator_full_name>Roohi Kharofa, MD, MPH</investigator_full_name>
    <investigator_title>Primary Care Research Fellow</investigator_title>
  </responsible_party>
  <keyword>Pediatric Obesity</keyword>
  <keyword>Body Mass Index</keyword>
  <keyword>Weight Perception</keyword>
  <keyword>Counseling</keyword>
  <keyword>Health Behavior</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/NCT02185248
org study id: 363990-4
nct id: NCT02185248
lead sponsor: 
has dmc: No
The objective of this study was to determine the effectiveness of a novel Wellness Action
      Plan aimed at 1) improving parent recall of diet and activity plans 2) increasing
      follow-through with plans and 3) aiding parents in identifying their child's weight category.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Diet plan recall directly after visit
time frame: On day of primary visit
description: Parents are given a questionnaire which asks whether they made a diet plan with their physician for their child during the visit and whether they will attempt to follow-through with the plan made.
measure: Activity plan recall directly after visit
time frame: On day of primary visit, directly after seeing physician
description: Parents are given a questionnaire which asks whether they made an activity plan with their physician for their child during the visit and whether they will attempt to follow-through with the plan made.
measure: Diet plan recall/follow-through 1 month post visit
time frame: 4 weeks after primary visit
description: Parents are contacted 4 weeks after their primary visit and given a phone questionnaire which asks whether they made a diet plan with their physician for their child during the last visit and whether they can recall the plan. If parents can recall the plan, they are then asked if they followed-through with the plan (yes, no) and how successful they were with the changes (1-10 scale).
measure: Diet plan recall/follow-through 3 months post visit
time frame: 12 weeks after primary visit
description: Parents are contacted 12 weeks after their primary visit and given a phone questionnaire which asks whether they made a diet plan with their physician for their child during the last visit and whether they can recall the plan. If parents can recall the plan, they are then asked if they followed-through with the plan (yes, no) and how successful they were with the changes (1-10 scale).
measure: Activity plan recall/follow-through 1 month post visit
time frame: 4 weeks after primary visit
description: Parents are contacted 4 weeks after their primary visit and given a phone questionnaire which asks whether they made an activity plan with their physician for their child during the last visit and whether they can recall the plan. If parents can recall the plan, they are then asked if they followed-through with the plan (yes, no) and how successful they were with the changes (1-10 scale).
measure: Activity plan recall/follow-through 3 months post visit
time frame: 12 weeks after primary visit
description: Parents are contacted 12 weeks after their primary visit and given a phone questionnaire which asks whether they made an activity plan with their physician for their child during the last visit and whether they can recall the plan. If parents can recall the plan, they are then asked if they followed-through with the plan (yes, no) and how successful they were with the changes (1-10 scale).
measure: BMI category identification directly after the visit
time frame: On day of primary visit
description: Parents are given a questionnaire which asks whether their physician told them their child's weight category and asks whether they can identify that category.
measure: BMI category identification 1 month post visit
time frame: 4 weeks after primary visit
description: Parents are contacted 4 weeks after their primary visit and given a phone questionnaire which asks whether their physician told them their child's weight category and asks whether they can identify that category.
measure: BMI category identification 3 months post visit
time frame: 12 weeks after primary visit
description: Parents are contacted 12 weeks after their primary visit and given a phone questionnaire which asks whether their physician told them their child's weight category and asks whether they can identify that category.
arm group label: Control Group
arm group type: No Intervention
description: General clinical counseling in regards to child's BMI category and necessary changes to diet and activity regimen.
arm group label: Wellness Plan
arm group type: Experimental
description: Received a wellness action plan. The plan included a color-coded BMI chart to help parents understand their child's weight category as well as a brief action planning worksheet to help families create personalized plans around healthy diet and activity changes.
intervention type: Behavioral
intervention name: Wellness Action Plan
description: The plan included a color-coded BMI chart to help parents understand their child's weight category as well as a brief action planning worksheet to help families create personalized plans around healthy diet and activity changes.
arm group label: Wellness Plan
criteria: 
gender: All
minimum age: 30 Months
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
last name: John R Meurer, MD, MBA
role: Principal Investigator
affiliation: Medical College of Wisconsin
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Medical College of Wisconsin
investigator full name: Roohi Kharofa, MD, MPH
investigator title: Primary Care Research Fellow
mesh term: Obesity
mesh term: Pediatric Obesity