<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/NCT04406441</url>
  </required_header>
  <id_info>
    <org_study_id>2020-0207</org_study_id>
    <nct_id>NCT04406441</nct_id>
  </id_info>
  <brief_title>Patient-Clinic-Community Integration to Prevent Obesity Among Rural Preschool Children</brief_title>
  <acronym>ENCIRCLE</acronym>
  <official_title>Patient-Clinic-Community Integration to Prevent Obesity Among Rural Preschool Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Geisinger Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Penn State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Iowa State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Nebraska</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Geisinger Clinic</source>
  <oversight_info>
    <has_dmc>No</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 goal of this research study is to compare two enhancements to well-child visits at&#xD;
      Geisinger designed to promote family-centered counseling for the prevention of obesity in a&#xD;
      high-risk population of rural, lower income, preschool-aged children. Compared to the&#xD;
      standard well-child visit, enhancements will offer advantages to obesity prevention, parent&#xD;
      involvement in counseling, lifestyle behaviors, and food resource management.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 17, 2020</start_date>
  <completion_date type="Anticipated">May 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2024</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>difference in difference in BMI z-score, based on WHO growth standards</measure>
    <time_frame>1-year</time_frame>
    <description>BMI values will be obtained from Geisinger clinical care visits, documented in the EHR and standardized or parent-reported. Values obtained at well child visits during the study period, ideally 12 months, 1 day apart will be utilized but values within a 9- to 18-month span of baseline to 1-year follow up may be used (e.g., 3 months pre-baseline WCV to 15 months post-baseline, baseline WCV to 18-months post-baseline, etc.) may be used to assess the primary outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>United States Household Food Security Survey Module: Six-Item Short Form</measure>
    <time_frame>1-year</time_frame>
    <description>The Six-item short form is an abbreviated form of the 10- and 18-item longer scales from the Economic Research Service, United States Department of Agriculture. A score of 0-1 indicates high or marginal food security; a score of 2-4 indicates low food security; a score of 5-6 indicates very low food security. Change in household food security status at 1-year is a planned analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Version of Perceived Involvement in Care Scale</measure>
    <time_frame>1-year</time_frame>
    <description>The Modified Perceived Involvement in Care Scale (M-PICS) measures patients' perceptions of doctor-patient communication during the medical encounter. Subscale results are provided for 4 domains (each scored on a 1-5 item Likert scale). 1- Health care provider information evaluates the degree to which the provider is perceived as controlling information with a higher score indicating more controlling behavior. 2- Patient information evaluates the extent to which the patient sought or shared information with a higher score indicating greater patient activation in information gathering. 3- Patient decision making evaluates patient participation in decision making during care with a higher score indicating greater participation. 4- Health care provider facilitation reflects patients encouragement to ask questions with a higher score indicating greater facilitation. There is not a summary score. Change in perceived involvement in care by each subscale at 1-year are planned analyses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Food Resource Management</measure>
    <time_frame>1-year</time_frame>
    <description>Nine items from the Cooking Matters Food Resource Management survey that assess 2 subscales (each scored on 1-5 item Likert scale)- Food Resource Management Practices (indicating the frequency with which respondents engaged in behaviors to maximize food resources) and Food Resource Management Confidence (extent to which participants showed self-confidence in shopping, preparing foods, and managing food resources on a budget). Higher scores indicate more frequent practices and greater confidence, respectively. There is not a summary score. Change in food resource management by each subscale at 1-year are planned analyses.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Raw BMI</measure>
    <time_frame>1-year</time_frame>
    <description>Differences in raw BMI will be evaluated amongst study arms.</description>
  </other_outcome>
  <other_outcome>
    <measure>Percent over BMI (BMI50)</measure>
    <time_frame>1-year</time_frame>
    <description>Differences in BMI50 will be evaluated amongst study arms.</description>
  </other_outcome>
  <other_outcome>
    <measure>Proportion of Children Overweight and Obese</measure>
    <time_frame>1-year</time_frame>
    <description>Evaluate the proportion of children overweight and obese at 1-year follow-up per CDC guidance and definitions.</description>
  </other_outcome>
  <other_outcome>
    <measure>BMIz extended</measure>
    <time_frame>1-year</time_frame>
    <description>Difference in BMIz extended (CDC) will be evaluated between study arms.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">2040</enrollment>
  <condition>Pediatric Obesity</condition>
  <condition>Preventive Medicine</condition>
  <condition>Mentoring</condition>
  <condition>Food Supply</condition>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will attend regularly scheduled well child visits (WCV) that follow standard clinical guidelines. Well child visits will include review of history, age-appropriate measurements (height/length, weight, body mass index (BMI), blood pressure), sensory and developmental screenings, physical exam, immunizations, oral health review, and anticipatory guidance (preventive counseling).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patient Reported Outcome</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Arm 2 builds on the standard of care WCV by adding a patient reported outcome measure, the Family Nutrition and Physical Activity risk assessment, to inform family-centered preventative counseling during clinical care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patient Reported Outcome + Food Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive all Arm 2 components, in addition to be referred to both the Geisinger Wellness Program for a Parent Training Program and a grocery store nutritionist for a tour aligned with the Cooking Matters program.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Patient Reported Outcome Well Child Visit</intervention_name>
    <description>Parents will complete the Family Nutrition and Physical Activity risk assessment (Patient Reported Outcome) prior to scheduled well child visit. Parent reported data is integrated into the child's electronic health record to inform the child's primary care provider and the provision of preventive counseling. The primary care provider documents preventive care provided.</description>
    <arm_group_label>Patient Reported Outcome</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Patient Reported Outcome Well Child Visit + Food Care</intervention_name>
    <description>Adapted Parent Training Program will be delivered via telehealth (video or telephone) to parents by trained Wellness Coaches as 6 individual sessions, distributed throughout a 26-week intervention period. Cooking Matters grocery store tours will be delivered (in-person or virtual) to parents by trained grocery store nutritionists during the 26-week intervention period.</description>
    <arm_group_label>Patient Reported Outcome + Food Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age (20-months to 59-months, 29-days old)&#xD;
&#xD;
          -  BMI-for-age and -sex &gt;50th percentile based on WHO growth standards&#xD;
&#xD;
          -  Parent commitment to participate in 18-month study&#xD;
&#xD;
          -  Plans to attend scheduled WCV and recommended follow-up WCV in 12 months&#xD;
&#xD;
          -  No plans to move or change health systems in 2 years&#xD;
&#xD;
          -  Parent age &gt; 18 years&#xD;
&#xD;
          -  Parent is English-speaking&#xD;
&#xD;
          -  Household is considered lower-income (i.e., eligible for or receiving Special&#xD;
             Supplemental Nutrition Program for Women, Infants and Children [WIC], Supplemental&#xD;
             Nutrition Assistance Program [SNAP], Temporary Assistance for Needy Families [TANF],&#xD;
             Medicaid, or Children's Health Insurance Program [CHIP]) or screens positive for food&#xD;
             insecurity.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Another child in family is participating&#xD;
&#xD;
          -  Pre-existing medical exclusions (cancer, type 1 diabetes, major developmental delays&#xD;
             such as autism)&#xD;
&#xD;
          -  Parents with self-reported major depression will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Months</minimum_age>
    <maximum_age>59 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lisa Bailey-Davis, DEd, RD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Geisinger Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shawnee L Lutcher</name>
      <address>
        <city>Danville</city>
        <state>Pennsylvania</state>
        <zip>17822</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Slusser W, Frankel F, Robison K, Fischer H, Cumberland WG, Neumann C. Pediatric overweight prevention through a parent training program for 2-4 year old Latino children. Child Obes. 2012 Feb;8(1):52-9. doi: 10.1089/chi.2011.0060.</citation>
    <PMID>22799481</PMID>
  </results_reference>
  <results_reference>
    <citation>Bailey-Davis L, Kling SMR, Wood GC, Cochran WJ, Mowery JW, Savage JS, Stametz RA, Welk GJ. Feasibility of enhancing well-child visits with family nutrition and physical activity risk assessment on body mass index. Obes Sci Pract. 2019 Apr 24;5(3):220-230. doi: 10.1002/osp4.339. eCollection 2019 Jun.</citation>
    <PMID>31275595</PMID>
  </results_reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>August 16, 2023</last_update_submitted>
  <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04406441
org study id: 2020-0207
nct id: NCT04406441
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of this research study is to compare two enhancements to well-child visits at
      Geisinger designed to promote family-centered counseling for the prevention of obesity in a
      high-risk population of rural, lower income, preschool-aged children. Compared to the
      standard well-child visit, enhancements will offer advantages to obesity prevention, parent
      involvement in counseling, lifestyle behaviors, and food resource management.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
measure: difference in difference in BMI z-score, based on WHO growth standards
time frame: 1-year
description: BMI values will be obtained from Geisinger clinical care visits, documented in the EHR and standardized or parent-reported. Values obtained at well child visits during the study period, ideally 12 months, 1 day apart will be utilized but values within a 9- to 18-month span of baseline to 1-year follow up may be used (e.g., 3 months pre-baseline WCV to 15 months post-baseline, baseline WCV to 18-months post-baseline, etc.) may be used to assess the primary outcome.
measure: United States Household Food Security Survey Module: Six-Item Short Form
time frame: 1-year
description: The Six-item short form is an abbreviated form of the 10- and 18-item longer scales from the Economic Research Service, United States Department of Agriculture. A score of 0-1 indicates high or marginal food security; a score of 2-4 indicates low food security; a score of 5-6 indicates very low food security. Change in household food security status at 1-year is a planned analysis.
measure: Modified Version of Perceived Involvement in Care Scale
time frame: 1-year
description: The Modified Perceived Involvement in Care Scale (M-PICS) measures patients' perceptions of doctor-patient communication during the medical encounter. Subscale results are provided for 4 domains (each scored on a 1-5 item Likert scale). 1- Health care provider information evaluates the degree to which the provider is perceived as controlling information with a higher score indicating more controlling behavior. 2- Patient information evaluates the extent to which the patient sought or shared information with a higher score indicating greater patient activation in information gathering. 3- Patient decision making evaluates patient participation in decision making during care with a higher score indicating greater participation. 4- Health care provider facilitation reflects patients encouragement to ask questions with a higher score indicating greater facilitation. There is not a summary score. Change in perceived involvement in care by each subscale at 1-year are planned analyses.
measure: Food Resource Management
time frame: 1-year
description: Nine items from the Cooking Matters Food Resource Management survey that assess 2 subscales (each scored on 1-5 item Likert scale)- Food Resource Management Practices (indicating the frequency with which respondents engaged in behaviors to maximize food resources) and Food Resource Management Confidence (extent to which participants showed self-confidence in shopping, preparing foods, and managing food resources on a budget). Higher scores indicate more frequent practices and greater confidence, respectively. There is not a summary score. Change in food resource management by each subscale at 1-year are planned analyses.
measure: Raw BMI
time frame: 1-year
description: Differences in raw BMI will be evaluated amongst study arms.
measure: Percent over BMI (BMI50)
time frame: 1-year
description: Differences in BMI50 will be evaluated amongst study arms.
measure: Proportion of Children Overweight and Obese
time frame: 1-year
description: Evaluate the proportion of children overweight and obese at 1-year follow-up per CDC guidance and definitions.
measure: BMIz extended
time frame: 1-year
description: Difference in BMIz extended (CDC) will be evaluated between study arms.
arm group label: Standard of Care
arm group type: No Intervention
description: Participants will attend regularly scheduled well child visits (WCV) that follow standard clinical guidelines. Well child visits will include review of history, age-appropriate measurements (height/length, weight, body mass index (BMI), blood pressure), sensory and developmental screenings, physical exam, immunizations, oral health review, and anticipatory guidance (preventive counseling).
arm group label: Patient Reported Outcome
arm group type: Active Comparator
description: Arm 2 builds on the standard of care WCV by adding a patient reported outcome measure, the Family Nutrition and Physical Activity risk assessment, to inform family-centered preventative counseling during clinical care.
arm group label: Patient Reported Outcome + Food Care
arm group type: Active Comparator
description: Participants will receive all Arm 2 components, in addition to be referred to both the Geisinger Wellness Program for a Parent Training Program and a grocery store nutritionist for a tour aligned with the Cooking Matters program.
intervention type: Behavioral
intervention name: Patient Reported Outcome Well Child Visit
description: Parents will complete the Family Nutrition and Physical Activity risk assessment (Patient Reported Outcome) prior to scheduled well child visit. Parent reported data is integrated into the child's electronic health record to inform the child's primary care provider and the provision of preventive counseling. The primary care provider documents preventive care provided.
arm group label: Patient Reported Outcome
intervention type: Behavioral
intervention name: Patient Reported Outcome Well Child Visit + Food Care
description: Adapted Parent Training Program will be delivered via telehealth (video or telephone) to parents by trained Wellness Coaches as 6 individual sessions, distributed throughout a 26-week intervention period. Cooking Matters grocery store tours will be delivered (in-person or virtual) to parents by trained grocery store nutritionists during the 26-week intervention period.
arm group label: Patient Reported Outcome + Food Care
criteria: 
gender: All
minimum age: 20 Months
maximum age: 59 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Lisa Bailey-Davis, DEd, RD
role: Principal Investigator
affiliation: Geisinger Clinic
facility: 
country: United States
citation: Slusser W, Frankel F, Robison K, Fischer H, Cumberland WG, Neumann C. Pediatric overweight prevention through a parent training program for 2-4 year old Latino children. Child Obes. 2012 Feb;8(1):52-9. doi: 10.1089/chi.2011.0060.
PMID: 22799481
citation: Bailey-Davis L, Kling SMR, Wood GC, Cochran WJ, Mowery JW, Savage JS, Stametz RA, Welk GJ. Feasibility of enhancing well-child visits with family nutrition and physical activity risk assessment on body mass index. Obes Sci Pract. 2019 Apr 24;5(3):220-230. doi: 10.1002/osp4.339. eCollection 2019 Jun.
PMID: 31275595
responsible party type: Sponsor
mesh term: Obesity
mesh term: Pediatric Obesity
sharing ipd: No