<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/NCT03246763</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00084070</org_study_id>
    <nct_id>NCT03246763</nct_id>
  </id_info>
  <brief_title>Active Recreation Through Community-Healthcare Engagement Study</brief_title>
  <acronym>ARCHES</acronym>
  <official_title>Active Recreation Through Community-Healthcare Engagement Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</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>
      Current obesity treatment guidelines recommend 26 or more hours of behavior treatment,&#xD;
      delivered over a 6-month period in a multidisciplinary weight management clinic. However,&#xD;
      this guideline is not feasible in real-world clinic settings where medical visits are costly&#xD;
      and poorly reimbursed, and attrition is high, particularly among the most vulnerable&#xD;
      children. The National Collaborative on Child Obesity Research has issued a call for research&#xD;
      investigating healthcare-community partnerships to improve the effectiveness of child obesity&#xD;
      treatment. The World Health Organization supports this approach, and in 2015 modified the&#xD;
      chronic disease model to include healthcare-community integration. ARCHES is a three-year&#xD;
      project that will develop and evaluate an effective, engaging, and scalable&#xD;
      community-healthcare treatment option for low-income and racially diverse children. The&#xD;
      project engages four communities in North Carolina and facilitates a local clinic-community&#xD;
      partnership, supports the development of an integrated childhood obesity treatment program,&#xD;
      and evaluates the feasibility of the integrated program model. The effectiveness of the&#xD;
      integrated model will also be evaluated, as we will monitor patient outcomes associated with&#xD;
      participation. Participation among teens (ages 11-18) will be incentivized where&#xD;
      teen/caregiver dyads will be randomized to a gain or loss frame group at the beginning of the&#xD;
      study and have the opportunity to receive and redeem points for attending sessions. Patient&#xD;
      and process outcomes associated with participation in the integrated model with and without&#xD;
      financial incentives will be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators propose a three-year project to evaluate the implementation feasibility and&#xD;
      effectiveness of an integrated clinic-community model of child obesity treatment. The&#xD;
      investigators will engage four communities in North Carolina, facilitate a local&#xD;
      clinic-community partnership, support the development of an integrated child obesity&#xD;
      treatment program, and monitor outcomes. To evaluate implementation feasibility the&#xD;
      investigators will measure fidelity, reach, acceptability, uptake and cost. To evaluate the&#xD;
      program model the investigators will conduct a classical program evaluation by monitoring&#xD;
      aggregate referral, enrollment and attendance data, as well as safety and patient&#xD;
      satisfaction. To report patient outcomes associated with participation in the integrated&#xD;
      model, the investigators will measure participant-level outcomes over a 6-month period,&#xD;
      including changes in nutrition and physical activity behaviors, quality of life,&#xD;
      cardiovascular fitness, and body mass index.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 7, 2018</start_date>
  <completion_date type="Actual">May 1, 2020</completion_date>
  <primary_completion_date type="Actual">May 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The investigators will conduct a mixed-methods study using focus groups and interviews to explore the facilitators and barriers to program implementation, and a time-series analysis to examine program engagement and individual health outcomes. This study design will be repeated at each of the four sites. Aim 1 will consent and enroll program providers to obtain qualitative feedback on program design and implementation; Aim 2 will collect de-identified program-level data on attendance and program components; Aim 3 will consent patients for individual-level baseline and outcomes data.Subjects will be enrolled at our community sites. A research assistant will conduct all the enrollment, consent, and data collection. Where needed, the investigators will report or obtain required IRB authorization agreements for each site, including Federal Wide Assurances, Data Transfer Agreements, or other documents as required by federal regulation.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Eligibility</measure>
    <time_frame>Baseline</time_frame>
    <description>Number of eligible patients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Referral</measure>
    <time_frame>Baseline</time_frame>
    <description>Number of referred patients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Enrollment</measure>
    <time_frame>Baseline</time_frame>
    <description>Number of patients referred who enroll</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Attendance</measure>
    <time_frame>Through study completion, average of 1 year</time_frame>
    <description>Number of participants present at each activity session</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fidelity</measure>
    <time_frame>Through study completion, average of 1 year</time_frame>
    <description>Measured by program post-session evaluation survey</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in quality of life</measure>
    <time_frame>Baseline, 6 months, 12 months</time_frame>
    <description>Measured by Sizing me Up survey</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in height</measure>
    <time_frame>0 months, 3 months, 6 months, 12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in nutrition habits (self report)</measure>
    <time_frame>0 months, 3 months, 6 months, 12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Food insecurity</measure>
    <time_frame>Baseline</time_frame>
    <description>Measured by The Hunger Vital Sign food insecurity assessment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in cardiovascular fitness</measure>
    <time_frame>0 months, 3 months, 6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>6 months</time_frame>
    <description>Measured by patient satisfaction survey</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in social cohesion</measure>
    <time_frame>3 months, 6 months</time_frame>
    <description>Measured by social cohesion questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in weight</measure>
    <time_frame>0 months, 3 months, 6 months, 12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in activity (self report)</measure>
    <time_frame>0 months, 3 months, 6 months, 12 months</time_frame>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">202</enrollment>
  <condition>Childhood Obesity</condition>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>Durham County</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention will include nutrition and fitness programming at a community center. The program will be open at least two sessions per week, each session lasting at least 1 hour. The program coordinator will run the programming, which will consist of comprehensive wellness activities. Each session will include at least 60 minutes of exercise and/or active play, and each session will have an additional special &quot;theme.&quot; For example, one session might include a cardio focused class, and one session might include a yoga class. The number and which sessions the participants attend each week is voluntary; clinic staff will recommend participation in as many sessions per week as possible. Participation is voluntary, and patients may opt-out at any time. Participants will be told that they can indicate to their provider or the program coordinator at any time either by phone or during the clinic appointment that they wish to opt-out of the study and its assessments.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Richmond/Montgomery Counties</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention will include nutrition and fitness programming at a community center. The program will be open at least two sessions per week, each session lasting at least 1 hour. The program coordinator will run the programming, which will consist of comprehensive wellness activities. Each session will include at least 60 minutes of exercise and/or active play, and each session will have an additional special &quot;theme.&quot; For example, one session might include a cardio focused class, and one session might include a yoga class. The number and which sessions the participants attend each week is voluntary; clinic staff will recommend participation in as many sessions per week as possible. Participation is voluntary, and patients may opt-out at any time. Participants will be told that they can indicate to their provider or the program coordinator at any time either by phone or during the clinic appointment that they wish to opt-out of the study and its assessments.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TBD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention will include nutrition and fitness programming at a community center. The program will be open at least two sessions per week, each session lasting at least 1 hour. The program coordinator will run the programming, which will consist of comprehensive wellness activities. Each session will include at least 60 minutes of exercise and/or active play, and each session will have an additional special &quot;theme.&quot; For example, one session might include a cardio focused class, and one session might include a yoga class. The number and which sessions the participants attend each week is voluntary; clinic staff will recommend participation in as many sessions per week as possible. Participation is voluntary, and patients may opt-out at any time. Participants will be told that they can indicate to their provider or the program coordinator at any time either by phone or during the clinic appointment that they wish to opt-out of the study and its assessments.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>To be determined</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention will include nutrition and fitness programming at a community center. The program will be open at least two sessions per week, each session lasting at least 1 hour. The program coordinator will run the programming, which will consist of comprehensive wellness activities. Each session will include at least 60 minutes of exercise and/or active play, and each session will have an additional special &quot;theme.&quot; For example, one session might include a cardio focused class, and one session might include a yoga class. The number and which sessions the participants attend each week is voluntary; clinic staff will recommend participation in as many sessions per week as possible. Participation is voluntary, and patients may opt-out at any time. Participants will be told that they can indicate to their provider or the program coordinator at any time either by phone or during the clinic appointment that they wish to opt-out of the study and its assessments.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Integrated community-healthcare childhood obesity treatment</intervention_name>
    <description>The intervention will include nutrition and fitness programming at a local community center. The program will be open at least two sessions per week, each session lasting at least 1 hour. The program coordinator will run the programming, which will consist of wellness activities. Each session will include at least 60 minutes of exercise and/or active play, and each session will have an additional special &quot;theme.&quot; For example, one session might include a cardio focused class, and one session might include a yoga class. The number and which sessions the participants attend each week is voluntary; clinic staff will recommend participation in as many sessions per week as possible. Participation is voluntary, and patients may opt-out at any time. Participants will be told that they can indicate to their provider or the program coordinator at any time either by phone or during the clinic appointment that they wish to opt-out of the study and its assessments.</description>
    <arm_group_label>Durham County</arm_group_label>
    <arm_group_label>Richmond/Montgomery Counties</arm_group_label>
    <arm_group_label>TBD</arm_group_label>
    <arm_group_label>To be determined</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Sampling:&#xD;
&#xD;
        - Patients enrolled by their physician in the clinic-community program&#xD;
&#xD;
        Inclusion:&#xD;
&#xD;
          -  Child aged 2-17 years&#xD;
&#xD;
          -  Child with age- and gender-specific BMI ≥ 85th percentile&#xD;
&#xD;
        Exclusion:&#xD;
&#xD;
          -  Inability to read and write in English or Spanish&#xD;
&#xD;
          -  Parent with severe medical or mental health condition limiting ability to attend&#xD;
             appointments&#xD;
&#xD;
          -  Child with severe medical or mental health condition limiting ability to attend&#xD;
             appointments or participate in behavioral therapies&#xD;
&#xD;
          -  Parent and child live greater than 50 miles from the clinic and community center&#xD;
&#xD;
          -  Plan to move out of state in the next 6 months, or plan to live in another state for 2&#xD;
             months or longer within the next 6 months (ex., summer vacation).&#xD;
&#xD;
          -  Child with medical condition as cause of obesity (e.g., hypothyroidism, Cushing's&#xD;
             Syndrome, Prader-Willi Syndrome, drug-induced obesity)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>First Health</name>
      <address>
        <city>Biscoe</city>
        <state>North Carolina</state>
        <zip>27209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Durham Children's Initiative</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke Healthy Lifestyles</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Better Health</name>
      <address>
        <city>Fayetteville</city>
        <state>North Carolina</state>
        <zip>28301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Goldsboro Parks and Recreation</name>
      <address>
        <city>Goldsboro</city>
        <state>North Carolina</state>
        <zip>27530</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Med</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Healthy Rowan</name>
      <address>
        <city>Salisbury</city>
        <state>North Carolina</state>
        <zip>28144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>August 13, 2020</last_update_submitted>
  <last_update_submitted_qc>August 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>childhood obesity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03246763
org study id: Pro00084070
nct id: NCT03246763
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Current obesity treatment guidelines recommend 26 or more hours of behavior treatment,
      delivered over a 6-month period in a multidisciplinary weight management clinic. However,
      this guideline is not feasible in real-world clinic settings where medical visits are costly
      and poorly reimbursed, and attrition is high, particularly among the most vulnerable
      children. The National Collaborative on Child Obesity Research has issued a call for research
      investigating healthcare-community partnerships to improve the effectiveness of child obesity
      treatment. The World Health Organization supports this approach, and in 2015 modified the
      chronic disease model to include healthcare-community integration. ARCHES is a three-year
      project that will develop and evaluate an effective, engaging, and scalable
      community-healthcare treatment option for low-income and racially diverse children. The
      project engages four communities in North Carolina and facilitates a local clinic-community
      partnership, supports the development of an integrated childhood obesity treatment program,
      and evaluates the feasibility of the integrated program model. The effectiveness of the
      integrated model will also be evaluated, as we will monitor patient outcomes associated with
      participation. Participation among teens (ages 11-18) will be incentivized where
      teen/caregiver dyads will be randomized to a gain or loss frame group at the beginning of the
      study and have the opportunity to receive and redeem points for attending sessions. Patient
      and process outcomes associated with participation in the integrated model with and without
      financial incentives will be evaluated.
The investigators propose a three-year project to evaluate the implementation feasibility and
      effectiveness of an integrated clinic-community model of child obesity treatment. The
      investigators will engage four communities in North Carolina, facilitate a local
      clinic-community partnership, support the development of an integrated child obesity
      treatment program, and monitor outcomes. To evaluate implementation feasibility the
      investigators will measure fidelity, reach, acceptability, uptake and cost. To evaluate the
      program model the investigators will conduct a classical program evaluation by monitoring
      aggregate referral, enrollment and attendance data, as well as safety and patient
      satisfaction. To report patient outcomes associated with participation in the integrated
      model, the investigators will measure participant-level outcomes over a 6-month period,
      including changes in nutrition and physical activity behaviors, quality of life,
      cardiovascular fitness, and body mass index.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: The investigators will conduct a mixed-methods study using focus groups and interviews to explore the facilitators and barriers to program implementation, and a time-series analysis to examine program engagement and individual health outcomes. This study design will be repeated at each of the four sites. Aim 1 will consent and enroll program providers to obtain qualitative feedback on program design and implementation; Aim 2 will collect de-identified program-level data on attendance and program components; Aim 3 will consent patients for individual-level baseline and outcomes data.Subjects will be enrolled at our community sites. A research assistant will conduct all the enrollment, consent, and data collection. Where needed, the investigators will report or obtain required IRB authorization agreements for each site, including Federal Wide Assurances, Data Transfer Agreements, or other documents as required by federal regulation.
primary purpose: Treatment
masking: None (Open Label)
measure: Eligibility
time frame: Baseline
description: Number of eligible patients
measure: Referral
time frame: Baseline
description: Number of referred patients
measure: Enrollment
time frame: Baseline
description: Number of patients referred who enroll
measure: Attendance
time frame: Through study completion, average of 1 year
description: Number of participants present at each activity session
measure: Fidelity
time frame: Through study completion, average of 1 year
description: Measured by program post-session evaluation survey
measure: Change in quality of life
time frame: Baseline, 6 months, 12 months
description: Measured by Sizing me Up survey
measure: Change in height
time frame: 0 months, 3 months, 6 months, 12 months
measure: Change in nutrition habits (self report)
time frame: 0 months, 3 months, 6 months, 12 months
measure: Food insecurity
time frame: Baseline
description: Measured by The Hunger Vital Sign food insecurity assessment
measure: Change in cardiovascular fitness
time frame: 0 months, 3 months, 6 months
measure: Patient satisfaction
time frame: 6 months
description: Measured by patient satisfaction survey
measure: Change in social cohesion
time frame: 3 months, 6 months
description: Measured by social cohesion questionnaire
measure: Change in weight
time frame: 0 months, 3 months, 6 months, 12 months
measure: Change in activity (self report)
time frame: 0 months, 3 months, 6 months, 12 months
arm group label: Durham County
arm group type: Experimental
description: The intervention will include nutrition and fitness programming at a community center. The program will be open at least two sessions per week, each session lasting at least 1 hour. The program coordinator will run the programming, which will consist of comprehensive wellness activities. Each session will include at least 60 minutes of exercise and/or active play, and each session will have an additional special "theme." For example, one session might include a cardio focused class, and one session might include a yoga class. The number and which sessions the participants attend each week is voluntary; clinic staff will recommend participation in as many sessions per week as possible. Participation is voluntary, and patients may opt-out at any time. Participants will be told that they can indicate to their provider or the program coordinator at any time either by phone or during the clinic appointment that they wish to opt-out of the study and its assessments.
arm group label: Richmond/Montgomery Counties
arm group type: Experimental
description: The intervention will include nutrition and fitness programming at a community center. The program will be open at least two sessions per week, each session lasting at least 1 hour. The program coordinator will run the programming, which will consist of comprehensive wellness activities. Each session will include at least 60 minutes of exercise and/or active play, and each session will have an additional special "theme." For example, one session might include a cardio focused class, and one session might include a yoga class. The number and which sessions the participants attend each week is voluntary; clinic staff will recommend participation in as many sessions per week as possible. Participation is voluntary, and patients may opt-out at any time. Participants will be told that they can indicate to their provider or the program coordinator at any time either by phone or during the clinic appointment that they wish to opt-out of the study and its assessments.
arm group label: TBD
arm group type: Experimental
description: The intervention will include nutrition and fitness programming at a community center. The program will be open at least two sessions per week, each session lasting at least 1 hour. The program coordinator will run the programming, which will consist of comprehensive wellness activities. Each session will include at least 60 minutes of exercise and/or active play, and each session will have an additional special "theme." For example, one session might include a cardio focused class, and one session might include a yoga class. The number and which sessions the participants attend each week is voluntary; clinic staff will recommend participation in as many sessions per week as possible. Participation is voluntary, and patients may opt-out at any time. Participants will be told that they can indicate to their provider or the program coordinator at any time either by phone or during the clinic appointment that they wish to opt-out of the study and its assessments.
arm group label: To be determined
arm group type: Experimental
description: The intervention will include nutrition and fitness programming at a community center. The program will be open at least two sessions per week, each session lasting at least 1 hour. The program coordinator will run the programming, which will consist of comprehensive wellness activities. Each session will include at least 60 minutes of exercise and/or active play, and each session will have an additional special "theme." For example, one session might include a cardio focused class, and one session might include a yoga class. The number and which sessions the participants attend each week is voluntary; clinic staff will recommend participation in as many sessions per week as possible. Participation is voluntary, and patients may opt-out at any time. Participants will be told that they can indicate to their provider or the program coordinator at any time either by phone or during the clinic appointment that they wish to opt-out of the study and its assessments.
intervention type: Behavioral
intervention name: Integrated community-healthcare childhood obesity treatment
description: The intervention will include nutrition and fitness programming at a local community center. The program will be open at least two sessions per week, each session lasting at least 1 hour. The program coordinator will run the programming, which will consist of wellness activities. Each session will include at least 60 minutes of exercise and/or active play, and each session will have an additional special "theme." For example, one session might include a cardio focused class, and one session might include a yoga class. The number and which sessions the participants attend each week is voluntary; clinic staff will recommend participation in as many sessions per week as possible. Participation is voluntary, and patients may opt-out at any time. Participants will be told that they can indicate to their provider or the program coordinator at any time either by phone or during the clinic appointment that they wish to opt-out of the study and its assessments.
arm group label: Durham County
arm group label: Richmond/Montgomery Counties
arm group label: TBD
arm group label: To be determined
criteria: 
gender: All
minimum age: 2 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pediatric Obesity
sharing ipd: No