<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/NCT02186327</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00054909</org_study_id>
    <nct_id>NCT02186327</nct_id>
  </id_info>
  <brief_title>Integrative Health Coaching in Community Settings</brief_title>
  <official_title>Community Coaching: Integrative Health Coaching Initiative for Behavior Change and Assessment of Perceived Needs in the Community Setting</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study examines a pilot project to introduce integrative health coaching to two community&#xD;
      clinical sites, Healing with CAARE Inc. and the Healthy Lifestyles program at Duke&#xD;
      Pediatrics. 10 participants and 10 controls will be referred for enrollment at each site&#xD;
      (n=20 per site) by on-site personnel, and 6 coaching sessions will be provided over a 3-month&#xD;
      period at no cost by coaching trainees completing their certification hours. Pre and post&#xD;
      measurements of BMI, patient activation, and perceived interpersonal support will be&#xD;
      collected and analyzed for interaction effects. Qualitative process evaluation will be&#xD;
      conducted as a thematic analysis via guided interviews with stakeholders and participants,&#xD;
      using the &quot;RE-AIM&quot; framework. Feasibility measures will include recruitment of both coaches&#xD;
      and clients, subject/client retention, and number and duration of coaching sessions&#xD;
      completed. Finally, a subset of the CAARE Inc. cohort will be consented to participate in a&#xD;
      post-intervention focus group that addresses the impact of coaching on perception of&#xD;
      health-related resources and needs in the community.&#xD;
&#xD;
      Primary Hypotheses:&#xD;
&#xD;
      Integrative health coaching will be a feasible intervention in both community and clinical&#xD;
      settings, in terms of required resources, patient or client adherence, and satisfaction by&#xD;
      community stakeholders, including providers and participants.&#xD;
&#xD;
      Additional hypotheses:&#xD;
&#xD;
      Individuals who receive integrative health coaching sessions as an adjunct to their standard&#xD;
      medical care will see improvements in patient activation and perception of interpersonal&#xD;
      supports, when compared to controls.&#xD;
&#xD;
      Individuals who receive integrative health coaching (or in the case of the pediatric cohort,&#xD;
      children of individuals who receive coaching) will see minor improvements in BMI over the&#xD;
      study period when compared to controls.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Integrative health coaching, based on a curriculum designed and implemented by Duke&#xD;
      Integrative Medicine, uses a patient-centered approach that features elements of&#xD;
      accountability, self-discovery, and patient-driven goals. It strives to empower patients to&#xD;
      enact lifestyle changes situated in the context of their lives, and invites them to identify&#xD;
      intrinsic values that might help guide those choices This type of approach is rooted in&#xD;
      validated theories of health psychology. Preliminary work using IHC has found this new&#xD;
      approach to be effective for improving lifestyle behaviors (diet, exercise, medication&#xD;
      adherence) with concomitant improvements in glycemic control in type 2 diabetes, and for&#xD;
      reducing the risk of cardiovascular disease (CVD) in patients with traditional risk factors.&#xD;
      In addition, program outcomes suggest reduced healthcare spending in patients enrolled in&#xD;
      IHC. A large trial to evaluate how this approach will perform in the primary care setting is&#xD;
      currently ongoing.&#xD;
&#xD;
      Health coaching and health literacy efforts that are &quot;community-based&quot; or take place in&#xD;
      community settings have also been evaluated for effectiveness as well as feasibility and&#xD;
      acceptability. Approaches utilized include telephonic coaching and peer coaches, often in an&#xD;
      effort to provide increased accessibility. These studies highlight diverse coaching&#xD;
      interventions with mixed results. There are no studies of Integrative Health Coaching&#xD;
      implemented in non-profit community settings.&#xD;
&#xD;
      Study Procedures&#xD;
&#xD;
      Baseline visit - After screening to confirm eligibility, an in-person baseline visit will be&#xD;
      organized with the participant, during which full consent will be obtained. Following subject&#xD;
      consent, each participant will be asked to fill out a brief survey instrument on paper&#xD;
      consisting of the ISEL-12 and PAM (or Parent PAM for the Healthy Lifestyles cohort).&#xD;
      Participants (in the case of the Healthy Lifestyles cohort, pediatric participants and not&#xD;
      parents or guardians) will then be weighed without shoes or outer garments using a zeroed&#xD;
      electronic scale. Weight will be recorded to the nearest tenth of a pound. Height will be&#xD;
      recorded to the nearest tenth of a centimeter using a stadiometer. Body mass index (BMI) will&#xD;
      be calculated from these measurements using the conversion formula BMI = weight (kg)/ height&#xD;
      (m2). Randomization will occur after collecting baseline measures. If randomized to receive&#xD;
      health coaching, the participant (or parent) will receive a handout briefly describing what&#xD;
      to expect from their health coaching sessions and how to best prepare. They will also be&#xD;
      asked to fill out a &quot;Current and Desired States&quot; form, which is part of the IHC coaching&#xD;
      model and will be passed along to coaches for use in the first session.&#xD;
&#xD;
      Integrative Health Coaching Sessions - After completing the baseline visit, each participant&#xD;
      randomized to coaching will be scheduled for an initial telephone call (~ 60-75 minutes in&#xD;
      length) to discuss the role of a health coach, when and how s/he may be contacted by&#xD;
      participants, and an initial participant self-assessment of health perceptions and goals.&#xD;
      This self-assessment creates the foundation for the personalization of the behavioral&#xD;
      intervention. From this point, participants will schedule weekly to biweekly (~ 30-45 minute)&#xD;
      calls with their health coach, for a total of 6 coaching calls over a 3-month intervention&#xD;
      period. For the Healthy Lifestyles cohort, all telephonic coaching sessions and activities&#xD;
      conducted therein will be directed towards the parent or guardian providing consent. While&#xD;
      family health goals and the child's weight management may be anticipated areas of focus in&#xD;
      these sessions, coaches and clients will not be limited to any particular topics of&#xD;
      discussion.&#xD;
&#xD;
      Participants may initiate coaching sessions from their own personal phone, or by using a&#xD;
      landline extension on site at CAARE Inc. or Healthy Lifestyles during business hours,&#xD;
      depending on which is more convenient for their schedule and budget. This protocol provides&#xD;
      no reimbursement for inadvertent phone charges.&#xD;
&#xD;
      Post-intervention follow-up meeting - Three months following baseline (+ or - one week) and&#xD;
      after 6 coaching sessions for the IHC group, participants will meet with a member of the&#xD;
      research team to complete the same survey instruments from the baseline visit, and to&#xD;
      reassess height and weight, using identical methods to those at baseline. At this time,&#xD;
      participants randomized to the IHC group will also have the opportunity to offer recorded&#xD;
      feedback regarding their experience in a coaching intervention. This feedback will be&#xD;
      solicited via an interview guide of pre-drafted questions, after which the participant will&#xD;
      have the opportunity to add additional comments. At this point, unless the participant is&#xD;
      part of the subset allocated to the focus group (see below), his/her role in the study is&#xD;
      completed. After the post-intervention survey has been completed, coaches and clients may&#xD;
      agree to continue sessions on an individual basis, although coaches-in-training must clearly&#xD;
      communicate that further sessions are not part of the study.&#xD;
&#xD;
      Focus Group regarding impact of coaching on community needs assessment - This portion of the&#xD;
      study will recruit a subset of those participants enrolled from the Healing with CAARE Inc.&#xD;
      site. All participants previously enrolled, consented and randomized to receive health&#xD;
      coaching will be asked to participate in a focus group session of about 1.5 hours regarding&#xD;
      community needs assessment; the target participatory goal is 6-8 participants. The session&#xD;
      will take place following post-intervention data collection for all participants who received&#xD;
      coaching. It will be guided around a series of questions detailed in a separate document, and&#xD;
      centered around data from the 2013 State of the County Health Report and 2013 Community&#xD;
      Health Assessment Survey Results conducted and reported by the Durham County Health&#xD;
      Department (DCHD) and Partnership for a Healthy Durham. 32 Participants will be invited to&#xD;
      comment on the results of these assessments relative to their personal experiences, and to&#xD;
      offer their perspectives on community needs, current resources or areas for improvement&#xD;
      regarding health and wellness. They will also be asked about their experiences in using&#xD;
      community resources or identifying community or environmental barriers through their behavior&#xD;
      change efforts while receiving coaching. Participants will be asked whether and how their&#xD;
      perspectives on community needs or available resources may have changed following coaching,&#xD;
      and if and how they intend to utilize or advocate for community resources in the future.&#xD;
&#xD;
      Post-Intervention Qualitative Evaluation In order to learn as much as possible from this&#xD;
      community engagement project, after completion of the study intervention, interviews will be&#xD;
      conducted with the coaches that delivered the interventions as well as clinical and&#xD;
      administrative staff of the respective community sites. These interviews will take place in&#xD;
      small groups or individually and may include briefer, follow-up conversations with the same&#xD;
      individuals by phone or in person, to clarify responses as needed. The interviews will be&#xD;
      recorded for the purposes of subsequent review and analysis. Participants in the interviews&#xD;
      will be identified only by their role in the study in any written analysis of interview&#xD;
      content.&#xD;
&#xD;
      The interviews will be structured around a series of interview guides, each of which is&#xD;
      composed of a series of questions directed at the health coaches, and community staff or&#xD;
      providers who referred patients. Participants will also have an opportunity to draft their&#xD;
      own questions regarding the study, and common themes of these questions will be explored&#xD;
      further in the group conversation.&#xD;
&#xD;
      Interviews will also be conducted with study participants individually, as outlined above, at&#xD;
      the time of their post-intervention follow-up visit. As in the provider and staff interviews,&#xD;
      the participant interviews will also be structured around interview guide questions, with an&#xD;
      opportunity for participants to draft additional questions or share feedback beyond the&#xD;
      question prompts.&#xD;
&#xD;
      The interviews will provide feedback regarding feasibility, delivery, resources utilized, and&#xD;
      interprofessional communication throughout the study. Specifically, the areas addressed will&#xD;
      include reach, effectiveness, adoption, implementation and maintenance, as have been outlined&#xD;
      in previous studies and briefs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Subject attrition rate</measure>
    <time_frame>3 months from baseline</time_frame>
    <description>As establishing feasibility is a primary purpose of this study, subject attrition will serve as one primary outcome measure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration (in minutes) of coaching sessions.</measure>
    <time_frame>3 months from baseline</time_frame>
    <description>In order to establish subject exposure to the main study intervention and to establish feasibility, number and duration of completed sessions will be measured.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subject and site personnel process evaluation (reach, effectiveness, adoption, implementation, and maintenance (RE-AIM)) following intervention completion</measure>
    <time_frame>up to 6 months (following 3 month timepoint collection for all subjects)</time_frame>
    <description>RE-AIM interview guides will tailored to subjects, health coaches, and site personnel will solicit qualitative information for process evaluation, which is the primary purpose of this study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in patient activation</measure>
    <time_frame>Baseline and 3 months</time_frame>
    <description>The Patient Activation Measure is a 13-item scale designed for this purpose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in subject perception of interpersonal support</measure>
    <time_frame>Baseline and 3 months</time_frame>
    <description>The Interpersonal Support Evaluation List (ISEL-12) will be used for this purpose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body mass index</measure>
    <time_frame>Baseline and 3 months</time_frame>
    <description>BMI will be calculated using height measurement from baseline, and weight measurements at baseline and then again at 3 months.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Subject perception of community health-related resources and needs following intervention completion</measure>
    <time_frame>up to 6 months (following 3 month timepoint for all subjects at the CAARE Inc. site))</time_frame>
    <description>A focus group will provide qualitative data on subject perception of community resources and community health-related needs for those participants at the CAARE site who received health coaching.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">74</enrollment>
  <condition>Health Knowledge, Attitudes, Practice</condition>
  <arm_group>
    <arm_group_label>Standard care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control arm will continue to receive standard care as they did prior to enrollment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Integrative health coaching</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this arm will receive 6 sessions of integrative health coaching over a 3 month period, in addition to standard care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Integrative Health Coaching</intervention_name>
    <description>Coaching sessions will guide subjects in establishing and maintaining behavior change goals related to their health and overall well-being.</description>
    <arm_group_label>Integrative health coaching</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Site one:&#xD;
&#xD;
          -  18 years or over&#xD;
&#xD;
          -  able to speak and understand English&#xD;
&#xD;
          -  able and willing to give informed consent&#xD;
&#xD;
        Site two (pediatric):&#xD;
&#xD;
          -  pediatric participant is 5-12&#xD;
&#xD;
          -  patient is in care of parent or guardian willing to participate in study intervention&#xD;
             and complete baseline and post-intervention surveys and interviews&#xD;
&#xD;
          -  both pediatric patient and parent/guardian can speak and understand English&#xD;
&#xD;
          -  parent/guardian is able and willing to provide consent (pediatric patients age 12 will&#xD;
             also provide assent)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  inability to ambulate or participate in physical activity&#xD;
&#xD;
          -  serious chronic disease related complications or conditions that could significantly&#xD;
             affect study outcomes (currently treated cancer, renal failure, CVA with residual&#xD;
             effects on functioning)&#xD;
&#xD;
          -  concurrent participation in a lifestyle-based intervention study for chronic disease&#xD;
             or health behaviors&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ruth Wolever, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Healing with CAARE Inc.</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke Healthy Lifestyles Program at Duke Children's Primary Care</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Seligman ME, Steen TA, Park N, Peterson C. Positive psychology progress: empirical validation of interventions. Am Psychol. 2005 Jul-Aug;60(5):410-21. doi: 10.1037/0003-066X.60.5.410.</citation>
    <PMID>16045394</PMID>
  </reference>
  <reference>
    <citation>Wolever RQ, Dreusicke M, Fikkan J, Hawkins TV, Yeung S, Wakefield J, Duda L, Flowers P, Cook C, Skinner E. Integrative health coaching for patients with type 2 diabetes: a randomized clinical trial. Diabetes Educ. 2010 Jul-Aug;36(4):629-39. doi: 10.1177/0145721710371523. Epub 2010 Jun 9.</citation>
    <PMID>20534872</PMID>
  </reference>
  <reference>
    <citation>Edelman D, Oddone EZ, Liebowitz RS, Yancy WS Jr, Olsen MK, Jeffreys AS, Moon SD, Harris AC, Smith LL, Quillian-Wolever RE, Gaudet TW. A multidimensional integrative medicine intervention to improve cardiovascular risk. J Gen Intern Med. 2006 Jul;21(7):728-34. doi: 10.1111/j.1525-1497.2006.00495.x.</citation>
    <PMID>16808774</PMID>
  </reference>
  <reference>
    <citation>Vorderstrasse AA, Ginsburg GS, Kraus WE, Maldonado MC, Wolever RQ. Health coaching and genomics-potential avenues to elicit behavior change in those at risk for chronic disease: protocol for personalized medicine effectiveness study in air force primary care. Glob Adv Health Med. 2013 May;2(3):26-38. doi: 10.7453/gahmj.2013.035.</citation>
    <PMID>24416670</PMID>
  </reference>
  <reference>
    <citation>Taggart J, Williams A, Dennis S, Newall A, Shortus T, Zwar N, Denney-Wilson E, Harris MF. A systematic review of interventions in primary care to improve health literacy for chronic disease behavioral risk factors. BMC Fam Pract. 2012 Jun 1;13:49. doi: 10.1186/1471-2296-13-49.</citation>
    <PMID>22656188</PMID>
  </reference>
  <reference>
    <citation>Holland SK, Greenberg J, Tidwell L, Malone J, Mullan J, Newcomer R. Community-based health coaching, exercise, and health service utilization. J Aging Health. 2005 Dec;17(6):697-716. doi: 10.1177/0898264305277959.</citation>
    <PMID>16377768</PMID>
  </reference>
  <reference>
    <citation>Holland SK, Greenberg J, Tidwell L, Newcomer R. Preventing disability through community-based health coaching. J Am Geriatr Soc. 2003 Feb;51(2):265-9. doi: 10.1046/j.1532-5415.2003.51068.x.</citation>
    <PMID>12558726</PMID>
  </reference>
  <reference>
    <citation>Steventon A, Tunkel S, Blunt I, Bardsley M. Effect of telephone health coaching (Birmingham OwnHealth) on hospital use and associated costs: cohort study with matched controls. BMJ. 2013 Aug 6;347:f4585. doi: 10.1136/bmj.f4585.</citation>
    <PMID>23920348</PMID>
  </reference>
  <reference>
    <citation>Rubin DL, Freimuth VS, Johnson SD, Kaley T, Parmer J. Training meals on wheels volunteers as health literacy coaches for older adults. Health Promot Pract. 2014 May;15(3):448-54. doi: 10.1177/1524839913494786. Epub 2013 Jul 22.</citation>
    <PMID>23877229</PMID>
  </reference>
  <reference>
    <citation>Nishita C, Cardazone G, Uehara DL, Tom T. Empowered diabetes management: life coaching and pharmacist counseling for employed adults with diabetes. Health Educ Behav. 2013 Oct;40(5):581-91. doi: 10.1177/1090198112465088. Epub 2012 Nov 21.</citation>
    <PMID>23174629</PMID>
  </reference>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>July 2, 2014</study_first_submitted>
  <study_first_submitted_qc>July 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>July 22, 2015</last_update_submitted>
  <last_update_submitted_qc>July 22, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 23, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Integrative Health Coaching</keyword>
  <!-- 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/NCT02186327
org study id: Pro00054909
nct id: NCT02186327
lead sponsor: 
has dmc: No
This study examines a pilot project to introduce integrative health coaching to two community
      clinical sites, Healing with CAARE Inc. and the Healthy Lifestyles program at Duke
      Pediatrics. 10 participants and 10 controls will be referred for enrollment at each site
      (n=20 per site) by on-site personnel, and 6 coaching sessions will be provided over a 3-month
      period at no cost by coaching trainees completing their certification hours. Pre and post
      measurements of BMI, patient activation, and perceived interpersonal support will be
      collected and analyzed for interaction effects. Qualitative process evaluation will be
      conducted as a thematic analysis via guided interviews with stakeholders and participants,
      using the "RE-AIM" framework. Feasibility measures will include recruitment of both coaches
      and clients, subject/client retention, and number and duration of coaching sessions
      completed. Finally, a subset of the CAARE Inc. cohort will be consented to participate in a
      post-intervention focus group that addresses the impact of coaching on perception of
      health-related resources and needs in the community.

      Primary Hypotheses:

      Integrative health coaching will be a feasible intervention in both community and clinical
      settings, in terms of required resources, patient or client adherence, and satisfaction by
      community stakeholders, including providers and participants.

      Additional hypotheses:

      Individuals who receive integrative health coaching sessions as an adjunct to their standard
      medical care will see improvements in patient activation and perception of interpersonal
      supports, when compared to controls.

      Individuals who receive integrative health coaching (or in the case of the pediatric cohort,
      children of individuals who receive coaching) will see minor improvements in BMI over the
      study period when compared to controls.
Integrative health coaching, based on a curriculum designed and implemented by Duke
      Integrative Medicine, uses a patient-centered approach that features elements of
      accountability, self-discovery, and patient-driven goals. It strives to empower patients to
      enact lifestyle changes situated in the context of their lives, and invites them to identify
      intrinsic values that might help guide those choices This type of approach is rooted in
      validated theories of health psychology. Preliminary work using IHC has found this new
      approach to be effective for improving lifestyle behaviors (diet, exercise, medication
      adherence) with concomitant improvements in glycemic control in type 2 diabetes, and for
      reducing the risk of cardiovascular disease (CVD) in patients with traditional risk factors.
      In addition, program outcomes suggest reduced healthcare spending in patients enrolled in
      IHC. A large trial to evaluate how this approach will perform in the primary care setting is
      currently ongoing.

      Health coaching and health literacy efforts that are "community-based" or take place in
      community settings have also been evaluated for effectiveness as well as feasibility and
      acceptability. Approaches utilized include telephonic coaching and peer coaches, often in an
      effort to provide increased accessibility. These studies highlight diverse coaching
      interventions with mixed results. There are no studies of Integrative Health Coaching
      implemented in non-profit community settings.

      Study Procedures

      Baseline visit - After screening to confirm eligibility, an in-person baseline visit will be
      organized with the participant, during which full consent will be obtained. Following subject
      consent, each participant will be asked to fill out a brief survey instrument on paper
      consisting of the ISEL-12 and PAM (or Parent PAM for the Healthy Lifestyles cohort).
      Participants (in the case of the Healthy Lifestyles cohort, pediatric participants and not
      parents or guardians) will then be weighed without shoes or outer garments using a zeroed
      electronic scale. Weight will be recorded to the nearest tenth of a pound. Height will be
      recorded to the nearest tenth of a centimeter using a stadiometer. Body mass index (BMI) will
      be calculated from these measurements using the conversion formula BMI = weight (kg)/ height
      (m2). Randomization will occur after collecting baseline measures. If randomized to receive
      health coaching, the participant (or parent) will receive a handout briefly describing what
      to expect from their health coaching sessions and how to best prepare. They will also be
      asked to fill out a "Current and Desired States" form, which is part of the IHC coaching
      model and will be passed along to coaches for use in the first session.

      Integrative Health Coaching Sessions - After completing the baseline visit, each participant
      randomized to coaching will be scheduled for an initial telephone call (~ 60-75 minutes in
      length) to discuss the role of a health coach, when and how s/he may be contacted by
      participants, and an initial participant self-assessment of health perceptions and goals.
      This self-assessment creates the foundation for the personalization of the behavioral
      intervention. From this point, participants will schedule weekly to biweekly (~ 30-45 minute)
      calls with their health coach, for a total of 6 coaching calls over a 3-month intervention
      period. For the Healthy Lifestyles cohort, all telephonic coaching sessions and activities
      conducted therein will be directed towards the parent or guardian providing consent. While
      family health goals and the child's weight management may be anticipated areas of focus in
      these sessions, coaches and clients will not be limited to any particular topics of
      discussion.

      Participants may initiate coaching sessions from their own personal phone, or by using a
      landline extension on site at CAARE Inc. or Healthy Lifestyles during business hours,
      depending on which is more convenient for their schedule and budget. This protocol provides
      no reimbursement for inadvertent phone charges.

      Post-intervention follow-up meeting - Three months following baseline (+ or - one week) and
      after 6 coaching sessions for the IHC group, participants will meet with a member of the
      research team to complete the same survey instruments from the baseline visit, and to
      reassess height and weight, using identical methods to those at baseline. At this time,
      participants randomized to the IHC group will also have the opportunity to offer recorded
      feedback regarding their experience in a coaching intervention. This feedback will be
      solicited via an interview guide of pre-drafted questions, after which the participant will
      have the opportunity to add additional comments. At this point, unless the participant is
      part of the subset allocated to the focus group (see below), his/her role in the study is
      completed. After the post-intervention survey has been completed, coaches and clients may
      agree to continue sessions on an individual basis, although coaches-in-training must clearly
      communicate that further sessions are not part of the study.

      Focus Group regarding impact of coaching on community needs assessment - This portion of the
      study will recruit a subset of those participants enrolled from the Healing with CAARE Inc.
      site. All participants previously enrolled, consented and randomized to receive health
      coaching will be asked to participate in a focus group session of about 1.5 hours regarding
      community needs assessment; the target participatory goal is 6-8 participants. The session
      will take place following post-intervention data collection for all participants who received
      coaching. It will be guided around a series of questions detailed in a separate document, and
      centered around data from the 2013 State of the County Health Report and 2013 Community
      Health Assessment Survey Results conducted and reported by the Durham County Health
      Department (DCHD) and Partnership for a Healthy Durham. 32 Participants will be invited to
      comment on the results of these assessments relative to their personal experiences, and to
      offer their perspectives on community needs, current resources or areas for improvement
      regarding health and wellness. They will also be asked about their experiences in using
      community resources or identifying community or environmental barriers through their behavior
      change efforts while receiving coaching. Participants will be asked whether and how their
      perspectives on community needs or available resources may have changed following coaching,
      and if and how they intend to utilize or advocate for community resources in the future.

      Post-Intervention Qualitative Evaluation In order to learn as much as possible from this
      community engagement project, after completion of the study intervention, interviews will be
      conducted with the coaches that delivered the interventions as well as clinical and
      administrative staff of the respective community sites. These interviews will take place in
      small groups or individually and may include briefer, follow-up conversations with the same
      individuals by phone or in person, to clarify responses as needed. The interviews will be
      recorded for the purposes of subsequent review and analysis. Participants in the interviews
      will be identified only by their role in the study in any written analysis of interview
      content.

      The interviews will be structured around a series of interview guides, each of which is
      composed of a series of questions directed at the health coaches, and community staff or
      providers who referred patients. Participants will also have an opportunity to draft their
      own questions regarding the study, and common themes of these questions will be explored
      further in the group conversation.

      Interviews will also be conducted with study participants individually, as outlined above, at
      the time of their post-intervention follow-up visit. As in the provider and staff interviews,
      the participant interviews will also be structured around interview guide questions, with an
      opportunity for participants to draft additional questions or share feedback beyond the
      question prompts.

      The interviews will provide feedback regarding feasibility, delivery, resources utilized, and
      interprofessional communication throughout the study. Specifically, the areas addressed will
      include reach, effectiveness, adoption, implementation and maintenance, as have been outlined
      in previous studies and briefs.
allocation: Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: Subject attrition rate
time frame: 3 months from baseline
description: As establishing feasibility is a primary purpose of this study, subject attrition will serve as one primary outcome measure.
measure: Duration (in minutes) of coaching sessions.
time frame: 3 months from baseline
description: In order to establish subject exposure to the main study intervention and to establish feasibility, number and duration of completed sessions will be measured.
measure: Subject and site personnel process evaluation (reach, effectiveness, adoption, implementation, and maintenance (RE-AIM)) following intervention completion
time frame: up to 6 months (following 3 month timepoint collection for all subjects)
description: RE-AIM interview guides will tailored to subjects, health coaches, and site personnel will solicit qualitative information for process evaluation, which is the primary purpose of this study.
measure: Change in patient activation
time frame: Baseline and 3 months
description: The Patient Activation Measure is a 13-item scale designed for this purpose.
measure: Change in subject perception of interpersonal support
time frame: Baseline and 3 months
description: The Interpersonal Support Evaluation List (ISEL-12) will be used for this purpose.
measure: Change in body mass index
time frame: Baseline and 3 months
description: BMI will be calculated using height measurement from baseline, and weight measurements at baseline and then again at 3 months.
measure: Subject perception of community health-related resources and needs following intervention completion
time frame: up to 6 months (following 3 month timepoint for all subjects at the CAARE Inc. site))
description: A focus group will provide qualitative data on subject perception of community resources and community health-related needs for those participants at the CAARE site who received health coaching.
arm group label: Standard care
arm group type: No Intervention
description: The control arm will continue to receive standard care as they did prior to enrollment.
arm group label: Integrative health coaching
arm group type: Experimental
description: Subjects in this arm will receive 6 sessions of integrative health coaching over a 3 month period, in addition to standard care.
intervention type: Behavioral
intervention name: Integrative Health Coaching
description: Coaching sessions will guide subjects in establishing and maintaining behavior change goals related to their health and overall well-being.
arm group label: Integrative health coaching
criteria: 
gender: All
minimum age: 5 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ruth Wolever, PhD
role: Principal Investigator
affiliation: Duke University
facility: 
facility: 
country: United States
citation: Seligman ME, Steen TA, Park N, Peterson C. Positive psychology progress: empirical validation of interventions. Am Psychol. 2005 Jul-Aug;60(5):410-21. doi: 10.1037/0003-066X.60.5.410.
PMID: 16045394
citation: Wolever RQ, Dreusicke M, Fikkan J, Hawkins TV, Yeung S, Wakefield J, Duda L, Flowers P, Cook C, Skinner E. Integrative health coaching for patients with type 2 diabetes: a randomized clinical trial. Diabetes Educ. 2010 Jul-Aug;36(4):629-39. doi: 10.1177/0145721710371523. Epub 2010 Jun 9.
PMID: 20534872
citation: Edelman D, Oddone EZ, Liebowitz RS, Yancy WS Jr, Olsen MK, Jeffreys AS, Moon SD, Harris AC, Smith LL, Quillian-Wolever RE, Gaudet TW. A multidimensional integrative medicine intervention to improve cardiovascular risk. J Gen Intern Med. 2006 Jul;21(7):728-34. doi: 10.1111/j.1525-1497.2006.00495.x.
PMID: 16808774
citation: Vorderstrasse AA, Ginsburg GS, Kraus WE, Maldonado MC, Wolever RQ. Health coaching and genomics-potential avenues to elicit behavior change in those at risk for chronic disease: protocol for personalized medicine effectiveness study in air force primary care. Glob Adv Health Med. 2013 May;2(3):26-38. doi: 10.7453/gahmj.2013.035.
PMID: 24416670
citation: Taggart J, Williams A, Dennis S, Newall A, Shortus T, Zwar N, Denney-Wilson E, Harris MF. A systematic review of interventions in primary care to improve health literacy for chronic disease behavioral risk factors. BMC Fam Pract. 2012 Jun 1;13:49. doi: 10.1186/1471-2296-13-49.
PMID: 22656188
citation: Holland SK, Greenberg J, Tidwell L, Malone J, Mullan J, Newcomer R. Community-based health coaching, exercise, and health service utilization. J Aging Health. 2005 Dec;17(6):697-716. doi: 10.1177/0898264305277959.
PMID: 16377768
citation: Holland SK, Greenberg J, Tidwell L, Newcomer R. Preventing disability through community-based health coaching. J Am Geriatr Soc. 2003 Feb;51(2):265-9. doi: 10.1046/j.1532-5415.2003.51068.x.
PMID: 12558726
citation: Steventon A, Tunkel S, Blunt I, Bardsley M. Effect of telephone health coaching (Birmingham OwnHealth) on hospital use and associated costs: cohort study with matched controls. BMJ. 2013 Aug 6;347:f4585. doi: 10.1136/bmj.f4585.
PMID: 23920348
citation: Rubin DL, Freimuth VS, Johnson SD, Kaley T, Parmer J. Training meals on wheels volunteers as health literacy coaches for older adults. Health Promot Pract. 2014 May;15(3):448-54. doi: 10.1177/1524839913494786. Epub 2013 Jul 22.
PMID: 23877229
citation: Nishita C, Cardazone G, Uehara DL, Tom T. Empowered diabetes management: life coaching and pharmacist counseling for employed adults with diabetes. Health Educ Behav. 2013 Oct;40(5):581-91. doi: 10.1177/1090198112465088. Epub 2012 Nov 21.
PMID: 23174629
responsible party type: Sponsor