<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/NCT03821896</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00083903</org_study_id>
    <nct_id>NCT03821896</nct_id>
  </id_info>
  <brief_title>Piloting Conversation Cards for Adolescents</brief_title>
  <official_title>Feasibility, User Experiences, and Preliminary Effectiveness of Conversation Cards for Adolescents, a Patient-centered Communication and Behavior Change Tool: a Pragmatic, Pilot Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Alberta Health services</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alberta</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>
      Providers are not opportunistic enough in addressing lifestyle habits of teens, and can&#xD;
      benefit from appropriate tools to support their conversations with families as well as engage&#xD;
      all family members in making changes. Since most teens with obesity do not meet minimum&#xD;
      lifestyle recommendations, our team developed Conversation Cards for Adolescents (CCAs), a&#xD;
      tool to help teens and providers communicate and set lifestyle goals together. In this study,&#xD;
      the investigators will (i) observe if and how CCAs fit in a clinical setting for changing&#xD;
      teen-provider interactions and teens's lifestyle habits, (ii) ask teens and providers for&#xD;
      their thoughts on CCAs and how they are used, and (iii) determine preliminary impact of CCAs&#xD;
      on teen behaviors and clinical factors. The investigators will do this with around 50 teens&#xD;
      from a primary/secondary care clinic in Edmonton, Alberta. Teens will be randomized to one of&#xD;
      two groups - one group will use CCAs in their appointment with their providers to set a goal&#xD;
      for change, while the other will also set a goal for change, but without using CCAs. Results&#xD;
      from this study will give us insight into how CCAs are best used in a clinical setting and&#xD;
      will help us plan a future full-scale study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background &amp; Rationale. The high prevalence and adverse health risks of adolescent obesity&#xD;
      are well-documented. Most adolescents with and without obesity do not meet minimum lifestyle&#xD;
      recommendations for nutrition, physical and sedentary activities, and sleep, and care&#xD;
      providers have identified a lack of tools and resources to help them better support families&#xD;
      in lifestyle change and weight management. Best practices encourage the use of appropriate&#xD;
      tools to augment discussions, in addition to the inclusion and engagement of all relevant&#xD;
      stakeholders. Our team conducted a multi-phase project that included adolescents, care&#xD;
      providers, and researchers to develop Conversation Cards for Adolescents (CCAs), an&#xD;
      adolescent-tailored educational tool aimed at facilitating lifestyle behavior change in&#xD;
      adolescents via collaborative goal-setting. This tool comprises a deck of 45 cards. Each card&#xD;
      contains an individual statement pertaining to a barrier, enabler, or potential enabler that&#xD;
      adolescents encounter in making and maintaining healthy lifestyle changes. These cards are&#xD;
      organized across seven categorical suits: nutrition, physical activity, sedentary activity,&#xD;
      sleep, mental health, relationships, and clinic factors. This deck is intended to be used by&#xD;
      adolescents and providers and may be complementary to an already existing deck of cards&#xD;
      (Conversation Cards©) created for parents and providers by our research team in 2012.&#xD;
&#xD;
      Objectives. To (i) assess the feasibility of the study design and procedures in a real-world&#xD;
      practice setting, (ii) investigate future trial procedures, (iii) assess user experiences of&#xD;
      CCAs, and (iv) determine the preliminary effectiveness of CCAs on changing behavioral and&#xD;
      affective-cognitive outcomes for adolescents with obesity.&#xD;
&#xD;
      Method &amp; Methodology. This is a pragmatic, pilot randomized controlled trial. Adolescents&#xD;
      will be randomly allocated to one of two groups (CCAs or control) with a 1:1 allocation ratio&#xD;
      and using permuted blocks of randomly varied sizes 2 and 4. Participant randomization will be&#xD;
      performed in REDCap, based on allocation tables that have been generated and uploaded by the&#xD;
      Data Coordinating Centre statistician. REDCap maintains an automated audit trail which&#xD;
      includes the assigned study identification number, treatment allocation, and date and time of&#xD;
      the transaction. The study coordinator will have access to REDcap onsite to randomize&#xD;
      adolescents and will provide corresponding allocations to adolescents. The investigators will&#xD;
      follow recommended sample sizes for pilot trials; that is, 25 individuals per trial arm for a&#xD;
      total of 50, which gives the main trial a 90% power, 0.2 effect size, and two-sided 5%&#xD;
      significance. Assuming a recruitment rate of ~85%, a margin of error for the confidence&#xD;
      interval of around 10% was estimated; this recruitment rate is derived from similar&#xD;
      randomized controlled trials conducted in a primary care setting surrounding obesity and&#xD;
      lifestyle in children and youth. The investigators will adhere to the CONSORT statement for&#xD;
      planning, conducting, and reporting pragmatic trials.&#xD;
&#xD;
      Recruitment.&#xD;
&#xD;
      Adolescents - Administrative and clinical (nurse) team members will approach families to&#xD;
      gauge interest and obtain verbal consent. If given, the study coordinator on-site (MK) will&#xD;
      approach families for more information (e.g., study description, developmental and language&#xD;
      eligibility screening) and full consent/assent procedures. On the day of their medical&#xD;
      appointment, clinic staff will measure adolescents' height and weight before they see their&#xD;
      provider. Providers will be recruited by email or verbal invitation through existing&#xD;
      relationships with research team members.&#xD;
&#xD;
      Providers - Researchers leading this study have pre-existing relationships with providers&#xD;
      practicing at this center. Researchers will hold several meetings with providers to explain&#xD;
      and refine the study and determine their interest in participation. Providers will be given&#xD;
      full freedom to accept or decline participation.&#xD;
&#xD;
      The investigators will document dates defining the periods of recruitment and follow-up.&#xD;
&#xD;
      Procedure. Adolescents in the experimental group will be given ~15 minutes before their&#xD;
      clinical appointment to review CCAs in a private room at the clinic; they will be instructed&#xD;
      to independently select the top 3 statements that most resonate with them and to make a note&#xD;
      of these on a provided chart note; these will be documented by the research coordinator on an&#xD;
      Excel data file before adolescents enter their appointment and afterwards (in case any&#xD;
      changes were made). Adolescents will then proceed to their appointment and collaboratively&#xD;
      set one (to facilitate achievement) S.M.A.R.T. (Specific, Measurable, Attainable, Relevant,&#xD;
      Time-Based) goal using shared decision-making principles with their provider based on their&#xD;
      chosen priorities. Adolescents will receive a hard copy of their specific goal to take home.&#xD;
      Adolescents in the control group will not be offered the tool, but will still set a&#xD;
      S.M.A.R.T. goal with their provider. The investigators will debrief with each participating&#xD;
      provider after their first experimental and first control clinical appointments for feedback&#xD;
      and any modifications to intervention procedures.&#xD;
&#xD;
      Outcomes. The study coordinator will create an anonymized detailed Excel data spreadsheet&#xD;
      (separate from the Master File) for each participating adolescent to document data. This file&#xD;
      will be updated on an ongoing basis. The investigators will collect adolescents' demographic&#xD;
      and anthropometric characteristics verbally at baseline and providers' sociodemographics via&#xD;
      hard-copy or electronic survey before study commencement. Participants will be instructed to&#xD;
      complete baseline outcome measures using an iPad. The investigators will complete 3-week&#xD;
      follow-up, where the study coordinator will call adolescents (~15 minutes) for completion of&#xD;
      one of the outcome measure assessments and to inquire about study procedures, including&#xD;
      ranking the outcome measures used for this study in order of importance (to inform a future&#xD;
      full-scale trial). Please refer to the sections below for details regarding outcome measure.&#xD;
&#xD;
      Data Analysis. As per recommendations for pilot studies, our analysis will be mainly of a&#xD;
      descriptive nature. Quantitative data will be summarized using quantitative descriptive&#xD;
      statistics and central tendencies, or will be compared between groups using independent&#xD;
      samples t-tests. Outcomes will be compared based on weight status contingent on&#xD;
      anthropometric distributions in our sample. Qualitative data will be audio-recorded,&#xD;
      transcribed verbatim using The Comma Police, managed using NVivo 11, and analyzed using&#xD;
      content analysis.&#xD;
&#xD;
      Evaluation. The investigators will use the Centers for Disease Control and Prevention&#xD;
      Framework for Program Evaluation for a formal evaluation of our intervention. This framework&#xD;
      includes engaging stakeholders (e.g., primary users of the evaluation), describing the&#xD;
      program (e.g., needs, resources, context, activities), focusing the evaluation design (e.g.,&#xD;
      purpose, users, questions, methods), gathering credible evidence (e.g., indicators, sources,&#xD;
      quality, quantity, logistics), justifying conclusions (e.g., analysis/synthesis,&#xD;
      interpretation, recommendations), and ensuring use and shared lessons learned (e.g., design,&#xD;
      preparation, feedback, follow-up, dissemination). Steps of this evaluation do not have to&#xD;
      occur in a linear sequence; however, earlier steps provide the foundation for subsequent&#xD;
      progress. Program evaluations are best completed in a team approach. Our team will include&#xD;
      the principal investigator, study coordinator, providers, adolescents, and other researchers&#xD;
      in various steps of the evaluation.&#xD;
&#xD;
      IMPLICATIONS. Conducting this research will provide us with lessons learned on how to best&#xD;
      use CCAs in a clinical setting. It will inform development of a full scale trial to measure&#xD;
      effectiveness of our tool in changing lifestyle behaviors and optimizing care that&#xD;
      adolescents receive.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Ongoing COVID-19 restrictions and very low (in-person) clinical activity prevented participant&#xD;
    recruitment.&#xD;
  </why_stopped>
  <start_date type="Actual">March 15, 2019</start_date>
  <completion_date type="Actual">July 7, 2022</completion_date>
  <primary_completion_date type="Actual">July 7, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>An external party (Women and Children's Health Research Institute, University of Alberta) will run data analysis for the study.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility outcomes for resource, management, and scientific assessments per open-ended questions outlined by Tickle-Degnen's (2013)</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>The study coordinator will monitor and document study procedures and feasibility based on continuous observation at the site.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Collaborative goal-setting using the Patient Perception of Collaborative Goal-Setting</measure>
    <time_frame>Baseline</time_frame>
    <description>This questionnaire includes five factors: listen and learn from each other; share ideas; caring relationship; agree on a measurable objective; support for goal achievement. It uses a 5-point scale (worse to better outcome: strongly disagree - disagree - neutral - agree - strongly agree) and has achieved reliability and construct validity. Goal-setting refers to setting one S.M.A.R.T. (specific, measurable, attainable, realistic, timely) goal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree of effort and achievement of treatment goals using researcher-developed questions</measure>
    <time_frame>3 weeks</time_frame>
    <description>Questions will use a 0-9 scale (better to worse outcome: 1 - 2 - 3 - 4 - 5 - 6 - 7 - 8 - 9) and will be asked by the study coordinator during the telephone follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient engagement: perspectives on priorities and study design using researcher-developed questions</measure>
    <time_frame>3 weeks</time_frame>
    <description>Questions will be open-ended and will be asked by the study coordinator during the telephone follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Appointment length using a timer on the study-specific iPad</measure>
    <time_frame>Baseline</time_frame>
    <description>The study coordinator will time the duration of the clinical appointments for both experimental and control groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>User experience as per the User Experience Questionnaires</measure>
    <time_frame>Baseline (pre-appt)</time_frame>
    <description>This questionnaire was designed to obtain participants' agreement on contrasting attributes representing gradations between the opposites that may apply to a product. It includes 26 attributes, uses a 7-point scale (better to worse outcome: 1 - 2 - 3 - 4 - 5 - 6 - 7), and has achieved satisfactory reliability and construct validity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>User acceptance as per the Technology Acceptance Model</measure>
    <time_frame>At study end point, an average of 1 year</time_frame>
    <description>This questionnaire includes 11 items representing perceived usefulness and perceived ease of use of a technology, uses a 7-point scale (better to worse outcome: extremely - quite - slightly - neither - slightly - quite - extremely), and has achieved reliability, internal consistency, and convergent and discriminant validity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tool likeability (adolescents) using researcher-developed questions</measure>
    <time_frame>Baseline</time_frame>
    <description>Questions will be open-ended and closed-ended using a 7-point Likert scale (worse to better outcome: strongly disagree - disagree - somewhat disagree - neutral - somewhat agree - agree - strongly agree)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tool usefulness (adolescents) using researcher-developed questions</measure>
    <time_frame>Baseline</time_frame>
    <description>Questions will be open-ended and closed-ended using a 7-point Likert scale (worse to better outcome: strongly disagree - disagree - somewhat disagree - neutral - somewhat agree - agree - strongly agree)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tool feasibility (adolescents) using researcher-developed questions</measure>
    <time_frame>Baseline</time_frame>
    <description>Questions will be closed-ended using a 7-point Likert scale (worse to better outcome: strongly disagree - disagree - somewhat disagree - neutral - somewhat agree - agree - strongly agree)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tool usability (adolescents) using researcher-developed questions</measure>
    <time_frame>Baseline</time_frame>
    <description>Questions will be closed-ended using a 7-point Likert scale (worse to better outcome: strongly disagree - disagree - somewhat disagree - neutral - somewhat agree - agree - strongly agree)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tool likeability (PCPs) using researcher-developed questions</measure>
    <time_frame>At study end point, an average of 1 year</time_frame>
    <description>Questions will be open-ended and closed-ended using a 7-point Likert scale (worse to better outcome: strongly disagree - disagree - somewhat disagree - neutral - somewhat agree - agree - strongly agree)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tool usefulness (PCPs) using researcher-developed questions</measure>
    <time_frame>At study end point, an average of 1 year</time_frame>
    <description>Questions will be open-ended and closed-ended using a 7-point Likert scale (worse to better outcome: strongly disagree - disagree - somewhat disagree - neutral - somewhat agree - agree - strongly agree)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tool feasibility (PCPs) using researcher-developed questions</measure>
    <time_frame>At study end point, an average of 1 year</time_frame>
    <description>Questions will be closed-ended using a 7-point Likert scale (worse to better outcome: strongly disagree - disagree - somewhat disagree - neutral - somewhat agree - agree - strongly agree)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tool usability (PCPs) using researcher-developed questions</measure>
    <time_frame>At study end point, an average of 1 year</time_frame>
    <description>Questions will be closed-ended using a 7-point Likert scale (worse to better outcome: strongly disagree - disagree - somewhat disagree - neutral - somewhat agree - agree - strongly agree)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Adolescent Obesity</condition>
  <condition>Life Style</condition>
  <condition>Health Behavior</condition>
  <condition>Health Communication</condition>
  <condition>Primary Health Care</condition>
  <arm_group>
    <arm_group_label>Conversation Cards for Adolescents and Goal-Setting</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adolescents in the experimental arm will receive the tool 15 minutes prior to their appointment with their primary care provider. They will be instructed to familiarize themselves with the tool and to select the top 3 factors that resonate most with them in their attemps to change their lifestyle habits. They will then proceed to their clinical appointment to set one S.M.A.R.T. goal based on their selections and in collaboration with their primary care provider.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Goal-Setting</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Adolescents in the control arm will not complete the tool activity, but will still set a S.M.A.R.T. goal with their primary care provider.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Conversation Cards for Adolescents and Goal-Setting</intervention_name>
    <description>The intervention includes using an adolescent-tailored tool (a deck of cards) created by researchers at the University of Alberta and adolescents with obesity seeking weight management care. It contains a list of factors that make it easy or hard for teens to make and maintain healthy lifestyle changes. Its use will be paired with a S.M.A.R.T. goal-setting activity using principles of shared decision-making.</description>
    <arm_group_label>Conversation Cards for Adolescents and Goal-Setting</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Goal-Setting</intervention_name>
    <description>Collaborative setting of S.M.A.R.T. goals using principles of shared decision-making.</description>
    <arm_group_label>Goal-Setting</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Adolescents are eligible to participate if they are:&#xD;
&#xD;
          -  13-17 years old&#xD;
&#xD;
          -  At a functioning grade level (English literacy and comprehension)&#xD;
&#xD;
          -  Interested in setting a lifestyle/behavioural goal related to improving diet, physical&#xD;
             activity or sedentary activity, and&#xD;
&#xD;
          -  Seeking health services at the Northeast Community Health Centre (NECHC; Edmonton,&#xD;
             Alberta, Canada)&#xD;
&#xD;
        All participating providers who deliver care to adolescents at the NECHC are eligible to&#xD;
        participate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        N/A&#xD;
&#xD;
        Our original eligibility criteria included a BMI ≥85th percentile. After recruiting the&#xD;
        first five patients with overweight/obesity from March to August 2019, we decided to remove&#xD;
        BMI eligibility criteria given the applicability of our tool's focus on lifestyle and&#xD;
        adolescents across the weight spectrum, as well as to enhance recruitment. This decision&#xD;
        was made by the research team in conjunction with clinical staff involved in the trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Geoff DC Ball, PhD, RD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alberta</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Maryam Kebbe, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Alberta</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northeast Community Health Centre</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T5A 5E4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Kebbe M, Damanhoury S, Browne N, Dyson MP, McHugh TF, Ball GDC. Barriers to and enablers of healthy lifestyle behaviours in adolescents with obesity: a scoping review and stakeholder consultation. Obes Rev. 2017 Dec;18(12):1439-1453. doi: 10.1111/obr.12602. Epub 2017 Sep 18.</citation>
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  </reference>
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    <citation>Kebbe M, Perez A, Buchholz A, McHugh TF, Scott SS, Richard C, Mohipp C, Dyson MP, Ball GDC. Barriers and enablers for adopting lifestyle behavior changes in adolescents with obesity: A multi-centre, qualitative study. PLoS One. 2018 Dec 18;13(12):e0209219. doi: 10.1371/journal.pone.0209219. eCollection 2018. Erratum In: PLoS One. 2019 Aug 8;14(8):e0221141.</citation>
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  <reference>
    <citation>Treweek S, Lockhart P, Pitkethly M, Cook JA, Kjeldstrom M, Johansen M, Taskila TK, Sullivan FM, Wilson S, Jackson C, Jones R, Mitchell ED. Methods to improve recruitment to randomised controlled trials: Cochrane systematic review and meta-analysis. BMJ Open. 2013 Feb 7;3(2):e002360. doi: 10.1136/bmjopen-2012-002360. Print 2013.</citation>
    <PMID>23396504</PMID>
  </reference>
  <reference>
    <citation>Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004 May;10(2):307-12. doi: 10.1111/j..2002.384.doc.x.</citation>
    <PMID>15189396</PMID>
  </reference>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 27, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>July 14, 2022</last_update_submitted>
  <last_update_submitted_qc>July 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adolescents; Obesity; Lifestyle; Goals; Communication</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/NCT03821896
org study id: Pro00083903
nct id: NCT03821896
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Providers are not opportunistic enough in addressing lifestyle habits of teens, and can
      benefit from appropriate tools to support their conversations with families as well as engage
      all family members in making changes. Since most teens with obesity do not meet minimum
      lifestyle recommendations, our team developed Conversation Cards for Adolescents (CCAs), a
      tool to help teens and providers communicate and set lifestyle goals together. In this study,
      the investigators will (i) observe if and how CCAs fit in a clinical setting for changing
      teen-provider interactions and teens's lifestyle habits, (ii) ask teens and providers for
      their thoughts on CCAs and how they are used, and (iii) determine preliminary impact of CCAs
      on teen behaviors and clinical factors. The investigators will do this with around 50 teens
      from a primary/secondary care clinic in Edmonton, Alberta. Teens will be randomized to one of
      two groups - one group will use CCAs in their appointment with their providers to set a goal
      for change, while the other will also set a goal for change, but without using CCAs. Results
      from this study will give us insight into how CCAs are best used in a clinical setting and
      will help us plan a future full-scale study.
Background & Rationale. The high prevalence and adverse health risks of adolescent obesity
      are well-documented. Most adolescents with and without obesity do not meet minimum lifestyle
      recommendations for nutrition, physical and sedentary activities, and sleep, and care
      providers have identified a lack of tools and resources to help them better support families
      in lifestyle change and weight management. Best practices encourage the use of appropriate
      tools to augment discussions, in addition to the inclusion and engagement of all relevant
      stakeholders. Our team conducted a multi-phase project that included adolescents, care
      providers, and researchers to develop Conversation Cards for Adolescents (CCAs), an
      adolescent-tailored educational tool aimed at facilitating lifestyle behavior change in
      adolescents via collaborative goal-setting. This tool comprises a deck of 45 cards. Each card
      contains an individual statement pertaining to a barrier, enabler, or potential enabler that
      adolescents encounter in making and maintaining healthy lifestyle changes. These cards are
      organized across seven categorical suits: nutrition, physical activity, sedentary activity,
      sleep, mental health, relationships, and clinic factors. This deck is intended to be used by
      adolescents and providers and may be complementary to an already existing deck of cards
      (Conversation Cards©) created for parents and providers by our research team in 2012.

      Objectives. To (i) assess the feasibility of the study design and procedures in a real-world
      practice setting, (ii) investigate future trial procedures, (iii) assess user experiences of
      CCAs, and (iv) determine the preliminary effectiveness of CCAs on changing behavioral and
      affective-cognitive outcomes for adolescents with obesity.

      Method & Methodology. This is a pragmatic, pilot randomized controlled trial. Adolescents
      will be randomly allocated to one of two groups (CCAs or control) with a 1:1 allocation ratio
      and using permuted blocks of randomly varied sizes 2 and 4. Participant randomization will be
      performed in REDCap, based on allocation tables that have been generated and uploaded by the
      Data Coordinating Centre statistician. REDCap maintains an automated audit trail which
      includes the assigned study identification number, treatment allocation, and date and time of
      the transaction. The study coordinator will have access to REDcap onsite to randomize
      adolescents and will provide corresponding allocations to adolescents. The investigators will
      follow recommended sample sizes for pilot trials; that is, 25 individuals per trial arm for a
      total of 50, which gives the main trial a 90% power, 0.2 effect size, and two-sided 5%
      significance. Assuming a recruitment rate of ~85%, a margin of error for the confidence
      interval of around 10% was estimated; this recruitment rate is derived from similar
      randomized controlled trials conducted in a primary care setting surrounding obesity and
      lifestyle in children and youth. The investigators will adhere to the CONSORT statement for
      planning, conducting, and reporting pragmatic trials.

      Recruitment.

      Adolescents - Administrative and clinical (nurse) team members will approach families to
      gauge interest and obtain verbal consent. If given, the study coordinator on-site (MK) will
      approach families for more information (e.g., study description, developmental and language
      eligibility screening) and full consent/assent procedures. On the day of their medical
      appointment, clinic staff will measure adolescents' height and weight before they see their
      provider. Providers will be recruited by email or verbal invitation through existing
      relationships with research team members.

      Providers - Researchers leading this study have pre-existing relationships with providers
      practicing at this center. Researchers will hold several meetings with providers to explain
      and refine the study and determine their interest in participation. Providers will be given
      full freedom to accept or decline participation.

      The investigators will document dates defining the periods of recruitment and follow-up.

      Procedure. Adolescents in the experimental group will be given ~15 minutes before their
      clinical appointment to review CCAs in a private room at the clinic; they will be instructed
      to independently select the top 3 statements that most resonate with them and to make a note
      of these on a provided chart note; these will be documented by the research coordinator on an
      Excel data file before adolescents enter their appointment and afterwards (in case any
      changes were made). Adolescents will then proceed to their appointment and collaboratively
      set one (to facilitate achievement) S.M.A.R.T. (Specific, Measurable, Attainable, Relevant,
      Time-Based) goal using shared decision-making principles with their provider based on their
      chosen priorities. Adolescents will receive a hard copy of their specific goal to take home.
      Adolescents in the control group will not be offered the tool, but will still set a
      S.M.A.R.T. goal with their provider. The investigators will debrief with each participating
      provider after their first experimental and first control clinical appointments for feedback
      and any modifications to intervention procedures.

      Outcomes. The study coordinator will create an anonymized detailed Excel data spreadsheet
      (separate from the Master File) for each participating adolescent to document data. This file
      will be updated on an ongoing basis. The investigators will collect adolescents' demographic
      and anthropometric characteristics verbally at baseline and providers' sociodemographics via
      hard-copy or electronic survey before study commencement. Participants will be instructed to
      complete baseline outcome measures using an iPad. The investigators will complete 3-week
      follow-up, where the study coordinator will call adolescents (~15 minutes) for completion of
      one of the outcome measure assessments and to inquire about study procedures, including
      ranking the outcome measures used for this study in order of importance (to inform a future
      full-scale trial). Please refer to the sections below for details regarding outcome measure.

      Data Analysis. As per recommendations for pilot studies, our analysis will be mainly of a
      descriptive nature. Quantitative data will be summarized using quantitative descriptive
      statistics and central tendencies, or will be compared between groups using independent
      samples t-tests. Outcomes will be compared based on weight status contingent on
      anthropometric distributions in our sample. Qualitative data will be audio-recorded,
      transcribed verbatim using The Comma Police, managed using NVivo 11, and analyzed using
      content analysis.

      Evaluation. The investigators will use the Centers for Disease Control and Prevention
      Framework for Program Evaluation for a formal evaluation of our intervention. This framework
      includes engaging stakeholders (e.g., primary users of the evaluation), describing the
      program (e.g., needs, resources, context, activities), focusing the evaluation design (e.g.,
      purpose, users, questions, methods), gathering credible evidence (e.g., indicators, sources,
      quality, quantity, logistics), justifying conclusions (e.g., analysis/synthesis,
      interpretation, recommendations), and ensuring use and shared lessons learned (e.g., design,
      preparation, feedback, follow-up, dissemination). Steps of this evaluation do not have to
      occur in a linear sequence; however, earlier steps provide the foundation for subsequent
      progress. Program evaluations are best completed in a team approach. Our team will include
      the principal investigator, study coordinator, providers, adolescents, and other researchers
      in various steps of the evaluation.

      IMPLICATIONS. Conducting this research will provide us with lessons learned on how to best
      use CCAs in a clinical setting. It will inform development of a full scale trial to measure
      effectiveness of our tool in changing lifestyle behaviors and optimizing care that
      adolescents receive.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: An external party (Women and Children's Health Research Institute, University of Alberta) will run data analysis for the study.
measure: Feasibility outcomes for resource, management, and scientific assessments per open-ended questions outlined by Tickle-Degnen's (2013)
time frame: Through study completion, an average of 1 year
description: The study coordinator will monitor and document study procedures and feasibility based on continuous observation at the site.
measure: Collaborative goal-setting using the Patient Perception of Collaborative Goal-Setting
time frame: Baseline
description: This questionnaire includes five factors: listen and learn from each other; share ideas; caring relationship; agree on a measurable objective; support for goal achievement. It uses a 5-point scale (worse to better outcome: strongly disagree - disagree - neutral - agree - strongly agree) and has achieved reliability and construct validity. Goal-setting refers to setting one S.M.A.R.T. (specific, measurable, attainable, realistic, timely) goal.
measure: Degree of effort and achievement of treatment goals using researcher-developed questions
time frame: 3 weeks
description: Questions will use a 0-9 scale (better to worse outcome: 1 - 2 - 3 - 4 - 5 - 6 - 7 - 8 - 9) and will be asked by the study coordinator during the telephone follow-up.
measure: Patient engagement: perspectives on priorities and study design using researcher-developed questions
time frame: 3 weeks
description: Questions will be open-ended and will be asked by the study coordinator during the telephone follow-up.
measure: Appointment length using a timer on the study-specific iPad
time frame: Baseline
description: The study coordinator will time the duration of the clinical appointments for both experimental and control groups.
measure: User experience as per the User Experience Questionnaires
time frame: Baseline (pre-appt)
description: This questionnaire was designed to obtain participants' agreement on contrasting attributes representing gradations between the opposites that may apply to a product. It includes 26 attributes, uses a 7-point scale (better to worse outcome: 1 - 2 - 3 - 4 - 5 - 6 - 7), and has achieved satisfactory reliability and construct validity.
measure: User acceptance as per the Technology Acceptance Model
time frame: At study end point, an average of 1 year
description: This questionnaire includes 11 items representing perceived usefulness and perceived ease of use of a technology, uses a 7-point scale (better to worse outcome: extremely - quite - slightly - neither - slightly - quite - extremely), and has achieved reliability, internal consistency, and convergent and discriminant validity.
measure: Tool likeability (adolescents) using researcher-developed questions
time frame: Baseline
description: Questions will be open-ended and closed-ended using a 7-point Likert scale (worse to better outcome: strongly disagree - disagree - somewhat disagree - neutral - somewhat agree - agree - strongly agree)
measure: Tool usefulness (adolescents) using researcher-developed questions
time frame: Baseline
description: Questions will be open-ended and closed-ended using a 7-point Likert scale (worse to better outcome: strongly disagree - disagree - somewhat disagree - neutral - somewhat agree - agree - strongly agree)
measure: Tool feasibility (adolescents) using researcher-developed questions
time frame: Baseline
description: Questions will be closed-ended using a 7-point Likert scale (worse to better outcome: strongly disagree - disagree - somewhat disagree - neutral - somewhat agree - agree - strongly agree)
measure: Tool usability (adolescents) using researcher-developed questions
time frame: Baseline
description: Questions will be closed-ended using a 7-point Likert scale (worse to better outcome: strongly disagree - disagree - somewhat disagree - neutral - somewhat agree - agree - strongly agree)
measure: Tool likeability (PCPs) using researcher-developed questions
time frame: At study end point, an average of 1 year
description: Questions will be open-ended and closed-ended using a 7-point Likert scale (worse to better outcome: strongly disagree - disagree - somewhat disagree - neutral - somewhat agree - agree - strongly agree)
measure: Tool usefulness (PCPs) using researcher-developed questions
time frame: At study end point, an average of 1 year
description: Questions will be open-ended and closed-ended using a 7-point Likert scale (worse to better outcome: strongly disagree - disagree - somewhat disagree - neutral - somewhat agree - agree - strongly agree)
measure: Tool feasibility (PCPs) using researcher-developed questions
time frame: At study end point, an average of 1 year
description: Questions will be closed-ended using a 7-point Likert scale (worse to better outcome: strongly disagree - disagree - somewhat disagree - neutral - somewhat agree - agree - strongly agree)
measure: Tool usability (PCPs) using researcher-developed questions
time frame: At study end point, an average of 1 year
description: Questions will be closed-ended using a 7-point Likert scale (worse to better outcome: strongly disagree - disagree - somewhat disagree - neutral - somewhat agree - agree - strongly agree)
arm group label: Conversation Cards for Adolescents and Goal-Setting
arm group type: Experimental
description: Adolescents in the experimental arm will receive the tool 15 minutes prior to their appointment with their primary care provider. They will be instructed to familiarize themselves with the tool and to select the top 3 factors that resonate most with them in their attemps to change their lifestyle habits. They will then proceed to their clinical appointment to set one S.M.A.R.T. goal based on their selections and in collaboration with their primary care provider.
arm group label: Goal-Setting
arm group type: Active Comparator
description: Adolescents in the control arm will not complete the tool activity, but will still set a S.M.A.R.T. goal with their primary care provider.
intervention type: Behavioral
intervention name: Conversation Cards for Adolescents and Goal-Setting
description: The intervention includes using an adolescent-tailored tool (a deck of cards) created by researchers at the University of Alberta and adolescents with obesity seeking weight management care. It contains a list of factors that make it easy or hard for teens to make and maintain healthy lifestyle changes. Its use will be paired with a S.M.A.R.T. goal-setting activity using principles of shared decision-making.
arm group label: Conversation Cards for Adolescents and Goal-Setting
intervention type: Behavioral
intervention name: Goal-Setting
description: Collaborative setting of S.M.A.R.T. goals using principles of shared decision-making.
arm group label: Goal-Setting
criteria: 
gender: All
minimum age: 13 Years
maximum age: 17 Years
healthy volunteers: No
last name: Geoff DC Ball, PhD, RD
role: Principal Investigator
affiliation: University of Alberta
last name: Maryam Kebbe, PhD
role: Study Director
affiliation: University of Alberta
facility: 
country: Canada
citation: Kebbe M, Damanhoury S, Browne N, Dyson MP, McHugh TF, Ball GDC. Barriers to and enablers of healthy lifestyle behaviours in adolescents with obesity: a scoping review and stakeholder consultation. Obes Rev. 2017 Dec;18(12):1439-1453. doi: 10.1111/obr.12602. Epub 2017 Sep 18.
PMID: 28925065
citation: Kebbe M, Perez A, Buchholz A, McHugh TF, Scott SS, Richard C, Mohipp C, Dyson MP, Ball GDC. Barriers and enablers for adopting lifestyle behavior changes in adolescents with obesity: A multi-centre, qualitative study. PLoS One. 2018 Dec 18;13(12):e0209219. doi: 10.1371/journal.pone.0209219. eCollection 2018. Erratum In: PLoS One. 2019 Aug 8;14(8):e0221141.
PMID: 30562377
citation: Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732.
PMID: 24570244
citation: Small L, Aplasca A. Child Obesity and Mental Health: A Complex Interaction. Child Adolesc Psychiatr Clin N Am. 2016 Apr;25(2):269-82. doi: 10.1016/j.chc.2015.11.008. Epub 2016 Jan 22.
PMID: 26980129
citation: Skinner AC, Ravanbakht SN, Skelton JA, Perrin EM, Armstrong SC. Prevalence of Obesity and Severe Obesity in US Children, 1999-2016. Pediatrics. 2018 Mar;141(3):e20173459. doi: 10.1542/peds.2017-3459. Erratum In: Pediatrics. 2018 Sep;142(3):
PMID: 29483202
citation: Tremblay MS, Feng M, Garriguet D, Ball GDC, Buchholz A, Chanoine JP, Lambert M, Morrison KM. Canadian Pediatric Weight Management Registry (CANPWR): baseline descriptive statistics and comparison to Canadian norms. BMC Obes. 2015 Aug 13;2:29. doi: 10.1186/s40608-015-0060-6. eCollection 2015.
PMID: 26417450
citation: Ball GD, Lenk JM, Barbarich BN, Plotnikoff RC, Fishburne GJ, Mackenzie KA, Willows ND. Overweight children and adolescents referred for weight management: are they meeting lifestyle behaviour recommendations? Appl Physiol Nutr Metab. 2008 Oct;33(5):936-45. doi: 10.1139/H08-088.
PMID: 18923569
citation: Wiegand S, Keller KM, Lob-Corzilius T, Pott W, Reinehr T, Robl M, Stachow R, Tuschy S, Weidanz I, Widhalm K, de Zwaan M, Holl RW. Predicting weight loss and maintenance in overweight/obese pediatric patients. Horm Res Paediatr. 2014;82(6):380-7. doi: 10.1159/000368963. Epub 2014 Dec 20.
PMID: 25531074
citation: He M, Piche L, Clarson CL, Callaghan C, Harris SB. Childhood overweight and obesity management: A national perspective of primary health care providers' views, practices, perceived barriers and needs. Paediatr Child Health. 2010 Sep;15(7):419-26. doi: 10.1093/pch/15.7.419.
PMID: 21886445
citation: McPherson AC, Hamilton J, Kingsnorth S, Knibbe TJ, Peters M, Swift JA, Krog K, Chen L, Steinberg A, Ball GD. Communicating with children and families about obesity and weight-related topics: a scoping review of best practices. Obes Rev. 2017 Feb;18(2):164-182. doi: 10.1111/obr.12485. Epub 2016 Nov 26.
PMID: 27888564
citation: Ball GD, Farnesi BC, Newton AS, Holt NL, Geller J, Sharma AM, Johnson ST, Matteson CL, Finegood DT. Join the conversation! The development and preliminary application of conversation cards in pediatric weight management. J Nutr Educ Behav. 2013 Sep-Oct;45(5):476-8. doi: 10.1016/j.jneb.2013.02.002. Epub 2013 Apr 19. No abstract available.
PMID: 23602164
citation: Arnold DM, Burns KE, Adhikari NK, Kho ME, Meade MO, Cook DJ; McMaster Critical Care Interest Group. The design and interpretation of pilot trials in clinical research in critical care. Crit Care Med. 2009 Jan;37(1 Suppl):S69-74. doi: 10.1097/CCM.0b013e3181920e33.
PMID: 19104228
citation: Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutical trials. J Clin Epidemiol. 2009 May;62(5):499-505. doi: 10.1016/j.jclinepi.2009.01.012.
PMID: 19348976
citation: Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
PMID: 26092476
citation: Thorpe KE, Zwarenstein M, Oxman AD, Treweek S, Furberg CD, Altman DG, Tunis S, Bergel E, Harvey I, Magid DJ, Chalkidou K. A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. J Clin Epidemiol. 2009 May;62(5):464-75. doi: 10.1016/j.jclinepi.2008.12.011.
PMID: 19348971
citation: Treweek S, Lockhart P, Pitkethly M, Cook JA, Kjeldstrom M, Johansen M, Taskila TK, Sullivan FM, Wilson S, Jackson C, Jones R, Mitchell ED. Methods to improve recruitment to randomised controlled trials: Cochrane systematic review and meta-analysis. BMJ Open. 2013 Feb 7;3(2):e002360. doi: 10.1136/bmjopen-2012-002360. Print 2013.
PMID: 23396504
citation: Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004 May;10(2):307-12. doi: 10.1111/j..2002.384.doc.x.
PMID: 15189396
responsible party type: Sponsor
mesh term: Pediatric Obesity
sharing ipd: No