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.
