Category
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Primary study
Registry of Trials»ANZCTR
Year
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2022
INTERVENTION: In a recent cluster randomised controlled trial (RCT) delivered in New South Wales (NSW) government schools, we demonstrated that the ‘Resistance Training for Teens’ (RT for Teens) intervention improved adolescents’ muscular fitness, body composition and RT skill competency (e.g., squat, lunge and push‐up technique). In the current project, we will partner with the NSW Department of Education (DoE) and five Local Health Districts (LHDs) to evaluate strategies to support the implementation of the RT for Teens program in NSW government and non‐government secondary schools. Using findings from our previous RCT and dissemination studies, we have adapted our implementation support strategies to optimise reach, dose delivered, fidelity, sustainability, and impact. The aim of our proposed study is to assess the effect of three implementation support models (i.e., Low, Moderate and High) on the implementation (i.e., reach, effectiveness, dose delivered, fidelity, adoption, sustainability, impact and cost) of the RT for Teens program in NSW schools. To achieve this aim, we will conduct a hybrid type III implementation‐effectiveness cluster RCT in 90 schools to determine the most effective and cost‐effective RT for Teens implementation model. One teacher from each school will attend the RT for Teens professional learning workshop, provided by members of the RT for Teens design team from University of Newcastle, and serve as the “school champion”. School champions will attend 1 full day face‐to‐face training and be provided with curricular materials, including units of work, lesson plans, assessments task, technique and workout cards. The workshop will occur in the first three weeks of Term 4 (2022), while the RT for Teens program can be delivered from Term 1 (2023) CONDITION: Diet and Nutrition ‐ Obesity Mental Health ‐ Studies of normal psychology, cognitive function and behaviour Poor health‐related fitness;Physical inactivity;Psychological well‐being;Sedentary behaviour;Obesity; ; Poor health‐related fitness ; Physical inactivity ; Psychological well‐being ; Sedentary behaviour ; Obesity Public Health ‐ Health promotion/education PRIMARY OUTCOME: Our primary outcome is Reach, including the proportion of Year 9 and 10 students that participate in the RT for Teens program. This information will be collected using consents for participation and teacher logbooks (i.e., class lists). Participation (%) will be defined as the number of Year 9 and 10 students who have participated in the program divided by the total number of students in Year 9 and 10 at the study schools. All data related to this outcome will be assessed as a composite outcome. [Consents for participation will be collected at baseline (before intervention) and teacher logbooks will be collected at 12‐month follow‐up (post‐intervention commencement).] SECONDARY OUTCOME: Acceptability: Perceptions among the delivery team that a given intervention is agreeable, palatable, or satisfactory. ; This outcome will be assessed via an online questionnaire for the teachers who delivered the RT for Teens program. ; Items from a validated questionnaire will be used, designed to assess the Acceptability of Intervention Measure (AIM) (Weiner et al., 2017). ; ; Weiner, B. J., Lewis, C. C., Stanick, C., Powell, B. J., Dorsey, C. N., Clary, A. S., ... & Halko, H. (2017). Psychometric assessment of three newly developed implementation outcome measures. Implementation Science, 12(1), 1‐12.[12‐month follow‐up (post‐intervention commencement).] Adaptability: Extent to which an intervention can be adapted, tailored, refined, or reinvented to meet local needs. ; This outcome will be assessed via an online questionnaire for the teachers who delivered the RT for Teens program. ; Items from the validated Program Sustainability Assessment Tool (PSAT) questionnaire will be used (Hall et al., 2021). ; ; H Hall, A., Shoesmith, A., Shelton, R. C., Lane, C., Wolfenden, L., & Nathan, N. (2021). Adaptation and Validation of the Program Sustainability Assessment Tool (PSAT) for Use in the Elementary School Setting. International journal of environmental research and public health, 18(21), 11414.[12‐month follow‐up (post‐intervention commencement).] Compatibility (appropriateness): Extent to which an intervention fits with the mission, priorities, and values of organizations or settings. ; This outcome will be assessed via an online questionnaire for the teachers who delivered the RT for Teens program. ; ; Items from a validated questionnaire will be used, designed to assess the Intervention Appropriateness Measure (IAM) (Weiner et al., 2017). ; ; Weiner, B. J., Lewis, C. C., Stanick, C., Powell, B. J., Dorsey, C. N., Clary, A. S., ... & Halko, H. (2017). Psychometric assessment of three newly developed implementation outcome measures. Implementation Science, 12(1), 1‐12.[Baseline and at 12‐month follow‐up (post‐intervention commencement).] Complexity: Perceptions among the delivery team that a given intervention is relatively difficult to understand and use; number of different intervention components. ; This outcome will be assessed via an online questionnaire for the teachers who delivered the RT for Teens program. ; ; Items from a previous study will be used and will be slightly adjusted to the current study (Carlson et al., 2017). ; ; Carlson JA, Engelberg JK, Cain KL, et al. Contextual factors related to implementation of classroom physical activity breaks. Transl Behav Med 2017;7:581–92. [Baseline and at 12‐month follow‐up (post‐intervention commencement).] Cost: We will conduct a within‐trial economic evaluation, from the perspective of the Education Sector, assessing cost‐effectiveness of the RT for Teens program across the three trial arms. ; ; Costs comprise intervention and implementation costs (not evaluation costs); the latter varies in intensity between trial arms. The opportunity cost of teacher, and other staff, time will also be costed at pro‐rata salary levels for intervention and implementation activities. An incremental cost‐effectiveness ratio (ICER) will assess the additional costs and additional effectiveness between trial arms. A probability sensitivity analysis will assess statistical uncertainty in the ICER, and a value of information analysis will assess the value of undertaking future research to further optimise implementation. A budget impact analysis will then estimate the total financial impact for the NSW DoE and Ministry of Health (MoH) from investing in the most cost‐effective implementation model for scale‐up across Australia. Central to our proposal is generating data to guide policy makers’ future decisions. To estimate RT for Teens value we will compare the incremental cost per participant with benefit achieved at the participant level across each group.[After all participating schools have implemented the intervention. ] Culture: Organizations’ norms, values, and basic assumptions around selected health outcomes. ; This outcome will be assessed via an online questionnaire for the teachers who delivered the RT for Teens program. ; ; Items from a previous study will be used and will be slightly adjusted to the current study (Kennedy et al., 2020). ; ; Kennedy, S. G., Leahy, A. A., Smith, J. J., Eather, N., Hillman, C. H., Morgan, P. J., ... & Lubans, D. R. (2020). Process evaluation of a school‐based high‐intensity interval training program for older adolescents: the burn 2 learn cluster randomised controlled trial. Children, 7(12), 299.[Baseline and at 12‐month follow‐up (post‐intervention commencement).] Dose (satisfaction): Delivery team’s satisfaction with an intervention and with interactions with the support system. ; This outcome will be assessed via an online questionnaire for the teachers who delivered the RT for Teens program. ; ; Items from a previous study will be used and will be slightly adjusted to the current study (Kennedy et al., 2020). ; ; Kennedy, S. G., Leahy, A. A., Smith, J. J., Eather, N., Hillman, C. H., Morgan, P. J., ... & Lubans, D. R. (2020). Process evaluation of a school‐based high‐intensity interval training program for older adolescents: the burn 2 learn cluster randomised controlled trial. Children, 7(12), 299.[Baseline and at 12‐month follow‐up (post‐intervention commencement).] Dose delivered: The number of RT for Teens sessions delivered to students (including practical sessions and theory lessons). ; Teacher logbooks and data from the RT for Teens app will be used for assessing this outcome. [12‐month follow‐up (post‐intervention commencement).] Feasibility: Perceptions among the delivery team that an intervention can be successfully used or carried out within a given organization or setting. ; This outcome will be assessed via an online questionnaire for the teachers who delivered the RT for Teens program. ; Items from a validated questionnaire will be used, designed to assess the Feasibility of Intervention Measure (FIM) (Weiner et al., 2017). ; ; Weiner, B. J., Lewis, C. C., Stanick, C., Powell, B. J., Dorsey, C. N., Clary, A. S., ... & Halko, H. (2017). Psychometric assessment of three newly developed implementation outcome measures. Implementation Science, 12(1), 1‐12.[Baseline and at 12‐month follow‐up (post‐intervention commencement).] Fidelity: members of the research team will observe a randomly selected sample of teachers (30%) deliver an RT for Teens session ( 90 observations). Research assistants will use the 'Supportive, Active, Autonomous, Fair, and Enjoyable' (SAAFE) observation checklist to determine intervention fidelity. [During the 10‐week intervention period] Impact: Impact outcomes will be collected by students using the RT for Teens smartphone app or teachers using the tablet version of the app (the latter applies only when students don't have access to a smartphone). The current version of the app allows students to enter their own results for fitness, RT skill competency and participation in muscle‐strengthening activity. Students can view animated images to get familiar with the performance criteria for each specific RT skill (i.e., Squat, Push‐ups, Lunge, Overhead Press, Suspended row, front support with chest touches). in the MY TECHNIQUE screen, students can see an overview of their si Xskills and current scores (rated with help from a peer, teacher, or can self‐assess using the video). Upper body and torso muscular endurance will be assessed using the validated 90° push‐up and plank tests, respectively. ; ; All the above mentioned measures will be assessed as a composite secondary outcome. [During the 10‐week intervention period, after completing of each practical RT session of the RT for Teens program. ] Self‐efficacy: Delivery team’s belief in its ability to execute courses of action to achieve implementation goals. ; This outcome will be assessed via an online questionnaire for the teachers who delivered the RT for Teens program. ; ; Items from several previous studies will be used and slightly adjusted to the current study (Kennedey et al., 2020; Morgan & Bourke, 2008; Keyworth et al., 2020). ; ; Kennedy, S. G., Leahy, A. A., Smith, J. J., Eather, N., Hillman, C. H., Morgan, P. J., ... & Lubans, D. R. (2020). Process evaluation of a school‐based high‐intensity interval training program for older adolescents: the burn 2 learn cluster randomised controlled trial. Children, 7(12), 299. ; ; Morgan, P., & Bourke, S. (2008). Non‐specialist teachers' confidence to teach PE: the nature and influence of personal school experiences in PE. Physical Education and Sport Pedagogy, 13(1), 1‐29. ; ; Keyworth, C., Epton, T., Goldthorpe, J., Calam, R., & Armitage, C. J. (2020). Acceptability, reliability, and validity of a brief measure of capabilities, opportunities, and motivations (“COM‐B”). British journal of health psychology, 25(3), 474‐501[Baseline and at 12‐month follow‐up (post‐intervention commencement).] Stakeholders' perceptions of the RT for Teens program. ; ; The final phase of this project will focus on engagement with key stakeholders in VIC, QLD and WA to guide national dissemination. This outcome will be assessed via a series of semi‐structured face‐to‐face (or virtual if more feasible) focus groups with key stakeholders and authorities in the education and health sectors. The details of this focus group (e.g., time and discussion items) will be determined in the final phase of the RCT, once the follow‐up data collection has been finalized for cohort 2. ; ; In each state, focus group participants will include: (i) Executive directors: Government and non‐government health and education authorities, (ii) School leaders: Secondary school principals and HPE head of departments who are responsible for school‐based program decisions, and (iii) Teachers: Secondary school HPE teachers. Focus group data will be recorded, transcribed and entered into NVIVO software for inductive thematic analysis. Data from the focus groups will be used to investigate state‐based parameters and pragmatic considerations for national dissemination.[Once the 12‐month follow‐up (post‐intervention commencement) data collection has been completed for cohort 2.] Sustainability: The extent to which the program has become embedded within the school setting will be determined by interviewing the HPE head teachers at follow‐up, by a 30‐minute semi‐structured one‐on‐one interview with a member of the research team. In addition, the school champion will complete the Program Sustainability Assessment Tool (with only the items for Environmental support (n=5) and Organizational capacity (n=5)). ; This feedback will be assessed as a composite secondary outcome. [12‐month follow‐up (post‐intervention commencement).] Teachers' perceptions of the RT for Teens program. ; This outcome will be assess via a 30‐minute semi‐structured one‐on‐one interview with a member of the research team. ; ; Interview items from a previous study on RT for Teens will be used and slightly adapted to the current program (Kennedy et al., 2018). ; ; Kennedy, S. G., Smith, J. J., Hansen, V., Lindhout, M. I., Morgan, P. J., & Lubans, D. R. (2018). Implementing resistance training in secondary schools: an exploration of teachers' perceptions. Translational Journal of the American College of Sports Medicine, 3(12), 85‐96.[at 12‐month follow‐up (post‐intervention commencement).] INCLUSION CRITERIA: The intervention will target students in Year 9 and 10 in secondary schools in NSW. All government (n = 367) and non‐government (n = 140) secondary schools will be eligible to participate. The study will involve two cohorts. Cohort 1 will involve NSW government schools only, start in 2022 and finish in 2022/2023. Cohort 2 will involve government and non‐government schools in NSW, start in 2022/2023 and finish in 2023. Teachers who have previously attended an RT for Teens professional learning workshop will not be eligible to be school champions, but their school may participate in the study if the program has not been integrated into their school curriculum. Schools will be required to answer this question during the consent process.
Epistemonikos ID: cfa270ae09276df0b4478b85d26315cbdbc87202
First added on: Aug 25, 2024