Consolidated guidance for behavioral intervention pilot and feasibility studies.

BACKGROUND: In the behavioral sciences, conducting pilot and/or feasibility studies (PFS) is a key step that provides essential information used to inform the design, conduct, and implementation of a larger-scale trial. There are more than 160 published guidelines, reporting checklists, frameworks, and recommendations related to PFS. All of these publications offer some form of guidance on PFS, but many focus on one or a few topics. This makes it difficult for researchers wanting to gain a broader understanding of all the relevant and important aspects of PFS and requires them to seek out multiple sources of information, which increases the risk of missing key considerations to incorporate into their PFS. The purpose of this study was to develop a consolidated set of considerations for the design, conduct, implementation, and reporting of PFS for interventions conducted in the behavioral sciences. METHODS: To develop this consolidation, we undertook a review of the published guidance on PFS in combination with expert consensus (via a Delphi study) from the authors who wrote such guidance to inform the identified considerations. A total of 161 PFS-related guidelines, checklists, frameworks, and recommendations were identified via a review of recently published behavioral intervention PFS and backward/forward citation tracking of a well-known PFS literature (e.g., CONSORT Ext. for PFS). Authors of all 161 PFS publications were invited to complete a three-round Delphi survey, which was used to guide the creation of a consolidated list of considerations to guide the design, conduct, and reporting of PFS conducted by researchers in the behavioral sciences. RESULTS: A total of 496 authors were invited to take part in the three-round Delphi survey (round 1, N = 46; round 2, N = 24; round 3, N = 22). A set of twenty considerations, broadly categorized into six themes (intervention design, study design, conduct of trial, implementation of intervention, statistical analysis, and reporting) were generated from a review of the 161 PFS-related publications as well as a synthesis of feedback from the three-round Delphi process. These 20 considerations are presented alongside a supporting narrative for each consideration as well as a crosswalk of all 161 publications aligned with each consideration for further reading. CONCLUSION: We leveraged expert opinion from researchers who have published PFS-related guidelines, checklists, frameworks, and recommendations on a wide range of topics and distilled this knowledge into a valuable and universal resource for researchers conducting PFS. Researchers may use these considerations alongside the previously published literature to guide decisions about all aspects of PFS, with the hope of creating and disseminating interventions with broad public health impact.

Psychosocial mediators and moderators of a school-based physical activity intervention among Brazilian adolescents.

School-based interventions are needed due to the low levels of physical activity (PA) in adolescents. The aim is to examine the mediation effects of psychosocial factors (attitude, self-efficacy, social support from parents, friends, general teachers, and PE teachers, and environment school perception) and moderation by sex, school grade, and socioeconomic level of a school-based PA intervention on the PA practice among adolescents. The Movimente Programme is a randomised controlled trial at schools in southern Brazil (n = 921 adolescents). Strategies included teacher training, educational actions, and environmental changes. Adolescents self-reported their weekly PA. Potential psychosocial mediators and moderators were investigated through validated questionnaires in a Brazilian sample. The product of the coefficients with percentile bootstrapping 95% confidence interval was performed. The Movimente Programme was related to positive changes in adolescents' perception of the school environment and social support from general and physical education teachers. Most psychosocial variables (attitude, self-efficacy, social support from friends, and social support from teachers) were associated with PA, but none mediated the impact of the Movimente Programme on PA. Results varied according to sex and school grade. The Movimente Programme increased the adolescents' perception of the school environment and social support from teachers, but no mediators were confirmed.

Use of guidelines, checklists, frameworks, and recommendations in behavioral intervention preliminary studies and associations with reporting comprehensiveness: a scoping bibliometric review.

BACKGROUND: Guidelines, checklists, frameworks, and recommendations (GCFRs) related to preliminary studies serve as essential resources to assist behavioral intervention researchers in reporting findings from preliminary studies, but their impact on preliminary study reporting comprehensiveness is unknown. The purpose of this study was to conduct a scoping bibliometric review of recently published preliminary behavioral-focused intervention studies to (1) examine the prevalence of GCFR usage and (2) determine the associations between GCFR usage and reporting feasibility-related characteristics. METHODS: A systematic search was conducted for preliminary studies of behavioral-focused interventions published between 2018 and 2020. Studies were limited to the top 25 journals publishing behavioral-focused interventions, text mined to identify usage of GCFRs, and categorized as either not citing GCFRs or citing ≥ 2 GCFRs (Citers). A random sample of non-Citers was text mined to identify studies which cited other preliminary studies that cited GCFRs (Indirect Citers) and those that did not (Never Citers). The presence/absence of feasibility-related characteristics was compared between Citers, Indirect Citers, and Never Citers via univariate logistic regression. RESULTS: Studies (n = 4143) were identified, and 1316 were text mined to identify GCFR usage (n = 167 Citers). A random sample of 200 studies not citing a GCFR were selected and categorized into Indirect Citers (n = 71) and Never Citers (n = 129). Compared to Never Citers, Citers had higher odds of reporting retention, acceptability, adverse events, compliance, cost, data collection feasibility, and treatment fidelity (ORrange = 2.62-14.15, p < 0.005). Citers also had higher odds of mentioning feasibility in purpose statements, providing progression criteria, framing feasibility as the primary outcome, and mentioning feasibility in conclusions (ORrange = 6.31-17.04, p < 0.005) and lower odds of mentioning efficacy in purpose statements, testing for efficacy, mentioning efficacy in conclusions, and suggesting future testing (ORrange = 0.13-0.54, p < 0.05). Indirect Citers had higher odds of reporting acceptability and treatment fidelity (ORrange = 2.12-2.39, p < 0.05) but lower odds of testing for efficacy (OR = 0.36, p < 0.05) compared to Never Citers. CONCLUSION: The citation of GCFRs is associated with greater reporting of feasibility-related characteristics in preliminary studies of behavioral-focused interventions. Researchers are encouraged to use and cite literature that provides guidance on design, implementation, analysis, and reporting to improve the comprehensiveness of reporting for preliminary studies.

Expert Perspectives on Pilot and Feasibility Studies: A Delphi Study and Consolidation of Considerations for Behavioral Interventions.

Background: In the behavioral sciences, conducting pilot and/or feasibility studies (PFS) is a key step that provides essential information used to inform the design, conduct, and implementation of a larger-scale trial. There are more than 160 published guidelines, reporting checklists, frameworks, and recommendations related to PFS. All of these publications offer some form of guidance on PFS, but many focus on one or a few topics. This makes it difficult for researchers wanting to gain a broader understanding of all the relevant and important aspects of PFS and requires them to seek out multiple sources of information, which increases the risk of missing key considerations to incorporate into their PFS. The purpose of this study was to develop a consolidated set of considerations for the design, conduct, implementation, and reporting of PFS for interventions conducted in the behavioral sciences. Methods: To develop this consolidation, we undertook a review of the published guidance on PFS in combination with expert consensus (via a Delphi study) from the authors who wrote such guidance to inform the identified considerations. A total of 161 PFS-related guidelines, checklists, frameworks, and recommendations were identified via a review of recently published behavioral intervention PFS and backward/forward citation tracking of well-know PFS literature (e.g., CONSORT Ext. for PFS). Authors of all 161 PFS publications were invited to complete a three-round Delphi survey, which was used to guide the creation of a consolidated list of considerations to guide the design, conduct, and reporting of PFS conducted by researchers in the behavioral sciences. Results: A total of 496 authors were invited to take part in the Delphi survey, 50 (10.1%) of which completed all three rounds, representing 60 (37.3%) of the 161 identified PFS-related guidelines, checklists, frameworks, and recommendations. A set of twenty considerations, broadly categorized into six themes (Intervention Design, Study Design, Conduct of Trial, Implementation of Intervention, Statistical Analysis and Reporting) were generated from a review of the 161 PFS-related publications as well as a synthesis of feedback from the three-round Delphi process. These 20 considerations are presented alongside a supporting narrative for each consideration as well as a crosswalk of all 161 publications aligned with each consideration for further reading. Conclusion: We leveraged expert opinion from researchers who have published PFS-related guidelines, checklists, frameworks, and recommendations on a wide range of topics and distilled this knowledge into a valuable and universal resource for researchers conducting PFS. Researchers may use these considerations alongside the previously published literature to guide decisions about all aspects of PFS, with the hope of creating and disseminating interventions with broad public health impact.

Clustering of Physical Activity, Sleep, Diet, and Screen-Based Device Use Associated with Self-Rated Health in Adolescents.

BACKGROUND: Little is known about how the interplay among health-related behaviors impacts self-rated health (SRH). We examined the clustering of physical activity (PA), sleep, diet, and specific screen-based device use, and the associations between the emergent clusters and SRH among Brazilian adolescents. METHOD: The data used in this cross-sectional study were from the baseline of the Movimente Program. Self-reported data were analyzed. SRH was recorded as a 5-point scale (from poor to excellent). Daily duration of exposure to the computer, the television, the cell phone, and games; PA; sleep; and weekly consumption of fruits and vegetables and ultra-processed foods were included in a Two-Step cluster analysis. Multilevel ordered logistic regressions assessed the associations between the clusters and SRH. RESULTS: The data of 750 students (girls: 52.8%, 13.1 ± 1.0 years) were analyzed. Good SRH was more prevalent (52.8%). Three clusters were identified: the Phubbers (50.53%; characterized by the longest cell phone use duration, shortest gaming and computer use, lowest PA levels, and low consumption of fruits and vegetables), the Gamers (22.80%; longest gaming and computer use duration, PA < sample average, highest intake of ultra-processed foods), and a Healthier cluster (26.67%; physically active, use of all screen-based devices < sample average, and healthier dietary patterns). For both Gamers (-0.85; 95% CI -1.24, -0.46) and Phubbers (-0.71; 95% CI -1.04, -0.38), it was found a decrease in the log-odds of being in a higher SRH category compared with the Healthier cluster. CONCLUSION: Specific clusters represent increased health-related risk. Assuming the interdependence of health-related behaviors is indispensable for accurately managing health promotion actions for distinguishable groups.

Implementation of a school-based physical activity intervention for Brazilian adolescents: a mixed-methods evaluation.

The effectiveness of physical activity interventions can be improved through examining the aspects related to their implementation. However, little such evidence has been collected, particularly in low- and middle-income countries. This study aimed to evaluate the implementation of a school-based physical activity intervention with qualitative and quantitative data from different actors (students, teachers and parents) involved in developing the program. The program was conducted in 2017 with three main components: (i) teacher training, (ii) environmental changes and (iii) educational actions. Mixed-method evaluation was performed by an independent evaluation team using a validated indicator matrix for the implementation process, including the self-reported information of students, teachers and parents, as well as interviews with teachers. In the 3 eligible schools, 350 adolescents (51% girls) answered the implementation questionnaire, as did 45 parents (84% mothers), and 47 teachers (70% female). In the qualitative analysis, 18 teachers participated. Categorical analysis found that the intervention was considered feasible by teachers. In general, teachers had a more positive perception of the implementation than did students. The lack of engagement from the school community and parents and the busy schedule of teachers were indicated to be the main difficulties. In conclusion, despite the teachers' motivation, some barriers prevented the successful implementation of the program.