10 results on '"Burkart, S."'
Search Results
2. Early-stage studies to larger-scale trials: investigators’ perspectives on scaling-up childhood obesity interventions
- Author
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von Klinggraeff, L., Dugger, R., Okely, A. D., Lubans, D., Jago, R., Burkart, S., Weaver, R. G., Armstrong, B., Pfledderer, C. D., and Beets, M. W.
- Published
- 2022
- Full Text
- View/download PDF
3. Correction to: Early-stage studies to larger-scale trials: investigators’ perspectives on scaling-up childhood obesity interventions
- Author
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von Klinggraef, L., Dugger, R., Okely, A. D., Lubans, D., Jago, R., Burkart, S., Weaver, R. G., Armstrong, B., Pfedderer, C. D., and Beets, M. W.
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- 2022
- Full Text
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4. Differences in elementary-age children's accelerometer - measured physical activity between school and summer: three-year findings from the What's UP (Undermining Prevention) with summer observational cohort study.
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Beets MW, Burkart S, Pfledderer C, Adams E, Weaver RG, Armstrong B, Brazendale K, Zhu X, McLain A, Turner-McGrievy B, Pate R, Kaczynski A, Fairchild A, Saelens B, and Parker H
- Subjects
- Humans, Male, Female, Child, Adolescent, Child, Preschool, Cohort Studies, Sedentary Behavior, Accelerometry, Seasons, Exercise, Schools, Body Mass Index
- Abstract
Background: Among elementary-aged children (5-12yrs), summer vacation is associated with accelerated gains in Body Mass Index (BMI). A key behavioral driver of BMI gain is a lack of physical activity (PA). Previous studies indicate PA decreases during summer, compared to the school year but whether this difference is consistent among boys and girls, across age, and by income status remains unclear. This study examined differences in school and summer movement behaviors in a diverse cohort of children across three years., Methods: Children (N = 1,203, age range 5-14 years, 48% girls) wore wrist-placed accelerometers for a 14-day wear-period during school (April/May) and summer (July) in 2021 to 2023, for a total of 6 timepoints. Mixed-effects models examined changes in school vs. summer movement behaviors (moderate-to-vigorous physical activity [MVPA], sedentary) for boys and girls, separately, and by age and household income groups (low, middle, and upper based on income-to-poverty ratio)., Results: Children provided a total of 35,435 valid days of accelerometry. Overall, boys (+ 9.1 min/day, 95CI 8.1 to 10.2) and girls (+ 6.2 min/day, 95CI 5.4 to 7.0) accumulated more MVPA during school compared to summer. Boys accumulated less time sedentary (-9.9 min/day, 95CI -13.0 to -6.9) during school, while there was no difference in sedentary time (-2.7 min/day, 95CI -5.7 to 0.4) for girls. Different patterns emerged across ages and income groups. Accumulation of MVPA was consistently greater during school compared to summer across ages and income groups. Generally, the difference between school and summer widened with increasing age, except for girls from middle-income households. Accumulation of sedentary time was higher during school for younger children (5-9yrs), whereas for older children (10-14yrs), sedentary time was greater during summer for the middle- and upper-income groups. For boys from low-income households and girls from middle-income households, sedentary time was consistently greater during summer compared to school across ages., Conclusions: Children are less active and more sedentary during summer compared to school, which may contribute to accelerated BMI gain. However, this differs by biological sex, age, and income. These findings highlight the complex factors influencing movement behaviors between school and summer., (© 2024. The Author(s).)
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- 2024
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5. Consolidated guidance for behavioral intervention pilot and feasibility studies.
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Pfledderer CD, von Klinggraeff L, Burkart S, da Silva Bandeira A, Lubans DR, Jago R, Okely AD, van Sluijs EMF, Ioannidis JPA, Thrasher JF, Li X, and Beets MW
- Abstract
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., (© 2024. The Author(s).)
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- 2024
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6. Use of guidelines, checklists, frameworks, and recommendations in behavioral intervention preliminary studies and associations with reporting comprehensiveness: a scoping bibliometric review.
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Pfledderer CD, von Klinggraeff L, Burkart S, da Silva Bandeira A, Armstrong B, Weaver RG, Adams EL, and Beets MW
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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 (OR
range = 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., (© 2023. BioMed Central Ltd., part of Springer Nature.)- Published
- 2023
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7. The mysterious case of the disappearing pilot study: a review of publication bias in preliminary behavioral interventions presented at health behavior conferences.
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von Klinggraeff L, Ramey K, Pfledderer CD, Burkart S, Armstrong B, Weaver RG, and Beets MW
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Background: The number of preliminary studies conducted and published has increased in recent years. However, there are likely many preliminary studies that go unpublished because preliminary studies are typically small and may not be perceived as methodologically rigorous. The extent of publication bias within preliminary studies is unknown but can prove useful to determine whether preliminary studies appearing in peer-reviewed journals are fundamentally different than those that are unpublished. The purpose of this study was to identify characteristics associated with publication in a sample of abstracts of preliminary studies of behavioral interventions presented at conferences., Methods: Abstract supplements from two primary outlets for behavioral intervention research (Society of Behavioral Medicine and International Society of Behavioral Nutrition and Physical Activity) were searched to identify all abstracts reporting findings of behavioral interventions from preliminary studies. Study characteristics were extracted from the abstracts including year presented, sample size, design, and statistical significance. To determine if abstracts had a matching peer-reviewed publication, a search of authors' curriculum vitae and research databases was conducted. Iterative logistic regression models were used to estimate odds of abstract publication. Authors with unpublished preliminary studies were surveyed to identify reasons for nonpublication., Results: Across conferences, a total of 18,961 abstracts were presented. Of these, 791 were preliminary behavioral interventions, of which 49% (388) were published in a peer-reviewed journal. For models with main effects only, preliminary studies with sample sizes greater than n = 24 were more likely to be published (range of odds ratios, 1.82 to 2.01). For models including interactions among study characteristics, no significant associations were found. Authors of unpublished preliminary studies indicated small sample sizes and being underpowered to detect effects as barriers to attempting publication., Conclusions: Half of preliminary studies presented at conferences go unpublished, but published preliminary studies appearing in peer-reviewed literature are not systematically different from those that remain unpublished. Without publication, it is difficult to assess the quality of information regarding the early-stage development of interventions. This inaccessibility inhibits our ability to learn from the progression of preliminary studies., (© 2023. The Author(s).)
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- 2023
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8. Feasibility indicators in obesity-related behavioral intervention preliminary studies: a historical scoping review.
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Pfledderer CD, von Klinggraeff L, Burkart S, Wolfenden L, Ioannidis JPA, and Beets MW
- Abstract
Background: Behavioral interventions are often complex, operate at multiple levels, across settings, and employ a range of behavior change techniques. Collecting and reporting key indicators of initial trial and intervention feasibility is essential to decisions for progressing to larger-scale trials. The extent of reporting on feasibility indicators and how this may have changed over time is unknown. The aims of this study were to (1) conduct a historical scoping review of the reporting of feasibility indicators in behavioral pilot/feasibility studies related to obesity published through 2020, and (2) describe trends in the amount and type of feasibility indicators reported in studies published across three time periods: 1982-2006, 2011-2013, and 2018-2020., Methods: A search of online databases (PubMed, Embase, EBSCOhost, Web of Science) for health behavior pilot/feasibility studies related to obesity published up to 12/31/2020 was conducted and a random sample of 600 studies, 200 from each of the three timepoints (1982-2006, 2011-2013, and 2018-2020), was included in this review. The presence/absence of feasibility indicators, including recruitment, retention, participant acceptability, attendance, compliance, and fidelity, were identified/coded for each study. Univariate logistic regression models were employed to assess changes in the reporting of feasibility indicators across time., Results: A total of 16,365 unique articles were identified of which 6873 of these were reviewed to arrive at the final sample of 600 studies. For the total sample, 428 (71.3%) studies provided recruitment information, 595 (99.2%) provided retention information, 219 (36.5%) reported quantitative acceptability outcomes, 157 (26.2%) reported qualitative acceptability outcomes, 199 (33.2%) reported attendance, 187 (31.2%) reported participant compliance, 23 (3.8%) reported cost information, and 85 (14.2%) reported treatment fidelity outcomes. When compared to the Early Group (1982-2006), studies in the Late Group (2018-2020) were more likely to report recruitment information (OR=1.60, 95%CI 1.03-2.49), acceptability-related quantitative (OR=2.68, 95%CI 1.76-4.08) and qualitative (OR=2.32, 95%CI 1.48-3.65) outcomes, compliance outcomes (OR=2.29, 95%CI 1.49-3.52), and fidelity outcomes (OR=2.13, 95%CI 1.21, 3.77)., Conclusion: The reporting of feasibility indicators within behavioral pilot/feasibility studies has improved across time, but key aspects of feasibility, such as fidelity, are still not reported in the majority of studies. Given the importance of behavioral intervention pilot/feasibility studies in the translational science spectrum, there is a need for improving the reporting of feasibility indicators., (© 2023. The Author(s).)
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- 2023
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9. Fund behavioral science like the frameworks we endorse: the case for increased funding of preliminary studies by the National Institutes of Health.
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Beets MW, Pfledderer C, von Klinggraeff L, Burkart S, and Armstrong B
- Abstract
Innovative, groundbreaking science relies upon preliminary studies (aka pilot, feasibility, proof-of-concept). In the behavioral sciences, almost every large-scale intervention is supported by a series of one or more rigorously conducted preliminary studies. The importance of preliminary studies was established by the National Institutes of Health (NIH) in 2014/2015 in two translational science frameworks (NIH Stage and ORBIT models). These frameworks outline the essential role preliminary studies play in developing the next generation of evidence-based behavioral prevention and treatment interventions. Data produced from preliminary studies are essential to secure funding from the NIH's most widely used grant mechanism for large-scale clinical trials, namely the R01. Yet, despite their unquestionable importance, the resources available for behavioral scientists to conduct rigorous preliminary studies are limited. In this commentary, we discuss ways the existing funding structure at the NIH, despite its clear reliance upon high-quality preliminary studies, inadvertently discourages and disincentivizes their pursuit by systematically underfunding them. We outline how multiple complementary and pragmatic steps via a small reinvestment of funds from larger trials could result in a large increase in funding for smaller preliminary studies. We make the case such a reinvestment has the potential to increase innovative science, increase the number of investigators currently funded, and would yield lasting benefits for behavioral science and scientists alike., (© 2022. The Author(s).)
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- 2022
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10. Small studies, big decisions: the role of pilot/feasibility studies in incremental science and premature scale-up of behavioral interventions.
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Beets MW, von Klinggraeff L, Weaver RG, Armstrong B, and Burkart S
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Background: Careful consideration and planning are required to establish "sufficient" evidence to ensure an investment in a larger, more well-powered behavioral intervention trial is worthwhile. In the behavioral sciences, this process typically occurs where smaller-scale studies inform larger-scale trials. Believing that one can do the same things and expect the same outcomes in a larger-scale trial that were done in a smaller-scale preliminary study (i.e., pilot/feasibility) is wishful thinking, yet common practice. Starting small makes sense, but small studies come with big decisions that can influence the usefulness of the evidence designed to inform decisions about moving forward with a larger-scale trial. The purpose of this commentary is to discuss what may constitute sufficient evidence for moving forward to a definitive trial. The discussion focuses on challenges often encountered when conducting pilot/feasibility studies, referred to as common (mis)steps, that can lead to inflated estimates of both feasibility and efficacy, and how the intentional design and execution of one or more, often small, pilot/feasibility studies can play a central role in developing an intervention that scales beyond a highly localized context., Main Body: Establishing sufficient evidence to support larger-scale, definitive trials, from smaller studies, is complicated. For any given behavioral intervention, the type and amount of evidence necessary to be deemed sufficient is inherently variable and can range anywhere from qualitative interviews of individuals representative of the target population to a small-scale randomized trial that mimics the anticipated larger-scale trial. Major challenges and common (mis)steps in the execution of pilot/feasibility studies discussed are those focused on selecting the right sample size, issues with scaling, adaptations and their influence on the preliminary feasibility and efficacy estimates observed, as well as the growing pains of progressing from small to large samples. Finally, funding and resource constraints for conducting informative pilot/feasibility study(ies) are discussed., Conclusion: Sufficient evidence to scale will always remain in the eye of the beholder. An understanding of how to design informative small pilot/feasibility studies can assist in speeding up incremental science (where everything needs to be piloted) while slowing down premature scale-up (where any evidence is sufficient for scaling)., (© 2021. The Author(s).)
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- 2021
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