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Background: This study assessed the initial feasibility and preliminary efficacy of providing children a free summer day camp and a parent intervention to improve self-regulation and mitigate accelerated summer BMI gain. Methods: This pilot 2x2 factorial randomized control trial used a mixed-methods design to evaluate providing children a free summer day camp (SCV), a parent intervention (PI), and the combination of these two strategies (SCV+PI) to mitigate accelerated summer body mass index (BMI) gain. Progression criteria for feasibility and efficacy were assessed to determine if a full-scale trial was warranted. Feasibility criteria included recruitment capability (≥80 participants recruited) retention (≥70% participants retained), compliance (≥80% of participants attending the summer program with children attending ≥60% of program days, and ≥80% of participants completing goal setting calls with ≥60% of weeks syncing their child's Fitbit), and treatment fidelity (≥80% of summer program days delivered for ≥9 h/day, and ≥80% of participant texts delivered). Efficacy criteria were assessed via achieving a clinically meaningful impact on zBMI (i.e., ≥0.15). Changes in BMI were estimated using intent-to-treat and post hoc dose-response analyses via multilevel mixed-effects regressions. Results: For recruitment, capability and retention progression criteria were met with a total of 89 families participating and 24 participants randomized to the PI group, 21 randomized to the SCV group, 23 randomized to the SCV+PI group, and 21 randomized to the control. However, fidelity and compliance progression criteria were not achieved due to COVID-19 and lack of transportation. Progression criteria for efficacy was also not achieved as intent-to-treat analyses did not show changes in BMI gain that were clinically meaningful. Post hoc dose-response analyses showed that for each day (0 to 29) of summer programming children attended they gained −0.009 (95CI= −0.018, −0.001) less in BMI z score. Conclusions: Engagement in both the SCV and PI was not ideal due to COVID-19 and lack of transportation. Providing children with structured summer programming to mitigate accelerated summer BMI gain may be an effective strategy. However, because feasibility and efficacy progression criteria were not met, a larger trial is not warranted until further pilot work is completed to ensure children attend the programming. Trial registration: The trial reported herein was prospectively registered at ClinicalTrials.gov. Trial #: NCT04608188. [ABSTRACT FROM AUTHOR]

Background: Pilot/feasibility studies play an important role in the development and refinement of behavioral interventions by providing information about feasibility, acceptability, and potential efficacy. Despite their importance and wide-spread use, the approaches taken by behavioral scientists to scale-up early-stage studies to larger-scale trials has received little attention. The aim of our study was to understand the role that pilot studies play in the development and execution of larger-scale trials. Methods: We conducted interviews with childhood obesity researchers who had published pilot behavioral interventions and larger-scale trials of the same or similar interventions. Questions were asked about the role of pilot studies in developing larger-scale trials and the challenges encountered when scaling-up an intervention based upon pilot findings. Data were coded and analyzed using an inductive analytic approach to identify themes. Results: Twenty-four interventionists (54% women, 37–70 years old, mean 20 years since terminal degree) completed a total of 148 pilot studies across their careers (mean 6.4, range 1–20), of which 59% were scaled-up. Scaling was described as resource intensive and pilot work was considered essential to successfully competing for funding by 63% of the sample (n = 15). When asked to define a high-quality pilot study, interventionists described studies that allowed them to evaluate two independent factors: components of their intervention (e.g., acceptability, feasibility) and study parameters (e.g., sample size, measures). Interventionists expressed that more process implementation measures, different study designs, and additional iterations could improve decisions to scale-up. Most agreed that pilot studies were likely to produce inflated estimates of potential efficacy though only nine interventionists provided potential solutions for decreasing inflated measures of efficacy. Suggested major causes of inflated effects included high levels of oversight in pilot studies (e.g., researcher support), reliance on subjective measures, and utilizing convenience or highly motivated samples. Potential solutions included designing pilots for real-world implementation, only conducting randomized controlled pilot studies, and pre-registering pilot studies. Conclusions: Pilot studies purposes are multifaceted and deemed essential to obtaining funding for larger-scale trials. Clarifying the form and function of preliminary, early-stage research may enhance the productive utilization of early-stage studies and reduced drops in efficacy when transitioning to larger scale studies. [ABSTRACT FROM AUTHOR]