Rationale and protocol for a cluster randomized, cross-over trial of recruitment methods of rural children in primary care clinics: A feasibility study of a pediatric weight control trial in the IDeA States Pediatric Clinical Trials Network.

A significant percentage of clinical trials fail due to poor recruitment. Despite this, few studies exist to evaluate clinical trial recruitment strategies using a randomized approach in any population, and none exist to test recruitment strategies for trials involving children or rural populations. For clinical trials focused on weight control, evaluating retention and dose are extremely important, as poor retention can lead to biased samples and existing research shows that dose (i.e. contact hours) is directly related to patient outcome. Finally, adequacy of blinding of assessment teams is rarely reported in pediatric trials, and unblinded staff may be more likely to inadvertently bias findings. Therefore, in this feasibility trial we aim to use rigorous clinical trial methodology to assess the effectiveness of two different recruitment strategies, as well as test retention, dose, and blinding. Specifically, we describe the rationale, design, and planned implementation of a feasibility study of a rural pediatric obesity treatment trial that will be implemented in four medical clinics in four states affiliated with the Environmental influences on Child Health Outcomes IDeA States Pediatric Clinical Trials Network (ECHO ISPCTN). The primary objective is to assess recruitment rate for consecutive recruitment (approaching recently seen eligible patients in consecutive order by date seen) compared to traditional recruitment (such as posters, flyers, tear-offs), as well as to assess retention, dose, and blinding. If successful, this trial will support the implementation of a large multi-state trial directed at addressing obesity in rural children and their families recruited from their primary care clinics. Registered with ClinicalTrials.gov NCT ID NCT04142034.