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.

ABSTRACT: 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 as

SUBMITTER: Davis AM 

PROVIDER: S-EPMC8429100 | biostudies-literature | 2021 Aug

REPOSITORIES: biostudies-literature