Modifications to Communities for Healthy Living trial design resulting from COVID-19.

To the Editor

We are reaching out to communicate modifications to our trial protocol, published in Contemporary Clinical Trials in 2019. Due to the covid-19 pandemic, the Communities for Healthy Living (CHL) intervention was not fully implemented in the final year of the trial (2019–2020). Additionally, the primary and secondary outcomes were not measured in spring 2019. The study design is illustrated in Fig. 1 of the protocol paper; in essence, the study did not include the final row (fall 2019- spring 2020) shown in the figure [1].

In terms of assessing the impact of CHL on the primary and secondary outcomes, the investigators and study statistician elected to analyze the results of the trial based on data collected up to the end of spring 2019, with one less year of implementation and outcome data than planned. Given the resulting reduction in analytic power, a series of sensitivity analyses will be performed to fully utilize the data available to gauge intervention effectiveness. Sensitivity analyses will examine the roles of intervention dose, implementation fidelity, child baseline weight status on intervention effects as measured by change in the primary and secondary outcomes. In addition, given the availability of data across three summers, the effects of the intervention on child summer weight gain will also be examined as a secondary outcome.

While CHL will be implemented virtually during the 2020–2021 academic year, the changes from the original intervention are too dramatic to integrate the data for in-person and virtual implementation. Therefore, virtual implementation of CHL will be treated as a pilot study for possible scale up and dissemination.

Modifications to the trial design resulting from the pandemic, as summarized above, have been documented in the clinical trial registration (NCT03334669).