Kids SIPsmartER, a cluster randomized controlled trial and multi-level intervention to improve sugar-sweetened beverages behaviors among Appalachian middle-school students: Rationale, design & methods.

The intake of sugar-sweetened beverages (SSB) is disproportionately high in Appalachia, including among adolescents whose intake is more than double the national average and more than four times the recommended daily amount. Unfortunately, there is insufficient evidence for effective strategies targeting SSB behaviors among Appalachian youth in real-world settings, including rural schools. Kids SIPsmartER is a 6-month, school-based, behavior and health literacy program aimed at improving SSB behaviors among middle school students. The program also integrates a two-way short message service (SMS) strategy to engage caregivers in SSB role modeling and supporting home SSB environment changes. Kids SIPsmartER is grounded by the Theory of Planned Behavior and health literacy, media literacy, numeracy, and public health literacy concepts. Guided by the RE-AIM framework (reach, effectiveness, adoption, implementation, and maintenance), this type 1 hybrid design and cluster randomized controlled trial targets 12 Appalachian middle schools in southwest Virginia. The primary aim evaluates changes in SSB behaviors at 7-months among 7th grade students at schools receiving Kids SIPsmartER, as compared to control schools. Secondary outcomes include other changes in students (e.g., BMI, quality of life, theory-related variables) and caregivers (e.g., SSB behaviors, home SSB environment), and 19-month maintenance of these outcomes. Reach is assessed, along with mixed-methods strategies (e.g., interviews, surveys, observation) to determine how teachers implement Kids SIPsmartER and the potential for institutionalization within schools. This paper discusses the rationale for implementing and evaluating a type 1 hybrid design and multi-level intervention addressing pervasive SSB behaviors in Appalachia. Clincialtrials.gov: NCT03740113.