Study protocol for weSIPsmarter: A cluster randomized-controlled trial to evaluate the efficacy of a digital health intervention aimed at reducing sugary drinks among rural Head Start preschoolers and their parents.

内容摘要

Despite the high prevalence of sugary drink consumption among preschool-aged children and strong evidence of risky sugary drink behaviors in rural communities, efficacious and scalable interventions remain limited. In partnership with rural Head Starts in Appalachia and the southern Black Belt, this trial targets parents as agents of change to improve sugary drink behaviors among parent-child dyads. Guided by the RE-AIM (reach, efficacy/effectiveness, adoption, implementation, maintenance) framework, the study uses a two-group cluster randomized controlled trial design. Twelve Head Starts are recruited and randomized 1:1 to either the weSIPsmarter experimental condition, a highly interactive, digital, theory-based program incorporating self-monitoring, action planning, a resource help line, and drinking water vouchers for eligible families, or the weLearn2Read control condition, an attention-matched digital program focused on reading readiness. Assessments occur at pre, 9-week, and 12-month follow-up. weSIPsmarter is hypothesized to be more efficacious at reducing sugary drink consumption than the control. Secondary outcomes include parent-child dyad measures (e.g., diet quality, water intake, body mass index, quality of life, behavioral theory constructs) and maintenance at 12 months. Additional aims include examining reach, describing parent engagement, and using a mixed-methods process evaluation to understand adoption, implementation, and potential sustainability across Head Starts. Mediators and moderators of engagement and efficacy outcomes will also be explored. The long-term goal of this primary prevention research is to develop an efficacious, scalable sugary drink reduction intervention with broad reach among rural, low-socioeconomic-status preschool-aged children and their parents, suitable for sustained implementation within Head Start programs.