Study protocol for iSIPsmarter: A randomized-controlled trial to evaluate the efficacy, reach, and engagement of a technology-based behavioral intervention to reduce sugary beverages among rural Appalachian adults.

Jamie M Zoellner, Kathleen J Porter, Wen You, Annie L Reid, Christina Frederick, Michelle Hilgart, Donna-Jean P Brock, Deborah F Tate, Lee M Ritterband

Journal: Contemporary clinical trials 2021;110():106566

PMID: 34492306

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Abstract

Sugar-sweetened beverage (SSB) consumption is disproportionately high among rural Appalachian adults, with intakes double the national average and nearly four times the recommended amount. This trial targets this major dietary risk factor and addresses notable gaps in the rural digital health intervention literature. iSIPsmarter is a technology-based behavior and health literacy intervention aimed at improving SSB behaviors. It is comprised of six Internet-delivered, interactive Cores delivered weekly, an integrated short message service (SMS) strategy to engage users in tracking and reporting SSB behaviors, and a cellular-enabled scale for in-home weighing. iSIPsmarter is adapted from an evidence-based intervention and is grounded by the Theory of Planned Behavior and health literacy, numeracy, and media literacy concepts. The RCT is guided by the RE-AIM framework and targets 244 rural Appalachian adults. The goal is to examine the efficacy of iSIPsmarter to reduce SSB in a two-group design [iSIPsmarter vs. static Participant Education website] with four assessment points. Changes in secondary outcomes (e.g., diet quality, weight, quality of life) and maintenance of outcomes will also be evaluated. Additional secondary aims are to examine reach and representativeness, patterns of user engagement, and cost. Two tertiary aims are exploratory mediation analyses and a systems-level, participatory evaluation to understand context for future organizational-level adoption of iSIPsmarter. The long-term goal is to sustain an effective, scalable, and high reach behavioral intervention to reduce SSB-related health inequities and related chronic conditions (i.e., obesity, diabetes, some obesity-related cancers, heart disease, hypertension, dental decay) in rural Appalachia and beyond. ClinicalTrial registry: NCT05030753.

Address: University of Virginia, School of Medicine, Department of Public Health Sciences, Cancer Center Research and Outreach Office, 16 East Main Street, Christiansburg, VA 24073, USA. Electronic address: [email protected].; University of Virginia, School of Medicine, Department of Public Health Sciences, Cancer Center Research and Outreach Office, 16 East Main Street, Christiansburg, VA 24073, USA.; University of Virginia, School of Medicine, Department of Public Health Sciences, 560 Ray C Hunt Drive, Charlottesville, VA 22908, USA.; University of Virginia, School of Medicine, Department of Psychiatry and Neurobehavioral Sciences, 560 Ray C Hunt Drive, Charlottesville, VA 22908, USA.; University of North Carolina, Gillings School of Global Public Health, Department of Health Behavior, Chapel Hill, NC 27599, USA.

DOI: 10.1016/j.cct.2021.106566

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MeSH Terms: Adult, Appalachian Region, Beverages, Humans, Quality of Life, Randomized Controlled Trials as Topic, Sugars, Technology