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. 2021 Nov:110:106566.
doi: 10.1016/j.cct.2021.106566. Epub 2021 Sep 4.

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  1 , Kathleen J Porter  2 , Wen You  3 , Annie L Reid  2 , Christina Frederick  4 , Michelle Hilgart  4 , Donna-Jean P Brock  2 , Deborah F Tate  5 , Lee M Ritterband  4
Affiliations

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 et al. Contemp Clin Trials. 2021 Nov.

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.

Keywords: Behavioral research; Beverages; Digital technology; Health literacy; Randomized controlled trial; Rural population.

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Conflict of interest statement

Declaration of interests

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

The authors declare the following financial interests/personal relationships which may be considered as potential competing interests:

Dr. Deborah Tate serves on the scientific advisory board for Weight Watchers and WondrHealth.

Yet, all other authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Figure 1.
Figure 1.
iSIPsmarter Overview
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