Supermarket and Web-Based Intervention Targeting Nutrition (SuperWIN) for Cardiovascular Risk Reduction
Condition: Obesity; Hypertension; Hyperlipidemias; Diet Modification
MeSH terms: Hyperlipidemias
Study type: Interventional

Summary: 
      The Supermarket and Web-based Intervention targeting Nutrition (SuperWIN) for cardiovascular
      risk reduction is a novel, randomized controlled trial aimed at increasing diet quality and
      decreasing cardiovascular risk. SuperWIN will deliver individualized, nutrition education at
      the point-of-purchase (POP), either in the aisles of the physical store or via online
      shopping platforms coupled with other modern software tools.
    

Detailed description: 
      This study is designed to test whether individualized, POP nutrition education can improve
      dietary quality. The two interventions to be evaluated in SuperWIN will utilize either an
      in-store POP education strategy or a combined online/in-store POP education strategy in
      participants with at least one cardiovascular disease risk factor. The POP education
      interventions will be enhanced with sophisticated, provider- and participant-facing,
      food-purchasing metrics, a novel counseling tool that here-to-fore has not been studied in
      regard to changing food shopping behavior. The primary outcome measure is the Dietary
      Approaches to Stop Hypertension (DASH) score, a measure of adherence to the DASH dietary
      pattern. The study is well-powered to test at Day 90: 1) whether any POP education
      intervention strategy (both intervention arms pooled) improves the DASH score compared to the
      control arm and 2) whether an improvement in DASH score depends on the POP education strategy
      utilized.

      Both POP education strategies will be delivered within a supermarket-based retail clinic and
      will utilize the aisles and products of the supermarket. The interventions will be delivered
      by a registered dietitian nutritionist (RDN). The online portion of the combined
      online/in-store education POP strategy will include online grocery shopping, online recipe
      resources, a grocery pickup or home delivery service, and a phone application to better
      select healthy foods.

      Both strategies will be offered in addition to a "standard of care" medical nutrition therapy
      session. The DASH dietary pattern has been empirically tested and shown to favorably modify
      blood pressure, blood cholesterol, insulin sensitivity, and weight status.
    

Intervention name(s): In-store POP education; Online POP education
Intervention type(s): Other; Other
Intervention description(s): Six in-store nutrition counseling sessions with a registered dietitian nutritionist.; Education on the use of an online grocery shopping, an online recipe tool, a grocery pickup service, a home grocery delivery service, and a phone application that promotes healthy food selection.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Due to COVID-19, recruitment and all in-person visits had to be temporarily stopped due to safety concerns in March 2020. Due to this stoppage, 20 randomized subjects could not complete their in-person study visits or data collection as per protocol. These 20 subjects will be excluded from all primary analyses, including the primary endpoint. Recruitment and in-person visits resumed in June 2020. To account for the exclusion of these 20 subjects, we randomized 267 subjects by the end of the study in order to have 247 subjects available for the primary analyses (e.g. 267-20= 247). A prespecified COVID impact analysis has been included in the statistical analysis plan.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment