Supermarket and Web-Based Intervention Targeting Nutrition (SuperWIN) for Cardiovascular Risk Reduction
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Diet Modification
- Hyperlipidemias
- Hypertension
- Obesity
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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, 17 randomized subjects could not complete their in-person study visits or data collection as per protocol. These 17 subjects will be excluded from all primary analyses, including the primary endpoint. To account for the exclusion of these 17 subjects, we will need need to randomize 267 subjects by the end of the study in order to have the protocol-defined 250 subjects available for the primary analyses (e.g. 267-17= 250). Recruitment and in-person visits resumed in June 2020.Masking: Double (Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 21 years and 75 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT03895580
- Collaborators
- The Kroger Company
- Children's Hospital Medical Center, Cincinnati
- Investigators
- Principal Investigator: Dylan L Steen, MD, MS University of Cincinnati Principal Investigator: Sarah C Couch, PhD, RDN University of Cincinnati
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