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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.
Full 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.
Enrollment
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Inclusion criteria
Age ≥21 to ≤75 years on the start date of the study (Day 0)
Speak, write, read English fluently
In-person outpatient visit with a UC Health primary care network (PCN) provider within the last 12 months
Major food planner of their household, which may include planning, purchasing, and/or preparing greater than 50% of the meals or foods consumed at home
Existing shopper at a study site Kroger (≥50% of grocery store food dollars spent at Kroger) with a Kroger Loyalty ID number
Willing to use a new individual Kroger Loyalty ID number for the duration of the study
Access to a home desktop or laptop computer with reliable internet access
Access to an email account that can be used for the duration of the study
Able to independently purchase and prepare food:
Presence of a cardiovascular risk factor(s) (at least one):
Hypertension (defined by one of the following):
Blood pressure measurement: systolic blood pressure (SBP) 130-189 mm Hg and/or diastolic blood pressure (DBP) 80-109 mm Hg (at Visit #1)
Current treatment with an oral medication prescribed by a physician for blood pressure lowering (defined by one of the following):
Body-mass index (BMI) measurement ≥30 kg/m2 (at Visit #1)
Hypercholesterolemia (defined by one of the following):
Low density lipoprotein cholesterol (LDL-C) 130-189 mg/dl (at Visit #1)
Current treatment with a medication prescribed by a physician for hypercholesterolemia (defined by one of the following):
Exclusion criteria
Unwillingness or inability to modify current diet
Actively engaged in another dietary intervention or taking a weight-loss supplement
SBP ≥190 mm Hg or DBP ≥110 mm Hg (at Visit #1)
Low-density lipoprotein cholesterol (LDL-C) ≥190 mg/dl, triglycerides (TG) ≥600 mg/dl, or glucose ≥400 mg/dl (at Visit #1)
Evidence of prior diagnosis of severe chronic kidney disease (CKD) defined by electronic health record codes for dialysis, CKD Stage 4 or 5 and/or last estimated glomerular filtration rate (eGFR) ≤30 ml/min/1.732 [based on Modification of Diet in Renal Disease (MDRD) formula]
Active cancer other than non-melanoma skin cancers (i.e. basal cell carcinoma or squamous cell carcinoma)
Diagnosis of celiac disease, ulcerative colitis, or Crohn's disease
High risk for alcohol use disorder:
Women who are pregnant or plan to become pregnant within the next 6 months from the start of the study (Day 0)
Food allergies requiring a specialized diet, including allergies to dairy products, eggs, peanuts, tree nuts, soy, gluten-containing wheat and grains, fish, and shellfish
Previous visit at TLC for diet counseling
Previous use of the Kroger's online shopping platform (Kroger.com or the Kroger app)
Participant lives greater than 20 miles from any participating Kroger study store (defined by zip codes)
Women, Infants, and Children (WIC) beneficiaries in their household
Primary purpose
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267 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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