Supermarket and Web-Based Intervention Targeting Nutrition (SuperWIN) for Cardiovascular Risk Reduction

Obesity Clinical Trial

— SuperWIN  

Official title:

Supermarket and Web-Based Intervention Targeting Nutrition (SuperWIN) for Cardiovascular Risk Reduction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03895580
• Other study ID #: 20168163
• Status: Completed
• Phase: N/A
• Start date: April 8, 2019
• Est. completion date: August 31, 2021

Study information

• Verified date: February 2022
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 267
• Est. completion date: August 31, 2021
• Est. primary completion date: June 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age =21 to =75 years on the start date of the study (Day 0)

2. Speak, write, read English fluently

3. In-person outpatient visit with a UC Health primary care network (PCN) provider within the last 12 months

4. 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

5. Existing shopper at a study site Kroger (=50% of grocery store food dollars spent at Kroger) with a Kroger Loyalty ID number

6. Willing to use a new individual Kroger Loyalty ID number for the duration of the study

7. Access to a home desktop or laptop computer with reliable internet access

8. Access to an email account that can be used for the duration of the study

9. Able to independently purchase and prepare food:

1. Reliable transportation to participating Kroger store

2. Ability to stand for significant periods of time to grocery shop and prepare food at home

3. Tools and equipment needed to prepare own food at home, such as a kitchen equipped with basic cooking tools (e.g. burner, pan, spatula, sink)

10. Presence of a cardiovascular risk factor(s) (at least one):

1. 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):

1. Beta blockers

2. Diuretics (e.g. thiazide or thiazide-like diuretics, loop diuretics, aldosterone antagonists, potassium-sparing diuretics)

3. Angiotensin-converting enzyme inhibitors

4. Angiotensin II receptor blockers

5. Direct renin inhibitors (i.e. aliskiren)

6. Calcium channel blockers (dihydropyridine and nondihydropyridine)

7. Calcium alpha2-agonist and other centrally acting drugs (e.g. clonidine)

8. Direct vasodilators (e.g. hydralazine)

2. Body-mass index (BMI) measurement =30 kg/m2 (at Visit #1)

3. 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):

1. Statins

2. Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors

3. Absorption inhibitors (i.e. ezetimibe)

4. Fibrates

5. High-dose niacin (=1 g per day)

6. Bile acid sequestrants (e.g. cholestyramine)

Exclusion Criteria:

1. Unwillingness or inability to modify current diet

2. Actively engaged in another dietary intervention or taking a weight-loss supplement

3. SBP =190 mm Hg or DBP =110 mm Hg (at Visit #1)

4. Low-density lipoprotein cholesterol (LDL-C) =190 mg/dl, triglycerides (TG) =600 mg/dl, or glucose =400 mg/dl (at Visit #1)

5. 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]

6. Active cancer other than non-melanoma skin cancers (i.e. basal cell carcinoma or squamous cell carcinoma)

7. Diagnosis of celiac disease, ulcerative colitis, or Crohn's disease

8. High risk for alcohol use disorder:

1. =21 drinks a week (men)

2. =14 drinks a week (women)

9. Women who are pregnant or plan to become pregnant within the next 6 months from the start of the study (Day 0)

10. Food allergies requiring a specialized diet, including allergies to dairy products, eggs, peanuts, tree nuts, soy, gluten-containing wheat and grains, fish, and shellfish

11. Previous visit at TLC for diet counseling

12. Previous use of the Kroger's online shopping platform (Kroger.com or the Kroger app)

13. Participant lives greater than 20 miles from any participating Kroger study store (defined by zip codes)

14. Women, Infants, and Children (WIC) beneficiaries in their household

Related Conditions & MeSH terms

• Diet Modification
• Hyperlipidemias
• Hypertension
• Obesity

Intervention

Other:
• In-store POP education
Six in-store nutrition counseling sessions with a registered dietitian nutritionist.
• Online POP education
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.

Locations

Country	Name	City	State
United States	University of Cincinnati Medical Center - UC Health	Cincinnati	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
University of Cincinnati	Children's Hospital Medical Center, Cincinnati, The Kroger Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in waist circumference	Measured. Units: cm	Baseline with follow-up measures at 90 days and 180 days.
Other	Change in food literacy	Assessed by participant survey.	Baseline with reassessment at 90 days.
Other	Participant experience and feedback	Assessed by participant survey.	Collected at 90 days.
Other	Dietitian experience and feedback	Assessed by dietitian survey.	Collected at 90 days.
Primary	Change in Dietary Approaches to Stop Hypertension (DASH) score	The DASH score will be calculated from food group analyses obtained from means of three 24-hour dietary intake recalls at each time-point. This DASH score is a 90-point continuous score used to measure change in overall dietary quality in response to an intervention. Given that the dietary focus of the SuperWIN interventions is the DASH dietary pattern, the DASH score will be used as a measure of adherence to a DASH eating pattern. Higher values indicate greater adherence.	Baseline with follow-up measures at 90 days and 180 days. Primary tests are between baseline and 90 day timepoint.
Secondary	Change in systolic arterial blood pressure	Measured in the arm. Units: mm Hg	Baseline with follow-up measures at 90 days and 180 days.
Secondary	Change in diastolic arterial blood pressure	Measured in the arm. Units: mm Hg	Baseline with follow-up measures at 90 days and 180 days.
Secondary	Change in body mass index	Height and weight measured. Units: kg/m2	Baseline with follow-up measures at 90 days and 180 days.
Secondary	Change in non-high density lipoprotein cholesterol (Non-HDL-C)	Total cholesterol minus HDL-C. Units: mg/dL	Baseline with follow-up measures at 90 days and 180 days.
Secondary	Change in total cholesterol	Measured. Units: mg/dL	Baseline with follow-up measures at 90 days and 180 days.
Secondary	Change in triglycerides	Measured. Units: mg/dL	Baseline with follow-up measures at 90 days and 180 days.