ObesitySuperWINNCT03895580
Supermarket and Web-Based Intervention Targeting Nutrition (SuperWIN) for Cardiovascular Risk Reduction
A study testing In-store POP education and Online POP education in people with Obesity and Hypertension, run by University of Cincinnati at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Obesity, Hypertension, Hyperlipidemias
- What is being tested?
- In-store POP education and Online POP education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2019to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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:
- Reliable transportation to participating Kroger store
- Ability to stand for significant periods of time to grocery shop and prepare food at home
- 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)
- 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):
- Beta blockers
- Diuretics (e.g. thiazide or thiazide-like diuretics, loop diuretics, aldosterone antagonists, potassium-sparing diuretics)
- Angiotensin-converting enzyme inhibitors
- Angiotensin II receptor blockers
- Direct renin inhibitors (i.e. aliskiren)
- Calcium channel blockers (dihydropyridine and nondihydropyridine)
- Calcium alpha2-agonist and other centrally acting drugs (e.g. clonidine)
- Direct vasodilators (e.g. hydralazine)
- 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):
- Statins
- Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors
- Absorption inhibitors (i.e. ezetimibe)
- Fibrates
- High-dose niacin (≥1 g per day)
- Bile acid sequestrants (e.g. cholestyramine)
Who cannot join
- 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)
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- Diagnosis of celiac disease, ulcerative colitis, or Crohn's disease
- High risk for alcohol use disorder:
- ≥21 drinks a week (men)
- ≥14 drinks a week (women)
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Cincinnati Medical Center - UC Health
Cincinnati, Ohio, 45219
About this study
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.
Read the 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.
- Conditions
- Obesity, Hypertension, Hyperlipidemias, Diet Modification
- Being tested
- In-store POP education, Online POP education
- Medical subject headings
- Obesity, Hypertension, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-store POP educationOther
Six in-store nutrition counseling sessions with a registered dietitian nutritionist.
Online POP educationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | No intervention | Medical nutrition therapy session with no further dietary counseling throughout the study. |
| Group 2 | Experimental | Medical nutrition therapy session plus in-store point-of-purchase (POP) education. Receives: Other: In-store POP education |
| Group 3 | Experimental | Medical nutrition therapy session plus combined in-store/online point-of-purchase (POP) education. Receives: Other: In-store POP education; Other: Online POP education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline with follow-up measures at 90 days and 180 days. Primary tests are between baseline and 90 day timepoint.
Secondary outcomes (6)
Change in systolic arterial blood pressure
Measured in the arm. Units: mm Hg
Measured: Baseline with follow-up measures at 90 days and 180 days.
Change in diastolic arterial blood pressure
Measured in the arm. Units: mm Hg
Measured: Baseline with follow-up measures at 90 days and 180 days.
Change in body mass index
Height and weight measured. Units: kg/m2
Measured: Baseline with follow-up measures at 90 days and 180 days.
Change in non-high density lipoprotein cholesterol (Non-HDL-C)
Total cholesterol minus HDL-C. Units: mg/dL
Measured: Baseline with follow-up measures at 90 days and 180 days.
Change in total cholesterol
Measured. Units: mg/dL
Measured: Baseline with follow-up measures at 90 days and 180 days.
Change in triglycerides
Measured. Units: mg/dL
Measured: Baseline with follow-up measures at 90 days and 180 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start8 Apr 2019
- Primary completion6 Jun 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- The Kroger Company, Children's Hospital Medical Center, Cincinnati
- Responsible party
- Principal investigator, Dylan Steen, University of Cincinnati
- Investigators
- Dylan L Steen, MD, MS, Principal investigator, University of CincinnatiSarah C Couch, RD, PhD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03895580
- Sponsor's protocol ID
- 20168163
- Acronym
- SuperWIN
- Status last verified
- Feb 2022
- First submitted
- 21 Mar 2019
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Steen DL, Helsley RN, Bhatt DL, King EC, Summer SS, Fenchel M, Saelens BE, Eckman MH, Couch SC. Efficacy of supermarket and web-based interventions for improving dietary quality: a randomized, controlled trial. Nat Med. 2022 Dec;28(12):2530-2536. doi: 10.1038/s41591-022-02077-7. Epub 2022 Dec 1.
PubMed 36456831
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supermarket and Web-Based Intervention Targeting Nutrition (SuperWIN) for Cardiovascular Risk Reduction
- ClinicalTrials.gov ID
- NCT03895580
- Acronym / sponsor ID
- SuperWIN / 20168163
- Conditions
- Obesity, Hypertension, Hyperlipidemias, Diet Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- The Kroger Company, Children's Hospital Medical Center, Cincinnati
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 6 Jun 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 29 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | No intervention | –Medical nutrition therapy session with no further dietary counseling throughout the study. |
| Group 2 | Experimental | Other: In-store POP educationMedical nutrition therapy session plus in-store point-of-purchase (POP) education. |
| Group 3 | Experimental | Other: In-store POP education, Other: Online POP educationMedical nutrition therapy session plus combined in-store/online point-of-purchase (POP) education. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (34 listed)
- 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
Key exclusion criteria (16 listed)
- 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]
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-store POP educationSix in-store nutrition counseling sessions with a registered dietitian nutritionist. | Other | Group 2, Group 3 |
| Online POP educationEducation 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. | Other | Group 3 |
Primary outcome
Change in Dietary Approaches to Stop Hypertension (DASH) score
Time frame: Baseline with follow-up measures at 90 days and 180 days. Primary tests are between baseline and 90 day timepoint.
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.
6 secondary outcomes
Change in systolic arterial blood pressure
Time frame: Baseline with follow-up measures at 90 days and 180 days.
Change in diastolic arterial blood pressure
Time frame: Baseline with follow-up measures at 90 days and 180 days.
Change in body mass index
Time frame: Baseline with follow-up measures at 90 days and 180 days.
Change in non-high density lipoprotein cholesterol (Non-HDL-C)
Time frame: Baseline with follow-up measures at 90 days and 180 days.
Change in total cholesterol
Time frame: Baseline with follow-up measures at 90 days and 180 days.
Change in triglycerides
Time frame: Baseline with follow-up measures at 90 days and 180 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
- Derived from this study: PubMed 36456831Steen DL, Helsley RN, Bhatt DL, King EC, Summer SS, Fenchel M, Saelens BE, Eckman MH, Couch SC. Efficacy of supermarket and web-based interventions for improving dietary quality: a randomized, controlled trial. Nat Med. 2022 Dec;28(12):2530-2536. doi: 10.1038/s41591-022-02077-7. Epub 2022 Dec 1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dylan L Steen, MD, MS principal investigator
University of Cincinnati
Sarah C Couch, RD, PhD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-store POP education and Online POP education in people with Obesity and Hypertension, run by University of Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 34 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dietary Approaches to Stop Hypertension (DASH) score (time frame: Baseline with follow-up measures at 90 days and 180 days. Primary tests are between baseline and 90 day timepoint.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03895580, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2022.