Diet ModificationWRAPPED2NCT03573973
Women's Responses to Adjusted Product Placement and Its Effects on Diet - 2
A study testing Improved product placement of fresh fruit and vegetables in people with Diet Modification, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study is the largest supermarket trial internationally and will assess the effectiveness and cost-effectiveness of improving the placement of fresh fruit and vegetables in discount supermarkets in improving the fresh fruit and vegetable purchasing of women aged 18-45 years. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diet Modification
- What is being tested?
- Improved product placement of fresh fruit and vegetables
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 667 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 May 2018to 31 Oct 2023
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 18-60 years
- Hold a store loyalty card
- Shop regularly in a study store
- Shoppers who choose items in-store but opt for home delivery
Who cannot join
- Women under the age of 18 or over 60 years
- Males or children
- Irregular shopper or online-only shopper
- Do not hold store loyalty card
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Univeristy of Southampton
Southampton, Hampshire, SO16 6YD
About this study
Official title: Nudging Healthier Dietary Habits: Evaluation of a Supermarket Placement Strategy in the WRAPPED Study
This study is the largest supermarket trial internationally and will assess the effectiveness and cost-effectiveness of improving the placement of fresh fruit and vegetables in discount supermarkets in improving the fresh fruit and vegetable purchasing of women aged 18-45 years.
Read the detailed description
WRAPPED2 (Women's Responses to Adjusted Product Placement and its Effects on Diet - 2) is a natural experiment with a prospective matched controlled cluster design. The setting is a discount supermarket chain in the United Kingdom regularly used by disadvantaged families for their main shop. The intervention is a store refurbishment programme that involves creation of a new fresh fruit and vegetable section in the store entrance. Control stores keep the existing layout with a limited range of fresh fruit and vegetables and placement of fresh fruit and vegetables at the back of the store.
A total of 45 participants will be recruited from each of 18 intervention and 18 matched control stores through the retailer's loyalty card scheme (postal letter) and shop floor recruitment; these methods proved effective during the pilot. Participants will be women aged 18-45 years who shopped at a study store in the 12 weeks before recruitment. This study is unique in its collection of individual level sales data, as well as demographic and dietary information, and is the first to collect outcome data for more than one family member. Participant's weekly sales data will be obtained through the retailer's loyalty card scheme and will cover 3 months before refurbishment, plus 0-3 months and 3-6 months after. Change in women's fresh fruit and vegetable purchasing from baseline to 3 months is the primary outcome. Secondary outcome data about women's diets, their young child's diet (2-6 years), food shopping habits, perceptions of supermarket environment, and psychosocial and demographic characteristics will be collected by telephone survey before refurbishment, and 1, 3 and 6 months after. Weekly sales data for study stores will be provided by the retailer.
Cost-effectiveness will be assessed from individual, retailer and societal perspectives. Process evaluation will assess implementation, mechanisms of impact and context.
This study is politically and scientifically important being one of the first field studies of this kind. The findings could provide strong evidence for future public health policy interventions to help address inequalities in diet and non-communicable disease risk by supporting development of a healthy store layout that could be adopted more widely in food retail outlets.
- Conditions
- Diet Modification
- Being tested
- Improved product placement of fresh fruit and vegetables, Sham comparator
- Keywords
- Dietary inequalities, Public Health, Choice architecture, Supermarkets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Improved product placement of fresh fruit and vegetablesOther
The intervention includes the creation of a new fresh fruit and vegetable section at the store entrance with expanded range thus improving the placement (availability and position) of fresh fruit and vegetables.
Sham comparatorOther
The control condition is the existing store layout with a limited range of fresh fruit and vegetables that are placed at the back of the store.
| Study group | Role | What they receive |
|---|---|---|
| Fresh fruit and vegetable placement intervention | Experimental | The intervention is a store refurbishment programme that includes the creation of a new fresh fruit and vegetable section at the store entrance with expanded range thus improving the availability and position of fresh fruit and vegetables. Receives: Other: Improved product placement of fresh fruit and vegetables |
| Control | Sham comparator | The control condition is the existing store layout with a limited range of fresh fruit and vegetables that are placed at the back of the store. Receives: Other: Sham comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant's weekly fruit and vegetable purchasing patterns
These data will be obtained through the retailer's loyalty card scheme and provide information about the number of items of each product purchased at each store visit.
Measured: 0-6 month period post-refurbishment
Secondary outcomes (6)
Women's dietary quality
20-item food frequency questionnaire (FFQ) will be used to create standardised diet quality scores for each woman. A dietary quality score for each woman will be calculated by multiplying their reported frequency of consumption of each of the 20 items from their FFQ by corresponding weightings derived from the appropriate principal components analysis and then summing the results.
Measured: 3 and 6 month follow-up post intervention commencement
Children's dietary quality
20-item food frequency questionnaire (FFQ) will be used to create standardised diet quality scores for each child. Dietary quality scores will be calculated by multiplying the reported frequency of consumption of each of the 20 items from their FFQ by corresponding weightings derived from the appropriate principal components analysis and then summing the results.
Measured: 3 and 6 month follow-up post intervention commencement
Women's daily fruit and vegetable intake
2-item tool has been validated against urinary potassium and plasma ascorbic acid to describe high (≥5 portions/day) and low (≤2.5 portions/day) intake.
Measured: 3 and 6 months follow-up post intervention commencement
Weekly store sales of fresh fruit and vegetables
Store sales data will be provided from electronic transaction records aggregated to the weekly level
Measured: 0-3 and 0-6 month periods post-refurbishment
To determine whether change in participants' in fruit and vegetable purchasing patterns (intervention effects) differ according to their level of educational attainment
To assess interaction on intervention effects according to participants' highest educational qualification attained in 3 groups (low=GCSE/school departure before 16 years of age, medium=A-levels/HND/diploma, high=degree)
Measured: 0-6 month period post-refurbishment
Economic evaluation to assess the costs and benefits of the intervention from individual, retailer and societal perspectives
Use participant survey and purchasing data for food expenditure, time spent food shopping, as well as travel costs to and from supermarkets; retailer costs will be estimates generated through discussion with supermarket staff; societal costs will be estimated for resources associated with the capital investment, changes in food expenditure, time and travel costs for individuals and health and social care costs for diet-related health conditions.
Measured: 6 month period post-refurbishment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start9 May 2018
- Primary completion30 Apr 2023
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diet ModificationStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Natural experiment with prospective matched controlled cluster design. The setting is a UK discount supermarket chain.
- Masking
- None (open label)
- Enrolment
- 667 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Medical Research Council, University of Southampton, City, University of London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03573973
- Sponsor's protocol ID
- 20986
- Acronym
- WRAPPED2
- Status last verified
- May 2022
- First submitted
- 25 Apr 2018
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vogel C, Crozier S, Dhuria P, Shand C, Lawrence W, Cade J, Moon G, Lord J, Ball K, Cooper C, Baird J. Protocol of a natural experiment to evaluate a supermarket intervention to improve food purchasing and dietary behaviours of women (WRAPPED study) in England: a prospective matched controlled cluster design. BMJ Open. 2020 Feb 10;10(2):e036758. doi: 10.1136/bmjopen-2020-036758.
PubMed 32047023Muir S, Dhuria P, Roe E, Lawrence W, Baird J, Vogel C. UK government's new placement legislation is a 'good first step': a rapid qualitative analysis of consumer, business, enforcement and health stakeholder perspectives. BMC Med. 2023 Jan 26;21(1):33. doi: 10.1186/s12916-023-02726-9.
PubMed 36703194Muir S, Dhuria P, Vogel C. Government must proceed with landmark anti-obesity regulations in England. BMJ. 2022 Sep 30;378:o2358. doi: 10.1136/bmj.o2358. No abstract available.
PubMed 36180089Vogel C, Crozier S, Dhuria P, Lord J, Moon G, Lawrence W, Cade J, Ball K, Cooper C, Baird J. Impact of supermarket fruit and vegetable placement on store sales, customer purchasing, diet and household waste: A prospective matched-controlled cluster trial. PLoS Med. 2026 Mar 31;23(3):e1004575. doi: 10.1371/journal.pmed.1004575. eCollection 2026 Mar.
PubMed 41915648Baird J, Dhuria P, Payne H, Crozier S, Lawrence W, Vogel C. Implementation of a UK supermarket intervention to increase purchasing of fresh fruit and vegetables: process evaluation of the WRAPPED natural experiment. Int J Behav Nutr Phys Act. 2024 Nov 11;21(1):128. doi: 10.1186/s12966-024-01679-3.
PubMed 39529139
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nudging Healthier Dietary Habits: Evaluation of a Supermarket Placement Strategy in the WRAPPED Study
- ClinicalTrials.gov ID
- NCT03573973
- Acronym / sponsor ID
- WRAPPED2 / 20986
- Conditions
- Diet Modification
- Keywords
- Dietary inequalities, Public Health, Choice architecture, Supermarkets
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 667 participants (actual)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Medical Research Council, University of Southampton, City, University of London
- Study start
- 9 May 2018 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 29 Jun 2018 (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.
This study is the largest supermarket trial internationally and will assess the effectiveness and cost-effectiveness of improving the placement of fresh fruit and vegetables in discount supermarkets in improving the fresh fruit and vegetable purchasing of women aged 18-45 years.
Detailed description
WRAPPED2 (Women's Responses to Adjusted Product Placement and its Effects on Diet - 2) is a natural experiment with a prospective matched controlled cluster design. The setting is a discount supermarket chain in the United Kingdom regularly used by disadvantaged families for their main shop. The intervention is a store refurbishment programme that involves creation of a new fresh fruit and vegetable section in the store entrance. Control stores keep the existing layout with a limited range of fresh fruit and vegetables and placement of fresh fruit and vegetables at the back of the store.
A total of 45 participants will be recruited from each of 18 intervention and 18 matched control stores through the retailer's loyalty card scheme (postal letter) and shop floor recruitment; these methods proved effective during the pilot. Participants will be women aged 18-45 years who shopped at a study store in the 12 weeks before recruitment. This study is unique in its collection of individual level sales data, as well as demographic and dietary information, and is the first to collect outcome data for more than one family member. Participant's weekly sales data will be obtained through the retailer's loyalty card scheme and will cover 3 months before refurbishment, plus 0-3 months and 3-6 months after. Change in women's fresh fruit and vegetable purchasing from baseline to 3 months is the primary outcome. Secondary outcome data about women's diets, their young child's diet (2-6 years), food shopping habits, perceptions of supermarket environment, and psychosocial and demographic characteristics will be collected by telephone survey before refurbishment, and 1, 3 and 6 months after. Weekly sales data for study stores will be provided by the retailer.
Cost-effectiveness will be assessed from individual, retailer and societal perspectives. Process evaluation will assess implementation, mechanisms of impact and context.
This study is politically and scientifically important being one of the first field studies of this kind. The findings could provide strong evidence for future public health policy interventions to help address inequalities in diet and non-communicable disease risk by supporting development of a healthy store layout that could be adopted more widely in food retail outlets.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Natural experiment with prospective matched controlled cluster design. The setting is a UK discount supermarket chain.
| Arm | Type | Receives |
|---|---|---|
| Fresh fruit and vegetable placement intervention | Experimental | Other: Improved product placement of fresh fruit and vegetablesThe intervention is a store refurbishment programme that includes the creation of a new fresh fruit and vegetable section at the store entrance with expanded range thus improving the availability and position of fresh fruit and vegetables. |
| Control | Sham comparator | Other: Sham comparatorThe control condition is the existing store layout with a limited range of fresh fruit and vegetables that are placed at the back of the store. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women aged 18-60 years
- Hold a store loyalty card
- Shop regularly in a study store
- Shoppers who choose items in-store but opt for home delivery
Key exclusion criteria (4 listed)
- Women under the age of 18 or over 60 years
- Males or children
- Irregular shopper or online-only shopper
- Do not hold store loyalty card
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 |
|---|---|---|
| Improved product placement of fresh fruit and vegetablesThe intervention includes the creation of a new fresh fruit and vegetable section at the store entrance with expanded range thus improving the placement (availability and position) of fresh fruit and vegetables. | Other | Fresh fruit and vegetable placement intervention |
| Sham comparatorThe control condition is the existing store layout with a limited range of fresh fruit and vegetables that are placed at the back of the store. | Other | Control |
Primary outcome
Participant's weekly fruit and vegetable purchasing patterns
Time frame: 0-6 month period post-refurbishment
These data will be obtained through the retailer's loyalty card scheme and provide information about the number of items of each product purchased at each store visit.
6 secondary outcomes
Women's dietary quality
Time frame: 3 and 6 month follow-up post intervention commencement
Children's dietary quality
Time frame: 3 and 6 month follow-up post intervention commencement
Women's daily fruit and vegetable intake
Time frame: 3 and 6 months follow-up post intervention commencement
Weekly store sales of fresh fruit and vegetables
Time frame: 0-3 and 0-6 month periods post-refurbishment
To determine whether change in participants' in fruit and vegetable purchasing patterns (intervention effects) differ according to their level of educational attainment
Time frame: 0-6 month period post-refurbishment
Economic evaluation to assess the costs and benefits of the intervention from individual, retailer and societal perspectives
Time frame: 6 month period post-refurbishment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- Background: PubMed 32047023Vogel C, Crozier S, Dhuria P, Shand C, Lawrence W, Cade J, Moon G, Lord J, Ball K, Cooper C, Baird J. Protocol of a natural experiment to evaluate a supermarket intervention to improve food purchasing and dietary behaviours of women (WRAPPED study) in England: a prospective matched controlled cluster design. BMJ Open. 2020 Feb 10;10(2):e036758. doi: 10.1136/bmjopen-2020-036758.
- Background: PubMed 36703194Muir S, Dhuria P, Roe E, Lawrence W, Baird J, Vogel C. UK government's new placement legislation is a 'good first step': a rapid qualitative analysis of consumer, business, enforcement and health stakeholder perspectives. BMC Med. 2023 Jan 26;21(1):33. doi: 10.1186/s12916-023-02726-9.
- Background: PubMed 36180089Muir S, Dhuria P, Vogel C. Government must proceed with landmark anti-obesity regulations in England. BMJ. 2022 Sep 30;378:o2358. doi: 10.1136/bmj.o2358. No abstract available.
- Derived from this study: PubMed 41915648Vogel C, Crozier S, Dhuria P, Lord J, Moon G, Lawrence W, Cade J, Ball K, Cooper C, Baird J. Impact of supermarket fruit and vegetable placement on store sales, customer purchasing, diet and household waste: A prospective matched-controlled cluster trial. PLoS Med. 2026 Mar 31;23(3):e1004575. doi: 10.1371/journal.pmed.1004575. eCollection 2026 Mar.
- Derived from this study: PubMed 39529139Baird J, Dhuria P, Payne H, Crozier S, Lawrence W, Vogel C. Implementation of a UK supermarket intervention to increase purchasing of fresh fruit and vegetables: process evaluation of the WRAPPED natural experiment. Int J Behav Nutr Phys Act. 2024 Nov 11;21(1):128. doi: 10.1186/s12966-024-01679-3.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Improved product placement of fresh fruit and vegetables in people with Diet Modification, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 15 May 2023. 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 Kingdom. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Participant's weekly fruit and vegetable purchasing patterns (time frame: 0-6 month period post-refurbishment). 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 NCT03573973, which also lists 5 linked publications.
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 15 May 2023.