Diet ModificationWRAPPED1NCT03518151
Women's Responses to Adjusted Product Placement and Its Effects on Diet - 1 (WRAPPED1)
A study testing Product placement intervention in people with Diet Modification, run by University Hospital Southampton NHS Foundation Trust.
Trial summary
This research project aims to help address a gap in understanding about the micro-environmental determinants of diet by exploring whether improving the placement of fresh and frozen fruit and vegetables and removing temptations of confectionary at checkouts in discount supermarkets influences the dietary behaviours of… 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?
- Product placement intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 6 Jul 2016to 30 Nov 2017
- 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 18-45 years
- Hold an store loyalty card
- Shop regularly in the 12-weeks before recruitment according to loyalty card data
- Shoppers who choose items in-store but opt for home delivery will be eligible
Who cannot join
- Women under the age of 18 or over 45 years
- Shopped less than once in 12-weeks prior to recruitment
- Online-only shopper
- No store loyalty card
About this study
This research project aims to help address a gap in understanding about the micro-environmental determinants of diet by exploring whether improving the placement of fresh and frozen fruit and vegetables and removing temptations of confectionary at checkouts in discount supermarkets influences the dietary behaviours of women aged 18-45 years and whether it is cost effective.
Read the detailed description
This study is a natural experiment with a prospective cluster controlled design. The intervention includes creating a new fresh fruit and vegetable section at the store entrance, placing frozen fruit and vegetable in the first aisle and removing confectionery from checkouts; it will be implemented continuously for 6 months in discount supermarkets.
The control condition is provision of a limited range of fresh fruit and vegetables, all placed at the back of the store, frozen vegetables in a middle aisle and confectionery sold at checkouts. Control and intervention stores will be located across England to improve generalizability of the sample. Each control store will be matched to an intervention store on i) sales profile, ii) customer profile and iii) neighbourhood deprivation (IMD deciles). Control stores will be located at least 50 miles from an intervention store to avoid contamination.
Women customers aged 18-45 years with a store loyalty card, who regularly shop at one of 3 intervention or 3 matched-control stores in England will be invited to participate. Women will be recruited via email, letter, SMS, shopping receipt note, Facebook advertisement, and in-store approach. Participants will contact the research team via text, email or Freephone and will be consented by phone after eligibility is assessed. Participants will be asked to complete four telephone surveys (baseline and 1, 3 and 6 months post intervention commencement) and will be offered 3x £10 Love2Shop vouchers that will be sent after completion of the baseline, 3 and 6 month surveys. A secure system to transfer store and participant loyalty card sales data has been established and confidentiality upheld through the use of study identification numbers.
Economic evaluation will be conducted from individual and retailer perspectives. Participant surveys will collect data about food expenditure, and travel costs to and from supermarkets that will be supplemented by loyalty card data. Refurbishment and ongoing costs, plus impact on sales will be estimated.
A process evaluation will be conducted to monitor intervention implementation (in-store surveys), mechanisms of impact (interviews with a sub-sample of supermarket staff and participants) and context (analysis of grocery shopping habits - location and frequency of different stores).
- Conditions
- Diet Modification
- Being tested
- Product placement intervention, Sham comparator
- Keywords
- public health, dietary inequalities, environment design
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Product placement interventionOther
The intervention includes 3 components: i) creation of a new fresh fruit and vegetable section and island in the first aisle; ii) placing frozen fruit and vegetables in the first aisle and iii) removal of all cakes, confectionary and sugar sweetened beverages from checkouts (replaced with non-food items, fruit and bottled water).
Sham comparatorOther
The control condition is provision of a limited range of fresh fruit and vegetables, all placed at the back of the store, frozen vegetables in a middle aisle and confectionery sold at checkouts.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention includes 3 components: i) creation of a new fresh fruit and vegetable section at store entrance; ii) placing frozen fruit and vegetables in the first aisle and iii) removal of all cakes, confectionary and sugar sweetened beverages from checkouts (replaced with non-food items, fruit and bottled water). Receives: Other: Product placement intervention |
| Control | Sham comparator | The control condition is provision of a limited range of fresh fruit and vegetables, all placed at the back of the store, frozen vegetables in a middle aisle and confectionery sold at checkouts. Receives: Other: Sham comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary quality score
The primary outcome is women's dietary quality measured using a 20-item food frequency questionnaire (FFQ) to create a standardised dietary quality score (validated against 100-item FFQ and red cell folate).
Measured: 3 month follow-up post intervention commencement
Secondary outcomes (5)
Child's dietary quality score
Child's dietary quality will be collected using a validated FFQ for use with parents of children aged 2-6 years.
Measured: 3 month follow-up post intervention commencement
Women's daily fruit and vegetable portions
Women's daily fruit and vegetable portions will be collected using a 2-item tool that 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 month follow-up post intervention commencement
Women's weekly confectionery intake
Frequency per week that women consume sweets and chocolates
Measured: 3 month follow-up post intervention commencement
Weekly sales of fresh fruit and vegetables
Total weekly sales of fresh fruit and vegetables collected via electronic sales data
Measured: 12 week period following intervention commencement
Weekly sales of confectionery
Total weekly sales of confectionery collected via electronic sales data
Measured: 12 week period following intervention commencement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start6 Jul 2016
- Primary completion30 Apr 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- WRAPPED1 is a natural experiment with a prospective matched controlled cluster design
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southampton, Medical Research Council
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03518151
- Sponsor's protocol ID
- 23361
- Acronym
- WRAPPED1
- Status last verified
- Apr 2018
- First submitted
- 25 Apr 2018
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Stuber JM, Beulens JW, Ayala GX, Crozier SR, Dijkstra SC, Lin SF, Vogel C, Mackenbach JD. Can nudge interventions targeting healthy food purchases in real-world grocery stores reduce diet-related health disparities? A pooled analysis of four controlled trials. Int J Behav Nutr Phys Act. 2024 Dec 3;21(1):137. doi: 10.1186/s12966-024-01687-3.
PubMed 39627771Vogel C, Crozier S, Penn-Newman D, Ball K, Moon G, Lord J, Cooper C, Baird J. Altering product placement to create a healthier layout in supermarkets: Outcomes on store sales, customer purchasing, and diet in a prospective matched controlled cluster study. PLoS Med. 2021 Sep 7;18(9):e1003729. doi: 10.1371/journal.pmed.1003729. eCollection 2021 Sep.
PubMed 34491999
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women's Responses to Adjusted Product Placement and Its Effects on Diet - 1 (WRAPPED1)
- ClinicalTrials.gov ID
- NCT03518151
- Acronym / sponsor ID
- WRAPPED1 / 23361
- Conditions
- Diet Modification
- Keywords
- public health, dietary inequalities, environment design
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Southampton, Medical Research Council
- Study start
- 6 Jul 2016 (actual)
- Primary completion
- 30 Apr 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 8 May 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 research project aims to help address a gap in understanding about the micro-environmental determinants of diet by exploring whether improving the placement of fresh and frozen fruit and vegetables and removing temptations of confectionary at checkouts in discount supermarkets influences the dietary behaviours of women aged 18-45 years and whether it is cost effective.
Detailed description
This study is a natural experiment with a prospective cluster controlled design. The intervention includes creating a new fresh fruit and vegetable section at the store entrance, placing frozen fruit and vegetable in the first aisle and removing confectionery from checkouts; it will be implemented continuously for 6 months in discount supermarkets.
The control condition is provision of a limited range of fresh fruit and vegetables, all placed at the back of the store, frozen vegetables in a middle aisle and confectionery sold at checkouts. Control and intervention stores will be located across England to improve generalizability of the sample. Each control store will be matched to an intervention store on i) sales profile, ii) customer profile and iii) neighbourhood deprivation (IMD deciles). Control stores will be located at least 50 miles from an intervention store to avoid contamination.
Women customers aged 18-45 years with a store loyalty card, who regularly shop at one of 3 intervention or 3 matched-control stores in England will be invited to participate. Women will be recruited via email, letter, SMS, shopping receipt note, Facebook advertisement, and in-store approach. Participants will contact the research team via text, email or Freephone and will be consented by phone after eligibility is assessed. Participants will be asked to complete four telephone surveys (baseline and 1, 3 and 6 months post intervention commencement) and will be offered 3x £10 Love2Shop vouchers that will be sent after completion of the baseline, 3 and 6 month surveys. A secure system to transfer store and participant loyalty card sales data has been established and confidentiality upheld through the use of study identification numbers.
Economic evaluation will be conducted from individual and retailer perspectives. Participant surveys will collect data about food expenditure, and travel costs to and from supermarkets that will be supplemented by loyalty card data. Refurbishment and ongoing costs, plus impact on sales will be estimated.
A process evaluation will be conducted to monitor intervention implementation (in-store surveys), mechanisms of impact (interviews with a sub-sample of supermarket staff and participants) and context (analysis of grocery shopping habits - location and frequency of different stores).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- WRAPPED1 is a natural experiment with a prospective matched controlled cluster design
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Product placement interventionThe intervention includes 3 components: i) creation of a new fresh fruit and vegetable section at store entrance; ii) placing frozen fruit and vegetables in the first aisle and iii) removal of all cakes, confectionary and sugar sweetened beverages from checkouts (replaced with non-food items, fruit and bottled water). |
| Control | Sham comparator | Other: Sham comparatorThe control condition is provision of a limited range of fresh fruit and vegetables, all placed at the back of the store, frozen vegetables in a middle aisle and confectionery sold at checkouts. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women aged 18-45 years
- Hold an store loyalty card
- Shop regularly in the 12-weeks before recruitment according to loyalty card data
- Shoppers who choose items in-store but opt for home delivery will be eligible
Key exclusion criteria (4 listed)
- Women under the age of 18 or over 45 years
- Shopped less than once in 12-weeks prior to recruitment
- Online-only shopper
- No 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 |
|---|---|---|
| Product placement interventionThe intervention includes 3 components: i) creation of a new fresh fruit and vegetable section and island in the first aisle; ii) placing frozen fruit and vegetables in the first aisle and iii) removal of all cakes, confectionary and sugar sweetened beverages from checkouts (replaced with non-food items, fruit and bottled water). | Other | Intervention |
| Sham comparatorThe control condition is provision of a limited range of fresh fruit and vegetables, all placed at the back of the store, frozen vegetables in a middle aisle and confectionery sold at checkouts. | Other | Control |
Primary outcome
Dietary quality score
Time frame: 3 month follow-up post intervention commencement
The primary outcome is women's dietary quality measured using a 20-item food frequency questionnaire (FFQ) to create a standardised dietary quality score (validated against 100-item FFQ and red cell folate).
5 secondary outcomes
Child's dietary quality score
Time frame: 3 month follow-up post intervention commencement
Women's daily fruit and vegetable portions
Time frame: 3 month follow-up post intervention commencement
Women's weekly confectionery intake
Time frame: 3 month follow-up post intervention commencement
Weekly sales of fresh fruit and vegetables
Time frame: 12 week period following intervention commencement
Weekly sales of confectionery
Time frame: 12 week period following intervention commencement
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 8 May 2018.
- Derived from this study: PubMed 39627771Stuber JM, Beulens JW, Ayala GX, Crozier SR, Dijkstra SC, Lin SF, Vogel C, Mackenbach JD. Can nudge interventions targeting healthy food purchases in real-world grocery stores reduce diet-related health disparities? A pooled analysis of four controlled trials. Int J Behav Nutr Phys Act. 2024 Dec 3;21(1):137. doi: 10.1186/s12966-024-01687-3.
- Derived from this study: PubMed 34491999Vogel C, Crozier S, Penn-Newman D, Ball K, Moon G, Lord J, Cooper C, Baird J. Altering product placement to create a healthier layout in supermarkets: Outcomes on store sales, customer purchasing, and diet in a prospective matched controlled cluster study. PLoS Med. 2021 Sep 7;18(9):e1003729. doi: 10.1371/journal.pmed.1003729. eCollection 2021 Sep.
Related trials for Diet Modification
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Not yet recruiting
Testing a Smartphone App to Support a Mediterranean Diet and Strength Exercise
Treatment Adherence and Compliance, Resistance Exercise
Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
Recruiting
Dietary Intervention Study on Liver Health in Young Adults
Liver Health
Active, not recruiting
Effects of an Anti-Inflammatory Diet on Inflammatory and Neuroendocrine Responses After Lumbar Discectomy
Lumbar Discectomy
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.
Questions about this trial
What is this clinical trial studying?
A study testing Product placement intervention in people with Diet Modification, run by University Hospital Southampton NHS Foundation Trust.
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: finished, as of the sponsor's last update on 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Dietary quality score (time frame: 3 month follow-up post intervention commencement). 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 NCT03518151, which also lists 2 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 8 May 2018.