Clinical trial NCT03573973: Women's Responses to Adjusted Product Placement and Its Effects on Diet - 2
Official title: Nudging Healthier Dietary Habits: Evaluation of a Supermarket Placement Strategy in the WRAPPED Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diet Modification
Keywords: Dietary inequalities
Public Health
Choice architecture
Supermarkets
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
name: Medical Research Council
name: University of Southampton
name: City, University of London
First posted: 2018-06-29
Enrollment: 667
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Natural experiment with prospective matched controlled cluster design. The setting is a UK discount supermarket chain.
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Participant's weekly fruit and vegetable purchasing patterns
timeFrame: 0-6 month period post-refurbishment
Secondary outcomes:
measure: Women's dietary quality
timeFrame: 3 and 6 month follow-up post intervention commencement
measure: Children's dietary quality
timeFrame: 3 and 6 month follow-up post intervention commencement
measure: Women's daily fruit and vegetable intake
timeFrame: 3 and 6 months follow-up post intervention commencement
measure: Weekly store sales of fresh fruit and vegetables
timeFrame: 0-3 and 0-6 month periods post-refurbishment
measure: To determine whether change in participants' in fruit and vegetable purchasing patterns (intervention effects) differ according to their level of educational attainment
timeFrame: 0-6 month period post-refurbishment
measure: Economic evaluation to assess the costs and benefits of the intervention from individual, retailer and societal perspectives
timeFrame: 6 month period post-refurbishment
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: Univeristy of Southampton
state: Hampshire
Study officials:
References:
citation: 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.
citation: Muir 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.
citation: Muir 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.