Women's Responses to Adjusted Product Placement and Its Effects on Diet - 2 (WRAPPED2)

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

667

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • Univeristy of Southampton

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fresh fruit and vegetable placement intervention
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.
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 Comparator: Control
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0-6 month period post-refurbishment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Women's dietary quality
Time Frame: 3 and 6 month follow-up post intervention commencement
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.
3 and 6 month follow-up post intervention commencement
Children's dietary quality
Time Frame: 3 and 6 month follow-up post intervention commencement
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.
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
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.
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
Store sales data will be provided from electronic transaction records aggregated to the weekly level
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
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)
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
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.
6 month period post-refurbishment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2018

Primary Completion (Actual)

April 30, 2023

Study Completion (Anticipated)

October 31, 2023

Study Registration Dates

First Submitted

April 25, 2018

First Submitted That Met QC Criteria

June 27, 2018

First Posted (Actual)

June 29, 2018

Study Record Updates

Last Update Posted (Actual)

May 15, 2023

Last Update Submitted That Met QC Criteria

May 11, 2023

Last Verified

May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 20986

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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