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

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ClinicalTrials.gov Identifier: NCT03573973
Recruitment Status : Recruiting
First Posted : June 29, 2018
Last Update Posted : December 1, 2020
Sponsor:
Collaborators:
National Institute for Health Research, United Kingdom
Medical Research Council
University of Southampton
Information provided by (Responsible Party):
University Hospital Southampton NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Diet Modification Other: Improved product placement of fresh fruit and vegetables Other: Sham comparator Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1080 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Natural experiment with prospective matched controlled cluster design. The setting is a UK discount supermarket chain.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Nudging Healthier Dietary Habits: Evaluation of a Supermarket Placement Strategy in the WRAPPED Study
Actual Study Start Date : May 9, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : February 28, 2022

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.
Other: Improved product placement 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.
Other: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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. 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.

  4. 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

  5. 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)

  6. 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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women aged 18-45 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 45 years
  • Males or children
  • Irregular shopper or online-only shopper
  • Do not hold store loyalty card

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03573973


Contacts
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Contact: Christina Vogel, PhD +44 2380 764042 cv@mrc.soton.ac.uk
Contact: Janis Baird, PhD +44 2380 764057 jb@mrc.soton.ac.uk

Locations
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United Kingdom
Univeristy of Southampton Recruiting
Southampton, Hampshire, United Kingdom, SO16 6YD
Contact: Christina Vogel, PhD    023 8076 4042    cv@mrc.soton.ac.uk   
Contact: Janis Baird, PhD    023 8076 4057    jb@mrc.soton.ac.uk   
Sponsors and Collaborators
University Hospital Southampton NHS Foundation Trust
National Institute for Health Research, United Kingdom
Medical Research Council
University of Southampton
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital Southampton NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03573973    
Other Study ID Numbers: 20986
First Posted: June 29, 2018    Key Record Dates
Last Update Posted: December 1, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Southampton NHS Foundation Trust:
Dietary inequalities
Public Health
Choice architecture
Supermarkets