Women's Responses to Adjusted Product Placement and Its Effects on Diet - 1 (WRAPPED1) (WRAPPED1)

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

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

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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: Intervention
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).
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 Comparator: Control
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
3 month follow-up post intervention commencement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child's dietary quality score
Time Frame: 3 month follow-up post intervention commencement
Child's dietary quality will be collected using a validated FFQ for use with parents of children aged 2-6 years.
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 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.
3 month follow-up post intervention commencement
Women's weekly confectionery intake
Time Frame: 3 month follow-up post intervention commencement
Frequency per week that women consume sweets and chocolates
3 month follow-up post intervention commencement
Weekly sales of fresh fruit and vegetables
Time Frame: 12 week period following intervention commencement
Total weekly sales of fresh fruit and vegetables collected via electronic sales data
12 week period following intervention commencement
Weekly sales of confectionery
Time Frame: 12 week period following intervention commencement
Total weekly sales of confectionery collected via electronic sales data
12 week period following intervention commencement

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)

July 6, 2016

Primary Completion (Actual)

April 30, 2017

Study Completion (Actual)

November 30, 2017

Study Registration Dates

First Submitted

April 25, 2018

First Submitted That Met QC Criteria

April 25, 2018

First Posted (Actual)

May 8, 2018

Study Record Updates

Last Update Posted (Actual)

May 8, 2018

Last Update Submitted That Met QC Criteria

April 25, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 23361

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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