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Completed

NCT Number: NCT03518151

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

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Product placement intervention

Other

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

Other

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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. Women's weekly confectionery intake

    Time frame: 3 month follow-up post intervention commencement

    Frequency per week that women consume sweets and chocolates

  4. 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

  5. Weekly sales of confectionery

    Time frame: 12 week period following intervention commencement

    Total weekly sales of confectionery collected via electronic sales data

Sponsors and collaborators

Lead sponsor

University Hospital Southampton NHS Foundation Trust

Other

Collaborators

  • Medical Research Council
  • University of Southampton

Registry information

Acronym: WRAPPED1

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 8, 2018
Registry last updated
May 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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