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

Diet Modification Clinical Trial

— WRAPPED1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03518151
• Other study ID #: 23361
• Status: Completed
• Phase: N/A
• Start date: July 6, 2016
• Est. completion date: November 30, 2017

Study information

• Verified date: April 2018
• Source: University Hospital Southampton NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 30, 2017
• Est. primary completion date: April 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diet Modification

Intervention

Other:
• Product placement intervention
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
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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Southampton NHS Foundation Trust	Medical Research Council, University of Southampton

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dietary quality score	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	Child's dietary quality score	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
Secondary	Women's daily fruit and vegetable portions	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
Secondary	Women's weekly confectionery intake	Frequency per week that women consume sweets and chocolates	3 month follow-up post intervention commencement
Secondary	Weekly sales of fresh fruit and vegetables	Total weekly sales of fresh fruit and vegetables collected via electronic sales data	12 week period following intervention commencement
Secondary	Weekly sales of confectionery	Total weekly sales of confectionery collected via electronic sales data	12 week period following intervention commencement