Viewing Study NCT03518151


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Study NCT ID: NCT03518151
Status: COMPLETED
Last Update Posted: 2018-05-08
First Post: 2018-04-25
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Women's Responses to Adjusted Product Placement and Its Effects on Diet - 1 (WRAPPED1)
Sponsor: University Hospital Southampton NHS Foundation Trust
Organization:

Study Overview

Official Title: Women's Responses to Adjusted Product Placement and Its Effects on Diet - 1 (WRAPPED1)
Status: COMPLETED
Status Verified Date: 2018-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: WRAPPED1
Brief 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.
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 Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: