- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03518151
Women's Responses to Adjusted Product Placement and Its Effects on Diet - 1 (WRAPPED1) (WRAPPED1)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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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