Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-25 @ 9:51 PM
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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'WRAPPED1 is a natural experiment with a prospective matched controlled cluster design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-25', 'studyFirstSubmitDate': '2018-04-25', 'studyFirstSubmitQcDate': '2018-04-25', 'lastUpdatePostDateStruct': {'date': '2018-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dietary quality score', 'timeFrame': '3 month follow-up post intervention commencement', 'description': "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)."}], 'secondaryOutcomes': [{'measure': "Child's dietary quality score", 'timeFrame': '3 month follow-up post intervention commencement', 'description': "Child's dietary quality will be collected using a validated FFQ for use with parents of children aged 2-6 years."}, {'measure': "Women's daily fruit and vegetable portions", 'timeFrame': '3 month follow-up post intervention commencement', 'description': "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."}, {'measure': "Women's weekly confectionery intake", 'timeFrame': '3 month follow-up post intervention commencement', 'description': 'Frequency per week that women consume sweets and chocolates'}, {'measure': 'Weekly sales of fresh fruit and vegetables', 'timeFrame': '12 week period following intervention commencement', 'description': 'Total weekly sales of fresh fruit and vegetables collected via electronic sales data'}, {'measure': 'Weekly sales of confectionery', 'timeFrame': '12 week period following intervention commencement', 'description': 'Total weekly sales of confectionery collected via electronic sales data'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['public health', 'dietary inequalities', 'environment design'], 'conditions': ['Diet Modification']}, 'referencesModule': {'references': [{'pmid': '39627771', 'type': 'DERIVED', 'citation': 'Stuber JM, Beulens JW, Ayala GX, Crozier SR, Dijkstra SC, Lin SF, Vogel C, Mackenbach JD. Can nudge interventions targeting healthy food purchases in real-world grocery stores reduce diet-related health disparities? A pooled analysis of four controlled trials. Int J Behav Nutr Phys Act. 2024 Dec 3;21(1):137. doi: 10.1186/s12966-024-01687-3.'}, {'pmid': '34491999', 'type': 'DERIVED', 'citation': 'Vogel C, Crozier S, Penn-Newman D, Ball K, Moon G, Lord J, Cooper C, Baird J. Altering product placement to create a healthier layout in supermarkets: Outcomes on store sales, customer purchasing, and diet in a prospective matched controlled cluster study. PLoS Med. 2021 Sep 7;18(9):e1003729. doi: 10.1371/journal.pmed.1003729. eCollection 2021 Sep.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nWomen 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.\n\nEconomic 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.\n\nA 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).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 18-45 years\n* Hold an store loyalty card\n* Shop regularly in the 12-weeks before recruitment according to loyalty card data\n* Shoppers who choose items in-store but opt for home delivery will be eligible\n\nExclusion Criteria:\n\n* Women under the age of 18 or over 45 years\n* Shopped less than once in 12-weeks prior to recruitment\n* Online-only shopper\n* No store loyalty card'}, 'identificationModule': {'nctId': 'NCT03518151', 'acronym': 'WRAPPED1', 'briefTitle': "Women's Responses to Adjusted Product Placement and Its Effects on Diet - 1 (WRAPPED1)", 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Southampton NHS Foundation Trust'}, 'officialTitle': "Women's Responses to Adjusted Product Placement and Its Effects on Diet - 1 (WRAPPED1)", 'orgStudyIdInfo': {'id': '23361'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': '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).', 'interventionNames': ['Other: Product placement intervention']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': '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.', 'interventionNames': ['Other: Sham comparator']}], 'interventions': [{'name': 'Product placement intervention', 'type': 'OTHER', 'description': '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).', 'armGroupLabels': ['Intervention']}, {'name': 'Sham comparator', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Control']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Southampton NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Southampton', 'class': 'OTHER'}, {'name': 'Medical Research Council', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}