Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-02-26 @ 3:37 PM
Study NCT ID:
NCT03252158
Status:
COMPLETED
Last Update Posted:
2018-05-03
First Post:
2017-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Altering the Availability of Healthier vs. Less Healthy Items in Vending Machines
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'An adapted multiple treatment reversal design will be used, in which the number of slots containing (i) less healthy items and (ii) healthier items are altered over eight 4-week periods.\n\nVending machines will be randomly allocated to one of two groups: (1) decreasing less healthy foods first or (2) decreasing healthier foods first.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-03-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-02', 'studyFirstSubmitDate': '2017-08-09', 'studyFirstSubmitQcDate': '2017-08-14', 'lastUpdatePostDateStruct': {'date': '2018-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Energy purchased', 'timeFrame': 'Restocking interval (between 2-4 days; restocking occurs on set weekdays for each machine, to match usual restocking)', 'description': 'Energy purchased (kcal) per restocking interval from intervention (standard-fare) vending machines'}], 'secondaryOutcomes': [{'measure': 'Number of items sold', 'timeFrame': 'Restocking interval (between 2-4 days; restocking occurs on set weekdays for each machine, to match usual restocking)', 'description': 'Number of items sold per restocking interval from intervention (standard-fare) vending machines'}, {'measure': 'Energy purchased (healthier alternative machines)', 'timeFrame': 'Restocking interval (between 2-4 days; restocking occurs on set weekdays for each machine, to match usual restocking)', 'description': 'Energy purchased (kcal) per restocking interval from non-intervention (healthier-fare) vending machines'}, {'measure': 'Number of items sold (healthier alternative machines)', 'timeFrame': 'Restocking interval (between 2-4 days; restocking occurs on set weekdays for each machine, to match usual restocking)', 'description': 'Number of items sold per restocking interval from non-intervention (healthier-fare) vending machines'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Diet']}, 'descriptionModule': {'briefSummary': 'Background: While there is some evidence that increasing the range of healthier foods and drinks and/or decreasing the range of less healthy options may increase healthier choices, more work is needed to establish the reproducibility of any effect. The current study aims to investigate the impact of altering the availability of healthier and less healthy foods and cold beverages in hospital vending machines.\n\nMethods: An adapted multiple treatment reversal design will be used, in which all standard vending machines serving snack foods and/or cold beverages in one hospital in England change the number of slots containing (i) less healthy items and (ii) healthier items over eight 4-week periods. Changes will take place in a two-step process whereby decreases are implemented in a separate study period prior to increases in the contrasting food group. Following a 4-week baseline period, all vending machines will be standardised to have 75% healthier drinks and/or 25% healthier snacks (study period 1). Vending machines (n=9) will be randomly allocated to the order in which they: (1) decrease less healthy foods and increase healthier foods or (2) decrease healthier foods and increase less healthy foods (study periods 2\\&3 and 5\\&6). After each decrease-increase pair, machines will return to the standardised 75% healthier drinks and 25% healthier snacks (study periods 4 and 7). Sales data will be obtained via records of machine restocking.\n\nPlanned Analysis: The impact of the availability intervention will be assessed in separate linear mixed models for cold drinks and snacks, examining the impact on total energy (kcal) purchased, per restocking interval, with random effects for vending machine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All vending machines at one UK hospital selling standard-fare (i.e. not healthier alternatives) cold beverages and snack foods\n\nExclusion Criteria:\n\n* Healthier alternative vending machines; vending machines selling hot drinks or meals'}, 'identificationModule': {'nctId': 'NCT03252158', 'briefTitle': 'Altering the Availability of Healthier vs. Less Healthy Items in Vending Machines', 'organization': {'class': 'OTHER', 'fullName': 'University of Cambridge'}, 'officialTitle': 'Impact of the Availability of Healthier vs. Less Healthy Foods and Beverages on Purchasing From Hospital Vending Machines', 'orgStudyIdInfo': {'id': 'PRE.2017.029'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Decrease less healthy item availability', 'description': 'Intervention: Availability of healthier vs. less healthy foods\n\nRemove less healthy items in 20% of slots, then fill the empty slots with healthier items.', 'interventionNames': ['Behavioral: Availability of healthier vs. less healthy foods']}, {'type': 'EXPERIMENTAL', 'label': 'Decrease healthier item availability', 'description': 'Intervention: Availability of healthier vs. less healthy foods\n\nRemove healthier items in 20% of slots, then fill the empty slots with less healthy items.', 'interventionNames': ['Behavioral: Availability of healthier vs. less healthy foods']}], 'interventions': [{'name': 'Availability of healthier vs. less healthy foods', 'type': 'BEHAVIORAL', 'description': 'Altering the number of slots containing (a) healthier and (b) less healthy foods or beverages in hospital vending machines.\n\nChanges follow a 2-step process whereby decreases are implemented in a separate study period prior to increases in the contrasting group. Following a 4-week baseline period, all vending machines will be standardised to have 75% healthier drinks and/or 25% healthier snacks (study period 1). Vending machines will be randomly allocated to the order in which they: (1) decrease less healthy foods and increase healthier foods or (2) decrease healthier foods and increase less healthy foods (study periods 2\\&3 and 5\\&6). After each decrease-increase pair, machines will return to the standardised 75% healthier drinks / 25% healthier snacks (study periods 4 and 7).', 'armGroupLabels': ['Decrease healthier item availability', 'Decrease less healthy item availability']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CB2 0SR', 'city': 'Cambridge', 'state': 'Cambridgeshire', 'country': 'United Kingdom', 'facility': 'University of Cambridge', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}], 'overallOfficials': [{'name': 'Rachel Pechey, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cambridge'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cambridge', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oxford University Hospitals NHS Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Research Associate', 'investigatorFullName': 'Rachel Pechey', 'investigatorAffiliation': 'University of Cambridge'}}}}