Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:46 PM
Study NCT ID:
NCT03567967
Status:
COMPLETED
Last Update Posted:
2020-07-17
First Post:
2018-05-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fruit and Vegetable Vouchers With and Without an SSB Tax
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005638', 'term': 'Fruit'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '24-hour dietary recalls are conducted by blinded registered dietitians'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 313}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-15', 'studyFirstSubmitDate': '2018-05-31', 'studyFirstSubmitQcDate': '2018-06-21', 'lastUpdatePostDateStruct': {'date': '2020-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in fruit and vegetable consumption', 'timeFrame': 'Month 0 to Month 6', 'description': 'Change in fruit and vegetable consumption from baseline (BL), i.e., before voucher receipt, to the end of the intervention at the end of month 6 (M6), i.e., during the final month of voucher receipt, measured by two 24-hour recalls at each data collection point (BL and M6).'}], 'secondaryOutcomes': [{'measure': 'Change in nutrition quality per HEI score', 'timeFrame': 'Month 0 to Month 6', 'description': 'Change in nutrition quality of study participants from BL to M6, measured by the Healthy Eating Index (HEI), which is calculated from two 24-hour recalls at each data collection point (BL and M6).'}, {'measure': 'Change in nutrition quality per AHEI score', 'timeFrame': 'Month 0 to Month 6', 'description': 'Change in nutrition quality of study participants from BL to M6, measured by the Alternative Healthy Eating Index (AHEI), which is calculated from two 24-hour recalls at each data collection point (BL and M6).'}, {'measure': 'Change in SSB consumption', 'timeFrame': 'Month 0 to Month 6', 'description': 'Change in SSB consumption from BL to M6, measured in change in fluid ounces, as measured by two 24-hour recalls at each data collection point (BL and M6).'}, {'measure': 'Change in overall caloric intake', 'timeFrame': 'Month 0 to Month 6', 'description': 'Change in overall caloric intake from BL to M6, measured in change in kcal, as measured by two 24-hour dietary recalls at each data collection point (BL and M6).'}, {'measure': 'Overall percentage of vouchers redeemed', 'timeFrame': 'Month 0 to Month 6', 'description': 'Overall percentage of vouchers redeemed per participant, measured by how many vouchers each participant redeemed as compared to how many vouchers they received over the 6 month intervention period.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nutrition', 'fruits and vegetables', 'sugar-sweetened beverages'], 'conditions': ['Cardiovascular Diseases']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://is.gd/chivesprojectSF', 'label': 'San Francisco program'}, {'url': 'https://is.gd/chivesprojectLA', 'label': 'Los Angeles program'}]}, 'descriptionModule': {'briefSummary': 'We aim to examine whether a purchasing incentive for healthy foods has the same effect on dietary intake in a community with and a community without a purchasing penalty for unhealthy foods. We will perform a randomized non-inferiority trial in two locations, San Francisco (SF) and Los Angeles (LA) to test whether a voucher for purchasing fresh fruits and vegetables has a similar effect in LA and in SF, where the former does not but the latter does have a tax on sugar-sweetened beverages. Participants will be recruited from 4 neighborhoods (N=312) with 2 SF neighborhoods (exposed to the SSB tax) and 2 LA neighborhoods (not exposed to the SSB tax).', 'detailedDescription': "We will test the hypothesis that a positive incentive for healthy foods (fresh fruits and vegetables, F\\&Vs) will be utilized as effectively in a community without a purchasing penalty for unhealthy foods (a sugar-sweetened beverage \\[SSB\\] tax) as in a community with a purchasing penalty for unhealthy foods (a SSB tax). Our experiment will test the empirically-driven hypothesis in a real-world setting through a noninferiority design: comparing the impact of F\\&V vouchers in two counties, one without (Los Angeles) and one with (San Francisco) a SSB tax.\n\nEach study participant will receive four paper vouchers per month for a total of six months. Each of these vouchers can be redeemed for fresh or frozen fruits and vegetables at a number of specified local corner stores, supermarkets, or farmer's markets.\n\nHalf of these participants will receive and spend these vouchers in an environment which has implemented a SSB tax (SF); the other half will receive and spend these same vouchers in a non-tax environment (LA).\n\nEach individual participant will be enrolled in the study for a total of seven months from initial orientation and participant consent (M0) to final data collection during final month of intervention (M6).\n\nWe are using a non-inferiority trial design. We are aiming to test whether there is a significant difference in total cup-equivalents of F\\&V intake in LA participants as compared to SF participants when given F\\&V vouchers. That is, we aim to test whether the F\\&V voucher is less effective in LA than in SF. This is important to test because it has been purported that SF has a unique food environment with high accessibility to fresh F\\&V through farmer's markets and a plethora of corner stores, as well as a SSB tax that discourages less healthy foods, potentially leaving more funds for healthier F\\&Vs. Thus, we aim to determine the change in consumption of F\\&V in LA participants is non-inferiority to that of SF participants, when both are given F\\&V vouchers."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Understand English sufficiently to provide informed consent;\n2. Provision of signed and dated informed consent form;\n3. Stated willingness to comply with all study procedures and availability for the duration of the study;\n4. Any gender, aged 21 years or older;\n5. Have self-reported income ≤250% of the federal poverty level;\n6. Have regular access to a mobile phone;\n7. Have a safe and secure mailing address at which to receive vouchers;\n8. Be a resident of the Counties of San Francisco or Los Angeles as defined by official municipal boundaries.\n\nExclusion Criteria:\n\n1. Currently participating in any other dietary or nutrition study that would impact his or her normal eating patterns;\n2. Currently be enrolled in and receiving EatSF, CHIVES, or Vouchers4Veggies vouchers;\n3. Has active diagnosis of cancer or congestive heart failure;\n4. Is planning to move out of San Francisco or Los Angeles in the next 12 months;\n5. Currently pregnant.\n6. Currently live with and share a food budget with a current Vouchers4Veggies, EVIDENCE, or CHIVES study participant.'}, 'identificationModule': {'nctId': 'NCT03567967', 'acronym': 'EVIDENCE', 'briefTitle': 'Fruit and Vegetable Vouchers With and Without an SSB Tax', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'The EValuating Interventions in Diabetogenic Environments Through Natural Controlled Experiments (EVIDENCE) Trial', 'orgStudyIdInfo': {'id': '43831'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'San Francisco', 'description': "Each study participant will receive four paper vouchers per month for a total of six months. Each of these vouchers can be redeemed for fresh or frozen fruits and vegetables at a number of specified local corner stores, supermarkets, or farmer's markets. The San Francisco participants will receive and spend these vouchers in an environment which has implemented a sugar-sweetened beverage tax.", 'interventionNames': ['Behavioral: Fruit and vegetable voucher']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Los Angeles', 'description': "Each study participant will receive four paper vouchers per month for a total of six months. Each of these vouchers can be redeemed for fresh or frozen fruits and vegetables at a number of specified local corner stores, supermarkets, or farmer's markets. The Los Angeles participants will receive and spend these vouchers in an environment which has NOT implemented a sugar-sweetened beverage tax.", 'interventionNames': ['Behavioral: Fruit and vegetable voucher']}], 'interventions': [{'name': 'Fruit and vegetable voucher', 'type': 'BEHAVIORAL', 'otherNames': ['Voucher'], 'description': "Participants will receive four vouchers, each dated for a month, to be used on fruits and vegetables at specified local corner stores, supermarkets, and farmer's markets for a duration of six months. Each study participant will have the same intervention, as this is a non-inferiority trial to compare voucher use in LA and test whether the nutritional effects of that use are non-inferior to use in SF.", 'armGroupLabels': ['Los Angeles', 'San Francisco']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Sanjay Basu, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant Professor of Medicine'}, {'name': 'Dean Schillinger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of California, San Francisco', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Christopher Gardner', 'investigatorAffiliation': 'Stanford University'}}}}