Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-27 @ 4:38 AM
Study NCT ID:
NCT03937934
Status:
COMPLETED
Last Update Posted:
2020-06-09
First Post:
2019-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Title: Food Rx
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015596', 'term': 'Nutrition Assessment'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-05', 'studyFirstSubmitDate': '2019-04-30', 'studyFirstSubmitQcDate': '2019-05-01', 'lastUpdatePostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the number of self-reported fruits per day', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'Number of self-reported fruits per day'}, {'measure': 'Change in the number of self-reported vegetables per day', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'Number of self-reported vegetables per day'}, {'measure': 'Change in number of days a week and minutes per day participants participate in physical activity and sedentary activity', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'Measured using self-reported Food Rx Pilot survey'}], 'secondaryOutcomes': [{'measure': 'Change in A1c', 'timeFrame': '6 months and 12 months', 'description': 'Identified through chart review'}, {'measure': 'Change in BMI kg/m2 (weight in kg, height in meters)', 'timeFrame': '6 months and 12 months', 'description': 'Identified through chart review'}, {'measure': 'Change in Systolic and/or Diastolic Hypertension mmHg', 'timeFrame': '6 months and 12 months', 'description': 'Identified through chart review'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes', 'High Blood Pressure', 'Obesity', 'Hypertension', 'Heart Diseases', 'Stroke', 'TIA', 'Osteoarthritis', 'Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'Researchers are trying to determine if subjects with lack of access to healthy food and a long term health problem, are helped by a weekly box of healthy groceries and nutrition education.', 'detailedDescription': "Participants that have a chronic preventable disease and food insecurity will be offered enrollment in the study. Once all participants are enrolled, they will be given weekly boxes of food which includes materials for a nutritious recipe and extra fruit and vegetables for a total of 6 weeks. The SNAP-Ed Educator and SHIP Public health coordinator will be present at food pick up to answer questions about the boxes, food preparation, etc. They will be given the option of participating in grocery store and farmer's market tours, as well as sign up for text messaging of nutrition information and recipes. At the end of 6 weeks, they will be asked to participate in a focus group. At baseline, 3 months and 6 months, they will be asked to complete a survey on lifestyle behaviors and food choices."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients that have been identified as having food insecurity based on a two question screening tool, AND\n* Also has one of more of the following chronic diseases:\n* Hypertension,\n* Heart disease,\n* Stroke/TIA,\n* DM 2,\n* Cancer/history of cancer,\n* obesity\n* osteoarthritis\n\nExclusion Criteria:\n\n* Pregnant women\n* Children'}, 'identificationModule': {'nctId': 'NCT03937934', 'briefTitle': 'Study Title: Food Rx', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Study Title: Food Rx', 'orgStudyIdInfo': {'id': '18-006630'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Subjects with long term health condition', 'description': 'Subjects that have been identified as having food insecurity based on a two question screening tool, and also has one of more of the following chronic diseases Hypertension, Heart disease, Stroke/TIA, DM 2, Cancer/history of cancer, obesity or osteoarthritis will receive weekly nutrition educaiton', 'interventionNames': ['Behavioral: Nutrition Education']}], 'interventions': [{'name': 'Nutrition Education', 'type': 'BEHAVIORAL', 'description': 'Weekly box of healthy groceries and nutrition education including a recipe, food to make the recipe, extra fruit and vegetables.', 'armGroupLabels': ['Subjects with long term health condition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56001', 'city': 'Mankato', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Health System', 'geoPoint': {'lat': 44.15906, 'lon': -94.00915}}], 'overallOfficials': [{'name': 'Erin Westfall, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Erin C. Westfall', 'investigatorAffiliation': 'Mayo Clinic'}}}}