Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-01-05 @ 5:21 PM
Study NCT ID:
NCT03266666
Status:
UNKNOWN
Last Update Posted:
2017-08-30
First Post:
2017-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Welcome to WellnessRX: Steps Toward a Healthier Life!
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001522', 'term': 'Behavior, Animal'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-28', 'studyFirstSubmitDate': '2017-08-01', 'studyFirstSubmitQcDate': '2017-08-28', 'lastUpdatePostDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Activity Questionnaire with Eating Behaviors', 'timeFrame': '45 day', 'description': 'Based on the UK National Health Service Assessments, a measure of physical activity, diet and general healthy lifestyle activities.'}, {'measure': 'Activity Questionnaire with Eating Behaviors', 'timeFrame': '90 day', 'description': 'Based on the UK National Health Service Assessments, a measure of physical activity, diet and general healthy lifestyle activities.'}, {'measure': 'Thrive Market Purchase Decisions', 'timeFrame': 'through 90 days', 'description': 'An analysis of purchase decisions by study participants on Thrive Market, the online natural goods store.'}], 'secondaryOutcomes': [{'measure': 'Customer Satisfaction', 'timeFrame': 'within 45 minutes', 'description': 'Participant perceptions of usefulness and quality of WellnessRX classes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['grocery', 'lifestyle', 'lifestyle change', 'behavior', 'nutrition'], 'conditions': ['Life Style', 'Behavior', 'Food Habits', 'Stress', 'Physical Activity']}, 'descriptionModule': {'briefSummary': "Wellness Rx is a 6 class prescription for a healthier lifestyle developed for people in Lake County at all levels of health including those struggling with chronic disease. The classes are running across the community at all times. It is designed for patients that could benefit from healthy diet, exercise, and other healthy lifestyle modifications.\n\nFor those participants attending the classes, they have the option of engaging in this evaluation. For those that do, participants will answer questions about their current lifestyle, their and their previous history. They will register attendance at each class and answer questions about their perception of the class. Then at 45 days and 90 days the participants will revisit the same baseline lifestyle questionnaires.\n\nAs participants attend classes, and complete questionnaires, they'll unlock grocery credits from online food store ThriveMarket, a basket of fresh produce from the local farmers market and local fitness classes to help you towards your goals. The use of these credits will be tracked through the 90-day point."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Lake County, California Resident\n* able to attend 6 lifestyle change classes held around the community'}, 'identificationModule': {'nctId': 'NCT03266666', 'acronym': 'WellnessRX', 'briefTitle': 'Welcome to WellnessRX: Steps Toward a Healthier Life!', 'organization': {'class': 'INDUSTRY', 'fullName': 'ProofPilot'}, 'officialTitle': 'An Evaluation of Lifestyle Change Classes and Grocery Credits to Promote Healthy Behavior Change', 'orgStudyIdInfo': {'id': '741'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Intervention Arm - WellnessRX', 'description': 'This is a longitudinal outcome study. All participants will receive the class and grocery credit intervention.', 'interventionNames': ['Behavioral: WellnessRX Lifestyle Change Classes', 'Other: Thrive Market Grocery Credits (4x$25 each)']}], 'interventions': [{'name': 'WellnessRX Lifestyle Change Classes', 'type': 'BEHAVIORAL', 'description': 'Lifestyle change classes on nutrition, physical activity, and stress management.', 'armGroupLabels': ['Intervention Arm - WellnessRX']}, {'name': 'Thrive Market Grocery Credits (4x$25 each)', 'type': 'OTHER', 'description': 'Thrive Market is an online grocery service available nationwide. Participants will be provided with up to $100 on grocery credits.', 'armGroupLabels': ['Intervention Arm - WellnessRX']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ProofPilot', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'North Coast Opportunities, Inc.', 'class': 'OTHER'}, {'name': 'Thrive Market', 'class': 'INDUSTRY'}, {'name': 'Adventist Health Clear Lake', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}