Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-02-23 @ 4:30 AM
Study NCT ID:
NCT03328520
Status:
COMPLETED
Last Update Posted:
2018-04-26
First Post:
2017-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
WILD 5 Wellness, A 30-Day Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-11-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-24', 'studyFirstSubmitDate': '2017-10-20', 'studyFirstSubmitQcDate': '2017-10-30', 'lastUpdatePostDateStruct': {'date': '2018-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Patient Health Questionnaire-9 (PHQ-9)', 'timeFrame': 'Day 0, Day 30+ 3 days (approximately)', 'description': 'PHQ-9 is a self reported depression scale. It is a 9-item scale with scores ranging from 0-27. Lower scores denote improvement.'}, {'measure': 'Change in Generalized Anxiety Disorder-7 (GAD-7)', 'timeFrame': 'Day 0, Day 30+ 3 days (approximately)', 'description': 'GAD-7 is a self-reported questionnaire used to assess anxiety symptoms. It is a 7-item scale with scores ranging from 0-21. Lower score denotes improvement.'}, {'measure': 'Change in the HERO Wellness Scale', 'timeFrame': 'Day 0, Day 30+ 3 days (approximately)', 'description': 'HERO Wellness Scale is a brief scale designed to measure mental wellness specifically happiness, enthusiasm, resilience and optimism. It is a 5-item scale with scores ranging from 0-10. Higher score denotes improvement.'}, {'measure': 'Change in World Health Organization-5 (WHO-5)', 'timeFrame': 'Day 0, Day 30+ 3 days (approximately)', 'description': 'WHO-5 is a brief scale that measures mental well-being. It is a 5-item scale with scores ranging from 0-25. Higher score denotes improvement.'}, {'measure': 'Change in Cognitive and Physical Functioning Questionnaire (CPFQ)', 'timeFrame': 'Day 0, Day 30+ 3 days (approximately)', 'description': 'CPFQ is a brief scale that measures cognitive and executive dysfunction. It is a 7-item scale with scores ranging from 7-42. Lower score denotes improvement.'}], 'secondaryOutcomes': [{'measure': 'The Post-Program Participant Questionnaire', 'timeFrame': 'Day 30+ 3 days (approximately)', 'description': "The Post-Program Participant Questionnaire is a brief survey that captures participants'opinions about WILD 5 Wellness."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anxiety', 'Depression', 'Cognitive Functioning', 'Wellness']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore the efficacy and feasibility of an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition in First Year Beloit College students self-selected into a wellness focused first year initiative. This program is called "WILD 5 Wellness: A 30-Day Intervention".'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '17 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Students 18 years of age or older or 17 years of age with legal guardian written permission.\n* Students enrolled in First Year Initiative Courses titled "Balance" or "Constructing Health"\n\nExclusion Criteria:\n\n* Individuals who are pregnant or plan to get pregnant during the next 30 days.\n* Students who are not enrolled in the First Year Initiative Courses titled "Balance" or "Constructing Health"'}, 'identificationModule': {'nctId': 'NCT03328520', 'briefTitle': 'WILD 5 Wellness, A 30-Day Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Beloit College'}, 'officialTitle': 'WILD 5 Wellness, A 30 Day Intervention in First Year Students at Beloit College', 'orgStudyIdInfo': {'id': '374'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'First Year Students in Wellness FYIs', 'interventionNames': ['Behavioral: WILD 5 Wellness Intervention']}], 'interventions': [{'name': 'WILD 5 Wellness Intervention', 'type': 'BEHAVIORAL', 'description': 'Behaviors in 6 areas of wellness: Sleep, Social Connectedness, Exercise, Nutrition, Mindfulness and "HERO" (Happiness, Enthusiasm, Resilience, Optimism)', 'armGroupLabels': ['First Year Students in Wellness FYIs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53511', 'city': 'Beloit', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Beloit College', 'geoPoint': {'lat': 42.50835, 'lon': -89.03178}}], 'overallOfficials': [{'name': 'Tara M Girard, BSN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beloit College'}, {'name': 'Suzanne Cox, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beloit College'}, {'name': 'Laura Parmentier, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beloit College'}, {'name': 'Saundra Jain, PsyD, LPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beloit College'}, {'name': 'Rakesh Jain, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beloit College'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beloit College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}