Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-01-01 @ 4:36 PM
Study NCT ID:
NCT04942535
Status:
COMPLETED
Last Update Posted:
2025-11-25
First Post:
2021-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
STEP Together: An Effectiveness-Implementation Study of Social Incentives and Physical Activity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-09-26', 'size': 334850, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-11-20T15:29', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 779}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-10-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2021-06-17', 'studyFirstSubmitQcDate': '2021-06-17', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in mean daily step counts during the 12 month intervention', 'timeFrame': 'Months 1-12', 'description': 'Change in mean daily steps from baseline to the end of the 12 month intervention period. Steps will be measured using the Fitbit Inspire 2 wearable device.'}], 'secondaryOutcomes': [{'measure': 'Change in mean daily step counts during the 12 month intervention and 6 month follow up', 'timeFrame': 'Months 1-18', 'description': 'Change in mean daily steps from baseline to the end of the 12 month intervention and 6 month follow up. Steps will be measured using the Fitbit Inspire 2 wearable device.'}, {'measure': 'Change in mean minutes of moderate-to-vigorous physical activity (MVPA) during the 12 month intervention', 'timeFrame': 'Months 1-12', 'description': 'Change in mean daily minutes of MVPA from baseline to the end of the 12 month intervention period. Minutes of MVPA will be measured using the Fitbit Inspire 2 wearable device.'}, {'measure': 'Change in mean minutes of moderate-to-vigorous physical activity (MVPA) during the 12 month intervention and 6 month follow up', 'timeFrame': 'Months 1-18', 'description': 'Change in mean daily minutes of MVPA from baseline to the end of the 12 month intervention and 6 month follow up. Minutes of MVPA will be measured using the Fitbit Inspire 2 wearable device.'}, {'measure': 'Difference in proportion of weeks physical activity guidelines were achieved during the 12 month intervention', 'timeFrame': 'Months 1-12', 'description': 'Difference between study arms in the proportion of weeks that physical activity guidelines (150 minutes per week of MVPA) were achieved. Minutes of MVPA will be measured using the Fitbit Inspire 2 wearable device.'}, {'measure': 'Difference in proportion of weeks physical activity guidelines were achieved during the 12 month intervention and 6 month follow up', 'timeFrame': 'Months 1-18', 'description': 'Difference between study arms in the proportion of weeks that physical activity guidelines (150 minutes per week of MVPA) were achieved. Minutes of MVPA will be measured using the Fitbit Inspire 2 wearable device.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Physical Activity', 'Older Adults', 'Gamification', 'Social Incentives', 'Charity', 'Family'], 'conditions': ['Physical Activity']}, 'referencesModule': {'references': [{'pmid': '40216076', 'type': 'DERIVED', 'citation': 'Scheffey K, Aronson J, Goncalves Y, Greysen SR, Iwu A, Kwong PL, Nezir F, Small D, Glanz K. Design and baseline characteristics of an implementation study to increase activity with social incentives: The STEP together trial. Contemp Clin Trials. 2025 Jun;153:107909. doi: 10.1016/j.cct.2025.107909. Epub 2025 Apr 10.'}]}, 'descriptionModule': {'briefSummary': 'Higher levels of physical activity have been demonstrated to improve health across a wide range of contexts and reduce cognitive decline as adults become older, but more than half of all adults in the United States do not meet their physical activity goals. One type of physical activity that is broadly applicable to people of all ages is walking. This study will use a Hybrid Type 1 effectiveness-implementation design to adapt and test the effectiveness of two successful social incentive-based interventions, a gamification strategy and financial incentives donated to charity on the participants behalf, to increase physical activity among low-income, mostly minority families in community settings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to read and speak English;\n* Has a smartphone or tablet;\n* Lives in the Philadelphia area;\n* Age 14 or older;\n* Able to provide informed consent;\n* Enrolled as a member of a 2 to 10 member family team with least one member 60 years or older.\n\nExclusion Criteria:\n\n* Already participating in another physical activity study;\n* An 18-month physical activity program is infeasible (e.g., metastatic cancer, unable to ambulate or provide informed consent) or unsafe (currently pregnant or told by a physician not to exercise);\n* Do not have sufficient eyesight or dexterity to operate device;\n* Average step count greater than 7,500 steps/day during the run-in period.'}, 'identificationModule': {'nctId': 'NCT04942535', 'briefTitle': 'STEP Together: An Effectiveness-Implementation Study of Social Incentives and Physical Activity', 'organization': {'class': 'OTHER', 'fullName': 'Abramson Cancer Center at Penn Medicine'}, 'officialTitle': 'STEP Together: A Hybrid Type 1 Effectiveness-Implementation Study of Social Incentives Strategies to Increase Physical Activity', 'orgStudyIdInfo': {'id': '02022'}, 'secondaryIdInfos': [{'id': '1R01HL152430', 'link': 'https://reporter.nih.gov/quickSearch/1R01HL152430', 'type': 'NIH'}, {'id': '842677', 'type': 'OTHER', 'domain': 'IRB Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Social Incentive Gamification', 'description': 'Each participant is enrolled as part of a family team. Each participant wears a Fitbit every day and strives to achieve their daily step goal.\n\nParticipants in this arm receive the Social Incentive Gamification intervention during the 12 month intervention and Daily Performance Feedback during the 6 month follow up.', 'interventionNames': ['Behavioral: Social Incentive Gamification', 'Behavioral: Daily Performance Feedback']}, {'type': 'EXPERIMENTAL', 'label': 'Social Goals through Incentives to Charity', 'description': 'Each participant is enrolled as part of a family team. Each participant wears a Fitbit every day and strives to achieve their daily step goal.\n\nParticipants in this arm receive the Social Goals through Incentives to Charity intervention during the 12 month intervention and Daily Performance Feedback during the 6 month follow up.', 'interventionNames': ['Behavioral: Social Goals through Incentives to Charity', 'Behavioral: Daily Performance Feedback']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Each participant is enrolled as part of a family team. Each participant wears a Fitbit every day and strives to achieve their daily step goal.\n\nParticipants in this arm receive Daily Performance Feedback during the 12 month intervention and 6 month follow up.', 'interventionNames': ['Behavioral: Daily Performance Feedback']}], 'interventions': [{'name': 'Social Incentive Gamification', 'type': 'BEHAVIORAL', 'description': "Participants enroll as a family team. They are asked to use a Fitbit activity tracker daily. Each participant sets a daily step goal based on their baseline step count.\n\nEach participant signs a pre-commitment contract. Participants are entered into a game with their family members. Each family receives 70 points weekly. Each day, a family member is selected at random to represent the family. If that person's step goal was achieved, the family keeps its points; if not, they lose 10 points. The participant is notified the following day if they were the family rep.\n\nAt the end of the week, if the family has 40 points or more, they advance 1 level. If they have less than 40 points, the family drops down 1 level. Each family team starts in the middle of 5 levels.\n\nAt the end of the intervention, families in the top 2 levels receive a small gift.\n\nIn the 6 month follow-up, participants receive a daily text message stating whether or not they achieved their step goal on the prior day.", 'armGroupLabels': ['Social Incentive Gamification']}, {'name': 'Social Goals through Incentives to Charity', 'type': 'BEHAVIORAL', 'description': "Participants enroll as a family team. They are asked to use a Fitbit activity tracker daily. Each participant sets a daily step goal based on their baseline step count.\n\nFamilies select a charity at the beginning of the intervention. They are informed that $20 is available each week to be donated to a charity of their choice. Each day, a family member is selected at random to represent the family. If that person's step goal was achieved, the family gets credit for meeting their goal; if not, the entire family does not get credit. The participant is notified the following day if they were the family rep.\n\nIf the family achieves their goal on at least 4 of 7 days in a week, $20 is donated to charity.\n\nIn the 6 month follow-up, participants receive a daily text message stating whether or not they achieved their step goal on the prior day.", 'armGroupLabels': ['Social Goals through Incentives to Charity']}, {'name': 'Daily Performance Feedback', 'type': 'BEHAVIORAL', 'description': 'Participants enroll as a family team. They are asked to use a Fitbit activity tracker daily. Each participant sets a daily step goal based on their baseline step count.\n\nParticipants receive a daily text message stating whether or not they achieved their step goal on the prior day.', 'armGroupLabels': ['Control', 'Social Goals through Incentives to Charity', 'Social Incentive Gamification']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Karen Glanz, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be made available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abramson Cancer Center at Penn Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}