Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2026-02-20 @ 6:48 PM
Study NCT ID:
NCT01277367
Status:
WITHDRAWN
Last Update Posted:
2016-08-19
First Post:
2011-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitality Health Incentives for Physical Activity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D057185', 'term': 'Sedentary Behavior'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-17', 'studyFirstSubmitDate': '2011-01-12', 'studyFirstSubmitQcDate': '2011-01-12', 'lastUpdatePostDateStruct': {'date': '2016-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Engagement in physical activity', 'timeFrame': '6 months', 'description': 'Levels of engagement in fitness related activities as measured by 1) continuous measure of Vitality fitness program points accrued, and 2) frequency count or proportion of members by fitness level groups'}], 'secondaryOutcomes': [{'measure': 'Fitness points earned', 'timeFrame': '6 months', 'description': 'The standard Vitality program offers members the ability to accumulate points for physical activity behavior through various means.'}, {'measure': 'Gym visits', 'timeFrame': '6 months', 'description': 'Average number of gym visits over the six month period will be measured.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obesity', 'Sedentary', 'Physical activity', 'exercise', 'incentives'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to prospectively compare the effectiveness of diverse incentives on physical activity behaviour, in a cohort of newly-enrolled, adult members of the Vitality health promotion programme based in South Africa.', 'detailedDescription': 'Newly enrolled adult members of the Discovery Health medical plan who have, themselves, prospectively registered for the Vitality health promotion programme will be eligible for the study, and will be invited to participate by Discovery Vitality. A final sample of 9000 adult members, who are recruited and have agreed to participate, will be randomly allocated by Discovery Vitality (with replacement) to one of six study (incentive) groups (n=1500 per group) and followed for six months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* enrolled in Vitality\n\nExclusion Criteria:\n\n* under 18 years of age'}, 'identificationModule': {'nctId': 'NCT01277367', 'briefTitle': 'Vitality Health Incentives for Physical Activity', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'A Prospective, Randomized Clinical Trial Comparing the Effectiveness of Different Types of Incentives in Increasing Physical Activity Behavior on the Vitality Health Promotion Programme', 'orgStudyIdInfo': {'id': '811570'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': 'These members will be offered no additional incentives', 'interventionNames': ['Behavioral: Discovery Vitality base program']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'These members will receive regular communications by Discovery Vitality.', 'interventionNames': ['Behavioral: Discovery Vitality base program', 'Behavioral: Communication']}, {'type': 'EXPERIMENTAL', 'label': 'C', 'description': "These members will nominate a charity which will benefit financially based on participants' level of physical activity.", 'interventionNames': ['Behavioral: Discovery Vitality base program', 'Behavioral: Charitable Incentive']}, {'type': 'EXPERIMENTAL', 'label': 'D', 'description': 'These members are entered into a prize draw for a monthly cash prize if they achieve physical activity targets.', 'interventionNames': ['Behavioral: Discovery Vitality base program', 'Behavioral: Prize Draw Incentive']}, {'type': 'EXPERIMENTAL', 'label': 'E', 'description': 'These members will receive a direct payment.', 'interventionNames': ['Behavioral: Discovery Vitality base program', 'Behavioral: Direct Payment']}, {'type': 'EXPERIMENTAL', 'label': 'F', 'description': 'These members will be offered the opportunity to choose one of three incentive options at the time of enrollment in the study.', 'interventionNames': ['Behavioral: Discovery Vitality base program', 'Behavioral: Free Choice']}], 'interventions': [{'name': 'Discovery Vitality base program', 'type': 'BEHAVIORAL', 'description': 'The existing Discovery Vitality health promotion base program, which offers points for various levels of physical activity.', 'armGroupLabels': ['A', 'B', 'C', 'D', 'E', 'F']}, {'name': 'Communication', 'type': 'BEHAVIORAL', 'description': 'Participants will be sent regular communications by Discovery Vitality -equivalent to the level of communications in the other incentive groups - which will provide information and tips about ways of accumulating Vitality points on the existing programme (concerning fitness-related activities, in particular).', 'armGroupLabels': ['B']}, {'name': 'Charitable Incentive', 'type': 'BEHAVIORAL', 'description': "Members will be asked to nominate a charity, from a selection of charities, which will benefit financially (Discovery Vitality will make a direct payment to a nominated charity) based on their (member's) level of participation in points-earning physical activity. Individuals will receive one of four possible payouts, corresponding to their level of engagement, for their selected charity (amounts given below). In addition, members will be sent regular updates of activities by their nominated charities (This will be operationalised and facilitated by Vitality- and as such, no direct mailing from nominated charity will take place, to maintain confidentiality.)", 'armGroupLabels': ['C']}, {'name': 'Prize Draw Incentive', 'type': 'BEHAVIORAL', 'description': 'Members will be entered into a prize draw for a monthly cash-prize if they achieve physical activity targets. Four lottery payouts, corresponding to their levels of engagement, will be made on a monthly basis. All members will be sent information regarding the winnings of those that are drawn (unlinked to personal identifiers, but to motivate).', 'armGroupLabels': ['D']}, {'name': 'Direct Payment', 'type': 'BEHAVIORAL', 'description': 'Members will receive a direct payment (in the form of gift voucher) of one of four possible amounts depending on the level of participation in fitness-related activities equivalent in expected value to the payouts in arms 3 and 4.', 'armGroupLabels': ['E']}, {'name': 'Free Choice', 'type': 'BEHAVIORAL', 'description': 'Members will be asked to choose one of the three aforementioned incentive options on enrollment to the study.', 'armGroupLabels': ['F']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Carnegie Mellon University', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'city': 'Cape Town', 'country': 'South Africa', 'facility': 'University of Cape Town', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'city': 'Johannesburg', 'country': 'South Africa', 'facility': 'Discovery Vitality', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}], 'overallOfficials': [{'name': 'Deepak Patel, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Discovery Holdings, LTD'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}