Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2025-12-27 @ 7:14 AM
Study NCT ID:
NCT07028450
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-19
First Post:
2025-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Proactive Call to Customers of Norsk Rikstoto (Horse Gambling Operator in Norway): A Randomized Controlled Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The two arms/conditions involves one proactive phone call or a control condition'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 192}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-11', 'studyFirstSubmitDate': '2025-06-11', 'studyFirstSubmitQcDate': '2025-06-11', 'lastUpdatePostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Theoretical loss', 'timeFrame': 'Change from baseline (30 days before the call) to day 1-90 after the call (short-term effect) and change from baseline (30 days before the call) to day 91-180 after the call (long-term effect).', 'description': 'Total bet x house advantage ((100%-payback%) / 100)'}], 'secondaryOutcomes': [{'measure': 'Total stake', 'timeFrame': 'Change from baseline (30 days before the call) to the first 90 days after the call (short term) and change from baseline to day 91-180 after the call', 'description': 'Total amount of money staked'}, {'measure': 'Loss percentage', 'timeFrame': 'Change from baseline (30 days before the call) to day 1-90 after the call (short-term effect) and change from baseline (30 days before the call) to day 91-180 after the call (long-term effect).', 'description': 'Percentage of stakes that are lost'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gambling Problem', 'Proactive calls', 'Randomized controlled trial', 'mini-intervention'], 'conditions': ['Gambling Problem']}, 'descriptionModule': {'briefSummary': 'Customers/gamblers gambling at Norsk Rikstoto (gambling monopolist in Norway providing horse gambling products with potential gambling problems will be randomly allocated to receive a proactive phone call (encouraging them to change their gambling behavior - e.g., be lowering the loss limit) or to a control condition. Outcomes will be short and long terms registered gambling behavior.', 'detailedDescription': 'Norsk Rikstoto (gambling monopolist in Norway providing horse gambling products) enforces registered play, hence all gambling transactions and outcomes of stakes of all customers are registered and stored for 5 years. Based on daily algorithms high risk gamblers are identified. Gamblers 18-35 years who for at least 5 of the last 30 days have been identified as high risk gamblers will according to a 1.5:1 ratio be allocated to a proactive call condition or to a control condition.\n\nThe call will be based on principles from motivating interviewing and will contain encouragements to alter gambling behavior (e.g., lowering loss limits). Primary outcome comprises theoretical loss (total bet x house advantage ((100% - payback%) / 100)). Secondary outcomes comprises total stakes made by the customer and loss percentage (proportion of stake that is lost). Baseline data comprises gambling behavior the 30 days before the call. Short-term effects comprise cumulative registered gambling behavior the first 90 days after the call whereas long-term effects consist of cumulative registered gambling behavior day 91-180 after the call. A random block design will be used where 15 eligible customers each week will be allocated either to the proactive call condition (n=9) or to the control condition (n=6).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being identified (based on an algorithm used by Norsk Rikstoto/the gambling provider) as a high risk gambler at least 5 of the last 30 days\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT07028450', 'briefTitle': 'Effects of Proactive Call to Customers of Norsk Rikstoto (Horse Gambling Operator in Norway): A Randomized Controlled Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Bergen'}, 'officialTitle': 'Effects of Proactive Calls: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'Spillforsk25/1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'One proactive call', 'description': 'The call is based on principles of motivating interviewing and will in addition encourage the recipient to change his/hers gambling behavior (e.g., lower pre-set loss limits).', 'interventionNames': ['Behavioral: Proactive call']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No contact/not reaching out'}], 'interventions': [{'name': 'Proactive call', 'type': 'BEHAVIORAL', 'description': 'The proactive call will be based on the principles of motivational interviewing. The content of the call comprises: 1) Asking the gambler/recipient to reflect on their gambling behavior, 2) providing to the gambler/recipient an overview of their gambling account and financial history, 3) offering to the gambler/recipient information about responsible gambling tools, such as setting lower limits, locking limits, taking a break, or self-exclusion, and 4) providing to the gambler/recipient information about relevant support services and the Gamban tool in cases where a need is expressed.', 'armGroupLabels': ['One proactive call']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5020', 'city': 'Bergen', 'state': 'Vestland', 'country': 'Norway', 'contacts': [{'name': 'Ståle Pallesen, PhD', 'role': 'CONTACT', 'email': 'staale.pallesen@uib.no', 'phone': '+4792632099'}, {'name': 'Andre Syvertsen, PhD', 'role': 'CONTACT', 'email': 'andre.syvertsen@uib.no'}, {'name': 'Ståle Pallesen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Bergen, Department of Psychosocial Science', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}], 'centralContacts': [{'name': 'Ståle Pallesen, PhD', 'role': 'CONTACT', 'email': 'staale.pallesen@uib.no', 'phone': '+4792632099'}, {'name': 'Andre Syvertsen, PhD', 'role': 'CONTACT', 'email': 'andre.syvertsen@uib.no', 'phone': '+4795137908'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES', 'description': 'Researchers may contact the principle investigator and ask for access to the data in anonymous form'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bergen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Norsk Rikstoto', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}