Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-03-18 @ 8:52 AM
Study NCT ID:
NCT03168451
Status:
COMPLETED
Last Update Posted:
2018-10-12
First Post:
2017-01-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
American Indians STOp Smoking by Mobile Phone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020340', 'term': 'Tobacco Use Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The intervention group will receive data collection messages and culturally tailored messages encouraging them to quit smoking. The control group will only receive data collection messages.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 346}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-10', 'studyFirstSubmitDate': '2017-01-30', 'studyFirstSubmitQcDate': '2017-05-24', 'lastUpdatePostDateStruct': {'date': '2018-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants who change smoking status as measured by self-report', 'timeFrame': '6, 12, 18, and 26 weeks after target quit date', 'description': 'Number of participants who quit smoking while receiving text messages, as measured by self-report at 4 time points over 6 months.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['text messaging'], 'conditions': ['Tobacco Use Cessation']}, 'descriptionModule': {'briefSummary': 'In an attempt to reduce smoking-related health disparities, investigators will implement a text messaging-based smoking cessation intervention in collaboration with state quit lines. The approach is based on the successful STOMP (STOp smoking by Mobile Phone) program, a text messaging-based smoking cessation intervention among young Maori adults in New Zealand. Investigators will adapt the STOMP intervention, which will result in a new intervention known as AI STOMP (American Indians STOp smoking by Mobile Phone).The primary aim of the study is to determine the effectiveness of the AI-STOMP intervention in smoking cessation among American Indians.', 'detailedDescription': "This is a randomized, single-blinded, controlled trial examining the effectiveness of a text messaging-based smoking cessation program among American Indian (AI) smokers who call state quit lines, in states with high AI populations. Participants will be randomized to either receive culturally-tailored text-messages to support smoking cessation or quit line's treatment as usual.\n\nParticipants will be recruited by Optum, the company who runs many state quit lines in the US. If - after answering some demographic questions for Optum from the following states: Alaska, Oklahoma, Wisconsin, Minnesota, and New Mexico - a person is found to be a AI/AN and 18+ years old, that person will be asked if they would like to receive information about the study. If they answer yes the WSU research team will receive their contact information from Optum via a secure email, and WSU researchers will send a text explaining the study in more detail and a link to the e-consent form.\n\nParticipants will also fill out 4 baseline questionnaires. After filling out baseline questionnaires, participants will be randomized to either the intervention group or the control group. Participants will be stratified into the intervention and control groups based on their age, gender, and Fagerstrom nicotine dependence score. Random permuted blocks will be used by on-campus research staff to manually assign participants to the two research groups.\n\nAll participants will begin receiving text messages one week before their chosen quit date."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Identify as American Indian\n* Be age 18 years or older\n* Possess or have access to a mobile phone with text messaging capacity\n* Be a current daily smoker; and\n* Be interested in quitting smoking within the next 30 days\n\nExclusion Criteria:\n\n* Not meeting inclusion criteria'}, 'identificationModule': {'nctId': 'NCT03168451', 'acronym': 'AI STOMP', 'briefTitle': 'American Indians STOp Smoking by Mobile Phone', 'organization': {'class': 'OTHER', 'fullName': 'Washington State University'}, 'orgStudyIdInfo': {'id': 'P20MD006871', 'link': 'https://reporter.nih.gov/quickSearch/P20MD006871', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Members of the intervention group will receive culturally tailored text messages encouraging them to quit smoking. They will receive data collection text messages at 6, 12, 18, and 26 weeks post target quit date, assessing their current tobacco smoking behavior.', 'interventionNames': ['Behavioral: Culturally Tailored Text Messages']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Members of the control group will receive data collection text messages at 6, 12, 18, and 26 weeks post target quit date, assessing their current tobacco smoking behavior.'}], 'interventions': [{'name': 'Culturally Tailored Text Messages', 'type': 'BEHAVIORAL', 'description': 'Members of the intervention group receive culturally tailored messages on the following schedule: 4 messages per day for 1 week prior to target quit date, 4 messages per day for 4 weeks following target quit date, 3 messages per week for 20 weeks following weeks.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '99202', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Washington State University Coordinating Center', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}], 'overallOfficials': [{'name': 'Dedra Buchwald, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington State University'}, {'name': 'Sterling McPherson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Optum, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director and Professor', 'investigatorFullName': 'Dedra Buchwald', 'investigatorAffiliation': 'Washington State University'}}}}