Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-01-04 @ 8:55 AM
Study NCT ID:
NCT03687658
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2018-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Applying Novel Technologies and Methods to Self-Regulation: Behavior Change Tools for Smoking and Binge Eating
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D002032', 'term': 'Bulimia'}, {'id': 'D001519', 'term': 'Behavior'}], 'ancestors': [{'id': 'D006963', 'term': 'Hyperphagia'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'poldrack@stanford.edu', 'phone': '(650) 497-8488', 'title': 'Russell Poldrack, PhD', 'organization': 'Stanford University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Average approximately 5 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Binge Eating Group', 'description': 'Overweight participants with binge eating disorder were administered Laddr over 4 weeks.', 'otherNumAtRisk': 67, 'deathsNumAtRisk': 67, 'otherNumAffected': 0, 'seriousNumAtRisk': 67, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Smoking Group', 'description': 'Participants who smoked 5 cigarettes or more per day were administered Laddr over 4 weeks.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Binge Eating Episodes - Loss of Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Binge Eating Group', 'description': 'Overweight participants with binge eating disorder were administered Laddr over 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.212', 'spread': '0.0213', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.066', 'groupIds': ['OG000'], 'statisticalMethod': 'Generalized linear mixed model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Generalized linear mixed model (GLMM) with a binomial distribution using a logit link function'}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'Self-reported binge eating episodes is assessed four times daily (morning, early afternoon, late afternoon/evening, and night). A binge eating episode is defined as self-reported overeating and loss of control. Loss of control is assessed by the question "When you ate most recently, did you lose control over your eating?" and is scored as 0 (No), 1 (Yes). Responses provided were averaged across the 28-day period.', 'unitOfMeasure': 'episodes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Binge Eating Group only and completed both scans were evaluated for this outcome.'}, {'type': 'PRIMARY', 'title': 'Binge Eating Episodes - Overeating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Binge Eating Group', 'description': 'Overweight participants with binge eating disorder were administered Laddr over 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.286', 'spread': '0.0235', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.273', 'groupIds': ['OG000'], 'statisticalMethod': 'Generalized linear mixed model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Generalized linear mixed model (GLMM) with a binomial distribution using a logit link function'}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'Self-reported binge eating episodes is assessed four times daily (morning, early afternoon, late afternoon/evening, and night). A binge eating episode is defined as self-reported overeating and loss of control. Overeating is assessed by the question "Since the last prompt, when you ate most recently, did you overeat?" and is scored as 0 (no) or 1 (yes). Responses provided were averaged across the 28-day period.', 'unitOfMeasure': 'episodes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Binge Eating Group only and completed both scans were evaluated for this outcome.'}, {'type': 'PRIMARY', 'title': 'Number of Cigarettes Smoked Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Smoking Group', 'description': 'Participants who smoked 5 cigarettes or more per day were administered Laddr over 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.97', 'spread': '0.547', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.403', 'groupIds': ['OG000'], 'statisticalMethod': 'Generalized linear mixed model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Generalized linear mixed model (GLMM) with a Poisson distribution using a log link function'}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'Self-reported smoking assessed four times daily (morning, early afternoon, late afternoon/evening, and night). A smoking episode is defined as self-reported smoking of more than zero cigarettes and is assessed by the question "Since the last prompt, how many cigarettes have you smoked?" Participants are asked to input a number into a number field and this was averaged over the 28 day period.', 'unitOfMeasure': 'cigarettes per day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Smoking Group only and completed both scans were evaluated for this outcome.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Binge Eating Group', 'description': 'Overweight participants with binge eating disorder were administered Laddr over 4 weeks.'}, {'id': 'FG001', 'title': 'Smoking Group', 'description': 'Participants who smoked 5 cigarettes or more per day were administered Laddr over 4 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'Completed 1st Scan', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'Completed 2nd Scan', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '14'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Binge Eating Group', 'description': 'Overweight participants with binge eating disorder were administered Laddr over 4 weeks.'}, {'id': 'BG001', 'title': 'Smoking Group', 'description': 'Participants who smoked 5 cigarettes or more per day were administered Laddr over 4 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.80', 'spread': '8.27', 'groupId': 'BG000'}, {'value': '39.7', 'spread': '8.6', 'groupId': 'BG001'}, {'value': '34.04', 'spread': '8.67', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Participants who completed both scans are included in the analysis.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-30', 'size': 2872213, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-08-29T17:51', 'hasProtocol': True}, {'date': '2023-08-29', 'size': 175410, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-08-30T15:20', 'hasProtocol': False}, {'date': '2021-09-30', 'size': 225020, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-08-05T17:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-31', 'studyFirstSubmitDate': '2018-09-26', 'resultsFirstSubmitDate': '2023-08-31', 'studyFirstSubmitQcDate': '2018-09-26', 'lastUpdatePostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-31', 'studyFirstPostDateStruct': {'date': '2018-09-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Binge Eating Episodes - Loss of Control', 'timeFrame': '28 days', 'description': 'Self-reported binge eating episodes is assessed four times daily (morning, early afternoon, late afternoon/evening, and night). A binge eating episode is defined as self-reported overeating and loss of control. Loss of control is assessed by the question "When you ate most recently, did you lose control over your eating?" and is scored as 0 (No), 1 (Yes). Responses provided were averaged across the 28-day period.'}, {'measure': 'Binge Eating Episodes - Overeating', 'timeFrame': '28 days', 'description': 'Self-reported binge eating episodes is assessed four times daily (morning, early afternoon, late afternoon/evening, and night). A binge eating episode is defined as self-reported overeating and loss of control. Overeating is assessed by the question "Since the last prompt, when you ate most recently, did you overeat?" and is scored as 0 (no) or 1 (yes). Responses provided were averaged across the 28-day period.'}, {'measure': 'Number of Cigarettes Smoked Per Day', 'timeFrame': '28 days', 'description': 'Self-reported smoking assessed four times daily (morning, early afternoon, late afternoon/evening, and night). A smoking episode is defined as self-reported smoking of more than zero cigarettes and is assessed by the question "Since the last prompt, how many cigarettes have you smoked?" Participants are asked to input a number into a number field and this was averaged over the 28 day period.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Smoking', 'Binge Eating', 'Behavior']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://scienceofbehaviorchange.org/what-is-sobc/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the extent to which we can engage and manipulate putative targets within the self-regulation domain within and outside of laboratory settings in samples of smokers and overweight/obese individuals with binge eating disorder. This is the fourth phase of a study that aims to identify putative mechanisms of behavior change to develop an overarching "ontology" of self-regulatory processes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Understand English sufficiently to provide informed consent\n* Right-handed\n* Normal or corrected-to-normal vision and no color blindness\n* Interest in engaging with Laddr to modify self-regulatory behavior\n\nAdditional Inclusion Criteria for Smoking sample:\n\n* Smoke 5 or more tobacco cigarettes/day for past year\n* BMI greater than or equal to 17 and less than 27\n\nAdditional Inclusion Criteria for Binge Eating Sample:\n\n* BMI greater than or equal to 27 and less than 45\n* Weight limit of 350 lbs\n* Non-smoking (defined as no cigarettes in past 12 months-this includes former and never smokers)\n\nExclusion Criteria:\n\n* Significant medical illness\n* History of mental disorder due to a medical condition\n* Lifetime history of major psychotic disorders (including schizophrenia and bipolar disorder)\n* Current use of any medication for psychiatric reasons (including stimulants and mood stabilizers)\n\nAdditional Exclusion criteria for Binge Eating Sample:\n\n* Lost weight in recent past (\\>10 pounds in past 6 months)\n* Currently in a weight-loss program (e.g., Weight Watchers, Jenny Craig)\n* Currently on a special diet for a serious health condition\n* Current engagement in psychotherapy for binge eating disorder\n\nAdditional Exclusion Criteria for Smoking Sample:\n\n* Binge eating behavior\n* Current engagement in psychotherapy for smoking behavior'}, 'identificationModule': {'nctId': 'NCT03687658', 'briefTitle': 'Applying Novel Technologies and Methods to Self-Regulation: Behavior Change Tools for Smoking and Binge Eating', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Applying Novel Technologies and Methods to Inform the Ontology of Self-Regulation: Aim 4', 'orgStudyIdInfo': {'id': '47143'}, 'secondaryIdInfos': [{'id': '4UH3DA041713-04', 'link': 'https://reporter.nih.gov/quickSearch/4UH3DA041713-04', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Binge Eating Group', 'description': 'All participants in the study will be invited to use Laddr, described in the intervention section.', 'interventionNames': ['Behavioral: Laddr']}, {'type': 'EXPERIMENTAL', 'label': 'Smoking Group', 'description': 'All participants in the study will be invited to use Laddr, described in the intervention section.', 'interventionNames': ['Behavioral: Laddr']}], 'interventions': [{'name': 'Laddr', 'type': 'BEHAVIORAL', 'description': 'Laddr is an integrated, personalized, web-based self-regulation assessment and behavior change system. It integrates tools that have been shown to be effective for a wide array of behavioral phenomena ranging from substance use and abuse, mental health, risk-taking, chronic pain management, medication adherence, diet, exercise, diabetes and other chronic disease management, and smoking. The organizational structure, functionality and content within Laddr\'s system centrally embrace these fundamental aspects of behavior change; thus, the Laddr platform is not "diagnosis-specific" but rather enables integrated care for any combination of individuals\' goals, needs, and preferences.', 'armGroupLabels': ['Binge Eating Group', 'Smoking Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Center for Cognitive and Neurobiological Imaging', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Russell A Poldrack, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}, {'name': 'Patrick G Bissett, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Data will be available upon submission of the paper detailing the findings of the research.', 'ipdSharing': 'YES', 'description': 'After completion of the study, a de-identified dataset (i.e., stripped of all codes or other information that could be linked back to an individual participant) will be generated and made available to the research community as a whole.', 'accessCriteria': 'All data will be shared openly, with no restrictions on access.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Russell Alan Poldrack', 'investigatorAffiliation': 'Stanford University'}}}}