Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-26 @ 4:13 PM
Study NCT ID:
NCT01408459
Status:
COMPLETED
Last Update Posted:
2025-05-16
First Post:
2011-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Adherence Dynamics for Whole Food Interventions in African-American Men
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pbowen@uic.edu', 'phone': '708-524-0586', 'title': 'Dr. Phyllis E. Bowen', 'organization': 'University of Illinois at Chicago'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The number of phone calls and collected diet recalls between groups was different because of concern that the control group would increase their tomato product intake.'}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Tomato Product', 'description': 'Tomato Product: Motivational Telephone Counseling weekly', 'otherNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'No Motivation telephone Counseling\n\nControl: No Motivational telephone Counseling', 'otherNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Tomato Product Intake Between Different Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tomato Product', 'description': 'Tomato Product: Motivational Telephone Counseling weekly'}, {'id': 'OG001', 'title': 'Control', 'description': 'No Motivation telephone Counseling\n\nControl: No Motivational telephone Counseling'}], 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'The intervention group: aimed to achieve the goal of more than five servings of TP/week while control group aimed to eat vegetable instead of tomatoes.', 'unitOfMeasure': 'servings/week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Diet Adherence to Tomato Product Consumption Between Different Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tomato Product', 'description': 'Tomato Product: Motivational Telephone Counseling weekly'}, {'id': 'OG001', 'title': 'Control', 'description': 'No Motivation telephone Counseling\n\nControl: No Motivational telephone Counseling'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months', 'description': 'Using 24-hr recall weekly, consumption of tomato product was measured by serving size.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Unit: Number of Participants'}, {'type': 'SECONDARY', 'title': 'Consumption of Tomato Products Between Different Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tomato Product', 'description': 'Tomato Product: Motivational Telephone Counseling weekly'}, {'id': 'OG001', 'title': 'Control', 'description': 'No Motivation telephone Counseling\n\nControl: No Motivational telephone Counseling'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': 'Using 24-hr diet recall, types of tomato products were counted.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Differences in Dietary Lycopene Intake Between Different Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tomato Product', 'description': 'Motivational telephone counseling weekly\n\nTomato Product: Motivational Telephone Counseling weekly'}, {'id': 'OG001', 'title': 'Control', 'description': 'No Motivation telephone Counseling\n\nControl: No Motivational telephone Counseling'}], 'classes': [{'categories': [{'measurements': [{'value': '20.6', 'spread': '11.3', 'groupId': 'OG000'}, {'value': '7.25', 'spread': '9.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'unitOfMeasure': 'mg/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Plasma Lycopene Concentration Between Different Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tomato Product', 'description': 'Tomato Product: Motivational Telephone Counseling weekly'}, {'id': 'OG001', 'title': 'Control', 'description': 'No Motivation telephone Counseling\n\nControl: No Motivational telephone Counseling'}], 'classes': [{'categories': [{'measurements': [{'value': '0.63', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0.41', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'unitOfMeasure': 'µmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tomato Product', 'description': 'Tomato Product: Motivational Telephone Counseling weekly'}, {'id': 'FG001', 'title': 'Control', 'description': 'No Motivation telephone Counseling\n\nControl: No Motivational telephone Counseling'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Medical Clinic from June 2007 to Aug 2008'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tomato Product', 'description': 'Tomato Product: Motivational Telephone Counseling weekly'}, {'id': 'BG001', 'title': 'Control', 'description': 'No Motivation telephone Counseling\n\nControl: No Motivational telephone Counseling'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.2', 'spread': '7.2', 'groupId': 'BG000'}, {'value': '68.4', 'spread': '7.44', 'groupId': 'BG001'}, {'value': '67.1', 'spread': '7.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2008-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-14', 'studyFirstSubmitDate': '2011-08-01', 'resultsFirstSubmitDate': '2014-11-05', 'studyFirstSubmitQcDate': '2011-08-02', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-08', 'studyFirstPostDateStruct': {'date': '2011-08-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tomato Product Intake Between Different Groups', 'timeFrame': '3 months', 'description': 'The intervention group: aimed to achieve the goal of more than five servings of TP/week while control group aimed to eat vegetable instead of tomatoes.'}], 'secondaryOutcomes': [{'measure': 'Diet Adherence to Tomato Product Consumption Between Different Groups', 'timeFrame': '3 months', 'description': 'Using 24-hr recall weekly, consumption of tomato product was measured by serving size.'}, {'measure': 'Consumption of Tomato Products Between Different Groups', 'timeFrame': '3 months', 'description': 'Using 24-hr diet recall, types of tomato products were counted.'}, {'measure': 'Differences in Dietary Lycopene Intake Between Different Groups', 'timeFrame': '3 months'}, {'measure': 'Plasma Lycopene Concentration Between Different Groups', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prostate cancer prevention'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '23200261', 'type': 'RESULT', 'citation': 'Park E, Stacewicz-Sapuntzakis M, Sharifi R, Wu Z, Freeman VL, Bowen PE. Diet adherence dynamics and physiological responses to a tomato product whole-food intervention in African-American men. Br J Nutr. 2013 Jun 28;109(12):2219-30. doi: 10.1017/S0007114512004436. Epub 2012 Nov 19.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/23200261', 'label': 'Pubmed'}]}, 'descriptionModule': {'briefSummary': 'The purposes of this study are to explore the dynamics of adherence, using a simple whole food intervention strategy, both prior to and during the intervention period and to identify nutrient shifts in self-selected diets and to determine health risks (blood pressure, hyperlipidemia, and body weight) that may have resulted from increased tomato product consumption.', 'detailedDescription': 'African-American (AA) men suffer the greatest proportion of health disparities of any studied category and adherence to advice among this group has been vastly understudied.\n\nAlthough there are several ongoing trials for behavioral change, either of diet or lifestyle, enrollment rates of AA men (\\< 25%) often provide insufficient numbers to evaluate adherence issues separately.\n\nTomatoes, more than lycopene alone, may have beneficial effects on prostate health, including BPH and prostate cancer. Efficacy trials would require long-term adherence to high levels of tomato product (TP) consumption.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* African-American men aged ≥ 50 yr who recently were found to have serum prostate specific antigen (PSA) concentrations of \\>2.5 ng/mL with negative prostate biopsy for prostate cancer.\n* English literacy\n* willing to consume tomato products on a regular basis.\n\nExclusion Criteria:\n\n* prostate cancer diagnosis\n* other cancers \\< 5 yrs postdiagnosis except for melanoma\n* already consuming four 1/2 cup servings of tomato products/wk.'}, 'identificationModule': {'nctId': 'NCT01408459', 'acronym': 'DAPH', 'briefTitle': 'Adherence Dynamics for Whole Food Interventions in African-American Men', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Chicago'}, 'officialTitle': 'Adherence Dynamics for Whole Food Interventions in African-American Men', 'orgStudyIdInfo': {'id': '2006-0354'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tomato product', 'description': 'Motivational telephone counseling weekly', 'interventionNames': ['Dietary Supplement: Tomato Product']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'No Motivation telephone Counseling', 'interventionNames': ['Dietary Supplement: Control']}], 'interventions': [{'name': 'Tomato Product', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Intervention group'], 'description': 'Motivational Telephone Counseling weekly', 'armGroupLabels': ['Tomato product']}, {'name': 'Control', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Control Group'], 'description': 'No Motivational telephone Counseling', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60606', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Eunyoung Park, M.S.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Illinois at Chicago'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}