Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-03-03 @ 2:06 PM
Study NCT ID:
NCT01864694
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2013-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Dietary Behavior Through Tailored Messages
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1224}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-24', 'studyFirstSubmitDate': '2013-05-02', 'studyFirstSubmitQcDate': '2013-05-24', 'lastUpdatePostDateStruct': {'date': '2013-05-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in diet from baseline to 6 months, 6 months to 18 months, and baseline to 18 months', 'timeFrame': 'Baseline, 6 months, and 18 months', 'description': 'Self-reported diet questionnaire to measure fat and fruits/vegetables'}], 'secondaryOutcomes': [{'measure': 'Change in psychosocial variables from baseline to 6 months, 6 months to 18 months, and baseline to 18 months', 'timeFrame': 'Baseline, 6 months, and 18 months', 'description': 'Additional theoretical variables, such as Stages of change, as measured by self-reported questionnaire'}, {'measure': 'Change in diet variables from baseline to 6 months, 6 months to 18 months, and baseline to 18 months', 'timeFrame': 'Baseline, 6 months, and 18 months', 'description': 'Additional diet variables, such as total calories, trans fat, and carotenoids, as measured by self-reported food frequency questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['behavioral research', 'diet', 'health information systems'], 'conditions': ['Cardiovascular Disease']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare a Web-based system and a computer telephone system to determine their effectiveness in improving diet behaviors compared to each other and a control group.', 'detailedDescription': 'The aim of this study is to compare a Web-based system (WEB-DIET) and a computer telephone system (TLC \\[Telephone Linked Communications\\]-DIET) for affecting dietary behavior change. These interventions will target the same dietary behaviors (consumption of fat and fruits and vegetables). The behavior change strategies and content will be derived from the same behavior change theory (the Transtheoretical Model \\[TTM\\]). A representative sample of \\~1200 adults from a large urban area will be recruited through a list-assisted telephone list which will be bought by the University of Rhode Island so that subjects can be randomized into one of three groups: a Web-based system (WEB- DIET), a computer telephone system (TLC \\[Telephone Linked Communications\\]-DIET), or assessment only control. The study hypotheses, which will be evaluated both at the end of the 6-month intervention period and at the end of 18-month follow-up (post-baseline) observation period, are: 1. TLC-DIET\\> Control 2. WEB-DIET\\> Control 3. WEB-DIET\\> TLC-DIET.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 years of age or older\n* Be at risk with regard to saturated fat\n* Have access to basic computer hardware and software\n* Use the Internet regularly (defined as 1 times per week) and with basic proficiency\n* Read and speak English at a fifth grade level\n* Have access to a telephone and be able to use it independently.\n\nExclusion Criteria:\n\n* Prescribed a diet that would conflict with a low saturated fat (e.g., a colectomy diet)\n* Have a serious medical, psychiatric, or cognitive disease that would interfere with participation (e.g., cancer undergoing chemotherapy, psychotic disorder, Alzheimer's disease, etc.)\n* If the individual does not use the Internet at least once a week"}, 'identificationModule': {'nctId': 'NCT01864694', 'briefTitle': 'Improving Dietary Behavior Through Tailored Messages', 'organization': {'class': 'OTHER', 'fullName': 'Boston Medical Center'}, 'officialTitle': 'Improving Dietary Behavior Through Tailored Messages', 'orgStudyIdInfo': {'id': '5R01HL081380', 'link': 'https://reporter.nih.gov/quickSearch/5R01HL081380', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TLC-Diet', 'description': 'Participants receive diet intervention through automated telephone system: TLC-Diet', 'interventionNames': ['Behavioral: TLC-Diet']}, {'type': 'EXPERIMENTAL', 'label': 'WEB-Diet', 'description': 'Participants receive diet intervention through web-based system: WEB-Diet', 'interventionNames': ['Behavioral: WEB-Diet']}, {'type': 'EXPERIMENTAL', 'label': 'Control', 'description': 'Assessment-only control group', 'interventionNames': ['Other: Assessment-only control']}], 'interventions': [{'name': 'TLC-Diet', 'type': 'BEHAVIORAL', 'description': 'Participants receive diet intervention through an automated telephone system', 'armGroupLabels': ['TLC-Diet']}, {'name': 'WEB-Diet', 'type': 'BEHAVIORAL', 'description': 'Participants receive diet intervention through a web-based system', 'armGroupLabels': ['WEB-Diet']}, {'name': 'Assessment-only control', 'type': 'OTHER', 'description': 'Assessment-only control', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Robert H Friedman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Rhode Island', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}