Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-01-07 @ 12:58 PM
Study NCT ID:
NCT00468156
Status:
COMPLETED
Last Update Posted:
2012-12-20
First Post:
2007-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Fruit and Vegetable Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-11', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-19', 'studyFirstSubmitDate': '2007-04-30', 'studyFirstSubmitQcDate': '2007-04-30', 'lastUpdatePostDateStruct': {'date': '2012-12-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Document enrollment success at a primary care clinic', 'timeFrame': '8 months'}], 'secondaryOutcomes': [{'measure': 'Determine change in fruit and vegetable consumption', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['fruit', 'vegetables', 'prevention', 'cancer', 'counseling', 'cancer risk'], 'conditions': ['Cancer']}, 'referencesModule': {'references': [{'pmid': '20226809', 'type': 'RESULT', 'citation': 'Djuric Z, Ellsworth JS, Ren J, Sen A, Ruffin MT 4th. A randomized feasibility trial of brief telephone counseling to increase fruit and vegetable intakes. Prev Med. 2010 May-Jun;50(5-6):265-71. doi: 10.1016/j.ypmed.2010.03.003. Epub 2010 Mar 11.'}]}, 'descriptionModule': {'briefSummary': 'The main aim of this study is to determine if persons can increase fruit and vegetable intakes if they make a specific plan to do so.', 'detailedDescription': 'The conduct of cancer prevention trials through community settings and/or national networks of clinical sites requires the development of appropriate interventions. One promising behavioral strategy that is very simple to administer is that of the formulation of implementation intentions. The premise of this intervention is that once persons formulate a plan of action, automatic behavior follows. Use of this intervention in primary care is an innovative approach to eliciting preventive behaviors with minimal staff time. The goal in this study will be to increase fruit and vegetable consumption by 2 servings/day without a change in overall energy intakes by decreasing consumption of a less nutritious food. Substitution of foods is critical for prevention of weight gain. This feasibility study aims conduct a randomized, controlled clinical trial to test whether formulation of implementation intentions, either alone or with telephone support, can increase fruit and vegetable consumption without an increase in overall energy intakes. Recruitment success in a family medicine clinic in Ypsilanti Michigan will be documented with emphasis on the extent of minority participation. Dietary assessment will be the main outcome variable. Other assessments will include demographics, self-assessment of behaviors targeted by the intervention and levels of carotenoids in plasma. We will enroll 105 subjects to retain 28/arm, and power is good to detect small differences in fruit and vegetable intakes among the three study arms. This will generate useful data for the design of larger dietary intervention trials that are cost-effective and which will utilize multiple clinical sites to optimize enrollment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 40 and older\n* Give informed consent\n* In general good health\n* Less than 5.5 servings/day of fruits and vegetables\n\nExclusion Criteria:\n\n* On medically prescribed diets that the study would not be consistent with\n* Evidence of eating disorders\n* Health problems that affect energy needs (eg. broken leg can interfere with normal activities and affect energy needs).'}, 'identificationModule': {'nctId': 'NCT00468156', 'briefTitle': 'The Fruit and Vegetable Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Implementation Intentions for Improving Fruit and Vegetable Intakes', 'orgStudyIdInfo': {'id': 'HUM00004225'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'written materials only', 'interventionNames': ['Behavioral: written materials only']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'written materials plus asked to form implementation intentions', 'interventionNames': ['Behavioral: written materials']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'same as arm 2 plus telephone support', 'interventionNames': ['Behavioral: telephone support']}], 'interventions': [{'name': 'written materials only', 'type': 'BEHAVIORAL', 'otherNames': ['control'], 'description': 'related to fruit/vegetable servings/day', 'armGroupLabels': ['1']}, {'name': 'written materials', 'type': 'BEHAVIORAL', 'otherNames': ['asked to form implementation intentions'], 'description': 'related to fruit/vegetable servings/day', 'armGroupLabels': ['2']}, {'name': 'telephone support', 'type': 'BEHAVIORAL', 'otherNames': ['written plus telephone'], 'description': 'related to fruit/vegetable servings/day', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48197', 'city': 'Ypsilanti', 'state': 'Michigan', 'country': 'United States', 'facility': 'Ypsilanti Family Health Center', 'geoPoint': {'lat': 42.24115, 'lon': -83.61299}}], 'overallOfficials': [{'name': 'Zora Djuric, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Professor', 'investigatorFullName': 'Zora Djuric', 'investigatorAffiliation': 'University of Michigan'}}}}