Individual Counseling and/or Computer-Based Counseling in Helping Healthy Women Adopt a Cancer Prevention Diet
Helping Women Adopt a Cancer Prevention Diet
3 other identifiers
interventional
621
1 country
3
Brief Summary
RATIONALE: Eating a diet high in fruits and vegetables and low in fat may lower the risk of some types of cancer. Dietary counseling may be effective in helping women change to a healthy diet. PURPOSE: This randomized clinical trial is studying how well individual counseling and/or computer-based counseling work in helping healthy women adopt a cancer prevention diet.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2005
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 20, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedResults Posted
Study results publicly available
April 4, 2017
CompletedApril 4, 2017
February 1, 2017
3.5 years
September 20, 2005
September 29, 2015
February 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Fruit, Vegetable Consumption as Measured by Food Frequency Questionnaire at 3 Months
Self reported dietary change in consumption as collected via Block Food Frequency Questionnaire (FFQ) servings of fruit or vegetable per day and average fat consumption. This FFQ asks participants to recall their average consumption of various categories of food during the previous three months.
Baseline and 3 months
Change in Percentage of Fat Consumed
Self reported dietary change in consumption as collected via Block Food Frequency Questionnaire (FFQ) servings of fruit or vegetable per day and average fat consumption. This FFQ asks participants to recall their average consumption of various categories of food during the previous three months.
Baseline and 3 months
Study Arms (4)
Computer Only
EXPERIMENTALDietary Counseling delivered by interactive computer program, without the addition of individual counseling provided by a health counselor. This arm tested a completely automated counseling program that did not include personalized behavioral counseling provided by a study staff member.
Counseling only
EXPERIMENTALIn this arm, dietary counseling was delivered by nutritionist, and this counseling did not include use of an automated, computer program.
Combined
EXPERIMENTALIn this arm, participants received dietary counseling delivered using both the automated computer program and additional counseling by a study nutritionist. That is, this arm combined the intervention programs delivered in the other two active intervention arms.
Physical Activity-computer
ACTIVE COMPARATORParticipants assigned to this arm did not receive nutrition counseling, but they were provided physical activity counseling delivered by computer only.
Interventions
An interactive computer program that addresses dietary change, barriers to change and possible solution to barriers to develop an action plan
A one on one counseling sessions to addresses dietary change, barriers to change and possible solution to barriers to develop an action plan
An interactive computer program plus one on one nutrition counseling that addresses dietary change, barriers to change and possible solution to barriers to develop an action plan
An interactive computer program that addresses increase to physical activity, barriers to change and possible solution to barriers to develop an action plan
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Kaiser Permanentelead
- National Cancer Institute (NCI)collaborator
Study Sites (3)
Kaiser Permanente - Aurora
Aurora, Colorado, 80014, United States
Oregon Research Institute
Eugene, Oregon, 97403, United States
Kaiser Permanente Center for Health Research
Portland, Oregon, 97227, United States
Related Publications (1)
Glasgow RE, Christiansen S, Smith KS, Stevens VJ, Toobert DJ. Development and implementation of an integrated, multi-modality, user-centered interactive dietary change program. Health Educ Res. 2009 Jun;24(3):461-71. doi: 10.1093/her/cyn042. Epub 2008 Aug 18.
PMID: 18711204BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Victor J. Stevens, PhD
- Organization
- Kaiser Permanente Center for Health Research
Study Officials
- STUDY CHAIR
Victor J. Stevens, PhD
Kaiser Permanente
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2005
First Posted
September 22, 2005
Study Start
March 1, 2005
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
April 4, 2017
Results First Posted
April 4, 2017
Record last verified: 2017-02