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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA098496 | U.S. NIH Grant/Contract | View source | |
| KAISER-R01-CA098496 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
OUTLINE: This is a randomized study. Participants are randomized to 1 of 4 arms.
After study completion, patients are followed at 3, 12, and 18 months.
PROJECTED ACCRUAL: A total of 600 participants (150 per arm) will be accrued for this study within 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Computer Only | Experimental | Dietary 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. |
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| Counseling only | Experimental | In this arm, dietary counseling was delivered by nutritionist, and this counseling did not include use of an automated, computer program. |
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| Combined | Experimental | In 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. |
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| Physical Activity-computer | Active Comparator | Participants assigned to this arm did not receive nutrition counseling, but they were provided physical activity counseling delivered by computer only. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dietary counseling via computer | Behavioral | An interactive computer program that addresses dietary change, barriers to change and possible solution to barriers to develop an action plan |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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DISEASE CHARACTERISTICS:
Healthy participant
Kaiser Permanente health plan member for at least 2 years
No current dietary goals
No diet comprising an average consumption of > 4 combined servings of fruits and vegetables per day and/or fat consumption below 30% of total energy
No physician-prescribed diets
PATIENT CHARACTERISTICS:
Age
Sex
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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| Name | Affiliation | Role |
|---|---|---|
| Victor J. Stevens, PhD | Kaiser Permanente | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente - Aurora | Aurora | Colorado | 80014 | United States | ||
| Oregon Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18711204 | Background | 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. |
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Women who agreed to come in for the initial visit and randomization were excluded if they were not willing to change diet or physical activity, could not speak and read English.
Women in Kaiser Permanente were identified from the electronic medical record and sent a letter inviting them to participate in the study. Recruitment started in 2003
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| ID | Title | Description |
|---|---|---|
| FG000 | Computer Only | Dietary Counseling delivered by interactive computer |
| FG001 | Counseling Only | Dietary counseling delivered by nutritionist |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| dietary counseling via nutritionist | Behavioral | A one on one counseling sessions to addresses dietary change, barriers to change and possible solution to barriers to develop an action plan |
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| combined computer and nutritionist | Behavioral | 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 |
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| physical activity counseling via computer | Other | An interactive computer program that addresses increase to physical activity, barriers to change and possible solution to barriers to develop an action plan |
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| Eugene |
| Oregon |
| 97403 |
| United States |
| Kaiser Permanente Center for Health Research | Portland | Oregon | 97227 | United States |
| FG002 | Combined | Dietary counseling delivered using computer program and nutritionist |
| FG003 | Physcial Activity-computer | Physical activity counseling delivered by computer only |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Computer Only | Dietary Counseling delivered by interactive computer |
| BG001 | Counseling Only | Dietary counseling delivered by nutritionist |
| BG002 | Combined | Dietary counseling delivered using computer program and nutritionist |
| BG003 | Physcial Activity-computer | Physical activity counseling delivered by computer only |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participant who returned for follow up visit | Posted | Mean | Standard Deviation | number of servings per day | Baseline and 3 months |
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| Primary | 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. | Participants who returned for follow up visit | Posted | Mean | Standard Deviation | Percentage of fat consumed | Baseline and 3 months |
|
18 months
No DSMB required. Low risk dietary behavioral change intervention
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Computer Only | Dietary Counseling delivered by interactive computer | 0 | 154 | 0 | 154 | ||
| EG001 | Counseling Only | Dietary counseling delivered by nutritionist | 0 | 153 | 0 | 153 | ||
| EG002 | Combined | Dietary counseling delivered using computer program and nutritionist | 0 | 155 | 0 | 155 | ||
| EG003 | Physcial Activity-computer | Physical activity counseling delivered by computer only | 0 | 153 | 0 | 153 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Victor J. Stevens, PhD | Kaiser Permanente Center for Health Research | 503 335 6751 | victor.j.stevens@kpchr.org |
| ID | Term |
|---|---|
| D064686 | Nutritionists |
| ID | Term |
|---|---|
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Units | Counts |
|---|---|
| Participants |
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