An interventional study of dietary counseling via computer and dietary counseling via nutritionist in Unspecified Adult Solid Tumor, Protocol Specific, sponsored by Kaiser Permanente. Completed at 3 sites in United States. Open to female participants aged 30 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-04.
Sponsored by Kaiser Permanente · Not applicable, Interventional, and Prevention
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.
Kaiser Permanente is the lead sponsor of 385 studies on the registry; 41 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Healthy participant
PATIENT CHARACTERISTICS:
Age
Sex
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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.
Behavioral: dietary counseling via computer
In this arm, dietary counseling was delivered by nutritionist, and this counseling did not include use of an automated, computer program.
Behavioral: dietary counseling via nutritionist
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.
Behavioral: combined computer and nutritionist
Participants assigned to this arm did not receive nutrition counseling, but they were provided physical activity counseling delivered by computer only.
Other: physical activity counseling via computer
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
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.
Time frame: 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.
Time frame: Baseline and 3 months
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
| Milestone | Computer Only | Counseling Only | Combined | Physcial Activity-computer |
|---|---|---|---|---|
| Started | 154 | 153 | 155 | 153 |
| Completed | 137 | 128 | 131 | 130 |
| Not completed | 17 | 25 | 24 | 23 |
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.
| number of servings per day | Computer Only | Counseling Only | Combined | Physcial Activity-computer |
|---|---|---|---|---|
| Change in Fruit, Vegetable Consumption as Measured by Food Frequency Questionnaire at 3 Months | 2.7272727 ± 2.7480483 | 2.9758065 ± 2.8426456 | 2.7330645 ± 2.7742053 | 0.4720000 ± 2.2229594 |
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.
| Percentage of fat consumed | Computer Only | Counseling Only | Combined | Physcial Activity-computer |
|---|---|---|---|---|
| Change in Percentage of Fat Consumed | -4.653333 ± 7.4788051 | -5.3439516 ± 7.3594025 | -6.0113710 ± 6.9703683 | -1.4154400 ± 7.9831426 |
Collected over 18 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Computer Only | — | 0/154 (0%) | 0/154 (0%) |
| Counseling Only | — | 0/153 (0%) | 0/153 (0%) |
| Combined | — | 0/155 (0%) | 0/155 (0%) |
| Physcial Activity-computer | — | 0/153 (0%) | 0/153 (0%) |
| Age, Categorical(Participants) | Computer Only | Counseling Only | Combined | Physcial Activity-computer | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 144 | 143 | 143 | 144 | 574 |
| >=65 years | 10 | 10 | 12 | 9 | 41 |
| Sex: Female, Male(Participants) | Computer Only | Counseling Only | Combined | Physcial Activity-computer | Total |
|---|---|---|---|---|---|
| Female | 154 | 153 | 155 | 153 | 615 |
| Male | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Computer Only | Counseling Only | Combined | Physcial Activity-computer | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 6 | 3 | 6 | 4 | 19 |
| Not Hispanic or Latino | 145 | 148 | 147 | 146 | 586 |
| Unknown or Not Reported | 3 | 2 | 2 | 3 | 10 |
| Race (NIH/OMB)(Participants) | Computer Only | Counseling Only | Combined | Physcial Activity-computer | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 2 | 2 | 1 | 1 | 6 |
| Asian | 2 | 4 | 1 | 1 | 8 |
| Native Hawaiian or Other Pacific Islander | 0 | 3 | 1 | 0 | 4 |
| Black or African American | 9 | 9 | 14 | 16 | 48 |
| White | 132 | 131 | 135 | 129 | 527 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 9 | 4 | 3 | 6 | 22 |
| Region of Enrollment(participants) | Computer Only | Counseling Only | Combined | Physcial Activity-computer | Total |
|---|---|---|---|---|---|
| United States | 154 | 153 | 155 | 153 | 615 |
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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