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Individual Counseling and/or Computer-Based Counseling in Helping Healthy Women Adopt a Cancer Prevention Diet

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00217490
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : April 4, 2017
Last Update Posted : April 4, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Kaiser Permanente

Study Description
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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.


Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Behavioral: dietary counseling via computer Behavioral: dietary counseling via nutritionist Behavioral: combined computer and nutritionist Other: physical activity counseling via computer Not Applicable

Detailed Description:

OBJECTIVES:

  • Compare 3-, 12-, and 18-month changes in self-reported daily servings of fruits and vegetables and percent of energy from fat in healthy women undergoing dietary modification intervention comprising in-person individualized counseling vs automated computer-based counseling vs both dietary modification interventions vs automated computer-based physical activity counseling (control).
  • Compare the efficacy and long-term effects of these interventions in these participants.
  • Compare participant acceptance of these interventions, in terms of the proportion and characteristics (e.g., age and race) of participants who accept the intervention and participate in intervention activities.
  • Compare initial dietary change, in terms of dietary habits, socio-demographics, and self-efficacy, in participants undergoing these interventions.
  • Compare the maintenance of dietary change, in terms of demographics, self efficacy, and perceived community environmental support, in participants undergoing these interventions.
  • Compare the cost of delivering these interventions to these participants.
  • Compare the cost of these interventions when used in routine practice.

OUTLINE: This is a randomized study. Participants are randomized to 1 of 4 arms.

  • Arm I (in-person individualized dietary modification counseling): Participants undergo in-person individualized counseling in weeks 0 and 3 and receive a phone call by a counselor in weeks 1, 6, and 9 about increasing daily fruit and vegetable intake to 5-9 servings and reducing fat intake to no more than 25% of energy.
  • Arm II (automated computer-based dietary modification counseling): Participants undergo automated computer-based counseling in weeks 0 and 3 and receive an automated phone call in weeks 1, 6, and 9 about increasing daily fruit and vegetable intake to 5-9 servings and reducing fat intake to no more than 25% of energy.
  • Arm III (in-person individualized and automated computer-based dietary modification counseling): Participants undergo in-person individualized counseling and automated computer-based counseling in weeks 0 and 3 and receive a phone call by a counselor in week 6 and an automated phone call in weeks 1 and 9 about increasing daily fruit and vegetable intake to 5-9 servings and reduce fat intake to no more than 25% of energy.
  • Arm IV (automated computer-based physical activity counseling [control]): Participants undergo automated computer-based counseling in weeks 0 and 3 and receive an automated phone call in weeks 1, 6, and 9 about increasing daily physical activity to a moderate amount (20-30 minutes per day).

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 621 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Helping Women Adopt a Cancer Prevention Diet
Study Start Date : March 2005
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008
Arms and Interventions
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Arm Intervention/treatment
Experimental: Computer Only
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
An interactive computer program that addresses dietary change, barriers to change and possible solution to barriers to develop an action plan
Experimental: Counseling only
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
A one on one counseling sessions to addresses dietary change, barriers to change and possible solution to barriers to develop an action plan
Experimental: Combined
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
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
Active Comparator: Physical Activity-computer
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 increase to physical activity, barriers to change and possible solution to barriers to develop an action plan


Outcome Measures
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Primary Outcome Measures :
  1. Change in Fruit, Vegetable Consumption as Measured by Food Frequency Questionnaire at 3 Months [ Time Frame: Baseline and 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.

  2. Change in Percentage of Fat Consumed [ Time Frame: Baseline and 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.


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

DISEASE CHARACTERISTICS:

  • Healthy participant

    • Not undergoing care for cancer
  • 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

  • 30 to 70

Sex

  • Female

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00217490


Locations
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United States, Colorado
Kaiser Permanente - Aurora
Aurora, Colorado, United States, 80014
United States, Oregon
Oregon Research Institute
Eugene, Oregon, United States, 97403
Kaiser Permanente Center for Health Research
Portland, Oregon, United States, 97227
Sponsors and Collaborators
Kaiser Permanente
National Cancer Institute (NCI)
Investigators
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Study Chair: Victor J. Stevens, PhD Kaiser Permanente
More Information
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Publications:

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Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT00217490    
Other Study ID Numbers: CDR0000441203
R01CA098496 ( U.S. NIH Grant/Contract )
KAISER-R01-CA098496
First Posted: September 22, 2005    Key Record Dates
Results First Posted: April 4, 2017
Last Update Posted: April 4, 2017
Last Verified: February 2017
Keywords provided by Kaiser Permanente:
unspecified adult solid tumor, protocol specific