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Individual Counseling and/or Computer-Based Counseling in Helping Healthy Women Adopt a Cancer Prevention Diet
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Kaiser Permanente
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00217490
  Purpose

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 Intervention
Unspecified Adult Solid Tumor, Protocol Specific
Procedure: behavioral dietary intervention
Procedure: counseling
Procedure: dietary intervention
Procedure: preventative dietary intervention

MedlinePlus related topics: Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Active Control
Official Title: Helping Women Adopt a Cancer Prevention Diet

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Self-reported change in fruit, vegetable, and fat consumption as measured by food frequency questionnaire at 3, 12, and 18 months [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self-reported change in physical acitivity as measured by CHAMPS at 3, 12, and 18 months [ Designated as safety issue: No ]
  • Change in weight as measured in pounds at 3, 12, and 18 months [ Designated as safety issue: No ]

Study Start Date: March 2005
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.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00217490

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

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000441203, KAISER-R01-CA098496
Study First Received: September 20, 2005
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00217490  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:
Healthy

ClinicalTrials.gov processed this record on January 14, 2009