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Clinical Trials/NCT00217490
NCT00217490
Completed
Not Applicable

Helping Women Adopt a Cancer Prevention Diet

Kaiser Permanente3 sites in 1 country621 target enrollmentMarch 2005

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Unspecified Adult Solid Tumor, Protocol Specific
Sponsor
Kaiser Permanente
Enrollment
621
Locations
3
Primary Endpoint
Change in Fruit, Vegetable Consumption as Measured by Food Frequency Questionnaire at 3 Months
Status
Completed
Last Updated
9 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
March 2005
End Date
September 2008
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

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.

Study Sites (3)

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