Overview

This trial is active, not recruiting.

Condition unspecified adult solid tumor, protocol specific
Treatments behavioral dietary intervention, dietary intervention, counseling intervention, preventative dietary intervention
Sponsor Kaiser Permanente
Collaborator National Cancer Institute (NCI)
Start date March 2005
Trial identifier NCT00217490, CDR0000441203, KAISER-R01-CA098496

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Primary purpose prevention

Primary Outcomes

Measure
Self-reported change in fruit, vegetable, and fat consumption as measured by food frequency questionnaire at 3, 12, and 18 months
time frame:

Secondary Outcomes

Measure
Self-reported change in physical acitivity as measured by CHAMPS at 3, 12, and 18 months
time frame:
Change in weight as measured in pounds at 3, 12, and 18 months
time frame:

Eligibility Criteria

Female participants from 30 years up to 70 years old.

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

Additional Information

Official title Helping Women Adopt a Cancer Prevention Diet
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2009.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).