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

Kaiser Permanente

Status: Completed

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Treatments: Behavioral: dietary counseling via computer; Behavioral: combined computer and nutritionist; Behavioral: dietary counseling via nutritionist; Other: physical activity counseling via computer

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00217490

KAISER-R01-CA098496

R01CA098496 (U.S. NIH Grant/Contract)

CDR0000441203

Details and patient eligibility

About

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.

Full 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.

Enrollment: 621 patients

Sex: Female

Ages: 30 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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621 participants in 4 patient groups

Computer Only

Experimental group

Description:

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.

Treatment:

Behavioral: dietary counseling via computer

Counseling only

Experimental group

Description:

In this arm, dietary counseling was delivered by nutritionist, and this counseling did not include use of an automated, computer program.

Treatment:

Behavioral: dietary counseling via nutritionist

Combined

Experimental group

Description:

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.

Treatment:

Behavioral: combined computer and nutritionist

Physical Activity-computer

Active Comparator group

Description:

Participants assigned to this arm did not receive nutrition counseling, but they were provided physical activity counseling delivered by computer only.

Treatment:

Other: physical activity counseling via computer