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

NCT ID: NCT00217490

Last Updated: 2017-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 621 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2008-09-30

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

dietary counseling via computer

Intervention Type: BEHAVIORAL

An interactive computer program that addresses dietary change, barriers to change and possible solution to barriers to develop an action plan

Counseling only

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

Group Type: EXPERIMENTAL

dietary counseling via nutritionist

Intervention Type: BEHAVIORAL

A one on one counseling sessions to addresses dietary change, barriers to change and possible solution to barriers to develop an action plan

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.

Group Type: EXPERIMENTAL

combined computer and nutritionist

Intervention Type: BEHAVIORAL

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

Physical Activity-computer

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

Group Type: ACTIVE_COMPARATOR

physical activity counseling via computer

Intervention Type: OTHER

An interactive computer program that addresses increase to physical activity, barriers to change and possible solution to barriers to develop an action plan

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: BEHAVIORAL

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Victor J. Stevens, PhD

Role: STUDY_CHAIR

Kaiser Permanente

Locations

Kaiser Permanente - Aurora

Aurora, Colorado, United States

Oregon Research Institute

Eugene, Oregon, United States

Kaiser Permanente Center for Health Research

Portland, Oregon, United States

Countries

United States

References

Glasgow RE, Christiansen S, Smith KS, Stevens VJ, Toobert DJ. Development and implementation of an integrated, multi-modality, user-centered interactive dietary change program. Health Educ Res. 2009 Jun;24(3):461-71. doi: 10.1093/her/cyn042. Epub 2008 Aug 18.

Reference Type: BACKGROUND

PMID: 18711204 (View on PubMed)

Other Identifiers

R01CA098496

Identifier Type: NIH

Identifier Source: secondary_id

View Link

KAISER-R01-CA098496

Identifier Type: -

Identifier Source: secondary_id

CDR0000441203

Identifier Type: -

Identifier Source: org_study_id