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

Not Applicable

Completed

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

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

Registration Number: NCT00217490

Lead Sponsor: Kaiser Permanente

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 621

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Counseling only	dietary counseling via nutritionist	In this arm, dietary counseling was delivered by nutritionist, and this counseling did not include use of an automated, computer program.
Physical Activity-computer	physical activity counseling via computer	Participants assigned to this arm did not receive nutrition counseling, but they were provided physical activity counseling delivered by computer only.
Combined	combined computer and nutritionist	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.
Computer Only	dietary counseling via computer	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.

Primary Outcome Measures

Name	Time	Method
Change in Fruit, Vegetable Consumption as Measured by Food Frequency Questionnaire at 3 Months	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	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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (3): Oregon Research Institute
🇺🇸
Eugene, Oregon, United States
Kaiser Permanente - Aurora
🇺🇸
Aurora, Colorado, United States
Kaiser Permanente Center for Health Research
🇺🇸
Portland, Oregon, United States