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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Helping Women Adopt a Cancer Prevention Diet

Conditions
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Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Behavioral: dietary counseling via computer
* Behavioral: dietary counseling via nutritionist
* Behavioral: combined computer and nutritionist
* Other: physical activity counseling via computer


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Computer Only<br>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. | Behavioral: dietary counseling via computer<br>* An interactive computer program that addresses dietary change, barriers to change and possible solution to barriers to develop an action plan<br>|
| Experimental: Counseling only<br>In this arm, dietary counseling was delivered by nutritionist, and this counseling did not include use of an automated, computer program. | Behavioral: dietary counseling via nutritionist<br>* A one on one counseling sessions to addresses dietary change, barriers to change and possible solution to barriers to develop an action plan<br>|
| Experimental: Combined<br>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. | Behavioral: combined computer and nutritionist<br>* 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<br>|
| Active Comparator: Physical Activity-computer<br>Participants assigned to this arm did not receive nutrition counseling, but they were provided physical activity counseling delivered by computer only. | Other: physical activity counseling via computer<br>* An interactive computer program that addresses increase to physical activity, barriers to change and possible solution to barriers to develop an action plan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fruit, Vegetable Consumption as Measured by Food Frequency Questionnaire at 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. | Baseline and 3 months | 
| Change in Percentage of Fat Consumed | 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. | Baseline and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unspecified adult solid tumor, protocol specific