Individual Counseling and/or Computer-Based Counseling in Helping Healthy Women Adopt a Cancer Prevention Diet
Condition: Unspecified Adult Solid Tumor, Protocol Specific
Study type: Interventional

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.
    

Intervention name(s): dietary counseling via computer; dietary counseling via nutritionist; combined computer and nutritionist; physical activity counseling via computer
Intervention type(s): Behavioral; Behavioral; Behavioral; Other
Intervention description(s): An interactive computer program that addresses dietary change, barriers to change and possible solution to barriers to develop an action plan; A one on one counseling sessions to addresses dietary change, barriers to change and possible solution to barriers to develop an action plan; 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; An interactive computer program that addresses increase to physical activity, barriers to change and possible solution to barriers to develop an action plan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: unspecified adult solid tumor, protocol specific