Trial Information

Helping Women Adopt a Cancer Prevention Diet

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.