Know Cancer

or
forgot password

Helping Women Adopt a Cancer Prevention Diet


N/A
30 Years
70 Years
Open (Enrolling)
Female
Unspecified Adult Solid Tumor, Protocol Specific

Thank you

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.

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Prevention

Outcome Measure:

Self-reported change in fruit, vegetable, and fat consumption as measured by food frequency questionnaire at 3, 12, and 18 months

Safety Issue:

No

Principal Investigator

Victor J. Stevens, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Kaiser Permanente

Authority:

United States: Federal Government

Study ID:

CDR0000441203

NCT ID:

NCT00217490

Start Date:

March 2005

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific

Name

Location

Kaiser Permanente Center for Health ResearchPortland, Oregon  97227-1098
Kaiser Permanente - AuroraAurora, Colorado  80014
Oregon Research InstituteEugene, Oregon  97403