NCT00217490

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
621

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
8.6 years until next milestone

Results Posted

Study results publicly available

April 4, 2017

Completed
Last Updated

April 4, 2017

Status Verified

February 1, 2017

Enrollment Period

3.5 years

First QC Date

September 20, 2005

Results QC Date

September 29, 2015

Last Update Submit

February 16, 2017

Conditions

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (4)

Computer Only

EXPERIMENTAL

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

Counseling only

EXPERIMENTAL

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

Combined

EXPERIMENTAL

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

Physical Activity-computer

ACTIVE COMPARATOR

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

Interventions

An interactive computer program that addresses dietary change, barriers to change and possible solution to barriers to develop an action plan

Computer Only

A one on one counseling sessions to addresses dietary change, barriers to change and possible solution to barriers to develop an action plan

Counseling only

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

Combined

An interactive computer program that addresses increase to physical activity, barriers to change and possible solution to barriers to develop an action plan

Physical Activity-computer

Eligibility Criteria

Age30 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Kaiser Permanente - Aurora

Aurora, Colorado, 80014, United States

Location

Oregon Research Institute

Eugene, Oregon, 97403, United States

Location

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

Location

Related Publications (1)

  • Glasgow RE, Christiansen S, Smith KS, Stevens VJ, Toobert DJ. Development and implementation of an integrated, multi-modality, user-centered interactive dietary change program. Health Educ Res. 2009 Jun;24(3):461-71. doi: 10.1093/her/cyn042. Epub 2008 Aug 18.

    PMID: 18711204BACKGROUND

MeSH Terms

Interventions

Nutritionists

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Victor J. Stevens, PhD
Organization
Kaiser Permanente Center for Health Research

Study Officials

  • Victor J. Stevens, PhD

    Kaiser Permanente

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2005

First Posted

September 22, 2005

Study Start

March 1, 2005

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

April 4, 2017

Results First Posted

April 4, 2017

Record last verified: 2017-02

Locations