Unspecified Adult Solid Tumor, Protocol SpecificNCT00217490

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

A study testing dietary counseling via computer, dietary counseling via nutritionist and combined computer and nutritionist in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Kaiser Permanente at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 30 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for: Unspecified Adult Solid Tumor, Protocol Specific
What is being tested?: dietary counseling via computer, dietary counseling via nutritionist and combined computer and nutritionist
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 621 participants
Where: 3 sitesUnited States
Study dates: Mar 2005to Sep 2008
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 70 years
Women only
Healthy volunteers accepted
Adult, Older adult

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Kaiser Permanente - Aurora
Aurora, Colorado, 80014
Oregon Research Institute
Eugene, Oregon, 97403
Kaiser Permanente Center for Health Research
Portland, Oregon, 97227

Other trials in United States

About this study

Official title: Helping Women Adopt a Cancer Prevention Diet

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.

Read the 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.

Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Being tested: dietary counseling via computer, dietary counseling via nutritionist, combined computer and nutritionist, physical activity counseling via computer
Keywords: unspecified adult solid tumor, protocol specific

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

dietary counseling via computerBehavioural
An interactive computer program that addresses dietary change, barriers to change and possible solution to barriers to develop an action plan
dietary counseling via nutritionistBehavioural
A one on one counseling sessions to addresses dietary change, barriers to change and possible solution to barriers to develop an action plan
combined computer and nutritionistBehavioural
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
physical activity counseling via computerOther
An interactive computer program that addresses increase to physical activity, barriers to change and possible solution to barriers to develop an action plan

Study groups in NCT00217490
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: physical activity counseling via computer

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Baseline and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2005Sep 2008

First posted22 Sep 2005 (estimated)
Study startMar 2005
Primary completionSep 2008
Study completionSep 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
More trials run by Kaiser PermanenteThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 621 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00217490
Sponsor's protocol ID: CDR0000441203
Other IDs: R01CA098496, KAISER-R01-CA098496
Status last verified: Feb 2017
First submitted: 20 Sep 2005
Last updated: 4 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 18711204

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Unspecified Adult Solid Tumor, Protocol Specific trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Helping Women Adopt a Cancer Prevention Diet
ClinicalTrials.gov ID: NCT00217490
Acronym / sponsor ID: CDR0000441203
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Keywords: unspecified adult solid tumor, protocol specific
Study type: Interventional
Recruitment status: Completed
Enrolment: 621 participants (actual)
Lead sponsor: Kaiser PermanenteUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: Mar 2005
Primary completion: Sep 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 22 Sep 2005 (estimated)
Results: Posted 4 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Computer Only	Experimental	Behavioral: dietary counseling via computerDietary 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.
Counseling only	Experimental	Behavioral: dietary counseling via nutritionistIn this arm, dietary counseling was delivered by nutritionist, and this counseling did not include use of an automated, computer program.
Combined	Experimental	Behavioral: combined computer and nutritionistIn 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.
Physical Activity-computer	Active comparator	Other: physical activity counseling via computerParticipants assigned to this arm did not receive nutrition counseling, but they were provided physical activity counseling delivered by computer only.

Who may qualify

Ages: 30 to 70 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
dietary counseling via computerAn interactive computer program that addresses dietary change, barriers to change and possible solution to barriers to develop an action plan	Behavioural	Computer Only
dietary counseling via nutritionistA one on one counseling sessions to addresses dietary change, barriers to change and possible solution to barriers to develop an action plan	Behavioural	Counseling only
combined computer and nutritionistAn 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	Behavioural	Combined
physical activity counseling via computerAn interactive computer program that addresses increase to physical activity, barriers to change and possible solution to barriers to develop an action plan	Other	Physical Activity-computer

Primary outcome

Change in Fruit, Vegetable Consumption as Measured by Food Frequency Questionnaire at 3 Months
Time frame: Baseline and 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.
Change in Percentage of Fat Consumed
Time frame: Baseline and 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.

Results and safety

Results posted to the registry on 4 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Computer Only	154	137
Counseling Only	153	128
Combined	155	131
Physcial Activity-computer	153	130

Primary outcome: Change in Fruit, Vegetable Consumption as Measured by Food Frequency Questionnaire at 3 Months

Time frame: Baseline and 3 months. Mean (Standard Deviation). Unit: number of servings per day

Measure	Computer Only n = 137	Counseling Only n = 128	Combined n = 131	Physcial Activity-computer n = 130
Value	2.7272727 (2.7480483)	2.9758065 (2.8426456)	2.7330645 (2.7742053)	0.4720000 (2.2229594)

Population analysed: Participant who returned for follow up visit

Primary outcome: Change in Percentage of Fat Consumed

Time frame: Baseline and 3 months. Mean (Standard Deviation). Unit: Percentage of fat consumed

Measure	Computer Only n = 132	Counseling Only n = 124	Combined n = 124	Physcial Activity-computer n = 125
Value	-4.653333 (7.4788051)	-5.3439516 (7.3594025)	-6.0113710 (6.9703683)	-1.4154400 (7.9831426)

Population analysed: Participants who returned for follow up visit

Adverse events

Time frame: 18 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Computer Only	0 of 154 (0%)	0 of 154 (0%)	Not reported
Counseling Only	0 of 153 (0%)	0 of 153 (0%)	Not reported
Combined	0 of 155 (0%)	0 of 155 (0%)	Not reported
Physcial Activity-computer	0 of 153 (0%)	0 of 153 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 18711204Glasgow 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Victor J. Stevens, PhD study chair

Kaiser Permanente

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Fruit, Vegetable Consumption as Measured by Food Frequency Questionnaire at 3 Months (time frame: Baseline and 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00217490, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.