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

Helping Women Adopt a Cancer Prevention Diet

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00217490
Enrollment
621
Registered
2005-09-22
Start date
2005-03-31
Completion date
2008-09-30
Last updated
2017-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

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.

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.

Interventions

BEHAVIORALdietary counseling via computer

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

BEHAVIORALdietary counseling via nutritionist

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

BEHAVIORALcombined computer and nutritionist

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

OTHERphysical activity counseling via computer

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

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Kaiser Permanente
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Fruit, Vegetable Consumption as Measured by Food Frequency Questionnaire at 3 MonthsBaseline and 3 monthsSelf 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 ConsumedBaseline and 3 monthsSelf 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.

Countries

United States

Participant flow

Recruitment details

Women in Kaiser Permanente were identified from the electronic medical record and sent a letter inviting them to participate in the study. Recruitment started in 2003

Pre-assignment details

Women who agreed to come in for the initial visit and randomization were excluded if they were not willing to change diet or physical activity, could not speak and read English.

Participants by arm

ArmCount
Computer Only
Dietary Counseling delivered by interactive computer
154
Counseling Only
Dietary counseling delivered by nutritionist
153
Combined
Dietary counseling delivered using computer program and nutritionist
155
Physcial Activity-computer
Physical activity counseling delivered by computer only
153
Total615

Baseline characteristics

CharacteristicCounseling OnlyCombinedPhyscial Activity-computerTotalComputer Only
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
10 Participants12 Participants9 Participants41 Participants10 Participants
Age, Categorical
Between 18 and 65 years
143 Participants143 Participants144 Participants574 Participants144 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants6 Participants4 Participants19 Participants6 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
148 Participants147 Participants146 Participants586 Participants145 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants2 Participants3 Participants10 Participants3 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants1 Participants1 Participants6 Participants2 Participants
Race (NIH/OMB)
Asian
4 Participants1 Participants1 Participants8 Participants2 Participants
Race (NIH/OMB)
Black or African American
9 Participants14 Participants16 Participants48 Participants9 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
3 Participants1 Participants0 Participants4 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
4 Participants3 Participants6 Participants22 Participants9 Participants
Race (NIH/OMB)
White
131 Participants135 Participants129 Participants527 Participants132 Participants
Region of Enrollment
United States
153 participants155 participants153 participants615 participants154 participants
Sex: Female, Male
Female
153 Participants155 Participants153 Participants615 Participants154 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
0 / 1540 / 1530 / 1550 / 153
serious
Total, serious adverse events
0 / 1540 / 1530 / 1550 / 153

Outcome results

Primary

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.

Time frame: Baseline and 3 months

Population: Participant who returned for follow up visit

ArmMeasureValue (MEAN)Dispersion
Computer OnlyChange in Fruit, Vegetable Consumption as Measured by Food Frequency Questionnaire at 3 Months2.7272727 number of servings per dayStandard Deviation 2.7480483
Counseling OnlyChange in Fruit, Vegetable Consumption as Measured by Food Frequency Questionnaire at 3 Months2.9758065 number of servings per dayStandard Deviation 2.8426456
CombinedChange in Fruit, Vegetable Consumption as Measured by Food Frequency Questionnaire at 3 Months2.7330645 number of servings per dayStandard Deviation 2.7742053
Physcial Activity-computerChange in Fruit, Vegetable Consumption as Measured by Food Frequency Questionnaire at 3 Months0.4720000 number of servings per dayStandard Deviation 2.2229594
Primary

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.

Time frame: Baseline and 3 months

Population: Participants who returned for follow up visit

ArmMeasureValue (MEAN)Dispersion
Computer OnlyChange in Percentage of Fat Consumed-4.653333 Percentage of fat consumedStandard Deviation 7.4788051
Counseling OnlyChange in Percentage of Fat Consumed-5.3439516 Percentage of fat consumedStandard Deviation 7.3594025
CombinedChange in Percentage of Fat Consumed-6.0113710 Percentage of fat consumedStandard Deviation 6.9703683
Physcial Activity-computerChange in Percentage of Fat Consumed-1.4154400 Percentage of fat consumedStandard Deviation 7.9831426

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026