Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217490
Status:
COMPLETED
Last Update Posted:
2017-04-04
First Post:
2005-09-20
Brief Title:
Individual Counseling andor Computer-Based Counseling in Helping Healthy Women Adopt a Cancer Prevention Diet
Sponsor:
Kaiser Permanente
Organization:
Kaiser Permanente
Study Overview
Official Title:
Helping Women Adopt a Cancer Prevention Diet
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor computer-based counseling work in helping healthy women adopt a cancer prevention diet
PURPOSE This randomized clinical trial is studying how well individual counseling andor 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 eg 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
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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| KAISER-R01-CA098496 | US NIH GrantContract | None | httpsreporternihgovquickSearchR01CA098496 |
| R01CA098496 | NIH | None | None |