Individual Counseling and/or Computer-Based Counseling in Helping Healthy Women Adopt a Cancer Prevention Diet
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.
研究概览
地位
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Colorado
-
Aurora、Colorado、美国、80014
- Kaiser Permanente - Aurora
-
-
Oregon
-
Eugene、Oregon、美国、97403
- Oregon Research Institute
-
Portland、Oregon、美国、97227
- Kaiser Permanente Center for Health Research
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Computer Only
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.
|
An interactive computer program that addresses dietary change, barriers to change and possible solution to barriers to develop an action plan
|
实验性的:Counseling only
In this arm, dietary counseling was delivered by nutritionist, and this counseling did not include use of an automated, computer program.
|
A one on one counseling sessions to addresses dietary change, barriers to change and possible solution to barriers to develop an action plan
|
实验性的:Combined
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.
|
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
|
有源比较器:Physical Activity-computer
Participants assigned to this arm did not receive nutrition counseling, but they were provided physical activity counseling delivered by computer only.
|
An interactive computer program that addresses increase to physical activity, barriers to change and possible solution to barriers to develop an action plan
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Change in Fruit, Vegetable Consumption as Measured by Food Frequency Questionnaire at 3 Months
大体时间: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.
|
Baseline and 3 months
|
Change in Percentage of Fat Consumed
大体时间: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.
|
Baseline and 3 months
|
合作者和调查者
调查人员
- 学习椅:Victor J. Stevens, PhD、Kaiser Permanente
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- CDR0000441203
- R01CA098496 (美国 NIH 拨款/合同)
- KAISER-R01-CA098496
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