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

2017年2月16日 更新者:Kaiser Permanente

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

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

介入性

注册 (实际的)

621

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

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

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

30年 至 70年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

女性

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Victor J. Stevens, PhD、Kaiser Permanente

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2005年3月1日

初级完成 (实际的)

2008年9月1日

研究完成 (实际的)

2008年9月1日

研究注册日期

首次提交

2005年9月20日

首先提交符合 QC 标准的

2005年9月20日

首次发布 (估计)

2005年9月22日

研究记录更新

最后更新发布 (实际的)

2017年4月4日

上次提交的符合 QC 标准的更新

2017年2月16日

最后验证

2017年2月1日

更多信息

与本研究相关的术语

其他研究编号

  • CDR0000441203
  • R01CA098496 (美国 NIH 拨款/合同)
  • KAISER-R01-CA098496

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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