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临床试验/NCT01415492
NCT01415492已完成不适用

Multiple Risk Behavior Intervention in Health Care Settings

Dana-Farber Cancer Institute1 个研究点 分布在 1 个国家目标入组 2,440 人开始时间: 2009年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
2,440
试验地点
1
主要终点
Change in multiple risk behavior (MRB) score

研究概览

简要总结

This study (aka Healthy Directions2 or HD2) builds on an earlier study titled Healthy Directions (aka Healthy Directions 1 or HD1). HD1 was an intervention designed to target cancer prevention among multi-ethnic populations; it led to significant improvements in the multiple risk behavior score (consumption of red meat, fruits and vegetables, and multi-vitamins). Building on the success of HD1, HD2 further expanded the intervention to include smoking and physical activity. In addition, it expanded the study goals to include increasing efficacy across all target risk behaviors, and promoting long-term maintenance of behavior change.

详细描述

HD2 conducted a randomized control trial at two metropolitan Harvard Vanguard Medical Associates (HVMA) sites. The unit of randomization was the primary care provider. Providers were randomized to one of three arms:

  1. Usual care, a control arm.
  2. HD2, an intervention arm, which included access to the study information via website or study information content via print materials. Content addressed the 5 targeted health behaviors and goals, the importance of tracking behaviors in order to improve behaviors, and the importance of social support during behavior change.
  3. HD2+, another intervention arm, which included access to the study information content just described, PLUS two coaching calls.

Note: access to the website was available for the 6 months after recruitment only.

In addition, the investigators wanted to test how use of electronic reminders might increase engagement with the intervention. So, a sub-set of both intervention arms was randomized to receive additional electronic reminders. Participants were allowed to choose either AVR (voicemail) or SMS (text messaging) for the delivery of these brief electronic reminders.

The investigators conducted recruitment on a rolling basis. Patients were assigned to the conditions to which their primary care providers were randomized. The investigators offered participation to providers from the Internal Medicine departments who had full patient panels and conducted annual well visit physicals with adult HVMA patients. All participating providers were informed about the HD2 study through a presentation by study staff. Providers could elect to opt out of participation prior to the patient recruitment period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •HVMA patient seeing a provider participating in HD2 for annual well visit
  • •18 years of age or older
  • •Able to read in English

排除标准

  • •No diagnosis of dementia or psychotic disorders
  • •Undergone cancer treatment within past year

研究组 & 干预措施

Usual Care

No Intervention

At recruitment this group only received five pamphlets from the study. Four of these pamphlets were from the American Cancer Society, and one from Quitworks (a smoking cessation program).

HD2

Active Comparator

The intervention study information was delivered via print materials or access to a HD2 Web Site. Patients chose modality. ADDITIONAL NOTE: A sub-set of these participants was randomly selected to receive the Electronic Reminders through the intervention.

干预措施: HD2 (Behavioral)

HD2+

Active Comparator

The intervention study information was delivered via print materials or access to a HD2 Web Site. Patients chose modality. In addition participants received two coaching calls from Health Coaches. ADDITIONAL NOTE: A sub-set of these participants was randomly selected to receive the Electronic Reminders through the intervention.

干预措施: HD2+ (Behavioral)

结局指标

主要结局

Change in multiple risk behavior (MRB) score

时间窗: 6- and 18- months post intervention follow-ups

Change in multiple risk behavior (MRB) score at the 6- and 18-months post-intervention follow-ups. This score is a composite measure comprised of status on 5 individual risk factors: red meat intake, multi-vitamin intake, and fruit and vegetable intake, physical activity, and smoking cessation

次要结局

  • Change in each of the target risk factors(6- and 18- months post intervention follow-ups)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Karen Emmons, PhD

Principal Investigator

Dana-Farber Cancer Institute

研究点 (1)

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