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Evaluation of the "Americans in Motion - Healthy Interventions" Project (AIM-HI)

2011年5月9日 更新者:American Academy of Family Physicians

The Impact of Brief Primary Care Counseling and Novel Physiological Measures on Patient Physical and Emotional Health

This research project brings together the American Academy of Family Physicians (AAFP) National Research Network (AAFP-NRN) and the AAFP's public health initiative, Americans In Motion (AIM). This project will develop and evaluate a practice improvement program to improve family physicians' delivery of effective patient-centered behavior change interventions for "fitness" (physical activity, nutrition and emotional well-being). The investigators seek to develop a unique program that positions fitness in a central role as "the treatment of choice" when dealing with issues of prevention and treatment of chronic conditions. In addition, this newly developed program is intended to help shift the paradigm of family physicians' use of common advice-giving methods to more effective patient-centered lifestyle counseling. Ultimately, this program will seek to improve care for all patients through fitness-related physician interventions.

Outcomes: This study design will allow the investigators to evaluate whether (and how) dissemination of educational materials impacts patient intervention by first engaging clinicians and staff in their personal use of these materials. This project will also evaluate the effects of the behavioral change tools, as well as, the added impact of new physiologic feedback measures (HOMA-IR and NMR Lipoprotein profiles) on physical activity and diet in study participants.

Conclusion: Primary care offices can become more effective settings to help patients improve physical activity, diet and emotional well-being. Demonstrating the value and impact of creating "healthy offices" that endorse and support clinicians, office staff and patients in the use of effective educational materials fits well with the new model of care as part of the AAFP's "Future of Family Medicine" initiatives, which emphasize the importance of lifestyle decisions and supporting successful changes in behaviors within primary care. This project will help define how to accomplish this.

研究概览

详细说明

Study Design: This trial will consist of a two-level randomized controlled trial. The first level of randomization will be performed at the practice level in order to study the impact of involving both clinicians and office staff in making their own personal changes (i.e., creating the "healthy" office)- a central component of AIM - on the translation of the project's educational tools to patients. The second level of randomization will occur at the patient level comparing two practice level interventions designed to improve nutrition, increase physical activity and improve emotional well-being. Furthermore, the effectiveness of the educational tools will be evaluated on self-reported diet, physical activity and emotional well-being and established physiologic measures on behavioral change. Both arms of the study will receive brief office-based counseling using established tools that have been compiled for this project. Practices will be asked to work on incorporating brief nutrition, physical activity and emotional well-being messages into routine care - either motivational in nature for people not willing to work on lifestyle changes, or goal-oriented for those working on changes. Patients in the intervention arm will also receive feedback concerning changes in two novel physiologic measures that correlate with improved nutrition and increased physical activity.

研究类型

介入性

注册 (预期的)

950

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

    • Kansas
      • Leawood、Kansas、美国、66211
        • American Academy of Family Physicians National Research Network

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

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Age 18 or above
  • BMI greater than or equal to 30
  • Able to participate in moderate physical activity including a 3-minute step test without worsening an existing medical condition
  • Life expectancy of greater than one year
  • Able to read English or Spanish; and
  • Able to be contacted via phone for follow-up with project staff

Exclusion Criteria:

  • Too ill to participate
  • A current diagnosis at the index visit of type 2 diabetes, hyperlipidemia, or coronary heart disease
  • Doctor's evaluation of patient as not appropriate for physical activity
  • Not capable of giving informed consent; and
  • Unable to read English or Spanish, including blindness

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

  • 分配:随机化
  • 介入模型:阶乘赋值
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:A, 1, I
Practice-level treatment group
Clinicians and office staff personally engage in AIM-HI fitness program, and promote program to patients
有源比较器:A, 1, II
Practice-level comparison group
Conventional office: Clinicians and office staff are not personally engaged in the AIM-HI fitness program, but promote program to patients.
实验性的:B, 1, I
Patient-level treatment group
Patient receives feedback on two novel indicators of their individual cardiovascular risk that: 1)appear to relate to obesity and lack of physical activity, and 2) may show relatively rapid change with improvements in these areas. These are the Homeostatic Assay - Insulin Resistance or HOMA-IR and Nuclear Molecular Resonance (NMR) lipoprotein profiles (NMRLP). These patients and their physicians also will receive periodic feedback on other outcome measures, including BMI, blood pressure, a 3-minute step test, eating assessment, physical activity assessment, and emotional well-being assessment.
有源比较器:B, 1, II
Patient-level comparison group
Patients will not receive feedback on two specific cardiovascular risk indicators (ie, Homeostatic Assay - Insulin Resistance, Nuclear Molecular Resonance lipoprotein profiles). However, patients will receive feedback on Body Mass Index, blood pressure, a 3-minute step test, eating assessment, physical activity assessment, and emotional well-being assessment.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Aggregate patient assessment of practice involvement in patient health behaviors
大体时间:12 months
12 months
Aggregate clinician and practice staff assessment of practice involvement in patient healthy behaviors
大体时间:12 months
12 months
Spread of billing codes for physician fitness counseling
大体时间:12 months
12 months
Body Mass Index
大体时间:baseline, 6, 9, and 12 months
baseline, 6, 9, and 12 months
Homeostatic Assay- Insulin Resistance
大体时间:baseline, 3, 6, 9, and 12 months
baseline, 3, 6, 9, and 12 months
Nuclear Molecular Resonance (NMR) Lipoprotein Profiles
大体时间:baseline, 3, 6, 9, and 12 months
baseline, 3, 6, 9, and 12 months
3-Minute Step Test
大体时间:baseline, 3, 6, 9, and 12 months
baseline, 3, 6, 9, and 12 months
Blood Pressure
大体时间:baseline, 3, 6, 9, and 12 months
baseline, 3, 6, 9, and 12 months

次要结果测量

结果测量
大体时间
Functional health status
大体时间:baseline, 3, 6, 9, and 12 months
baseline, 3, 6, 9, and 12 months
Quality of life and well-being
大体时间:baseline, 3, 6, 9, and 12 months
baseline, 3, 6, 9, and 12 months
Treatment self-regulation items related to diet
大体时间:baseline, 3, 6, 9, and 12 months
baseline, 3, 6, 9, and 12 months
Treatment self-regulation items related to physical activity
大体时间:baseline, 3, 6, 9, and 12 months
baseline, 3, 6, 9, and 12 months
Perceived competence for maintaining healthy eating
大体时间:baseline, 3, 6, 9, and 12 months
baseline, 3, 6, 9, and 12 months
Perceived competence for maintaining physical activity
大体时间:baseline, 3, 6, 9, and 12 months
baseline, 3, 6, 9, and 12 months
Perceived competence for maintaining emotional health
大体时间:baseline, 3, 6, 9, and 12 months
baseline, 3, 6, 9, and 12 months
Diet and nutrition related items
大体时间:baseline, 3, 6, 9, and 12 months
baseline, 3, 6, 9, and 12 months
Physical activity related items
大体时间:baseline, 3, 6, 9, and 12 months
baseline, 3, 6, 9, and 12 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

  • 首席研究员:Wilson D Pace, MD, FAAFP、American Academy of Family Physicians

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

2007年7月1日

初级完成 (实际的)

2009年4月1日

研究完成 (实际的)

2009年10月1日

研究注册日期

首次提交

2007年9月24日

首先提交符合 QC 标准的

2007年9月24日

首次发布 (估计)

2007年9月26日

研究记录更新

最后更新发布 (估计)

2011年5月10日

上次提交的符合 QC 标准的更新

2011年5月9日

最后验证

2011年5月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • 07-034

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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