Evaluation of the "Americans in Motion - Healthy Interventions" Project (AIM-HI)
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
地位
详细说明
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Kansas
-
Leawood、Kansas、美国、66211
- American Academy of Family Physicians National Research Network
-
-
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
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
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
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
一般刊物
- Stern SE, Williams K, Ferrannini E, DeFronzo RA, Bogardus C, Stern MP. Identification of individuals with insulin resistance using routine clinical measurements. Diabetes. 2005 Feb;54(2):333-9. doi: 10.2337/diabetes.54.2.333.
- Shadid S, LaForge R, Otvos JD, Jensen MD. Treatment of obesity with diet/exercise versus pioglitazone has distinct effects on lipoprotein particle size. Atherosclerosis. 2006 Oct;188(2):370-6. doi: 10.1016/j.atherosclerosis.2005.10.038. Epub 2005 Nov 28.
- McClernon FJ, Yancy WS Jr, Eberstein JA, Atkins RC, Westman EC. The effects of a low-carbohydrate ketogenic diet and a low-fat diet on mood, hunger, and other self-reported symptoms. Obesity (Silver Spring). 2007 Jan;15(1):182-7. doi: 10.1038/oby.2007.516.
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 (估计)
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
- 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.
Enhanced Office的临床试验
-
University of MichiganNational Institute of Mental Health (NIMH)完全的
-
Sidney Kimmel Cancer Center at Thomas Jefferson...National Cancer Institute (NCI); University of California, San Diego; GE Healthcare; National Institutes... 和其他合作者完全的
-
Centre Integre Universitaire de Sante et Services...招聘中