The Impact of Brief Primary Care Counseling and Novel Physiological Measures on Patient Physical and Emotional Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 950
- 试验地点
- 2
- 主要终点
- Aggregate patient assessment of practice involvement in patient health behaviors
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 盲法
- None
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
- •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
排除标准
- •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
结局指标
主要结局
Aggregate patient assessment of practice involvement in patient health behaviors
时间窗: 12 months
Aggregate clinician and practice staff assessment of practice involvement in patient healthy behaviors
时间窗: 12 months
Spread of billing codes for physician fitness counseling
时间窗: 12 months
Body Mass Index
时间窗: baseline, 6, 9, and 12 months
Homeostatic Assay- Insulin Resistance
时间窗: baseline, 3, 6, 9, and 12 months
Nuclear Molecular Resonance (NMR) Lipoprotein Profiles
时间窗: baseline, 3, 6, 9, and 12 months
3-Minute Step Test
时间窗: baseline, 3, 6, 9, and 12 months
Blood Pressure
时间窗: baseline, 3, 6, 9, and 12 months
次要结局
- Functional health status(baseline, 3, 6, 9, and 12 months)
- Quality of life and well-being(baseline, 3, 6, 9, and 12 months)
- Treatment self-regulation items related to diet(baseline, 3, 6, 9, and 12 months)
- Treatment self-regulation items related to physical activity(baseline, 3, 6, 9, and 12 months)
- Perceived competence for maintaining healthy eating(baseline, 3, 6, 9, and 12 months)
- Perceived competence for maintaining physical activity(baseline, 3, 6, 9, and 12 months)
- Perceived competence for maintaining emotional health(baseline, 3, 6, 9, and 12 months)
- Diet and nutrition related items(baseline, 3, 6, 9, and 12 months)
- Physical activity related items(baseline, 3, 6, 9, and 12 months)