Physical Activity Clinical Trial
Official title:
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.
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. ;
Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label
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