Evaluation of the "Americans in Motion - Healthy Interventions" Project (AIM-HI)
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|ClinicalTrials.gov Identifier: NCT00534482|
Recruitment Status : Completed
First Posted : September 26, 2007
Last Update Posted : May 10, 2011
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.
|Condition or disease||Intervention/treatment|
|Physical Activity Diet Mental Health||Behavioral: Enhanced Office Behavioral: Conventional Office Behavioral: AIM-HI program with enhanced feedback Behavioral: AIM-HI program and regular feedback|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||950 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Impact of Brief Primary Care Counseling and Novel Physiological Measures on Patient Physical and Emotional Health|
|Study Start Date :||July 2007|
|Primary Completion Date :||April 2009|
|Study Completion Date :||October 2009|
Experimental: A, 1, I
Practice-level treatment group
Behavioral: Enhanced Office
Clinicians and office staff personally engage in AIM-HI fitness program, and promote program to patients
Active Comparator: A, 1, II
Practice-level comparison group
Behavioral: Conventional Office
Conventional office: Clinicians and office staff are not personally engaged in the AIM-HI fitness program, but promote program to patients.
Experimental: B, 1, I
Patient-level treatment group
Behavioral: AIM-HI program with enhanced feedback
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.
Active Comparator: B, 1, II
Patient-level comparison group
Behavioral: AIM-HI program and regular feedback
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.
- Aggregate patient assessment of practice involvement in patient health behaviors [ Time Frame: 12 months ]
- Aggregate clinician and practice staff assessment of practice involvement in patient healthy behaviors [ Time Frame: 12 months ]
- Spread of billing codes for physician fitness counseling [ Time Frame: 12 months ]
- Body Mass Index [ Time Frame: baseline, 6, 9, and 12 months ]
- Homeostatic Assay- Insulin Resistance [ Time Frame: baseline, 3, 6, 9, and 12 months ]
- Nuclear Molecular Resonance (NMR) Lipoprotein Profiles [ Time Frame: baseline, 3, 6, 9, and 12 months ]
- 3-Minute Step Test [ Time Frame: baseline, 3, 6, 9, and 12 months ]
- Blood Pressure [ Time Frame: baseline, 3, 6, 9, and 12 months ]
- Functional health status [ Time Frame: baseline, 3, 6, 9, and 12 months ]
- Quality of life and well-being [ Time Frame: baseline, 3, 6, 9, and 12 months ]
- Treatment self-regulation items related to diet [ Time Frame: baseline, 3, 6, 9, and 12 months ]
- Treatment self-regulation items related to physical activity [ Time Frame: baseline, 3, 6, 9, and 12 months ]
- Perceived competence for maintaining healthy eating [ Time Frame: baseline, 3, 6, 9, and 12 months ]
- Perceived competence for maintaining physical activity [ Time Frame: baseline, 3, 6, 9, and 12 months ]
- Perceived competence for maintaining emotional health [ Time Frame: baseline, 3, 6, 9, and 12 months ]
- Diet and nutrition related items [ Time Frame: baseline, 3, 6, 9, and 12 months ]
- Physical activity related items [ Time Frame: baseline, 3, 6, 9, and 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00534482
|United States, Kansas|
|American Academy of Family Physicians National Research Network|
|Leawood, Kansas, United States, 66211|
|Principal Investigator:||Wilson D Pace, MD, FAAFP||American Academy of Family Physicians|