Evaluation of the "Americans in Motion - Healthy Interventions" Project (AIM-HI)
9 de mayo de 2011 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
950
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Kansas
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Leawood, Kansas, Estados Unidos, 66211
- American Academy of Family Physicians National Research Network
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: A, 1, I
Practice-level treatment group
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Clinicians and office staff personally engage in AIM-HI fitness program, and promote program to patients
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Comparador activo: A, 1, II
Practice-level comparison group
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Conventional office: Clinicians and office staff are not personally engaged in the AIM-HI fitness program, but promote program to patients.
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Experimental: B, 1, I
Patient-level treatment group
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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.
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Comparador activo: B, 1, II
Patient-level comparison group
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Aggregate patient assessment of practice involvement in patient health behaviors
Periodo de tiempo: 12 months
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12 months
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Aggregate clinician and practice staff assessment of practice involvement in patient healthy behaviors
Periodo de tiempo: 12 months
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12 months
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Spread of billing codes for physician fitness counseling
Periodo de tiempo: 12 months
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12 months
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Body Mass Index
Periodo de tiempo: baseline, 6, 9, and 12 months
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baseline, 6, 9, and 12 months
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Homeostatic Assay- Insulin Resistance
Periodo de tiempo: baseline, 3, 6, 9, and 12 months
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baseline, 3, 6, 9, and 12 months
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|
Nuclear Molecular Resonance (NMR) Lipoprotein Profiles
Periodo de tiempo: baseline, 3, 6, 9, and 12 months
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baseline, 3, 6, 9, and 12 months
|
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3-Minute Step Test
Periodo de tiempo: baseline, 3, 6, 9, and 12 months
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baseline, 3, 6, 9, and 12 months
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Blood Pressure
Periodo de tiempo: baseline, 3, 6, 9, and 12 months
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baseline, 3, 6, 9, and 12 months
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Functional health status
Periodo de tiempo: baseline, 3, 6, 9, and 12 months
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baseline, 3, 6, 9, and 12 months
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Quality of life and well-being
Periodo de tiempo: baseline, 3, 6, 9, and 12 months
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baseline, 3, 6, 9, and 12 months
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Treatment self-regulation items related to diet
Periodo de tiempo: baseline, 3, 6, 9, and 12 months
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baseline, 3, 6, 9, and 12 months
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Treatment self-regulation items related to physical activity
Periodo de tiempo: baseline, 3, 6, 9, and 12 months
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baseline, 3, 6, 9, and 12 months
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Perceived competence for maintaining healthy eating
Periodo de tiempo: baseline, 3, 6, 9, and 12 months
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baseline, 3, 6, 9, and 12 months
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Perceived competence for maintaining physical activity
Periodo de tiempo: baseline, 3, 6, 9, and 12 months
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baseline, 3, 6, 9, and 12 months
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Perceived competence for maintaining emotional health
Periodo de tiempo: baseline, 3, 6, 9, and 12 months
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baseline, 3, 6, 9, and 12 months
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Diet and nutrition related items
Periodo de tiempo: baseline, 3, 6, 9, and 12 months
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baseline, 3, 6, 9, and 12 months
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Physical activity related items
Periodo de tiempo: baseline, 3, 6, 9, and 12 months
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baseline, 3, 6, 9, and 12 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Wilson D Pace, MD, FAAFP, American Academy of Family Physicians
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de julio de 2007
Finalización primaria (Actual)
1 de abril de 2009
Finalización del estudio (Actual)
1 de octubre de 2009
Fechas de registro del estudio
Enviado por primera vez
24 de septiembre de 2007
Primero enviado que cumplió con los criterios de control de calidad
24 de septiembre de 2007
Publicado por primera vez (Estimar)
26 de septiembre de 2007
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
10 de mayo de 2011
Última actualización enviada que cumplió con los criterios de control de calidad
9 de mayo de 2011
Última verificación
1 de mayo de 2011
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 07-034
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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