Clinical trial NCT00534482: Evaluation of the "Americans in Motion - Healthy Interventions" Project
Official title: The Impact of Brief Primary Care Counseling and Novel Physiological Measures on Patient Physical and Emotional Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Diet
Mental Health
Keywords: fitness
Lead sponsor: American Academy of Family Physicians
Sponsor class: OTHER
Collaborators: name: The PepsiCo Foundation
First posted: 2007-09-26
Enrollment: 950
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Aggregate patient assessment of practice involvement in patient health behaviors
timeFrame: 12 months
measure: Aggregate clinician and practice staff assessment of practice involvement in patient healthy behaviors
timeFrame: 12 months
measure: Spread of billing codes for physician fitness counseling
timeFrame: 12 months
measure: Body Mass Index
timeFrame: baseline, 6, 9, and 12 months
measure: Homeostatic Assay- Insulin Resistance
timeFrame: baseline, 3, 6, 9, and 12 months
measure: Nuclear Molecular Resonance (NMR) Lipoprotein Profiles
timeFrame: baseline, 3, 6, 9, and 12 months
measure: 3-Minute Step Test
timeFrame: baseline, 3, 6, 9, and 12 months
measure: Blood Pressure
timeFrame: baseline, 3, 6, 9, and 12 months
Secondary outcomes:
measure: Functional health status
timeFrame: baseline, 3, 6, 9, and 12 months
measure: Quality of life and well-being
timeFrame: baseline, 3, 6, 9, and 12 months
measure: Treatment self-regulation items related to diet
timeFrame: baseline, 3, 6, 9, and 12 months
measure: Treatment self-regulation items related to physical activity
timeFrame: baseline, 3, 6, 9, and 12 months
measure: Perceived competence for maintaining healthy eating
timeFrame: baseline, 3, 6, 9, and 12 months
measure: Perceived competence for maintaining physical activity
timeFrame: baseline, 3, 6, 9, and 12 months
measure: Perceived competence for maintaining emotional health
timeFrame: baseline, 3, 6, 9, and 12 months
measure: Diet and nutrition related items
timeFrame: baseline, 3, 6, 9, and 12 months
measure: Physical activity related items
timeFrame: baseline, 3, 6, 9, and 12 months
Other outcomes:
Locations:
city: Leawood
country: United States
facility: American Academy of Family Physicians National Research Network
state: Kansas
Study officials:
affiliation: American Academy of Family Physicians
name: Wilson D Pace, MD, FAAFP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.