Evaluation of the "Americans in Motion - Healthy Interventions" Project

NCT ID: NCT00534482

Last Updated: 2011-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 950 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2009-10-31

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.

Conditions

Physical Activity; Diet; Mental Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Blinding Strategy: NONE

Study Groups

A, 1, I

Practice-level treatment group

Group Type: EXPERIMENTAL

Enhanced Office

Intervention Type: BEHAVIORAL

Clinicians and office staff personally engage in AIM-HI fitness program, and promote program to patients

A, 1, II

Practice-level comparison group

Group Type: ACTIVE_COMPARATOR

Conventional Office

Intervention Type: BEHAVIORAL

Conventional office: Clinicians and office staff are not personally engaged in the AIM-HI fitness program, but promote program to patients.

B, 1, I

Patient-level treatment group

Group Type: EXPERIMENTAL

AIM-HI program with enhanced feedback

Intervention Type: BEHAVIORAL

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.

B, 1, II

Patient-level comparison group

Group Type: ACTIVE_COMPARATOR

AIM-HI program and regular feedback

Intervention Type: BEHAVIORAL

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.

Interventions

Enhanced Office

Clinicians and office staff personally engage in AIM-HI fitness program, and promote program to patients

Intervention Type: BEHAVIORAL

Conventional Office

Conventional office: Clinicians and office staff are not personally engaged in the AIM-HI fitness program, but promote program to patients.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The PepsiCo Foundation

OTHER

Sponsor Role: collaborator

American Academy of Family Physicians

OTHER

Sponsor Role: lead

Responsible Party

American Academy of Family Physicians; University of CO - Health Sciences

Principal Investigators

Wilson D Pace, MD, FAAFP

Role: PRINCIPAL_INVESTIGATOR

American Academy of Family Physicians

Locations

American Academy of Family Physicians National Research Network

Leawood, Kansas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 15677489 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16313908 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17228046 (View on PubMed)

Other Identifiers

07-034

Identifier Type: -

Identifier Source: org_study_id