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

NCT00534482 | Completed

• 1 other identifier: 07-034
• Study Type: interventional
• Target: 950
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Activity; Diet; Mental Health

Keywords

fitness

Outcome Measures

Primary Outcomes (8)

• Aggregate patient assessment of practice involvement in patient health behaviors

  12 months

• Aggregate clinician and practice staff assessment of practice involvement in patient healthy behaviors

  12 months

• Spread of billing codes for physician fitness counseling

  12 months

• Body Mass Index

  baseline, 6, 9, and 12 months

• Homeostatic Assay- Insulin Resistance

  baseline, 3, 6, 9, and 12 months

• Nuclear Molecular Resonance (NMR) Lipoprotein Profiles

  baseline, 3, 6, 9, and 12 months

• 3-Minute Step Test

  baseline, 3, 6, 9, and 12 months

• Blood Pressure

  baseline, 3, 6, 9, and 12 months

Secondary Outcomes (9)

• Functional health status

  baseline, 3, 6, 9, and 12 months

• Quality of life and well-being

  baseline, 3, 6, 9, and 12 months

• Treatment self-regulation items related to diet

  baseline, 3, 6, 9, and 12 months

• Treatment self-regulation items related to physical activity

  baseline, 3, 6, 9, and 12 months

• Perceived competence for maintaining healthy eating

  baseline, 3, 6, 9, and 12 months

Study Arms (4)

A, 1, I

EXPERIMENTAL

Practice-level treatment group

Behavioral: Enhanced Office

A, 1, II

ACTIVE COMPARATOR

Practice-level comparison group

Behavioral: Conventional Office

B, 1, I

EXPERIMENTAL

Patient-level treatment group

Behavioral: AIM-HI program with enhanced feedback

B, 1, II

ACTIVE COMPARATOR

Patient-level comparison group

Behavioral: AIM-HI program and regular feedback

Interventions

Enhanced Office BEHAVIORAL

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

A, 1, I

Conventional Office BEHAVIORAL

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

A, 1, II

AIM-HI program with enhanced feedback 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, I

AIM-HI program and regular feedback 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.

B, 1, II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• American Academy of Family Physicians: lead
• The PepsiCo Foundation: collaborator

Study Sites (1)

American Academy of Family Physicians National Research Network

Leawood, Kansas, 66211, United States

Location

Related Publications (3)

• 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.

  PMID: 15677489 BACKGROUND

• 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.

  PMID: 16313908 BACKGROUND

• 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.

  PMID: 17228046 BACKGROUND

MeSH Terms

Conditions

Motor Activity; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavior; Personal Satisfaction

Study Officials

• Wilson D Pace, MD, FAAFP

  American Academy of Family Physicians

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 24, 2007
• First Posted: September 26, 2007
• Study Start: July 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: October 1, 2009
• Last Updated: May 10, 2011

Record last verified: 2011-05

Locations

US (1)