Evaluation of the "Americans in Motion - Healthy Interventions" Project (AIM-HI)

This study has been completed.
Sponsor:
Collaborator:
The PepsiCo Foundation
Information provided by:
American Academy of Family Physicians
ClinicalTrials.gov Identifier:
NCT00534482
First received: September 24, 2007
Last updated: May 9, 2011
Last verified: May 2011
  Purpose

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 Intervention
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
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Official Title: The Impact of Brief Primary Care Counseling and Novel Physiological Measures on Patient Physical and Emotional Health

Resource links provided by NLM:


Further study details as provided by American Academy of Family Physicians:

Primary Outcome Measures:
  • Aggregate patient assessment of practice involvement in patient health behaviors [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Aggregate clinician and practice staff assessment of practice involvement in patient healthy behaviors [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Spread of billing codes for physician fitness counseling [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Body Mass Index [ Time Frame: baseline, 6, 9, and 12 months ] [ Designated as safety issue: No ]
  • Homeostatic Assay- Insulin Resistance [ Time Frame: baseline, 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
  • Nuclear Molecular Resonance (NMR) Lipoprotein Profiles [ Time Frame: baseline, 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
  • 3-Minute Step Test [ Time Frame: baseline, 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
  • Blood Pressure [ Time Frame: baseline, 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional health status [ Time Frame: baseline, 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
  • Quality of life and well-being [ Time Frame: baseline, 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
  • Treatment self-regulation items related to diet [ Time Frame: baseline, 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
  • Treatment self-regulation items related to physical activity [ Time Frame: baseline, 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
  • Perceived competence for maintaining healthy eating [ Time Frame: baseline, 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
  • Perceived competence for maintaining physical activity [ Time Frame: baseline, 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
  • Perceived competence for maintaining emotional health [ Time Frame: baseline, 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
  • Diet and nutrition related items [ Time Frame: baseline, 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
  • Physical activity related items [ Time Frame: baseline, 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 950
Study Start Date: July 2007
Study Completion Date: October 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00534482

Locations
United States, Kansas
American Academy of Family Physicians National Research Network
Leawood, Kansas, United States, 66211
Sponsors and Collaborators
American Academy of Family Physicians
The PepsiCo Foundation
Investigators
Principal Investigator: Wilson D Pace, MD, FAAFP American Academy of Family Physicians
  More Information

Publications:
Responsible Party: Wilson Pace, MD, FAAFP, American Academy of Family Physicians; University of CO - Health Sciences
ClinicalTrials.gov Identifier: NCT00534482     History of Changes
Other Study ID Numbers: 07-034
Study First Received: September 24, 2007
Last Updated: May 9, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by American Academy of Family Physicians:
fitness

ClinicalTrials.gov processed this record on July 22, 2014