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Completed

NCT Number: NCT00534482

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

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.

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Key information

Conditions

Physical Activity Behavior Diet Mental Health Motor Activity Personal Satisfaction Psychological Well-Being

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

American Academy of Family Physicians National Research Network

Leawood, Kansas, 66211, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enhanced Office

Behavioral

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

Conventional Office

Behavioral

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

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.

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.

Primary outcomes

  1. Aggregate patient assessment of practice involvement in patient health behaviors

    Time frame: 12 months

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

    Time frame: 12 months

  3. Spread of billing codes for physician fitness counseling

    Time frame: 12 months

  4. Body Mass Index

    Time frame: baseline, 6, 9, and 12 months

  5. Homeostatic Assay- Insulin Resistance

    Time frame: baseline, 3, 6, 9, and 12 months

  6. Nuclear Molecular Resonance (NMR) Lipoprotein Profiles

    Time frame: baseline, 3, 6, 9, and 12 months

  7. 3-Minute Step Test

    Time frame: baseline, 3, 6, 9, and 12 months

  8. Blood Pressure

    Time frame: baseline, 3, 6, 9, and 12 months

Secondary outcomes

  1. Functional health status

    Time frame: baseline, 3, 6, 9, and 12 months

  2. Quality of life and well-being

    Time frame: baseline, 3, 6, 9, and 12 months

  3. Treatment self-regulation items related to diet

    Time frame: baseline, 3, 6, 9, and 12 months

  4. Treatment self-regulation items related to physical activity

    Time frame: baseline, 3, 6, 9, and 12 months

  5. Perceived competence for maintaining healthy eating

    Time frame: baseline, 3, 6, 9, and 12 months

  6. Perceived competence for maintaining physical activity

    Time frame: baseline, 3, 6, 9, and 12 months

  7. Perceived competence for maintaining emotional health

    Time frame: baseline, 3, 6, 9, and 12 months

  8. Diet and nutrition related items

    Time frame: baseline, 3, 6, 9, and 12 months

  9. Physical activity related items

    Time frame: baseline, 3, 6, 9, and 12 months

Sponsors and collaborators

Lead sponsor

American Academy of Family Physicians

Other

Collaborators

  • The PepsiCo Foundation

Registry information

Official study title

The Impact of Brief Primary Care Counseling and Novel Physiological Measures on Patient Physical and Emotional Health

Acronym: AIM-HI

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Sep 26, 2007
Registry last updated
May 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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