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

9. Mai 2011 aktualisiert von: American Academy of Family Physicians

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

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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

950

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Kansas
      • Leawood, Kansas, Vereinigte Staaten, 66211
        • American Academy of Family Physicians National Research Network

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Zuteilung: Zufällig
  • Interventionsmodell: Fakultätszuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: A, 1, I
Practice-level treatment group
Verhalten: Enhanced Office
Clinicians and office staff personally engage in AIM-HI fitness program, and promote program to patients
Aktiver Komparator: A, 1, II
Practice-level comparison group
Verhalten: 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
Verhalten: 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.
Aktiver Komparator: B, 1, II
Patient-level comparison group
Verhalten: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Aggregate patient assessment of practice involvement in patient health behaviors
Zeitfenster: 12 months
12 months
Aggregate clinician and practice staff assessment of practice involvement in patient healthy behaviors
Zeitfenster: 12 months
12 months
Spread of billing codes for physician fitness counseling
Zeitfenster: 12 months
12 months
Body Mass Index
Zeitfenster: baseline, 6, 9, and 12 months
baseline, 6, 9, and 12 months
Homeostatic Assay- Insulin Resistance
Zeitfenster: baseline, 3, 6, 9, and 12 months
baseline, 3, 6, 9, and 12 months
Nuclear Molecular Resonance (NMR) Lipoprotein Profiles
Zeitfenster: baseline, 3, 6, 9, and 12 months
baseline, 3, 6, 9, and 12 months
3-Minute Step Test
Zeitfenster: baseline, 3, 6, 9, and 12 months
baseline, 3, 6, 9, and 12 months
Blood Pressure
Zeitfenster: baseline, 3, 6, 9, and 12 months
baseline, 3, 6, 9, and 12 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Functional health status
Zeitfenster: baseline, 3, 6, 9, and 12 months
baseline, 3, 6, 9, and 12 months
Quality of life and well-being
Zeitfenster: baseline, 3, 6, 9, and 12 months
baseline, 3, 6, 9, and 12 months
Treatment self-regulation items related to diet
Zeitfenster: baseline, 3, 6, 9, and 12 months
baseline, 3, 6, 9, and 12 months
Treatment self-regulation items related to physical activity
Zeitfenster: baseline, 3, 6, 9, and 12 months
baseline, 3, 6, 9, and 12 months
Perceived competence for maintaining healthy eating
Zeitfenster: baseline, 3, 6, 9, and 12 months
baseline, 3, 6, 9, and 12 months
Perceived competence for maintaining physical activity
Zeitfenster: baseline, 3, 6, 9, and 12 months
baseline, 3, 6, 9, and 12 months
Perceived competence for maintaining emotional health
Zeitfenster: baseline, 3, 6, 9, and 12 months
baseline, 3, 6, 9, and 12 months
Diet and nutrition related items
Zeitfenster: baseline, 3, 6, 9, and 12 months
baseline, 3, 6, 9, and 12 months
Physical activity related items
Zeitfenster: baseline, 3, 6, 9, and 12 months
baseline, 3, 6, 9, and 12 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

American Academy of Family Physicians

Mitarbeiter

The PepsiCo Foundation

Ermittler

  • Hauptermittler: Wilson D Pace, MD, FAAFP, American Academy of Family Physicians

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Juli 2007

Primärer Abschluss (Tatsächlich)

1. April 2009

Studienabschluss (Tatsächlich)

1. Oktober 2009

Studienanmeldedaten

Zuerst eingereicht

24. September 2007

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

24. September 2007

Zuerst gepostet (Schätzen)

26. September 2007

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

10. Mai 2011

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

9. Mai 2011

Zuletzt verifiziert

1. Mai 2011

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • 07-034

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