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

9 mei 2011 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Verwacht)

950

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Kansas
      • Leawood, Kansas, Verenigde Staten, 66211
        • American Academy of Family Physicians National Research Network

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Faculteitstoewijzing
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: A, 1, I
Practice-level treatment group
Gedragsmatig: Enhanced Office
Clinicians and office staff personally engage in AIM-HI fitness program, and promote program to patients
Actieve vergelijker: A, 1, II
Practice-level comparison group
Gedragsmatig: Conventional Office
Conventional office: Clinicians and office staff are not personally engaged in the AIM-HI fitness program, but promote program to patients.
Experimenteel: B, 1, I
Patient-level treatment group
Gedragsmatig: 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.
Actieve vergelijker: B, 1, II
Patient-level comparison group
Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

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

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

American Academy of Family Physicians

Medewerkers

The PepsiCo Foundation

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juli 2007

Primaire voltooiing (Werkelijk)

1 april 2009

Studie voltooiing (Werkelijk)

1 oktober 2009

Studieregistratiedata

Eerst ingediend

24 september 2007

Eerst ingediend dat voldeed aan de QC-criteria

24 september 2007

Eerst geplaatst (Schatting)

26 september 2007

Updates van studierecords

Laatste update geplaatst (Schatting)

10 mei 2011

Laatste update ingediend die voldeed aan QC-criteria

9 mei 2011

Laatst geverifieerd

1 mei 2011

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • 07-034

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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