- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00674518
Changing Healthy Outcomes In Clinic Environments (CHOICE)
18. juni 2019 oppdatert av: Kerry Kuehl, Oregon Health and Science University
Health Promotion Intervention: Sedentary Primary Care Patients
This study will compare three methods of counseling to determine which is most effective at motivating participants to adopt healthy lifestyle habits.
The three methods are: individual counseling, working in groups with a health educator, and receiving advice from a physician.
The health goals for subjects in this study are: 1) increase physical activity to 30 minutes each day, 2) reduce fat intake to less than 30% of total calories, 3) increase consumption of fruits and vegetables to at least 5 servings each day, and 4) reduce percentage of body fat to a healthy level.
Studieoversikt
Status
Fullført
Detaljert beskrivelse
The benefits of physical activity and proper nutrition have been well established to prevent and reduce the devastating effects of chronic illness including, cardiovascular disease, diabetes, and obesity.
Unfortunately, nearly 80% of individuals fail to get enough exercise and eat a proper diet to alter these health disorders.
In the United States, physicians do not routinely counsel patients about physical activity and nutrition.
Although few studies have examined promotion of physical activity in the primary care setting, most have been disappointing.
Achieving and maintaining healthy behaviors remain a major challenge to promoting health and caring for illness.
This research proposals aims are to a) evaluate two health behavior change intervention strategies to improve physical activity and dietary behaviors among sedentary patients in a primary care office; and b) assess by cost-benefit analysis, the impact of each model intervention.
After initial recruitment from OHSU Internal Medicine and Family Practice clinics, 105 sedentary patients will be randomly assigned to Model 1, Model 2, or Model 3. Model #1, a one-on-one, individualized counseling intervention known as Motivational Interviewing, based on the transtheoretical model of behavior change, will use twelve health educator counseling meetings and ten bi-weekly follow-up phone calls the first year and six 60-minute sessions will occur in the second year of the intervention.
Model #2, a team-centered intervention where the health promotion curriculum is delivered by a group facilitator to a team of patients (based on the social influence theory) consists of twelve 60-minute peer facilitated group meetings and ten follow-up phone calls, with six sessions occurring the second year of the full outcome study.
Group facilitators will be trained and use scripted lesson plans.
Model #3, a usual practice control condition (5 minute physician advice using the Physician Advice Counseling Exercise or PACE format).
Models 1 and 2 contact hours are the same.
Year 01 is the pilot study to revise and refine the curriculum and study protocol.
The full intervention will last two years while the behavior change durability will be assessed over another full year.
The study's primary outcomes are increased physical activity as measured by peak oxygen uptake and survey, dietary changes assessed by intake survey, and body composition changes as measured by DEXA.
Secondary outcome measures include blood pressure lipid and lipoprotein levels, biochemical markers of inflammation (CRP) and hormonal markers of obesity.
Outcomes will be assessed using repeated measures design.
Relationships among mediators, the intervention, and the outcome measures will be identified.
Studietype
Intervensjonell
Registrering (Faktiske)
103
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Oregon
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Portland, Oregon, Forente stater, 97239
- Oregon Health & Science University
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
30 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Primary care patient patients who are sedentary (less than one exercise bout per week
- 30 - 65 years old
- In stable health, defined as an absence of serious chronic disease (i.e., recent myocardial infarction or CVA, uncontrolled metabolic conditions like thyrotoxicosis or poorly controlled diabetes mellitus).
- If the participants are taking medication for medical conditions, they have to be on a stable dose for at least three months with no medication change in past 3 months.
- Participants must be independent in living and able to obtain weekly transportation to OHSU
- able to increase their physical activity.
Exclusion Criteria:
- Non ambulatory
- Contraindications to exercise due to medical conditions using the AHA criteria and the ACSM Guidelines For Exercise Testing and Prescription. Examples are CAD, CHF, Recent CVA, poorly controlled DM (fasting glucose over 200 mg/dl), poorly controlled HTN, Severe COPD, Thyrotoxicosis, and Morbid Obesity with BMI > 40.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Faktoriell oppgave
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Counseling
One-on-one sessions conducted by a professional motivational counselor to explore ways to help motivate participants to exercise, eat healthier, and lose weight.
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Motivational Interviewing
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Eksperimentell: Group
A nutrition and exercise specialist will lead and teach a group of 4 to 5 subjects in healthy nutrition, exercise and weight loss habits
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peer led, scripted health promotion curriculum in groups of 4-5 individual, with team building activities and health education for 12, 1-hour sessions per year.
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Aktiv komparator: MD Advice
A physician will provide exercise and nutrition advice to participants immediately following testing
|
PACE format for physician exercise and nutrition counseling annually.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Improve physical activity and dietary behaviors among sedentary patients
Tidsramme: annually x 3 years
|
annually x 3 years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Improve biomarkers of obesity including glucose, lipid levels, CRP, leptin and insulin.
Tidsramme: annually x 3 years
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annually x 3 years
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Kerry S Kuehl, MD, Oregon Health and Science University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Kuehl KS, Elliot D, Edholm K, Frohnmayer S. Changing Healthy Outcomes In Clinical Environments (CHOICE) Study. Annals of Behavioral Medicine 33(Supplement):S094, 2007.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. januar 2005
Primær fullføring (Faktiske)
1. juni 2008
Studiet fullført (Faktiske)
1. mars 2009
Datoer for studieregistrering
Først innsendt
6. mai 2008
Først innsendt som oppfylte QC-kriteriene
6. mai 2008
Først lagt ut (Anslag)
8. mai 2008
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
20. juni 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. juni 2019
Sist bekreftet
1. juni 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1K23RR017554-01A2 (U.S. NIH-stipend/kontrakt)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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