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- Essai clinique NCT00674518
Changing Healthy Outcomes In Clinic Environments (CHOICE)
18 juin 2019 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
103
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Oregon
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Portland, Oregon, États-Unis, 97239
- Oregon Health & Science University
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
30 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 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.
|
Motivational Interviewing
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Expérimental: 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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Comparateur actif: MD Advice
A physician will provide exercise and nutrition advice to participants immediately following testing
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PACE format for physician exercise and nutrition counseling annually.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Improve physical activity and dietary behaviors among sedentary patients
Délai: annually x 3 years
|
annually x 3 years
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Improve biomarkers of obesity including glucose, lipid levels, CRP, leptin and insulin.
Délai: annually x 3 years
|
annually x 3 years
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Kerry S Kuehl, MD, Oregon Health and Science University
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Kuehl KS, Elliot D, Edholm K, Frohnmayer S. Changing Healthy Outcomes In Clinical Environments (CHOICE) Study. Annals of Behavioral Medicine 33(Supplement):S094, 2007.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 janvier 2005
Achèvement primaire (Réel)
1 juin 2008
Achèvement de l'étude (Réel)
1 mars 2009
Dates d'inscription aux études
Première soumission
6 mai 2008
Première soumission répondant aux critères de contrôle qualité
6 mai 2008
Première publication (Estimation)
8 mai 2008
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
20 juin 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
18 juin 2019
Dernière vérification
1 juin 2019
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 1K23RR017554-01A2 (Subvention/contrat des NIH des États-Unis)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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