- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00569595
Improving Health Habits in Impoverished Populations
6 juin 2011 mis à jour par: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Poor diet, physical inactivity, and sedentary behaviors among low-income, minority populations have been linked to greater risk of chronic health conditions such as overweight/obesity, cardiovascular disease, and type 2 diabetes.
Low-income clinics that serve these populations often represent an untapped opportunity for health promotion in impoverished individuals.
This exploratory project proposes to address this scientific gap by introducing and conducting a randomized controlled pilot of the Self-Care Stimulating Disease Prevention Program to address poor dietary habits, physical inactivity, and sedentary lifestyle behaviors among low income, uninsured patient populations.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
Poor diet, physical inactivity, and sedentary behaviors among low-income, minority populations have been linked to greater risk of chronic health conditions such as overweight/obesity, cardiovascular disease, and type 2 diabetes.
Low-income clinics that serve these populations often represent an untapped opportunity for health promotion in impoverished individuals.
Few studies have examined the feasibility of using brief physician advice and multi-level, clinic-based interventions to change poor dietary habits, physical inactivity, and sedentary lifestyle behaviors among these culturally diverse populations that comprise the clinic population.
This exploratory project proposes to address this scientific gap by introducing and piloting a Self-Care Stimulating Disease Prevention Program (SCSDPP) to address poor dietary habits, physical inactivity, and sedentary lifestyle behaviors among low income, uninsured patient populations (primarily Latinos) served by the community clinics of the Venice Family Clinic (VFC) health center in Los Angeles County.
The program will include the development of 1) a simple-to-use patient Health Priority Assessment (HPA) tool designed to assess patient preferences for behavior change; 2) a standard protocol for physicians to provide brief health advice using motivation interviewing (< 2 minutes per visit); 3) a protocol for distributing self-help aids for patient use (e.g., pedometer, exercise videos); and 4) a series of monthly follow-up counseling sessions by lay health educators (e.g., promotores) to help patients address their lifestyle change priorities over time.
We will conduct a randomized controlled pilot of the SCSDPP in approximately 100 patient cases at two community health clinics within the VFC health center system.
The pilot will utilize precise outcome measures, including commonly-accepted biomarkers (e.g., HgbA1c, fasting blood glucose) and psychometrically-validated measures of process and health status, to accurately assess the magnitude of changes in diet and physical activity among patients over a 12-month observation period.
The feasibility of integrating the SCSDPP into the community health clinic setting will be evaluated, and is the primary aim of this project.
The results will inform efforts to plan a larger, successor study.
Relevance to Public Health: this study evaluates a clinic-based brief intervention to help prevent overweight/obesity, a public health problem that has been linked to the development of the metabolic syndrome and other precursors of diabetes.
Type d'étude
Interventionnel
Inscription (Anticipé)
100
Phase
- Phase 3
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
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California
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Los Angeles, California, États-Unis, 90024
- UCLA Department of Family Medicine
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Los Angeles, California, États-Unis, 90028
- Queenscare Family Clinics
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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
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Ages 18 and older
- English or Spanish-speaking
- Accessible by telephone or in person over time
- Willing to cooperate with data collection
- Planning to be in the Los Angeles area for the next 6 to 12 months so they can complete the study period
Exclusion Criteria:
- Women who are pregnant
- History of cancer, except non-melanoma skin cancer or in situ cancers
- Medical conditions preventing free choice of foods (e.g., colitis, poorly-controlled diabetes)
- Medical conditions precluding participation in common forms of aerobic or resistance exercise (e.g., uncontrolled angina, asthma or hypertension; severe physical impairment; and end-stage disease conditions such as congestive heart failure, nephropathy from any cause, or advanced chronic pulmonary disease)
- Does not show any desire to change any of their health behaviors (i.e., healthy eating, physical activity, sedentary behavior, or control their weight)
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 parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 1
Multi-Level, Patient-Directed, Lifestyle Change, Health Promotion Program
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The intervention is aimed at improving diet, increasing physical activity, and reducing sedentary behaviors among low-income patients, assuming that this will increase motivation and self-confidence to adhere to self-care regimens based on personal prioritizing and progressive goal setting.
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Comparateur factice: 2
Patient health counseling program by lay health educators Entitled "Fighting Cancer with Advice."
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Patient health counseling program by lay health educators entitled "Fighting Cancer with Advice."
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Serum glycosylated hemoglobin, heart rate recovery step test
Délai: 4 and 6 months
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4 and 6 months
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Total Cholesterol, BMI, waist circumference, healthy eating, physical activity, perceived health status, patient satisfaction, mood
Délai: 4 and 6 months
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4 and 6 months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Chercheur principal: Lillian Gelberg, MD, MSPH, UCLA Department of Family Medicine
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
1 novembre 2008
Achèvement primaire (Réel)
1 novembre 2009
Achèvement de l'étude (Réel)
1 novembre 2009
Dates d'inscription aux études
Première soumission
5 décembre 2007
Première soumission répondant aux critères de contrôle qualité
6 décembre 2007
Première publication (Estimation)
7 décembre 2007
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
7 juin 2011
Dernière mise à jour soumise répondant aux critères de contrôle qualité
6 juin 2011
Dernière vérification
1 juin 2011
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- R21 DK71065 (completed)
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 .