- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00869583
Increasing Physical Activity Among Mexican American Women (The Enlace Study)
Enlace: A Partnership to Promote Physical Activity Among Mexican Immigrant Women
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Mexican American women in the United States are more likely to live a sedentary lifestyle than women of other ethnic groups. As a result, obesity affects Mexican American women at a high rate. Obesity and a lack of physical activity are risk factors for many diseases, including heart disease, diabetes, and certain types of cancers. Increasing physical activity can lead to weight loss and lower the risk of developing these diseases. This study represents a partnership between the University of South Carolina, the South Carolina Hispanic Latino Health Coalition, and the University of Texas Health Sciences Center at San Antonio (UTHSCSA) Regional Academic Health Center in the Lower Rio Grande Valley of Texas. Study researchers from these institutions will first conduct interviews and focus groups and then develop a program aimed at encouraging moderately intense physical activity among Mexican American women. Next, the study will evaluate the effectiveness of that program at increasing physical activity levels and promoting weight loss among Mexican American women in Columbia, South Carolina and the Lower Rio Grande Valley of Texas.
This study will enroll Mexican American women. Participants will be randomly assigned to either immediately take part in the physical activity program or take part in the program at the end of the 6-month study. At baseline, all participants will receive home visits from study staff. During these visits, participants will undergo weight, height, and waist measurements. Participants will also complete questionnaires to assess their medical history and physical activity habits. For 1 week after the study visit, participants will wear a physical activity monitor and keep an activity diary. Participants who are assigned to immediately take part in the physical activity program will receive counseling from a community health educator that will focus on the importance of changing physical activity habits. They will be encouraged to partake in 30 minutes of daily physical activity for at least 5 days a week. Each month, participants will receive educational materials and telephone calls or visits from the health educator. Participants will receive a pedometer and will be asked to keep a daily log of their physical activity. At Month 6, all participants will receive another home study visit for repeat baseline testing. At this time, participants who did not take part initially in the physical activity program will start the program. However, they will have no further study visits or evaluations.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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South Carolina
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Columbia, South Carolina, États-Unis, 29208
- University of South Carolina
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Texas
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San Antonio, Texas, États-Unis, 78230
- University of Texas Health Science Center San Antonio
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Self-identifies as being of Mexican origin
- Has a personal telephone
- Resides in the study area and intends to stay in the area for the entire study period
- Able to understand Spanish
- Does not currently meet physical activity level recommendations
- Interested in receiving information on physical activity
- Willing to be assigned to either study group
- Willing to attend the program sessions and complete standardized measurements
Exclusion Criteria:
- Not physically able to participate in a moderate intensity walking program and not able to understand and verbally respond to questions
- Pregnant
- Diabetes
- Uncontrolled hypertension
- Undergoing therapy for life-threatening illnesses (e.g., chemotherapy or radiation therapy)
- Positive (risk) responses on the Physical Activity Readiness Questionnaire (PAR-Q) and subsequent physician disapproval on the Physical Activity Readiness Medical Examination (PAR-Med-X)
- Already gets 5 or more days per week of 30 minutes of moderately intense activity, based on the responses to the six questions concerning frequency and duration of moderately and vigorously intense physical activity from the Behavioral Risk Factor Surveillance Survey
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Aucune intervention: 2
|
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Expérimental: 1
Participants will immediately take part in the physical activity program.
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Participants will receive counseling from a community health educator that will focus on the importance of increasing physical activity.
Participants will be encouraged to engage in moderate physical activity (3.0 to 6.0 metabolic equivalents [METS]) for 30 minutes on 5 or more days per week.
Participants will be encouraged to start their physical activity program slowly and to gradually increase both frequency and intensity to meet the study goal (e.g., beginning with three sessions per week for 15 minutes and building up to five sessions per week for 30 minutes by Week 12).
They will receive educational materials and telephone calls or visits from health educators on a monthly basis for 6 months.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Moderate to vigorous physical activity (measured by accelerometry and self-report)
Délai: Measured at baseline and Month 6
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Measured at baseline and Month 6
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Body mass index
Délai: Measured at baseline and Month 6
|
Measured at baseline and Month 6
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Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: Deborah Parra-Medina, PhD, The University of Texas Health Science Center, Houston
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 642
- R21HL087765 (Subvention/contrat des NIH des États-Unis)
- 7R21HL087765 (Subvention/contrat des NIH des États-Unis)
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