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- Essai clinique NCT02707432
Reducing Cardiovascular Disease Risk Factors in Rural Communities in North Carolina
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Cardiovascular disease (CVD), the leading cause of death in the United States (US), disproportionately burdens rural communities. CVD prevalence rates for residents of rural areas (13.1%) is higher compared to those in urban areas (11.2%) of the US. The proposed settings for this research report similar trends in CVD prevalence, where CVD and stroke are among the top three leading causes of death. In community health assessments conducted in the last three years CVD risk factors such as obesity and hypertension were among the top 10 health priorities in our target counties. Compared to residents of metropolitan areas, rural residents have higher rates of cigarette smoking, obesity, mortality from ischemic heart disease, and are physically inactive. These disparities are likely to widen; at the current rate, its estimated 50% of individuals in the US will have CVD by 2030.
Using a community-based participatory research (CBPR) approach, our specific aims for the study are to:
- Expand and sustain a coalition of community and academic stakeholders to develop successful CVD risk prevention strategies in rural communities;
- Conduct a mixed-method community needs and assets assessment based on: a) assemble, review and assess existing sources of CVD data; b) identification of community strengths and resources using a web-based survey of community, faith based, social service and healthcare organizations; c) determine the acceptability of components of CVD risk reduction EBIs and community members' perceptions of possible targets for intervention using focus group interviews; d) determine specific family influences (barriers and facilitators) on acceptability of EBI acceptability;
- Adapt PREMIER, a multi-component EBI using intervention mapping;
- Conduct a small-scale randomized control trial to assess a) efficacy; and, b) feasibility and adaption of implementing adapted PREMIER in rural settings.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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North Carolina
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Rocky Mount, North Carolina, États-Unis, 27801
- Project Momentum Inc.
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Rocky Mount, North Carolina, États-Unis, 27891
- Shirley McFarlin
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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:
- African American
- Aged 21 and older
- Has at least one of the following cardiovascular disease (CVD) risk factors: pre-diabetes, hypertension, obesity, family history of early CVD, prior CVD
- Reside in Nash or Edgecombe counties of North Carolina
Exclusion Criteria:
- Evidence of active or unstable CVD
- Cognitive impairment that limits informed consent
Plan d'étude
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: Time 1 (T1) Intervention Group
This group will be the first to receive the adapted intervention, "Heart Matters" (adapted from the PREMIER intervention).
The intervention will be 12 months long.
|
"Heart Matters" is an intervention adapted from PREMIER, an evidence-based, comprehensive lifestyle intervention that focuses on blood pressure as the primary outcome.
To assess the feasibility and efficacy of adapting PREMIER for rural African Americans, Heart Matters will be delivered to multiple intervention groups, but at two different stages.
Autres noms:
|
|
Expérimental: Time 2 (T2) Intervention Group
This delayed intervention group will receive the adapted intervention, "Heart Matters," six months after the T1 Intervention group.
The intervention will be 12 months long.
|
"Heart Matters" is an intervention adapted from PREMIER, an evidence-based, comprehensive lifestyle intervention that focuses on blood pressure as the primary outcome.
To assess the feasibility and efficacy of adapting PREMIER for rural African Americans, Heart Matters will be delivered to multiple intervention groups, but at two different stages.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Weight
Délai: Baseline and 6 months after initiated treatment
|
Measured in pounds
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Baseline and 6 months after initiated treatment
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Systolic Blood Pressure
Délai: Baseline, Month 6
|
Blood pressure as measured in mmHg
|
Baseline, Month 6
|
|
Change in Diastolic Blood Pressure
Délai: Baseline, Month 6
|
As measured in mmHg
|
Baseline, Month 6
|
Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: Giselle Corbie-Smith, MD, MSc, University of North Carolina, Chapel Hill
- Chercheur principal: Mysha Wynn, MA, Project Momentum, Inc.
- Chercheur principal: Shirley McFarlin, BA, James McFarlin Community Development, Inc.
Publications et liens utiles
Publications générales
- Frerichs L, Bess K, Young TL, Hoover SM, Calancie L, Wynn M, McFarlin S, Cene CW, Dave G, Corbie-Smith G. A Cluster Randomized Trial of a Community-Based Intervention Among African-American Adults: Effects on Dietary and Physical Activity Outcomes. Prev Sci. 2020 Apr;21(3):344-354. doi: 10.1007/s11121-019-01067-5.
- Corbie-Smith G, Wiley-Cene C, Bess K, Young T, Dave G, Ellis K, Hoover SM, Lin FC, Wynn M, McFarlin S, Ede J. Heart Matters: a study protocol for a community based randomized trial aimed at reducing cardiovascular risk in a rural, African American community. BMC Public Health. 2018 Jul 31;18(1):938. doi: 10.1186/s12889-018-5802-1.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 13-2576
- 5R01HL120690-02 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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