- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02428920
Grenada Heart Project - Community Health Action to Encourage Healthy Behaviors (GHP CHANGE)
The Grenada Heart Project (GHP) conducted an observational study within a randomly selected adult sample of Grenadians in 2008-2009. The aim of the study was to assess the clinical, biological and psychosocial determinants of the cardiovascular health in Grenada, in order to develop and implement a nationwide cardiovascular health promotion program.
The sample of 2,827 adults was randomly selected from the national electronic voter list. The main outcome measures were self-reported cardiovascular disease and behavioral risk factors, anthropometric measures, blood pressure (BP), point-of-care testing for glucose and lipids, and ankle-brachial index. Analysis of the data revealed prevalence rates of obesity, hypertension and diabetes significantly exceeding those seen in the U.S.
Since the completion of this assessment, an additional effort has contributed significantly to the current project. A parallel community health-promotion project was carried out in Cardona, Spain called the "Cardona Integral Fifty-Fifty" project with 80 subjects. The preliminary results of the Cardona study have a shown that peer motivation may significantly improve healthy behaviors and thus modify cardiovascular risk.
The GHP CHANGE community -based intervention aims to promote positive behaviors and focus more on what creates health, rather than what prevents sickness. It is built on the foundations of social support, assessing whether people going through similar challenges will support each other, work together to identify and address barriers to success, and motivate each other to move forward. In this program we test for the impact of promotion of healthy lifestyle behaviors through peer motivation on blood pressure, physical activity, eating behavior, weight, and smoking.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This culturally-tailored intervention program will take place over a 12-month period in the following four regions on the island:
- St. David's Parish
- St. Andrew's Parish
- St. George's Parish
- St. John's/St. Mark's Parish (combined ) •The program will involve approximately 400 randomized participants (100 from each region). Participants, aged 18-70, from each parish will be divided into one of two groups: Intervention Group arm (peer support) or Control Group arm (individual study).
The investigators will identify study participants previously enrolled in the Grenada Heart Project, with at least one vascular risk factor, as defined by the Adult Treatment Panel III guidelines which include: elevated BP, increased blood glucose level, increased waist circumference, minimal reported physical activity, minimally reported fruit and vegetable intake, or current smoking habits. Given a 10% refusal rate and 10% failure rate in the run-in phase, 120 participants from each site will be invited randomly, from the high risk group, to recruit for participation in the study.
All eligible participants are invited to attend an informational half-day session, during which a general overview of the program is presented and participants have an opportunity to have any questions answered. During this session, eligible and interested individuals complete the written consent forms. Upon consenting, participants are informed of their randomization arm (education intervention or group intervention) and entered into a run-in phase. All participants receive a notebook, as well as certain health literate materials, provided by the American Heart Association. The educational materials will promote management of risk factors and the notebook will provide an avenue for recording of lifestyle behaviors, such as health goals, BP values, and eating habits.
•Participants enrolled in the run-in phase will complete the following assessments at three time points (baseline, 6-months, and 12-months):
- Anthropometric measurements
- GHP data collection form
- International physical activity questionnaire (iPAQ)
- Lifestyle Assessment [modified SF-36 questionnaire tailored to the Grenadian population]
- Point-of-care testing using an LDX analyzer (solely for the 12 month assessment).
The investigators have developed a "GHP Health outcomes Score" which captures a person's health profile on a 0-to-3 point scale related to smoking habits, overweight, sedentary lifestyle, and hypertension During the run-in phase, participants will attend a series of core lifestyle and risk factor education workshops related to motivation for change, nutrition (two sessions), smoking cessation, physical education and BP control. Only those participants who attend 4 of the 6 sessions will be eligible for randomization.
Eligible participants will be randomized to the intervention arm or to the control arm, stratified by parish. In the group intervention arm a group leader will be selected internally within the support groups, who will receive additional training from the research team in regards to group motivation and facilitation. Those randomized into the Intervention arm will be organized into peer groups of approximately 10 persons.
The specific aims of this study are:
Specific Aim 1: Hypothesis: Individuals will show an improvement of health-related behaviors through directed peer education groups (intervention group), compared to the individuals not receiving such peer support (control group).
Specific Aim 2: Hypothesis: Individuals will show an improvement in their quality of life through directed peer education groups (intervention group), compared to the individuals not receiving such peer support (control group).
Specific Aim 3: Hypothesis: Individuals will show an improvement in cardiovascular risk factors through directed peer education groups (intervention group), compared to the individuals not receiving such peer support (control group).
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
-
-
-
St. George's, Grenade
- St. George's University
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Resident of Grenada
One or more vascular risk factors:
- Borderline to elevated blood pressure (defined as systolic blood pressure ≥120 mm Hg to SBP < 160 or diastolic blood pressure ≥ 80 and < 90 mm Hg)
- Waist circumference of >40 inches for men and >35 inches for women
- Smoking (active self-reported smoking, of any type of tobacco, at least daily)
- Physical inactivity (reporting less than 120 min/week of activity)
- Fasting glucose level > 100 mg/dl
- Total Cholesterol >250 mg/dl, LDL > 130 mg/dl
- Fruit/vegetable intake less than 2 servings daily
Exclusion Criteria:
- Unable/unwilling to provide consent
- Age of under 18 or more than 70 years old (inclusive) as of December 2012
- Inability of self-monitoring
- Pregnant women
- Morbidly ill with expectation of death within a year
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Peer Groups
Individuals in Intervention Group Arm will attend biweekly or monthly peer support groups (approximately 10 people per group) for evaluating changes and promoting mutual support.
12-month duration.
|
The intervention group arm will attend biweekly or monthly peer group meetings to discuss health successes and challenges.
|
|
Aucune intervention: Control Arm
The control arm, will attend the initial educational group lectures at baseline assessment and will receive no intervention thereafter.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Composite GHP outcomes health score
Délai: baseline
|
The GHP outcomes health score assimilates scores related to weight, diet, smoking, physical activity, blood pressure and quality of life.
|
baseline
|
|
Composite GHP outcomes health score
Délai: 6 months
|
The GHP outcomes health score assimilates scores related to weight, diet, smoking, physical activity, blood pressure and quality of life.
|
6 months
|
|
Composite GHP outcomes health score
Délai: 12 months
|
The GHP outcomes health score assimilates scores related to weight, diet, smoking, physical activity, blood pressure and quality of life.
|
12 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in blood pressure
Délai: baseline and 12 months
|
Change in blood pressure at 12 months as compared to baseline
|
baseline and 12 months
|
|
Change in body weight
Délai: baseline and 12 months
|
Change in body weight at 12 months as compared to baseline
|
baseline and 12 months
|
|
Change in behavior
Délai: baseline and 12 months
|
Change in behavior as 12 months as compared to baseline
|
baseline and 12 months
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Valentin Fuster, MD, Icahn School of Medicine at Mount Sinai
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 (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- GCO 12-2004
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 .
Essais cliniques sur Comportement de santé
-
Seattle Children's HospitalEunice Kennedy Shriver National Institute of Child Health and Human Development... et autres collaborateursPas encore de recrutementServices de santé préventifs (PREV HEALTH SERV)États-Unis
-
University of Colorado, DenverEunice Kennedy Shriver National Institute of Child Health and Human Development... et autres collaborateursComplétéServices de santé préventifs (PREV HEALTH SERV)États-Unis
-
Queens College, The City University of New YorkRecrutementPublication d'articles soumis à l'American Journal of Public HealthÉtats-Unis
-
Gümüşhane UniversıtyKaradeniz Technical UniversityComplétéEnregistré auprès de Kelkit District State Hospital Home Health Unit | Être patient des soins à domicileTurquie
-
Hopital MontfortChildren's Hospital of Eastern Ontario Research InstituteRecrutementTroubles liés au stress thermique | Soins de santé primaires | Exposition environnementale | Comportement de réduction des risques | Santé publique | Exposition à la chaleur | Changement climatique | Services de santé préventifs (PREV HEALTH SERV) | Sujets sainsCanada
-
University of California, San FranciscoUniversity of California, DavisPas encore de recrutementLes participantes doivent être des femmes âgées de 25 ans ou plus | Les participants ne doivent pas avoir d'antécédents autodéclarés de maladie cardiaque ou d'accident vasculaire cérébral | Les participants ne doivent pas être atteints d'une maladie en phase terminale ou d'un trouble... et d'autres conditionsÉtats-Unis
Essais cliniques sur Peer Groups
-
King's College LondonGuy's and St Thomas' NHS Foundation Trust; MND Association; Marie Curie CharityComplétéMaladie du motoneurone | La sclérose latérale amyotrophiqueRoyaume-Uni
-
MYnd AnalyticsUniversity of Ottawa; Canadian Forces Health Services Centre OttawaInconnueLa dépression | Diagnostic non psychotique en tant que comorbiditéCanada
-
Medipol UniversityComplétéNiveau de connaissanceTurquie
-
MYnd AnalyticsSuspendu
-
Monash University MalaysiaMinistry of Higher Education, MalaysiaComplétéPrévention primaire des maladies cardiovasculairesMalaisie
-
Medical University of South CarolinaNational Institute on Drug Abuse (NIDA); The Emmes Company, LLC; National Drug...ComplétéSurdose d'opioïdesÉtats-Unis
-
University of California, Los AngelesPas encore de recrutement
-
Amager HospitalThe Peer partnership associationComplétéTrouble de santé mentale | Troubles de la santé mentale | Groupe de pairs | Problèmes PsychosociauxDanemark
-
University of LisbonAssociacao Protectora dos Diabeticos de PortugalComplété
-
University of Maryland, College ParkNational Institute on Drug Abuse (NIDA); Medical Research Council, South AfricaComplétéTroubles liés à une substance | VIH | Consommation de substances | Troubles liés à l'utilisation de substances | Adhésion au traitement | Adhésion et conformité au traitement | Stigmatisation | Prestation des soins de santé | Stigmatisation sociale | Attitude du personnel de santé | Agents de santé communautaires et d'autres conditionsAfrique du Sud