A Web-based Approach to Treating Cardiovascular Disease Risk in Employees With Metabolic Syndrome (BEHHS)
19 février 2015 mis à jour par: Baptist Health South Florida
Baptist Employee Healthy Heart Study (BEHHS) - A Novel Web-based Approach to Reduce Cardiovascular Disease Risk in a Diverse Employee Population With Metabolic Syndrome Via Diet and Lifestyle Change
The purpose of BEHHS is first to assess the baseline sub-clinical disease in a population of Baptist Health Employees who have Metabolic Syndrome, a known contributor to cardiovascular disease.
Second, the investigators wish to encourage a healthy lifestyle through personalized nutrition and fitness advice, delivered as part of a web based program, which will in turn lead to increases in heart healthy behaviors such as increased consumption of heart healthy foods, increased exercise initiation, and more positive attitudes about health.
To assess this, the investigators plan to randomize 200 employees with Metabolic Syndrome to either the new web-based diet and lifestyle program, or to care-as-usual, which is the currently offered MyWellnessAdvantage and WebMD websites.
The investigators hypothesize that the web-based group will show greater improvements in physical health (such as weight loss, cholesterol reduction, etc.) as well as increased consumption of heart healthy foods, exercise initiation, and quality of sleep as measured by surveys administered at the 4,8, and 12 month follow-up appointments.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
182
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
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Florida
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Miami, Florida, États-Unis, 33143
- South Miami Heart Center Outpatient Services
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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
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Employee of Baptist Health
- Access to Internet
- Has a smart phone (Android or Apple supported) with data plan
- Has an email address
Diagnosis of three or more of the following:
- Waist circumference >=40 inches in and male and >= 35 inches in a female
- Fasting triglyceride level > 150 mg/dl*
- HDL-C < 40 mg/dl in men or < 50 mg/dl in women*
- BP > 130/85 mm Hg*
Fasting blood glucose > 110 mg/dl
- Or currently on medication to treat the abnormal condition
Exclusion Criteria:
- Prior history of major cardiovascular events (angina, myocardial infarction, prior coronary revascularization
- Any woman of childbearing potential who is pregnant, breastfeeding/currently lactating, seeking to become pregnant or suspects that she may be pregnant**
- Active treatment for cancer
- Known history of a bilateral mastectomy
- Known history of diabetes (already being treated as high-risk group, would not qualify as having Metabolic Syndrome for purposes of our study)
- Known history of Chronic Obstructive Pulmonary Disease
- Currently in atrial fibrillation
- Known history of hypo-tension
- Known history of heart failure
- Known history of aortic valve stenosis
- Known history of heart block
- Chest CT scan in the last year
- Cognitive inability as judged by the interviewer
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: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: My Everyday Health Group
Subjects in this group will be randomized to a web based diet and weight modification program (MyEveryday Health) and provided personal access codes.
They will also continue to have access to the WebMD website provided as part of their employment with Baptist Health South Florida.
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MyEveryday Health is a web-based nutritional and lifestyle management program.
The program includes personalized diet and weight guidance, meal planners, shopping list generator, recipe finder, weight tracker and dining out and fast food guides.
Based on specific algorithms, tips and suggestions on how to make changes in their diet and lifestyle will be give each time the subject logs in.
The MyEverydayHealth website will also be available as an app for their smart phone to the participants.
If they choose to use the app, daily reminders to log in and use their tools will be sent, along with motivating tool/tips/tricks to stay with the program.
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Aucune intervention: WebMD Group
This group will continue to have access to a website that is available for use of all employees (WebMD) at Baptist Health South Florida.
This is the care-as-usual arm.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Reduction in BMI
Délai: 4 months, 12 months
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4 months, 12 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in waist circumference
Délai: 4 months, 12 months
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4 months, 12 months
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Change in Lipids
Délai: 4 months, 12 months
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Examining any changes in advanced lipids such as HDL, LDL, triglycerides, particle size
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4 months, 12 months
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Change in Blood Pressure
Délai: 4 months, 12 months
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4 months, 12 months
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Change in Glucose Regulation
Délai: 4 months, 12 months
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Change in fasting blood glucose(FBG) and HbA1C
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4 months, 12 months
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Lifestyle Change
Délai: 4 months, 12 months
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Changes in reported physical activity, diet, and behavioral scores based on self report by survey
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4 months, 12 months
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Change in Sub-Clinical Disease
Délai: 12 months
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Change in measures of sub-clinical cardiovascular disease; Endothelial function, Carotid intima-medial thickness, coronary artery calcium
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12 months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Khurram Nasir, MD, MPH, Baptist Health Medical Group
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
- Aziz M, Gannarapu S, Humayun C, Siddiqui U, Nasir K, Aneni EC. Association of particles of lipoprotein subclasses with arterial stiffness in a high-risk working population: the Baptist Employee Healthy Heart Study (BEHHS). Egypt Heart J. 2020 Mar 19;72(1):12. doi: 10.1186/s43044-020-00046-4.
- Post JM, Ali SS, Roberson LL, Aneni EC, Shaharyar S, Younus A, Jamal O, Ahmad R, Aziz MA, Malik R, Spatz ES, Feldman T, Fialkow J, Veledar E, Cury RC, Agatston AS, Nasir K. Rationale and design of the Baptist Employee Healthy Heart Study: a randomized trial assessing the efficacy of the addition of an interactive, personalized, web-based, lifestyle intervention tool to an existing health information web platform in a high-risk employee population. Trials. 2016 Jul 1;17(1):308. doi: 10.1186/s13063-016-1424-z.
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 août 2013
Achèvement primaire (Réel)
1 février 2015
Achèvement de l'étude (Réel)
1 février 2015
Dates d'inscription aux études
Première soumission
3 juillet 2013
Première soumission répondant aux critères de contrôle qualité
30 juillet 2013
Première publication (Estimation)
31 juillet 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
20 février 2015
Dernière mise à jour soumise répondant aux critères de contrôle qualité
19 février 2015
Dernière vérification
1 février 2015
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 13-028
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