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A Web-based Approach to Treating Cardiovascular Disease Risk in Employees With Metabolic Syndrome (BEHHS)

19. februar 2015 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

182

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Florida
      • Miami, Florida, Forenede Stater, 33143
        • South Miami Heart Center Outpatient Services

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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:

    1. Waist circumference >=40 inches in and male and >= 35 inches in a female
    2. Fasting triglyceride level > 150 mg/dl*
    3. HDL-C < 40 mg/dl in men or < 50 mg/dl in women*
    4. BP > 130/85 mm Hg*

    5. Fasting blood glucose > 110 mg/dl

      • Or currently on medication to treat the abnormal condition

Exclusion Criteria:

  1. Prior history of major cardiovascular events (angina, myocardial infarction, prior coronary revascularization
  2. Any woman of childbearing potential who is pregnant, breastfeeding/currently lactating, seeking to become pregnant or suspects that she may be pregnant**
  3. Active treatment for cancer
  4. Known history of a bilateral mastectomy
  5. Known history of diabetes (already being treated as high-risk group, would not qualify as having Metabolic Syndrome for purposes of our study)
  6. Known history of Chronic Obstructive Pulmonary Disease
  7. Currently in atrial fibrillation
  8. Known history of hypo-tension
  9. Known history of heart failure
  10. Known history of aortic valve stenosis
  11. Known history of heart block
  12. Chest CT scan in the last year
  13. Cognitive inability as judged by the interviewer

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: My Everyday Health
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.
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Reduction in BMI
Tidsramme: 4 months, 12 months
4 months, 12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in waist circumference
Tidsramme: 4 months, 12 months
4 months, 12 months
Change in Lipids
Tidsramme: 4 months, 12 months
Examining any changes in advanced lipids such as HDL, LDL, triglycerides, particle size
4 months, 12 months
Change in Blood Pressure
Tidsramme: 4 months, 12 months
4 months, 12 months
Change in Glucose Regulation
Tidsramme: 4 months, 12 months
Change in fasting blood glucose(FBG) and HbA1C
4 months, 12 months
Lifestyle Change
Tidsramme: 4 months, 12 months
Changes in reported physical activity, diet, and behavioral scores based on self report by survey
4 months, 12 months
Change in Sub-Clinical Disease
Tidsramme: 12 months
Change in measures of sub-clinical cardiovascular disease; Endothelial function, Carotid intima-medial thickness, coronary artery calcium
12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Baptist Health South Florida

Efterforskere

  • Ledende efterforsker: Khurram Nasir, MD, MPH, Baptist Health Medical Group

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2013

Primær færdiggørelse (Faktiske)

1. februar 2015

Studieafslutning (Faktiske)

1. februar 2015

Datoer for studieregistrering

Først indsendt

3. juli 2013

Først indsendt, der opfyldte QC-kriterier

30. juli 2013

Først opslået (Skøn)

31. juli 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

20. februar 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. februar 2015

Sidst verificeret

1. februar 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 13-028

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med My Everyday Health

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Jordan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner