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Published in: Trials 1/2016

Open Access 01-12-2016 | Study Protocol

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

Authors: Janisse M. Post, Shozab S. Ali, Lara L. Roberson, Ehimen C. Aneni, Sameer Shaharyar, Adnan Younus, Omar Jamal, Rameez Ahmad, Muhammad A. Aziz, Rehan Malik, Erica S. Spatz, Theodore Feldman, Jonathan Fialkow, Emir Veledar, Ricardo C. Cury, Arthur S. Agatston, Khurram Nasir

Published in: Trials | Issue 1/2016

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Abstract

Background

Metabolic syndrome (MetS) and diabetes confer a high risk for developing subsequent cardiovascular disease (CVD). Persons with MetS constitute 24–34 % of the employee population at Baptist Health South Florida (BHSF), a self-insured healthcare organization. The Baptist Employee Healthy Heart Study (BEHHS) aims to assess the addition of a personalized, interactive, web-based, nutrition-management and lifestyle-management program to the existing health-expertise web platform available to BHSF employees in reducing and/or stabilizing CVD and lifestyle risk factors and markers of subclinical CVD.

Methods/design

Subjects with MetS or Type II Diabetes will be recruited from an employee population at BHSF and randomized to either an intervention or a control arm. The intervention arm will be given access to a web-based personalized diet-modification and weight-modification program. The control arm will be reminded to use the standard informational health website available and accessible to all BHSF employees. Subjects will undergo coronary calcium testing, carotid intima-media thickness scans, peripheral arterial tonometry, and advanced lipid panel testing at visit 1, in addition to lifestyle and medical history questionnaires. All tests will be repeated at visits 2 and 4 with the exception of the coronary calcium test, which will only be performed at baseline and visit 4. Visit 3 will capture vitals, anthropometrics, and responses to the questionnaires only.

Conclusion

Results of this study will provide information on the effectiveness of personalized, web-based, lifestyle-management tools in reducing healthcare costs, promoting healthy choices, and reducing cardiovascular risk in an employee population. It will also provide information about the natural history of carotid atherosclerosis and endothelial dysfunction in asymptomatic but high-risk populations.

Trial registration

ClinicalTrials.gov registry, NCT01912209. Registered on 3 July 2013.
Literature
1.
Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002;106(25):3143–421.
2.
Malik S, Wong ND, Franklin SS, Kamath TV, L’Italien GJ, Pio JR, Williams GR. Impact of the metabolic syndrome on mortality from coronary heart disease, cardiovascular disease, and all causes in United States adults. Circulation. 2004;110(10):1245–50.
3.
Nichols GA, Moler EJ. Metabolic syndrome components are associated with future medical costs independent of cardiovascular hospitalization and incident diabetes. Metab Syndr Relat Disord. 2011;9(2):127–33.CrossRefPubMedPubMedCentral
4.
Kannel WB, McGee DL. Diabetes and cardiovascular disease: the Framingham study. JAMA. 1979;241(19):2035–8.CrossRefPubMed
5.
Folsom AR, Yatsuya H, Nettleton JA, Lutsey PL, Cushman M, Rosamond WD. Community prevalence of ideal cardiovascular health, by the American Heart Association definition, and relationship with cardiovascular disease incidence. J Am Coll Cardiol. 2011;57(16):1690–6.CrossRefPubMedPubMedCentral
6.
Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes estimates for the year 2000 and projections for 2030. Diabetes Care. 2004;27(5):1047–53.CrossRefPubMed
7.
Zimmet P, Alberti K, Shaw J. Global and societal implications of the diabetes epidemic. Nature. 2001;414(6865):782–7.CrossRefPubMed
8.
Claxton G, DiJulio B, Whitmore H, Pickreign JD, McHugh M, Osei-Anto A, Finder B. Health benefits in 2010: premiums rise modestly, workers pay more toward coverage. Health Aff. 2010;29(10):1942–50.
9.
Carnethon M, Whitsel LP, Franklin BA, Kris-Etherton P, Milani R, Pratt CA, Wagner GR. Worksite wellness programs for cardiovascular disease prevention: a policy statement from the American Heart Association. Circulation. 2009;120(17):1725–41.
10.
Dalzill C, Nigam A, Juneau M, Guilbeault V, Latour E, Mauriege P, Gayda M. Intensive lifestyle intervention improves cardiometabolic and exercise parameters in metabolically healthy obese and metabolically unhealthy obese individuals. Can J Cardiol. 2014;30(4):434–40.
11.
Bassi N, Karagodin I, Wang S, Vassallo P, Priyanath A, Massaro E, Stone NJ. Lifestyle modification for metabolic syndrome: a systematic review. Am J Med. 2014; 127(12):1242.e1-10.
12.
Aneni EC, Roberson LL, Maziak W, Agatston AS, Feldman T, Rouseff M, Tran TH, Blumenthal RS, Blaha MJ, Blankstein R, et al. A systematic review of internet-based worksite wellness approaches for cardiovascular disease risk management: outcomes, challenges & opportunities. PLoS One. 2014;9(1):e83594.
13.
Roberson LL, Aneni E, Shaharyar S, Oni E, Rouseff M, Tran T, Guzman H, Das S, Brown D, Santiago-Charles J. Abstract P385: my unlimited health potential: short term effect of participation in a worksite lifestyle intervention program on significant weight loss and eligibility criteria for bariatric surgery among high risk individuals. Circulation. 2014;129 Suppl 1:AP385–5.
14.
15.
Chapman LS. Building a sustainable administrative infrastructure for worksite wellness programs. Am J Health Promot. 2009;24(2):TAHP1–10. iii.
16.
Chapman LS, Whitehead D, Connors MC. The changing role of incentives in health promotion and wellness. Am J Health Promot. 2008;23(1):suppl 1–11. iii.
17.
Pickering TG, Hall JE, Appel LJ, Falkner BE, Graves JW, Hill MN, Jones DH, Kurtz T, Sheps SG, Roccella EJ. Recommendations for blood pressure measurement in humans: an AHA scientific statement from the Council on High Blood Pressure Research Professional and Public Education Subcommittee. J Clin Hypertens. 2005;7(2):102–9.
18.
Mullie P, Vansant G, Hulens M, Clarys P, Degrave E. Evaluation of body fat estimated from body mass index and impedance in Belgian male military candidates: comparing two methods for estimating body composition. Mil Med. 2008;173(3):266–70.CrossRefPubMed
19.
Vanoli D, Lindqvist P, Wiklund U, Henein M, Naslund U. Fully automated on-screen carotid intima-media thickness measurement: a screening tool for subclinical atherosclerosis. J Clin Ultrasound. 2013;41(6):333–9.CrossRefPubMed
20.
Axtell AL, Gomari FA, Cooke JP. Assessing endothelial vasodilator function with the Endo-PAT 2000. J Vis Exp. 2010(44). 2167. doi:10.​3791/​2167.
21.
Agatston AS, Janowitz WR, Hildner FJ, Zusmer NR, Viamonte Jr M, Detrano R. Quantification of coronary artery calcium using ultrafast computed tomography. J Am Coll Cardiol. 1990;15(4):827–32.CrossRefPubMed
22.
Baicker K, Cutler D, Song Z. Workplace wellness programs can generate savings. Health Aff (Millwood). 2010;29(2):304–11.CrossRef
Metadata
Title
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
Authors
Janisse M. Post
Shozab S. Ali
Lara L. Roberson
Ehimen C. Aneni
Sameer Shaharyar
Adnan Younus
Omar Jamal
Rameez Ahmad
Muhammad A. Aziz
Rehan Malik
Erica S. Spatz
Theodore Feldman
Jonathan Fialkow
Emir Veledar
Ricardo C. Cury
Arthur S. Agatston
Khurram Nasir
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1424-z

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