The Electronic CardioMetabolic Program (eCMP) for Patients With Cardiometabolic Risk: A Randomized Controlled Trial

Kristen M J Azar, Suneil Koliwad, Tak Poon, Lan Xiao, Nan Lv, Robert Griggs, Jun Ma, Kristen M J Azar, Suneil Koliwad, Tak Poon, Lan Xiao, Nan Lv, Robert Griggs, Jun Ma

Abstract

Background: Effective lifestyle interventions targeting high-risk adults that are both practical for use in ambulatory care settings and scalable at a population management level are needed.

Objective: Our aim was to examine the potential effectiveness, feasibility, and acceptability of delivering an evidence-based Electronic Cardio-Metabolic Program (eCMP) for improving health-related quality of life, improving health behaviors, and reducing cardiometabolic risk factors in ambulatory care high-risk adults.

Methods: We conducted a randomized, wait-list controlled trial with 74 adults aged ≥18 years recruited from a large multispecialty health care organization. Inclusion criteria were (1) BMI ≥35 kg/m(2) and prediabetes, previous gestational diabetes and/or metabolic syndrome, or (2) BMI ≥30 kg/m(2) and type 2 diabetes and/or cardiovascular disease. Participants had a mean age of 59.7 years (SD 11.2), BMI 37.1 kg/m(2) (SD 5.4) and were 59.5% female, 82.4% white. Participants were randomized to participate in eCMP immediately (n=37) or 3 months later (n=37). eCMP is a 6-month program utilizing video conferencing, online tools, and pre-recorded didactic videos to deliver evidence-based curricula. Blinded outcome assessments were conducted at 3 and 6 months postbaseline. Data were collected and analyzed between 2014 and 2015. The primary outcome was health-related quality of life. Secondary outcomes included biometric cardiometabolic risk factors (eg, body weight), self-reported diet and physical activity, mental health status, retention, session attendance, and participant satisfaction.

Results: Change in quality of life was not significant in both immediate and delayed participants. Both groups significantly lost weight and reduced waist circumference at 6 months, with some cardiometabolic factors trending accordingly. Significant reduction in self-reported anxiety and perceived stress was seen in the immediate intervention group at 6 months. Retention rate was 93% at 3 months and 86% at 6 months post-baseline. Overall eCMP attendance was high with 59.5-83.8% of immediate and delayed intervention participants attending 50% of the virtual stress management and behavioral lifestyle sessions and 37.8-62.2% attending at least 4 out of 7 in-person physical activity sessions. The intervention received high ratings for satisfaction.

Conclusions: The technology-assisted eCMP is a feasible and well-accepted intervention and may significantly decrease cardiometabolic risk among high-risk individuals.

Trial registration: Clinicaltrials.gov NCT02246400; https://ichgcp.net/clinical-trials-registry/NCT02246400 (Archived by WebCite at http://www.webcitation.org/6h6mWWokP).

Keywords: behavior change; cardiovascular disease; health technology; lifestyle; metabolic syndrome; prevention.

Conflict of interest statement

Conflicts of Interest: None declared.

Figures

Figure 1
Figure 1
CONSORT diagram.

References

    1. Ogden CL, Carroll MD, Flegal KM. Prevalence of obesity in the United States. JAMA. 2014 Jul;312(2):189–190. doi: 10.1001/jama.2014.6228.
    1. Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, Hu FB, Hubbard VS, Jakicic JM, Kushner RF, Loria CM, Millen BE, Nonas CA, Pi-Sunyer FX, Stevens J, Stevens VJ, Wadden TA, Wolfe BM, Yanovski SZ, American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Obesity S. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):2985–3023. doi: 10.1016/j.jacc.2013.11.004.
    1. Spring B, Duncan JM, Janke EA, Kozak AT, McFadden HG, DeMott A, Pictor A, Epstein LH, Siddique J, Pellegrini CA, Buscemi J, Hedeker D. Integrating technology into standard weight loss treatment: a randomized controlled trial. JAMA Intern Med. 2013 Jan 28;173(2):105–111. doi: 10.1001/jamainternmed.2013.1221.
    1. Cole-Lewis H, Kershaw T. Text messaging as a tool for behavior change in disease prevention and management. Epidemiol Rev. 2010;32:56–69. doi: 10.1093/epirev/mxq004.
    1. Chaudhry B, Wang J, Wu S, Maglione M, Mojica W, Roth E, Morton SC, Shekelle PG. Systematic review: impact of health information technology on quality, efficiency, and costs of medical care. Ann Intern Med. 2006 May 16;144(10):742–752.
    1. Free C, Phillips G, Watson L, Galli L, Felix L, Edwards P, Patel V, Haines A. The effectiveness of mobile-health technologies to improve health care service delivery processes: a systematic review and meta-analysis. PLoS Med. 2013 Jan;10(1):e1001363. doi: 10.1371/journal.pmed.1001363.
    1. Levine DM, Savarimuthu S, Squires A, Nicholson J, Jay M. Technology-assisted weight loss interventions in primary care: a systematic review. J Gen Intern Med. 2015 Jan;30(1):107–117. doi: 10.1007/s11606-014-2987-6.
    1. Lyden JR, Zickmund SL, Bhargava TD, Bryce CL, Conroy MB, Fischer GS, Hess R, Simkin-Silverman LR, McTigue KM. Implementing health information technology in a patient-centered manner: patient experiences with an online evidence-based lifestyle intervention. J Healthc Qual. 2013;35(5):47–57. doi: 10.1111/jhq.12026.
    1. Xiao L, Lavori PW, Wilson SR, Ma J. Comparison of dynamic block randomization and minimization in randomized trials: a simulation study. Clin Trials. 2011 Feb;8(1):59–69. doi: 10.1177/1740774510391683.
    1. Blumenthal JA, Sherwood A, Babyak MA, Watkins LL, Waugh R, Georgiades A, Bacon SL, Hayano J, Coleman RE, Hinderliter A. Effects of exercise and stress management training on markers of cardiovascular risk in patients with ischemic heart disease: a randomized controlled trial. JAMA. 2005 Apr 6;293(13):1626–1634. doi: 10.1001/jama.293.13.1626.
    1. Blumenthal JA, Wang JT, Babyak M, Watkins L, Kraus W, Miller P, Hinderliter A, Sherwood A. Enhancing standard cardiac rehabilitation with stress management training: background, methods, and design for the enhanced study. J Cardiopulm Rehabil Prev. 2010;30(2):77–84. doi: 10.1097/HCR.0b013e3181d0c1d3.
    1. Cohen BE, Panguluri P, Na B, Whooley MA. Psychological risk factors and the metabolic syndrome in patients with coronary heart disease: findings from the Heart and Soul Study. Psychiatry Res. 2010 Jan 30;175(1-2):133–137. doi: 10.1016/j.psychres.2009.02.004.
    1. Quartana PJ, Burns JW. Emotion suppression affects cardiovascular responses to initial and subsequent laboratory stressors. Br J Health Psychol. 2010 Sep;15(Pt 3):511–528. doi: 10.1348/135910709X474613.
    1. Rozanski A, Blumenthal JA, Davidson KW, Saab PG, Kubzansky L. The epidemiology, pathophysiology, and management of psychosocial risk factors in cardiac practice: the emerging field of behavioral cardiology. J Am Coll Cardiol. 2005 Mar 1;45(5):637–651. doi: 10.1016/j.jacc.2004.12.005.
    1. Jaremka LM, Lindgren ME, Kiecolt-Glaser JK. Synergistic relationships among stress, depression, and troubled relationships: insights from psychoneuroimmunology. Depress Anxiety. 2013 Apr;30(4):288–296. doi: 10.1002/da.22078.
    1. Roohafza H, Sadeghi M, Naghnaeian M, Shokouh P, Ahmadi A, Sarrafzadegan N. Relationship between Metabolic Syndrome and Its Components with Psychological Distress. Int J Endocrinol. 2014;2014:203463. doi: 10.1155/2014/203463.
    1. Bergmann N, Gyntelberg F, Faber J. The appraisal of chronic stress and the development of the metabolic syndrome: a systematic review of prospective cohort studies. Endocr Connect. 2014 Jun;3(2):R55–80. doi: 10.1530/EC-14-0031.
    1. Kramer MK, Kriska AM, Venditti EM, Miller RG, Brooks MM, Burke LE, Siminerio LM, Solano FX, Orchard TJ. Translating the Diabetes Prevention Program: a comprehensive model for prevention training and program delivery. Am J Prev Med. 2009 Dec;37(6):505–511. doi: 10.1016/j.amepre.2009.07.020.
    1. Diabetes Prevention Support Center . Group Lifestyle Balance Manual of Operations. Pittsburgh, PA: University of Pittsburgh; 2011. [2016-01-19]. .
    1. Wilcox S, Dowda M, Griffin SF, Rheaume C, Ory MG, Leviton L, King AC, Dunn A, Buchner DM, Bazzarre T, Estabrooks PA, Campbell-Voytal K, Bartlett-Prescott J, Dowdy D, Castro CM, Carpenter RA, Dzewaltowski DA, Mockenhaupt R. Results of the first year of active for life: translation of 2 evidence-based physical activity programs for older adults into community settings. Am J Public Health. 2006 Jul;96(7):1201–1209. doi: 10.2105/AJPH.2005.074690.
    1. Human Kinetics. 2015. [2016-01-19]. Active Living Partners
    1. Ware J, Kosinski M, Dewey J, Gandek B. How to Score and Interpret Single-Item Health Status Measures: A Manual for Users of the SF-8 Health Survey. Lincoln, RI: QualityMetric Incorporated; 2001.
    1. PhenX (consensus measures of Phenotypes and eXposures) 2014. Feb 04, [2016-04-28]. Measures from the PhenX Toolkit version February 4 2011 Ver 4.2
    1. Pickering TG, Hall JE, Appel LJ, Falkner BE, Graves J, Hill MN, Jones DW, Kurtz T, Sheps SG, Roccella EJ, Subcommittee of Professional and Public Education of the American Heart Association Council on High Blood Pressure Research Recommendations for blood pressure measurement in humans and experimental animals: Part 1: blood pressure measurement in humans: a statement for professionals from the Subcommittee of Professional and Public Education of the American Heart Association Council on High Blood Pressure Research. Hypertension. 2005 Jan;45(1):142–161. doi: 10.1161/01.HYP.0000150859.47929.8e.
    1. Conway JM, Ingwersen LA, Vinyard BT, Moshfegh AJ. Effectiveness of the US Department of Agriculture 5-step multiple-pass method in assessing food intake in obese and nonobese women. Am J Clin Nutr. 2003 May;77(5):1171–1178.
    1. Mellen PB, Gao SK, Vitolins MZ, Goff DC. Deteriorating dietary habits among adults with hypertension: DASH dietary accordance, NHANES 1988-1994 and 1999-2004. Arch Intern Med. 2008 Feb 11;168(3):308–314. doi: 10.1001/archinternmed.2007.119.
    1. Blair SN, Haskell WL, Ho P, Paffenbarger RS, Vranizan KM, Farquhar JW, Wood PD. Assessment of habitual physical activity by a seven-day recall in a community survey and controlled experiments. Am J Epidemiol. 1985 Nov;122(5):794–804.
    1. Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999 Nov 10;282(18):1737–1744.
    1. Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606–613.
    1. Spitzer RL, Kroenke K, Williams JBW, Löwe Bernd. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092–1097. doi: 10.1001/archinte.166.10.1092.
    1. Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385–396.
    1. Grundy SM, Cleeman JI, Daniels SR, Donato KA, Eckel RH, Franklin BA, Gordon DJ, Krauss RM, Savage PJ, Smith SC, Spertus JA, Costa F, American HA, National Heart‚ Lung‚ and Blood Institute Diagnosis and management of the metabolic syndrome: an American Heart Association/National Heart, Lung, and Blood Institute Scientific Statement. Circulation. 2005 Oct 25;112(17):2735–2752. doi: 10.1161/CIRCULATIONAHA.105.169404.
    1. Centers for Disease Control and Prevention . Diabetes Prevention Recognition Program, Standards and Operating Procedures. Atlanta, GA: CDC; 2015. [2016-04-28]. .
    1. Centers for Disease Control and Prevention (CDC) 2015. [2016-01-19]. National Diabetes Prevention Program .
    1. Lloyd-Jones DM, Hong Y, Labarthe D, Mozaffarian D, Appel LJ, Van HL, Greenlund K, Daniels S, Nichol G, Tomaselli GF, Arnett DK, Fonarow GC, Ho PM, Lauer MS, Masoudi FA, Robertson RM, Roger V, Schwamm LH, Sorlie P, Yancy CW, Rosamond WD, American Heart Association Strategic Planning Task ForceStatistics Committee Defining and setting national goals for cardiovascular health promotion and disease reduction: the American Heart Association's strategic Impact Goal through 2020 and beyond. Circulation. 2010 Feb 2;121(4):586–613. doi: 10.1161/CIRCULATIONAHA.109.192703.
    1. Ebrahim S, Taylor F, Ward K, Beswick A, Burke M, Davey SG. Multiple risk factor interventions for primary prevention of coronary heart disease. Cochrane Database Syst Rev. 2011;(1):CD001561. doi: 10.1002/14651858.CD001561.pub3.
    1. American Telemedicine Association Telemedicine in the Patient Protection and Affordable Care Act 2010. 2016. [2016-01-19]. .
    1. Ostroff C, Kinicki A, Tamkins M. Organizational culture and climate. In: Borman WC, Ilgen DR, Kilmoski RJ, editors. Handbook of Psychology. New York: Wiley; 2003.
    1. Mohr DC, Siddique J, Ho J, Duffecy J, Jin L, Fokuo JK. Interest in behavioral and psychological treatments delivered face-to-face, by telephone, and by internet. Ann Behav Med. 2010 Aug;40(1):89–98. doi: 10.1007/s12160-010-9203-7.
    1. Ma J, Yank V, Xiao L, Lavori PW, Wilson SR, Rosas LG, Stafford RS. Translating the Diabetes Prevention Program lifestyle intervention for weight loss into primary care: a randomized trial. JAMA Intern Med. 2013 Jan 28;173(2):113–121. doi: 10.1001/2013.jamainternmed.987.
    1. Sevick MA, Zickmund S, Korytkowski M, Piraino B, Sereika S, Mihalko S, Snetselaar L, Stumbo P, Hausmann L, Ren D, Marsh R, Sakraida T, Gibson J, Safaien M, Starrett TJ, Burke LE. Design, feasibility, and acceptability of an intervention using personal digital assistant-based self-monitoring in managing type 2 diabetes. Contemp Clin Trials. 2008 May;29(3):396–409. doi: 10.1016/j.cct.2007.09.004.
    1. Burke LE, Conroy MB, Sereika SM, Elci OU, Styn MA, Acharya SD, Sevick MA, Ewing LJ, Glanz K. The effect of electronic self-monitoring on weight loss and dietary intake: a randomized behavioral weight loss trial. Obesity (Silver Spring) 2011 Feb;19(2):338–344. doi: 10.1038/oby.2010.208.
    1. Neuhausera L, Kreps G. eHealth communication and behavior change: promise and performance. Soc Semiot. 2010;20(1):9–27.
    1. Krukowski RA, West DS, Harvey-Berino J. Recent advances in internet-delivered, evidence-based weight control programs for adults. J Diabetes Sci Technol. 2009 Jan;3(1):184–189.
    1. Krebs P, Prochaska JO, Rossi JS. A meta-analysis of computer-tailored interventions for health behavior change. Prev Med. 2010;51(3-4):214–221. doi: 10.1016/j.ypmed.2010.06.004.
    1. Neve M, Morgan PJ, Jones PR, Collins CE. Effectiveness of web-based interventions in achieving weight loss and weight loss maintenance in overweight and obese adults: a systematic review with meta-analysis. Obes Rev. 2010 Apr;11(4):306–321. doi: 10.1111/j.1467-789X.2009.00646.x.
    1. Arem H, Irwin M. A review of web-based weight loss interventions in adults. Obes Rev. 2011;12(20804523):236–243.
    1. Manzoni GM, Pagnini F, Corti S, Molinari E, Castelnuovo G. Internet-based behavioral interventions for obesity: an updated systematic review. Clin Pract Epidemiol Ment Health. 2011 Mar;7:19–28. doi: 10.2174/1745017901107010019.
    1. Spring B, Duncan JM, Janke EA, Kozak AT, McFadden HG, DeMott A, Pictor A, Epstein LH, Siddique J, Pellegrini CA, Buscemi J, Hedeker D. Integrating technology into standard weight loss treatment: a randomized controlled trial. JAMA Intern Med. 2013 Jan 28;173(2):105–111. doi: 10.1001/jamainternmed.2013.1221.
    1. Allen JK, Stephens J, Patel A. Technology-assisted weight management interventions: systematic review of clinical trials. Telemed J E Health. 2014 Dec;20(12):1103–1120. doi: 10.1089/tmj.2014.0030.
    1. Khaylis A, Yiaslas T, Bergstrom J, Gore-Felton C. A review of efficacious technology-based weight-loss interventions: five key components. Telemed J E Health. 2010 Nov;16(9):931–938. doi: 10.1089/tmj.2010.0065.
    1. Appel LJ, Clark JM, Yeh H, Wang N, Coughlin JW, Daumit G, Miller ER, Dalcin A, Jerome GJ, Geller S, Noronha G, Pozefsky T, Charleston J, Reynolds JB, Durkin N, Rubin RR, Louis TA, Brancati FL. Comparative effectiveness of weight-loss interventions in clinical practice. N Engl J Med. 2011 Nov 24;365(21):1959–1968. doi: 10.1056/NEJMoa1108660.
    1. Azar KMJ, Aurora M, Wang EJ, Muzaffar A, Pressman A, Palaniappan LP. Virtual small groups for weight management: an innovative delivery mechanism for evidence-based lifestyle interventions among obese men. Transl Behav Med. 2015 Mar;5(1):37–44. doi: 10.1007/s13142-014-0296-6.
    1. Dunn C, Whetstone LM, Kolasa KM, Jayaratne KSU, Thomas C, Aggarwal S, Nordby K, Riley KEM. Using synchronous distance-education technology to deliver a weight management intervention. J Nutr Educ Behav. 2014;46(6):602–609. doi: 10.1016/j.jneb.2014.06.001.
    1. Brown MJ, Sinclair M, Liddle D, Hill AJ, Madden E, Stockdale J. A systematic review investigating healthy lifestyle interventions incorporating goal setting strategies for preventing excess gestational weight gain. PLoS One. 2012;7(7):e39503. doi: 10.1371/journal.pone.0039503.
    1. Cabassa LJ, Ezell JM, Lewis-Fernández R. Lifestyle interventions for adults with serious mental illness: a systematic literature review. Psychiatr Serv. 2010 Aug;61(8):774–782. doi: 10.1176/ps.2010.61.8.774.
    1. Fleming P, Godwin M. Lifestyle interventions in primary care: systematic review of randomized controlled trials. Can Fam Physician. 2008 Dec;54(12):1706–1713.
    1. Lombard CB, Deeks AA, Teede HJ. A systematic review of interventions aimed at the prevention of weight gain in adults. Public Health Nutr. 2009 Nov;12(11):2236–2246. doi: 10.1017/S1368980009990577.
    1. Goodpaster BH, Delany JP, Otto AD, Kuller L, Vockley J, South-Paul JE, Thomas SB, Brown J, McTigue K, Hames KC, Lang W, Jakicic JM. Effects of diet and physical activity interventions on weight loss and cardiometabolic risk factors in severely obese adults: a randomized trial. JAMA. 2010 Oct 27;304(16):1795–1802. doi: 10.1001/jama.2010.1505.
    1. Vetter ML, Wadden TA, Chittams J, Diewald LK, Panigrahi E, Volger S, Sarwer DB, Moore RH, POWER- UG. Effect of lifestyle intervention on cardiometabolic risk factors: results of the POWER-UP trial. Int J Obes (Lond) 2013 Aug;37 Suppl 1:S19–24. doi: 10.1038/ijo.2013.92.

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