Evaluation of lifestyle interventions to treat elevated cardiometabolic risk in primary care (E-LITE): a randomized controlled trial

Jun Ma, Abby C King, Sandra R Wilson, Lan Xiao, Randall S Stafford, Jun Ma, Abby C King, Sandra R Wilson, Lan Xiao, Randall S Stafford

Abstract

Background: Efficacy research has shown that intensive individual lifestyle intervention lowers the risk for developing type 2 diabetes mellitus and the metabolic syndrome. Translational research is needed to test real-world models of lifestyle interventions in primary care settings.

Design: E-LITE is a three-arm randomized controlled clinical trial aimed at testing the feasibility and potential effectiveness of two lifestyle interventions: information technology-assisted self-management, either alone or in combination with care management by a dietitian and exercise counselor, in comparison to usual care. Overweight or obese adults with pre-diabetes and/or metabolic syndrome (n = 240) recruited from a community-based primary care clinic are randomly assigned to one of three treatment conditions. Treatment will last 15 months and involves a three-month intensive treatment phase followed by a 12-month maintenance phase. Follow-up assessment occurs at three, six, and 15 months. The primary outcome is change in body mass index. The target sample size will provide 80% power for detecting a net difference of half a standard deviation in body mass index at 15 months between either of the self-management or care management interventions and usual care at a two-sided alpha level of 0.05, assuming up to a 20% rate of loss to 15-month follow-up. Secondary outcomes include glycemic control, additional cardiovascular risk factors, and health-related quality of life. Potential mediators (e.g., treatment adherence, caloric intake, physical activity level) and moderators (e.g., age, gender, race/ethnicity, baseline mental status) of the intervention's effect on weight change also will be examined.

Discussion: This study will provide objective evidence on the extent of reductions in body mass index and related cardiometabolic risk factors from two lifestyle intervention programs of varying intensity that could be implemented as part of routine health care.

Trial registration: ClinicalTrials.gov NCT00842426.

References

    1. Centers for Disease Control and Prevention. National diabetes fact sheet: general information and national estimates on diabetes in the United States, 2007. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention; 2008.
    1. Boyle JP, Honeycutt AA, Narayan KM, Hoerger TJ, Geiss LS, Chen H, Thompson TJ. Projection of diabetes burden through impact of changing demography and disease prevalence in the U.S. Diabetes Care. 2050;24:1936–1940. doi: 10.2337/diacare.24.11.1936.
    1. Must A, Spadano J, Coakley EH, Field AE, Colditz G, Dietz WH. The disease burden associated with overweight and obesity. Jama. 1999;282:1523–1529. doi: 10.1001/jama.282.16.1523.
    1. Ogden CL, Carroll MD, Curtin LR, McDowell MA, Tabak CJ, Flegal KM. Prevalence of overweight and obesity in the United States, 1999-2004. Jama. 2006;295:1549–1555. doi: 10.1001/jama.295.13.1549.
    1. Grundy SM, Cleeman JI, Daniels SR, Donato KA, Eckel RH, Franklin BA, Gordon DJ, Krauss RM, Savage PJ, Smith SC Jr. Diagnosis and management of the metabolic syndrome: an American Heart Association/National Heart, Lung, and Blood Institute Scientific Statement. Circulation. 2005;112:2735–2752. doi: 10.1161/CIRCULATIONAHA.105.169404.
    1. Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002;346:393–403. doi: 10.1056/NEJMoa012512.
    1. DPP. The Diabetes Prevention Program (DPP): description of lifestyle intervention. Diabetes Care. 2002;25:2165–2171. doi: 10.2337/diacare.25.12.2165.
    1. The Diabetes Prevention Program Research Group. Within-trial cost-effectiveness of lifestyle intervention or metformin for the primary prevention of type 2 diabetes. Diabetes Care. 2003;26:2518–2523. doi: 10.2337/diacare.26.9.2518.
    1. Herman WH, Hoerger TJ, Brandle M, Hicks K, Sorensen S, Zhang P, Hamman RF, Ackermann RT, Engelgau MM, Ratner RE. The cost-effectiveness of lifestyle modification or metformin in preventing type 2 diabetes in adults with impaired glucose tolerance. Ann Intern Med. 2005;142:323–332.
    1. Ackermann RT, Finch EA, Brizendine E, Zhou H, Marrero DG. Translating the Diabetes Prevention Program into the community. The DEPLOY Pilot Study. Am J Prev Med. 2008;35:357–363. doi: 10.1016/j.amepre.2008.06.035.
    1. Amundson HA, Butcher MK, Gohdes D, Hall TO, Harwell TS, Helgerson SD, Vanderwood KK. Translating the diabetes prevention program into practice in the general community: findings from the Montana Cardiovascular Disease and Diabetes Prevention Program. Diabetes Educ. 2009;35:209–210. doi: 10.1177/0145721709333269. 213-204, 216-220 passim.
    1. Boltri JM, Davis-Smith YM, Seale JP, Shellenberger S, Okosun IS, Cornelius ME. Diabetes prevention in a faith-based setting: results of translational research. J Public Health Manag Pract. 2008;14:29–32.
    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. in press .
    1. Seidel MC, Powell RO, Zgibor JC, Siminerio LM, Piatt GA. Translating the Diabetes Prevention Program into an urban medically underserved community: a nonrandomized prospective intervention study. Diabetes Care. 2008;31:684–689. doi: 10.2337/dc07-1869.
    1. McTigue KM, Conroy MB, Bigi L, Murphy C, McNeil M. Weight loss through living well: translating an effective lifestyle intervention into clinical practice. Diabetes Educ. 2009;35:199–204. doi: 10.1177/0145721709332815. 208.
    1. Kingsley RG, Wilson GT. Behavior therapy for obesity: a comparative investigation of long-term efficacy. J Consult Clin Psychol. 1977;45:288–298. doi: 10.1037/0022-006X.45.2.288.
    1. Renjilian DA, Perri MG, Nezu AM, McKelvey WF, Shermer RL, Anton SD. Individual versus group therapy for obesity: effects of matching participants to their treatment preferences. J Consult Clin Psychol. 2001;69:717–721. doi: 10.1037/0022-006X.69.4.717.
    1. Tate DF, Jackvony EH, Wing RR. A randomized trial comparing human e-mail counseling, computer-automated tailored counseling, and no counseling in an Internet weight loss program. Arch Intern Med. 2006;166:1620–1625. doi: 10.1001/archinte.166.15.1620.
    1. Tate DF, Wing RR, Winett RA. Using Internet technology to deliver a behavioral weight loss program. JAMA. 2001;285:1172–1177. doi: 10.1001/jama.285.9.1172.
    1. Wing RR, Tate DF, Gorin AA, Raynor HA, Fava JL. A self-regulation program for maintenance of weight loss. N Engl J Med. 2006;355:1563–1571. doi: 10.1056/NEJMoa061883.
    1. Tate DF, Jackvony EH, Wing RR. Effects of Internet behavioral counseling on weight loss in adults at risk for type 2 diabetes: a randomized trial. Jama. 2003;289:1833–1836. doi: 10.1001/jama.289.14.1833.
    1. Ma J, Urizar GG Jr, Alehegn T, Stafford RS. Diet and physical activity counseling during ambulatory care visits in the United States. Prev Med. 2004;39:815–822. doi: 10.1016/j.ypmed.2004.03.006.
    1. Ma J, Xiao L, Stafford RS. Adult Obesity and Office-based Quality of Care in the United States. Obesity (Silver Spring) 2009;17:1077–1085. doi: 10.1038/oby.2008.653.
    1. Blair SN, Haskell WL, Ho P, Paffenbarger RS Jr, 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;122:794–804.
    1. Rose G, McCartney P, Reid DD. Self-administration of a questionnaire on chest pain and intermittent claudication. Br J Prev Soc Med. 1977;31:42–48.
    1. Pocock SJ. Clinical Trials, A Practical Approach. Chichester: John Wiley and Sons; 1991.
    1. Efron B. Forcing sequential experiment to be balanced. Biometrika. 1971;58:403–417. doi: 10.1093/biomet/58.3.403.
    1. Friedewald W, Levy R, Fredrickson D. Estimation of the concentration of low-density lipoprotein cholesterol in plasma, with use of the preparative ultracentrifuge. Clinical Chemistry. 1972;18:499–502.
    1. NHLBI. Practical Guide to the Identification, Evaluation and Treatment of Overweight and Obesity in Adults. Bethesda, MD: Public Health Service, U.S. Department of Health and Human Services; 2000.
    1. Pickering TG, Hall JE, Appel LJ, Falkner BE, Graves J, Hill MN, Jones DW, Kurtz T, Sheps SG, Roccella EJ. 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;45:142–161.
    1. Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996;34:220–233. doi: 10.1097/00005650-199603000-00003.
    1. Karlsson J, Taft C, Sjostrom L, Torgerson JS, Sullivan M. Psychosocial functioning in the obese before and after weight reduction: construct validity and responsiveness of the Obesity-related Problems scale. Int J Obes Relat Metab Disord. 2003;27:617–630. doi: 10.1038/sj.ijo.0802272.
    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;282:1737–1744. doi: 10.1001/jama.282.18.1737.
    1. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. fourth. Washington, D.C.: American Psychiatric Association; 1994.
    1. Antony MM, Bieling PJ, Cox BJ, Enns MW, Swinson RP. Psychometric properties of the 42-item and 21-item versions of the Depression Anxiety Stress Scales (DASS) in clinical groups and a community sample. Psychological Assessment. 1998;10:176–181. doi: 10.1037/1040-3590.10.2.176.
    1. Block G. A review of validations of dietary assessment methods. Am J Epidemiol. 1982;115:492–505.
    1. Dunn AL, Marcus BH, Kampert JB, Garcia ME, Kohl HW, Blair SN. Reduction in cardiovascular disease risk factors: 6-month results from Project Active. Prev Med. 1997;26:883–892. doi: 10.1006/pmed.1997.0218.
    1. Young DR, Haskell WL, Taylor CB, Fortmann SP. Effect of community health education on physical activity knowledge, attitudes, and behavior. The Stanford Five-City Project. Am J Epidemiol. 1996;144:264–274.
    1. Sallis JF, Pinski RB, Grossman RM, Patterson TL, Nader PR. The development of self-efficacy scales for health-related diet and exercise behaviors. Heath Educ Res. 1988;3:283–292. doi: 10.1093/her/3.3.283.
    1. Sallis JF, Grossman RM, Pinski RB, Patterson TL, Nader PR. The development of scales to measure social support for diet and exercise behaviors. Prev Med. 1987;16:825–836. doi: 10.1016/0091-7435(87)90022-3.
    1. Venkatesh VV, Morris MG, Davis GB, Davis FD. User acceptance of information technology: toward a unified view. Mis Quarterly. 2003;27:425–478.
    1. Bandura A. Social Foundations of Thought and Action: A Social Cognitive Theory. Englewood Cliffs, N.J.: Prentice Hall; 1986.
    1. Prochaska JO, DiClemente CC. Stages and processes of self-change of smoking: toward an integrative model of change. J Consult Clin Psychol. 1983;51:390–395. doi: 10.1037/0022-006X.51.3.390.
    1. Bodenheimer T, Lorig K, Holman H, Grumbach K. Patient self-management of chronic disease in primary care. Jama. 2002;288:2469–2475. doi: 10.1001/jama.288.19.2469.
    1. Holman H, Lorig K. Patient self-management: a key to effectiveness and efficiency in care of chronic disease. Public Health Rep. 2004;119:239–243. doi: 10.1016/j.phr.2004.04.002.
    1. Lorig KR, Holman H. Self-management education: history, definition, outcomes, and mechanisms. Ann Behav Med. 2003;26:1–7. doi: 10.1207/S15324796ABM2601_01.
    1. Winett RA, Tate DF, Anderson ES, Wojcik JR, Winett SG. Long-term weight gain prevention: a theoretically based Internet approach. Prev Med. 2005;41:629–641. doi: 10.1016/j.ypmed.2004.12.005.
    1. Physical Activity Guidelines for Americans.
    1. Haskell WL, Lee IM, Pate RR, Powell KE, Blair SN, Franklin BA, Macera CA, Heath GW, Thompson PD, Bauman A. Physical activity and public health: updated recommendation for adults from the American College of Sports Medicine and the American Heart Association. Circulation. 2007;116:1081–1093. doi: 10.1161/CIRCULATIONAHA.107.185649.
    1. Nelson ME, Rejeski WJ, Blair SN, Duncan PW, Judge JO, King AC, Macera CA, Castaneda-Sceppa C. Physical activity and public health in older adults: recommendation from the American College of Sports Medicine and the American Heart Association. Med Sci Sports Exer. 2007;39:1435–1445. doi: 10.1249/mss.0b013e3180616aa2.
    1. Hill JO, Wyatt HR. Role of physical activity in preventing and treating obesity. J Appl Physiol. 2005;99:765–770. doi: 10.1152/japplphysiol.00137.2005.
    1. Dietary Guidelines for Americans.
    1. Cook R, V F. Multiplicity Considerations in the Design and Analysis of Clinical Trials. Journal of the Royal Statistical Society, Series A. 1996;159:93–110.
    1. Littell RC, Milliken GA. SAS System for Mixed Models. Cary, NC: SAS Institute Inc; 1996.
    1. Little RJA, Rubin DB. Statistical Analysis with Missing Data. New York: John Wiley & Sons, Inc.; 1987.
    1. Mazumdar S, Liu KS, Houck PR, Reynolds CF. Intent-to-treat analysis for longitudinal clinical trials: coping with the challenge of missing values. J Psychiatr Res. 1999;33:87–95. doi: 10.1016/S0022-3956(98)00058-2.
    1. Kraemer HC, Kiernan M, Essex M, Kupfer DJ. How and why criteria defining moderators and mediators differ between the Baron & Kenny and MacArthur approaches. Health Psychol. 2008;27:S101–108. doi: 10.1037/0278-6133.27.2(Suppl.).S101.
    1. Hoffman C, Rice D, Sung HY. Persons with chronic conditions. Their prevalence and costs. Jama. 1996;276:1473–1479. doi: 10.1001/jama.276.18.1473.
    1. Wagner EH, Austin BT, Davis C, Hindmarsh M, Schaefer J, Bonomi A. Improving chronic illness care: translating evidence into action. Health Aff (Millwood) 2001;20:64–78. doi: 10.1377/hlthaff.20.6.64.

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