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BMC Primary Care

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Open Access 01-12-2009 | Study protocol

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

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

Published in: BMC Primary Care | Issue 1/2009

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 α 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

NCT00842426

Centers for Disease Control and Prevention: National diabetes fact sheet: general information and national estimates on diabetes in the United States, 2007. 2008, Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention

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. 10.2337/diacare.24.11.1936.CrossRef

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. 10.1001/jama.282.16.1523.CrossRefPubMed

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. 10.1001/jama.295.13.1549.CrossRefPubMed

Grundy SM, Cleeman JI, Daniels SR, Donato KA, Eckel RH, Franklin BA, Gordon DJ, Krauss RM, Savage PJ, Smith SC, et al: Diagnosis and management of the metabolic syndrome: an American Heart Association/National Heart, Lung, and Blood Institute Scientific Statement. Circulation. 2005, 112: 2735-2752. 10.1161/CIRCULATIONAHA.105.169404.CrossRefPubMed

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. 10.1056/NEJMoa012512.CrossRefPubMed

DPP: The Diabetes Prevention Program (DPP): description of lifestyle intervention. Diabetes Care. 2002, 25: 2165-2171. 10.2337/diacare.25.12.2165.CrossRef

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. 10.2337/diacare.26.9.2518.CrossRefPubMedCentral

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.CrossRefPubMedPubMedCentral

10.

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. 10.1016/j.amepre.2008.06.035.CrossRefPubMedPubMedCentral

11.

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. 10.1177/0145721709333269. 213-204, 216-220 passim.CrossRefPubMed

12.

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.CrossRefPubMed

13.

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.

14.

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. 10.2337/dc07-1869.CrossRefPubMed

15.

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. 10.1177/0145721709332815. 208.CrossRefPubMed

16.

Kingsley RG, Wilson GT: Behavior therapy for obesity: a comparative investigation of long-term efficacy. J Consult Clin Psychol. 1977, 45: 288-298. 10.1037/0022-006X.45.2.288.CrossRefPubMed

17.

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. 10.1037/0022-006X.69.4.717.CrossRefPubMed

18.

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. 10.1001/archinte.166.15.1620.CrossRefPubMed

19.

Tate DF, Wing RR, Winett RA: Using Internet technology to deliver a behavioral weight loss program. JAMA. 2001, 285: 1172-1177. 10.1001/jama.285.9.1172.CrossRefPubMed

20.

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. 10.1056/NEJMoa061883.CrossRefPubMed

21.

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. 10.1001/jama.289.14.1833.CrossRefPubMed

22.

Ma J, Urizar GG, Alehegn T, Stafford RS: Diet and physical activity counseling during ambulatory care visits in the United States. Prev Med. 2004, 39: 815-822. 10.1016/j.ypmed.2004.03.006.CrossRefPubMed

23.

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. 10.1038/oby.2008.653.CrossRef

24.

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, 122: 794-804.PubMed

25.

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.PubMedPubMedCentral

26.

Pocock SJ: Clinical Trials, A Practical Approach. 1991, Chichester: John Wiley and Sons

27.

Efron B: Forcing sequential experiment to be balanced. Biometrika. 1971, 58: 403-417. 10.1093/biomet/58.3.403.CrossRef

28.

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.PubMed

29.

NHLBI: Practical Guide to the Identification, Evaluation and Treatment of Overweight and Obesity in Adults. 2000, Bethesda, MD: Public Health Service, U.S. Department of Health and Human Services

30.

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.CrossRefPubMed

31.

Ware J, 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. 10.1097/00005650-199603000-00003.CrossRefPubMed

32.

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. 10.1038/sj.ijo.0802272.CrossRefPubMed

33.

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. 10.1001/jama.282.18.1737.CrossRefPubMed

34.

American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders. 1994, Washington, D.C.: American Psychiatric Association, fourth

35.

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. 10.1037/1040-3590.10.2.176.CrossRef

36.

Block G: A review of validations of dietary assessment methods. Am J Epidemiol. 1982, 115: 492-505.PubMed

37.

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. 10.1006/pmed.1997.0218.CrossRefPubMed

38.

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.CrossRefPubMed

39.

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. 10.1093/her/3.3.283.CrossRef

40.

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. 10.1016/0091-7435(87)90022-3.CrossRefPubMed

41.

Venkatesh VV, Morris MG, Davis GB, Davis FD: User acceptance of information technology: toward a unified view. Mis Quarterly. 2003, 27: 425-478.

42.

Bandura A: Social Foundations of Thought and Action: A Social Cognitive Theory. 1986, Englewood Cliffs, N.J.: Prentice Hall

43.

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. 10.1037/0022-006X.51.3.390.CrossRefPubMed

44.

Bodenheimer T, Lorig K, Holman H, Grumbach K: Patient self-management of chronic disease in primary care. Jama. 2002, 288: 2469-2475. 10.1001/jama.288.19.2469.CrossRefPubMed

45.

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. 10.1016/j.phr.2004.04.002.CrossRefPubMedPubMedCentral

46.

Lorig KR, Holman H: Self-management education: history, definition, outcomes, and mechanisms. Ann Behav Med. 2003, 26: 1-7. 10.1207/S15324796ABM2601_01.CrossRefPubMed

47.

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. 10.1016/j.ypmed.2004.12.005.CrossRefPubMed

48.

Physical Activity Guidelines for Americans. [http://www.health.gov/paguidelines/pdf/paguide.pdf]

49.

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. 10.1161/CIRCULATIONAHA.107.185649.CrossRefPubMed

50.

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. 10.1249/mss.0b013e3180616aa2.CrossRef

51.

Hill JO, Wyatt HR: Role of physical activity in preventing and treating obesity. J Appl Physiol. 2005, 99: 765-770. 10.1152/japplphysiol.00137.2005.CrossRefPubMed

52.

Dietary Guidelines for Americans. [http://www.healthierus.gov/dietaryguidelines]

53.

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.CrossRef

54.

Littell RC, Milliken GA: SAS System for Mixed Models. 1996, Cary, NC: SAS Institute Inc

55.

Little RJA, Rubin DB: Statistical Analysis with Missing Data. 1987, New York: John Wiley & Sons, Inc.

56.

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. 10.1016/S0022-3956(98)00058-2.CrossRefPubMed

57.

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. 10.1037/0278-6133.27.2(Suppl.).S101.CrossRefPubMedPubMedCentral

58.

Hoffman C, Rice D, Sung HY: Persons with chronic conditions. Their prevalence and costs. Jama. 1996, 276: 1473-1479. 10.1001/jama.276.18.1473.CrossRefPubMed

59.

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. 10.1377/hlthaff.20.6.64.CrossRef

The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2296/10/71/prepub

Title: Evaluation of lifestyle interventions to treat elevated cardiometabolic risk in primary care (E-LITE): a randomized controlled trial
Authors: Jun Ma
Abby C King
Sandra R Wilson
Lan Xiao
Randall S Stafford
Publication date: 01-12-2009
Publisher: BioMed Central
Published in: BMC Primary Care / Issue 1/2009
Electronic ISSN: 2731-4553
DOI: https://doi.org/10.1186/1471-2296-10-71

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Background

Design

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Design

Discussion

Trial registration

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