Top

22-02-2017 | Osteoarthritis | Article

Weight-loss and exercise for communities with arthritis in North Carolina (we-can): design and rationale of a pragmatic, assessor-blinded, randomized controlled trial

Journal: BMC Musculoskeletal Disorders

Authors: Stephen P. Messier, Leigh F. Callahan, Daniel P. Beavers, Kate Queen, Shannon L. Mihalko, Gary D. Miller, Elena Losina, Jeffrey N. Katz, Richard F. Loeser, Sara A. Quandt, Paul DeVita, David J. Hunter, Mary F. Lyles, Jovita Newman, Betsy Hackney, Joanne M. Jordan

Publisher: BioMed Central

Abstract

Background

Recently, we determined that in a rigorously monitored environment an intensive diet-induced weight loss of 10% combined with exercise was significantly more effective at reducing pain in men and women with symptomatic knee osteoarthritis (OA) than either intervention alone. Compared to previous long-term weight loss and exercise trials of knee OA, our intensive diet-induced weight loss and exercise intervention was twice as effective at reducing pain intensity. Whether these results can be generalized to less intensively monitored cohorts is unknown. Thus, the policy relevant and clinically important question is: Can we adapt this successful solution to a pervasive public health problem in real-world clinical and community settings? This study aims to develop a systematic, practical, cost-effective diet-induced weight loss and exercise intervention implemented in community settings and to determine its effectiveness in reducing pain and improving other clinical outcomes in persons with knee OA.

Methods/Design

This is a Phase III, pragmatic, assessor-blinded, randomized controlled trial. Participants will include 820 ambulatory, community-dwelling, overweight and obese (BMI ≥ 27 kg/m²) men and women aged ≥ 50 years who meet the American College of Rheumatology clinical criteria for knee OA. The primary aim is to determine whether a community-based 18-month diet-induced weight loss and exercise intervention based on social cognitive theory and implemented in three North Carolina counties with diverse residential (from urban to rural) and socioeconomic composition significantly decreases knee pain in overweight and obese adults with knee OA relative to a nutrition and health attention control group. Secondary aims will determine whether this intervention improves self-reported function, health-related quality of life, mobility, and is cost-effective.

Discussion

Many physicians who treat people with knee OA have no practical means to implement weight loss and exercise treatments as recommended by numerous OA treatment guidelines. This study will establish the effectiveness of a community program that will serve as a blueprint and exemplar for clinicians and public health officials in urban and rural communities to implement a diet-induced weight loss and exercise program designed to reduce knee pain and improve other clinical outcomes in overweight and obese adults with knee OA.

Trial registration

clinicaltrials.gov Identifier: NCT02577549 October 12, 2015.

Basedow M, Esterman A. Assessing appropriateness of osteoarthritis care using quality indicators: a systematic review. J Eval Clin Pract. 2015;21(5):782–9. doi:10.1111/jep.12402. Epub 2015/06/18.CrossRefPubMed

Brand CA, Ackerman IN, Bohensky MA, Bennell KL. Chronic disease management: a review of current performance across quality of care domains and opportunities for improving osteoarthritis care. Rheum Dis Clin North Am. 2013;39(1):123–43. doi:10.1016/j.rdc.2012.10.005. Epub 2013/01/15.CrossRefPubMed

Vos T, Flaxman AD, Naghavi M, Lozano R, Michaud C, Ezzati M, et al. Years lived with disability [YLDs] for 1160 sequelae of 289 diseases and injuries 1990–2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012;380(9859):2163–96. doi:10.1016/S0140-6736[12]61729-2.CrossRefPubMed

Lawrence RC, Felson DT, Helmick CG, Arnold LM, Choi H, Deyo RA, et al. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States: Part II. Arthritis Rheum. 2008;58(1):26–35.CrossRefPubMedPubMedCentral

Losina E, Weinstein AM, Reichmann WM, Burbine SA, Solomon DH, Daigle ME, Rome BN, Chen SP, Hunter DJ, Suter LG, Jordan JM, Katz JN. Lifetime risk and age at diagnosis of symptomatic knee osteoarthritis in the US. Arthritis Care Res (Hoboken). 2013;65(5):703–11.

Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, et al. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008;16(2):137–62.CrossRefPubMed

Fernandes L, Hagen KB, Bijlsma JW, Andreassen O, Christensen P, Conaghan PG, et al. EULAR recommendations for the non-pharmacological core management of hip and knee osteoarthritis. Ann Rheum Dis. 2013;72(7):1125–35. doi:10.1136/annrheumdis-2012-202745. Epub 2013/04/19.CrossRefPubMed

Li LC, Sayre EC, Kopec JA, Esdaile JM, Bar S, Cibere J. Quality of nonpharmacological care in the community for people with knee and hip osteoarthritis. J Rheumatol. 2011;38(10):2230–7. doi:10.3899/jrheum.110264. Epub 2011/08/03.CrossRefPubMed

Messier SP, Loeser RF, Miller GD, Morgan TM, Rejeski WJ, Sevick MA, et al. Exercise and dietary weight loss in overweight and obese older adults with knee osteoarthritis: the arthritis, diet, and activity promotion trial. Arthritis Rheum. 2004;50(5):1501–10.CrossRefPubMed

10.

Messier SP, Mihalko SL, Legault C, Miller GD, Nicklas BJ, Devita P, et al. Effects of intensive diet and exercise on knee joint loads, inflammation, and clinical outcomes among overweight and obese adults with knee osteoarthritis: the IDEA randomized clinical trial. JAMA. 2013;310(12):1263–73. doi:10.1001/jama.2013.277669.CrossRefPubMedPubMedCentral

11.

Aaboe J, Bliddal H, Messier SP, Alkjaer T, Henriksen M. Effects of an intensive weight loss program on knee joint loading in obese adults with knee osteoarthritis. Osteoarthritis Cartilage. 2011;19(7):822–8. doi:10.1016/j.joca.2011.03.006.CrossRefPubMed

12.

Lewis-Faning E, Fletcher E. Chronic rheumatic diseases: statistical study of 1000 cases of chronic rheumatism. Postgrad Med J. 1945;21:137.CrossRefPubMedPubMedCentral

13.

Leach RE, Baumgard S, Broom J. Obesity: its relationship to osteoarthritis of the knee. Clin Orthop. 1973;93:271–3.CrossRef

14.

Coggon D, Reading I, Croft P, McLaren M, Barrett D, Cooper C. Knee osteoarthritis and obesity. Int J Obes Relat Metab Disord. 2001;25(5):622–7.CrossRefPubMed

15.

Cooper C, Snow S, McAlindon TE, Kellingray S, Stuart B, Coggon D, et al. Risk factors for the incidence and progression of radiographic knee osteoarthritis. Arthritis Rheum. 2000;43(5):995–1000.CrossRefPubMed

16.

Murphy L, Schwartz TA, Helmick CG, Renner JB, Tudor G, Koch G, et al. Lifetime risk of symptomatic knee osteoarthritis. Arthritis Rheum. 2008;59(9):1207–13. doi:10.1002/art.24021.CrossRefPubMedPubMedCentral

17.

Fortney JC, Pyne JM, Mouden SB, Mittal D, Hudson TJ, Schroeder GW, et al. Practice-based versus telemedicine-based collaborative care for depression in rural federally qualified health centers: a pragmatic randomized comparative effectiveness trial. Am J Psychiatry. 2013;170(4):414–25. doi:10.1176/appi.ajp.2012.12050696.CrossRefPubMed

18.

Gooch K, Marshall DA, Faris PD, Khong H, Wasylak T, Pearce T, et al. Comparative effectiveness of alternative clinical pathways for primary hip and knee joint replacement patients: a pragmatic randomized, controlled trial. Osteoarthritis Cartilage. 2012;20(10):1086–94. doi:10.1016/j.joca.2012.06.017.CrossRefPubMed

19.

Schmidt B, Wenitong M, Esterman A, Hoy W, Segal L, Taylor S, et al. Getting better at chronic care in remote communities: study protocol for a pragmatic cluster randomised controlled of community based management. BMC Public Health. 2012;12:1017. doi:10.1186/1471-2458-12-1017.CrossRefPubMedPubMedCentral

20.

United States Department of Agriculture. Rural america at a glance: Economic Research Service; 2013 [updated 1 Nov 2013]. EB-24:[Available from: http://www.ers.usda.gov/publications/eb-economic-brief/eb24.aspx#.VARk2mNVqSo.

21.

National Rural Health Association. What's different about rural health care? : National Rural Health Association; 2014 [updated 2014]. Available from: http://www.ruralhealthweb.org/go/left/about-rural-health.

22.

National Center for Chronic Disease Prevention and Health Promotion. Preventing chronic disease: eliminating the leading preventable causes of premature death and disabiity in the United States. 2015. Available from: https://www.cdc.gov/mwg-internal/de5fs23hu73ds/progress?id=Y7tLJHC_nWzKXHoy07OeKQEsUcW3p5JcKkOSJLrtiwQ.

23.

Thorpe KE, Zwarenstein M, Oxman AD, Treweek S, Furberg CD, Altman DG, et al. A pragmatic-explanatory continuum indicator summary [PRECIS]: a tool to help trial designers. CMAJ. 2009;180(10):E47–57. doi:10.1503/cmaj.090523.CrossRefPubMedPubMedCentral

24.

Messier SP, Callahan LF, Golightly YM, Keefe FJ. OARSI clinical trials recommendations: design and conduct of clinical trials of lifestyle diet and exercise interventions for osteoarthritis. Osteoarthritis Cartilage. 2015;23(5):787–97. doi:10.1016/j.joca.2015.03.008. Epub 2015/05/09.CrossRefPubMed

25.

Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Arthritis Rheum. 1986;29(8):1039–49.CrossRefPubMed

26.

NHLBI. Aim for a healthy weight. Key recommendations. 2015. Available from: https://www.nhlbi.nih.gov/health/educational/lose_wt/recommen.htm.

27.

NHLBI. Clinical guidelines on the identification, evaluation, and treatment of overweight and obesity in adults: the evidence report. Chapter 5 Section C. 1998. Report No.: 98–4083.

28.

Messier SP, Mihalko SL, Beavers DP, Nicklas BJ, Devita P, Carr JJ, et al. Strength Training for Arthritis Trial [START]: design and rationale. BMC Musculoskelet Disord. 2013;14(1):208. doi:10.1186/1471-2474-14-208.CrossRefPubMedPubMedCentral

29.

Miller GD, Rejeski WJ, Williamson JD, Morgan T, Sevick MA, Loeser RF, et al. The Arthritis, Diet and Activity Promotion Trial [ADAPT]: design, rationale, and baseline results. Control Clin Trials. 2003;24(4):462–80.CrossRefPubMed

30.

Messier SP, Legault C, Mihalko S, Miller GD, Loeser RF, Devita P, et al. The Intensive Diet and Exercise for Arthritis [IDEA] trial: design and rationale. BMC Musculoskelet Disord. 2009;10:93.CrossRefPubMedPubMedCentral

31.

Pamuk ER, Williamson DF, Madans J, Serdula MK, Kleinman JC, Byers T. Weight loss and mortality in a national cohort of adults, 1971–1987. Am J Epidemiol. 1992;136(6):686–97.CrossRefPubMed

32.

Harrington M, Gibson S, Cottrell RC. A review and meta-analysis of the effect of weight loss on all-cause mortality risk. Nutr Res Rev. 2009;22(1):93–108. doi:10.1017/S0954422409990035.CrossRefPubMed

33.

Owen OE, Kavle E, Owen RS, Polansky M, Caprio S, Mozzoli MA, et al. A reappraisal of caloric requirements in healthy women. Am J Clin Nutr. 1986;44(1):1–19. Epub 1986/07/01.PubMed

34.

Esposito K, Pontillo A, Di Palo C, Giugliano G, Masella M, Marfella R, et al. Effect of weight loss and lifestyle changes on vascular inflammatory markers in obese women: a randomized trial. JAMA. 2003;289(14):1799–804.CrossRefPubMed

35.

Bauer J, Biolo G, Cederholm T, Cesari M, Cruz-Jentoft AJ, Morley JE, et al. Evidence-based recommendations for optimal dietary protein intake in older people: a position paper from the PROT-AGE Study Group. J Am Med Dir Assoc. 2013;14(8):542–59. doi:10.1016/j.jamda.2013.05.021.CrossRefPubMed

36.

Subar AF, Thompson FE, Kipnis V, Midthune D, Hurwitz P, McNutt S, et al. Comparative validation of the block, Willett, and national cancer institute food frequency questionnaires : the eating at America’s table study. Am J Epidemiol. 2001;154(12):1089–99.CrossRefPubMed

37.

Thompson FE, Subar AF, Brown CC, Smith AF, Sharbaugh CO, Jobe JB, et al. Cognitive research enhances accuracy of food frequency questionnaire reports: results of an experimental validation study. J Am Diet Assoc. 2002;102(2):212–25.CrossRefPubMed

38.

Chodzko-Zajko WJ, Proctor DN, Fiatarone Singh MA, Minson CT, Nigg CR, Salem GJ, et al. American college of sports medicine position stand. Exercise and physical activity for older adults. Med Sci Sports Exerc. 2009;41(7):1510–30. doi:10.1249/MSS.0b013e3181a0c95c.CrossRefPubMed

39.

Karvonen MJ. Effects of vigorous exercise on the heart. In: Belknap FFREL, editor. Work and the heart. New York: Paul B. Hoeber, Inc; 1959.

40.

Ettinger Jr WH, Burns R, Messier SP, Applegate W, Rejeski WJ, Morgan T, et al. A randomized trial comparing aerobic exercise and resistance exercise with a health education program in older adults with knee osteoarthritis. The Fitness Arthritis and Seniors Trial [FAST]. JAMA. 1997;277(1):25–31.CrossRefPubMed

41.

Mihalko SL, Brenes GA, Farmer DF, Katula JA, Balkrishnan R, Bowen DJ. Challenges and innovations in enhancing adherence. Control Clin Trials. 2004;25(5):447–57. doi:10.1016/j.cct.2004.07.003. Epub 2004/10/07.CrossRefPubMed

42.

Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt L. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes following total hip or knee arthroplasty in osteoarthritis. J Orthop Rheumatol. 1988;1:95–108.

43.

Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988;15(12):1833–40.PubMed

44.

Roos EM, Toksvig-Larsen S. Knee injury and Osteoarthritis Outcome Score [KOOS] - validation and comparison to the WOMAC in total knee replacement. Health Qual Life Outcomes. 2003;1:17. doi:10.1186/1477-7525-1-17.CrossRefPubMedPubMedCentral

45.

Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c869. doi:10.1136/bmj.c869. Epub 2010/03/25. PubMed PMID: 20332511; PubMed Central PMCID: PMCPmc2844943.CrossRefPubMedPubMedCentral

46.

Tubach F, Ravaud P, Martin-Mola E, Awada H, Bellamy N, Bombardier C, et al. Minimum clinically important improvement and patient acceptable symptom state in pain and function in rheumatoid arthritis, ankylosing spondylitis, chronic back pain, hand osteoarthritis, and hip and knee osteoarthritis: Results from a prospective multinational study. Arthritis Care Res [Hoboken]. 2012;64(11):1699–707. doi:10.1002/acr.21747.CrossRef

47.

Siegel JE, Weinstein MC, Russell LB, Gold MR. Recommendations for reporting cost-effectiveness analyses. Panel on cost-effectiveness in health and medicine. JAMA. 1996;276(16):1339–41.CrossRefPubMed

48.

Weinstein MC, Siegel JE, Gold MR, Kamlet MS, Russell LB. Recommendations of the panel on cost-effectiveness in health and medicine. JAMA. 1996;276(15):1253–8.CrossRefPubMed

49.

Sanders GD, Neumann PJ, Basu A, Brock DW, Feeny D, Krahn M, et al. Recommendations for conduct, methodological practices, and reporting of cost-effectiveness analyses: second panel on cost-effectiveness in health and medicine. JAMA. 2016;316(10):1093–103. doi:10.1001/jama.2016.12195. Epub 2016/09/14.CrossRefPubMed

50.

Neumann PJ, Sanders GD, Russell LB, Siegel JE, Ganiats TG. Editor. Cost-effectiveness in health and medicine. Second edition ed. Oxford, England: Oxford University Press; 2016.

51.

Brownell KD. The humbling experience of treating obesity: Should we persist or desist? Behav Res Ther. 2010;48(8):717–9. doi:10.1016/j.brat.2010.05.018.CrossRefPubMed

52.

de Vos BC, Runhaar J, Bierma-Zeinstra SM. Effectiveness of a tailor-made weight loss intervention in primary care. Eur J Nutr. 2014;53(1):95–104. doi:10.1007/s00394-013-0505-y. Epub 2013/02/23.CrossRefPubMed

53.

de Vos BC, Runhaar J, van Middelkoop M, Krul M, Bierma-Zeinstra SM. Long-term effects of a randomized, controlled, tailor-made weight-loss intervention in primary care on the health and lifestyle of overweight and obese women. Am J Clin Nutr. 2016;104(1):33–40. doi:10.3945/ajcn.116.133512. Epub 2016/06/17.CrossRefPubMed

54.

Riebe D, Franklin BA, Thompson PD, Garber CE, Whitfield GP, Magal M, et al. Updating ACSM’s recommendations for exercise preparticipation health screening. Med Sci Sports Exerc. 2015;47(11):2473–9. doi:10.1249/mss.0000000000000664. Epub 2015/10/17.CrossRefPubMed

55.

Sangha O, Stucki G, Liang MH, Fossel AH, Katz JN. The self-administered comorbidity questionnaire: a new method to assess comorbidity for clinical and health services research. Arthritis Rheum. 2003;49(2):156–63. doi:10.1002/art.10993.CrossRefPubMed

56.

Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score [KOOS]--development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998;28(2):88–96. doi:10.2519/jospt.1998.28.2.88. Epub 1998/08/12.CrossRefPubMed

57.

Ruyssen-Witrand A, Fernandez-Lopez CJ, Gossec L, Anract P, Courpied JP, Dougados M. Psychometric properties of the OARSI/OMERACT osteoarthritis pain and functional impairment scales: ICOAP, KOOS-PS and HOOS-PS. Clin Exp Rheumatol. 2011;29(2):231–7. Epub 2011/04/08.PubMed

58.

Washburn RA, McAuley E, Katula J, Mihalko SL, Boileau RA. The physical activity scale for the elderly [PASE]: evidence for validity. J Clin Epidemiol. 1999;52(7):643–51.CrossRefPubMed

59.

Nasreddine ZS, Phillips N, Chertkow H. Normative data for the Montreal Cognitive Assessment [MoCA] in a population-based sample. Neurology. 2012;78(10):765–6. doi:10.1212/01.wnl.0000413072.54070.a3.CrossRefPubMed

60.

Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, et al. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005;53(4):695–9. doi:10.1111/j.1532-5415.2005.53221.x.CrossRefPubMed

61.

Burnam MA, Wells KB, Leake B, Landsverk J. Development of a brief screening instrument for detecting depressive disorders. Med Care. 1988;26(8):775–89. Epub 1988/08/01.CrossRefPubMed

62.

EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990;16(3):199–208.

63.

Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoecon. 1993;4(5):353–65.CrossRef

64.

Ware Jr JE, Sherbourne CD. The MOS 36-item short-form health survey [SF-36]. I. Conceptual framework and item selection. Med Care. 1992;30(6):473–83.CrossRefPubMed

65.

McAuley E, Mihalko SL. In: Duda JL, editor. Advances in sport and exercise psychology measurement. Morgantown: Fitness Information Technology, Inc; 1998. p. 371–89. Measuring Exercise-Related Self-Efficacy.

66.

Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983;24(4):385–96. Epub 1983/12/01.CrossRefPubMed

67.

Sullivan MJ, Stanish W, Waite H, Sullivan M, Tripp DA. Catastrophizing, pain, and disability in patients with soft-tissue injuries. Pain. 1998;77(3):253–60. Epub 1998/11/10.CrossRefPubMed

68.

Osman A, Barrios FX, Kopper BA, Hauptmann W, Jones J, O’Neill E. Factor structure, reliability, and validity of the Pain Catastrophizing Scale. J Behav Med. 1997;20(6):589–605. Epub 1998/01/16.CrossRefPubMed

69.

Baker DW, Williams MV, Parker RM, Gazmararian JA, Nurss J. Development of a brief test to measure functional health literacy. Patient Educ Couns. 1999;38(1):33–42. Epub 2003/10/08.CrossRefPubMed

70.

Clark MM, Abrams DB, Niaura RS, Eaton CA, Rossi JS. Self-efficacy in weight management. J Consult Clin Psychol. 1991;59(5):739–44. Epub 1991/10/01.CrossRefPubMed

71.

Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988;54(6):1063–70. Epub 1988/06/01.CrossRefPubMed

72.

investigators TA. The Atherosclerosis Risk in Communities [ARIC] Study: design and objectives. Am J Epidemiol. 1989;129(4):687–702.CrossRef

73.

Diener E, Emmons RA, Larsen RJ, Griffin S. The satisfaction with life scale. J Pers Assess. 1985;49(1):71–5. doi:10.1207/s15327752jpa4901_13. Epub 1985/02/01.CrossRefPubMed

74.

Escobar A, Quintana JM, Bilbao A, Arostegui I, Lafuente I, Vidaurreta I. Responsiveness and clinically important differences for the WOMAC and SF-36 after total knee replacement. Osteoarthritis Cartilage. 2007;15(3):273–80. doi:10.1016/j.joca.2006.09.001. Epub 2006/10/21.CrossRefPubMed

75.

Penninx BW, Messier SP, Rejeski WJ, Williamson JD, DiBari M, Cavazzini C, et al. Physical exercise and the prevention of disability in activities of daily living in older persons with osteoarthritis. Arch Intern Med. 2001;161(19):2309–16.CrossRefPubMed

76.

Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, et al. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994;49(2):M85–94.CrossRefPubMed

77.

Nightingale EJ, Pourkazemi F, Hiller CE. Systematic review of timed stair tests. J Rehabil Res Dev. 2014;51(3):335–50. doi:10.1682/jrrd.2013.06.0148. Epub 2014/07/16.CrossRefPubMed