The Breathe Easier through Weight Loss Lifestyle (BE WELL) Intervention: a randomized controlled trial

Jun Ma, Peg Strub, Carlos A Camargo Jr, Lan Xiao, Estela Ayala, Christopher D Gardner, A Sonia Buist, William L Haskell, Phillip W Lavori, Sandra R Wilson, Jun Ma, Peg Strub, Carlos A Camargo Jr, Lan Xiao, Estela Ayala, Christopher D Gardner, A Sonia Buist, William L Haskell, Phillip W Lavori, Sandra R Wilson

Abstract

Background: Obesity and asthma have reached epidemic proportions in the US. Their concurrent rise over the last 30 years suggests that they may be connected. Numerous observational studies support a temporally-correct, dose-response relationship between body mass index (BMI) and incident asthma. Weight loss, either induced by surgery or caloric restriction, has been reported to improve asthma symptoms and lung function. Due to methodological shortcomings of previous studies, however, well-controlled trials are needed to investigate the efficacy of weight loss strategies to improve asthma control in obese individuals.

Methods/design: BE WELL is a 2-arm parallel randomized clinical trial (RCT) of the efficacy of an evidence-based, comprehensive, behavioral weight loss intervention, focusing on diet, physical activity, and behavioral therapy, as adjunct therapy to usual care in the management of asthma in obese adults. Trial participants (n = 324) are patients aged 18 to 70 years who have suboptimally controlled, persistent asthma, BMI between 30.0 and 44.9 kg/m2, and who do not have serious comorbidities (e.g., diabetes, heart disease, stroke). The 12-month weight loss intervention to be studied is based on the principles of the highly successful Diabetes Prevention Program lifestyle intervention. Intervention participants will attend 13 weekly group sessions over a four-month period, followed by two monthly individual sessions, and will then receive individualized counseling primarily by phone, at least bi-monthly, for the remainder of the intervention. Follow-up assessment will occur at six and 12 months. The primary outcome variable is the overall score on the Juniper Asthma Control Questionnaire measured at 12 months. Secondary outcomes include lung function, asthma-specific and general quality of life, asthma medication use, asthma-related and total health care utilization. Potential mediators (e.g., weight loss and change in physical activity level and nutrient intake) and moderators (e.g., socio-demographic characteristics and comorbidities) of the intervention effects also will be examined.

Discussion: This RCT holds considerable potential for illuminating the nature of the obesity-asthma relationship and advancing current guidelines for treating obese adults with asthma, which may lead to reduced morbidity and mortality related to the comorbidity of the two disorders.

Trial registration: NCT00901095.

References

    1. Masoli M, Fabian D, Holt S, Beasley R. The global burden of asthma: executive summary of the GINA Dissemination Committee report. Allergy. 2004;59:469–478. doi: 10.1111/j.1398-9995.2004.00526.x.
    1. World Health Organization. WHO Technical Report Series 894. Geneva, Switzerland: WHO; 2000. Obesity: preventing and managing the global epidemic.
    1. Beuther DA, Sutherland ER. Overweight, obesity, and incident asthma: a meta-analysis of prospective epidemiologic studies. Am J Respir Crit Care Med. 2007;175:661–666. doi: 10.1164/rccm.200611-1717OC.
    1. Ford ES. The epidemiology of obesity and asthma. J Allergy Clin Immunol. 2005;115:897–909. doi: 10.1016/j.jaci.2004.11.050. quiz 910.
    1. Shore SA, Johnston RA. Obesity and asthma. Pharmacol Ther. 2006;110:83–102. doi: 10.1016/j.pharmthera.2005.10.002.
    1. Carroll CL, Bhandari A, Zucker AR, Schramm CM. Childhood obesity increases duration of therapy during severe asthma exacerbations. Pediatr Crit Care Med. 2006;7:527–531. doi: 10.1097/01.PCC.0000243749.14555.E8.
    1. Lavoie KL, Bacon SL, Labrecque M, Cartier A, Ditto B. Higher BMI is associated with worse asthma control and quality of life but not asthma severity. Respir Med. 2006;100:648–657. doi: 10.1016/j.rmed.2005.08.001.
    1. Saint-Pierre P, Bourdin A, Chanez P, Daures JP, Godard P. Are overweight asthmatics more difficult to control? Allergy. 2006;61:79–84.
    1. Akerman MJ, Calacanis CM, Madsen MK. Relationship between asthma severity and obesity. J Asthma. 2004;41:521–526. doi: 10.1081/JAS-120037651.
    1. Dixon AE, Shade DM, Cohen RI, Skloot GS, Holbrook JT, Smith LJ, Lima JJ, Allayee H, Irvin CG, Wise RA. Effect of obesity on clinical presentation and response to treatment in asthma. J Asthma. 2006;43:553–558. doi: 10.1080/02770900600859123.
    1. Peters-Golden M, Swern A, Bird SS, Hustad CM, Grant E, Edelman JM. Influence of body mass index on the response to asthma controller agents. Eur Respir J. 2006;27:495–503. doi: 10.1183/09031936.06.00077205.
    1. Chinn S, Downs SH, Anto JM, Gerbase MW, Leynaert B, de Marco R, Janson C, Jarvis D, Kunzli N, Sunyer J. Incidence of asthma and net change in symptoms in relation to changes in obesity. Eur Respir J. 2006;28:763–771. doi: 10.1183/09031936.06.00150505.
    1. Chen Y, Dales R, Tang M, Krewski D. Obesity may increase the incidence of asthma in women but not in men: longitudinal observations from the Canadian National Population Health Surveys. Am J Epidemiol. 2002;155:191–197. doi: 10.1093/aje/155.3.191.
    1. Hancox RJ, Milne BJ, Poulton R, Taylor DR, Greene JM, McLachlan CR, Cowan JO, Flannery EM, Herbison GP, Sears MR. Sex differences in the relation between body mass index and asthma and atopy in a birth cohort. Am J Respir Crit Care Med. 2005;171:440–445. doi: 10.1164/rccm.200405-623OC.
    1. Kim S, Camargo CA Jr. Sex-race differences in the relationship between obesity and asthma: the behavioral risk factor surveillance system, 2000. Ann Epidemiol. 2003;13:666–673. doi: 10.1016/S1047-2797(03)00054-1.
    1. Johnston RA, Theman TA, Shore SA. Augmented responses to ozone in obese carboxypeptidase E-deficient mice. Am J Physiol Regul Integr Comp Physiol. 2006;290:R126–133.
    1. Lu FL, Johnston RA, Flynt L, Theman TA, Terry RD, Schwartzman IN, Lee A, Shore SA. Increased pulmonary responses to acute ozone exposure in obese db/db mice. Am J Physiol Lung Cell Mol Physiol. 2006;290:L856–865. doi: 10.1152/ajplung.00386.2005.
    1. Shore SA, Rivera-Sanchez YM, Schwartzman IN, Johnston RA. Responses to ozone are increased in obese mice. J Appl Physiol. 2003;95:938–945.
    1. Tantisira KG, Weiss ST. Complex interactions in complex traits: obesity and asthma. Thorax. 2001;56(Suppl 2):ii64–73.
    1. Weiss ST, Shore S. Obesity and asthma: directions for research. Am J Respir Crit Care Med. 2004;169:963–968. doi: 10.1164/rccm.200303-403WS.
    1. Schaub B, von Mutius E. Obesity and asthma, what are the links? Curr Opin Allergy Clin Immunol. 2005;5:185–193. doi: 10.1097/01.all.0000162313.64308.b5.
    1. National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR 3): Guidelines for the Diagnosis and Management of Asthma. Bethesda, MD: National Institutes of Health; 2007.
    1. Aaron SD, Fergusson D, Dent R, Chen Y, Vandemheen KL, Dales RE. Effect of weight reduction on respiratory function and airway reactivity in obese women. Chest. 2004;125:2046–2052. doi: 10.1378/chest.125.6.2046.
    1. Hakala K, Stenius-Aarniala B, Sovijarvi A. Effects of weight loss on peak flow variability, airways obstruction, and lung volumes in obese patients with asthma. Chest. 2000;118:1315–1321. doi: 10.1378/chest.118.5.1315.
    1. Johnson JB, Summer W, Cutler RG, Martin B, Hyun DH, Dixit VD, Pearson M, Nassar M, Tellejohan R, Maudsley S. Alternate day calorie restriction improves clinical findings and reduces markers of oxidative stress and inflammation in overweight adults with moderate asthma. Free Radic Biol Med. 2007;42:665–674. doi: 10.1016/j.freeradbiomed.2006.12.005.
    1. Stenius-Aarniala B, Poussa T, Kvarnstrom J, Gronlund EL, Ylikahri M, Mustajoki P. Immediate and long term effects of weight reduction in obese people with asthma: randomised controlled study. Bmj. 2000;320:827–832. doi: 10.1136/bmj.320.7238.827.
    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. Juniper EF, O'Byrne PM, Guyatt GH, Ferrie PJ, King DR. Development and validation of a questionnaire to measure asthma control. Eur Respir J. 1999;14:902–907. doi: 10.1034/j.1399-3003.1999.14d29.x.
    1. Carter BR, Hood K. Balance algorithm for cluster randomized trials. BMC Med Res Methodol. 2008;8:65. doi: 10.1186/1471-2288-8-65.
    1. Raab GM, Butcher I. Balance in cluster randomized trials. Stat Med. 2001;20:351–365. doi: 10.1002/1097-0258(20010215)20:3<351::AID-SIM797>;2-C.
    1. Juniper EF, Bousquet J, Abetz L, Bateman ED. Identifying 'well-controlled' and 'not well-controlled' asthma using the Asthma Control Questionnaire. Respir Med. 2006;100:616–621. doi: 10.1016/j.rmed.2005.08.012.
    1. Juniper EF, Guyatt GH, Cox FM, Ferrie PJ, King DR. Development and validation of the Mini Asthma Quality of Life Questionnaire. Eur Respir J. 1999;14:32–38. doi: 10.1034/j.1399-3003.1999.14a08.x.
    1. Wilson SR, Strub P, Buist AS, Knowles SB, Lavori PW, Lapidus J, Vollmer WM. Shared treatment decision making improves adherence and outcomes in poorly controlled asthma. Am J Respir Crit Care Med. pp. 566–577.
    1. Mahler DA, Weinberg DH, Wells CK, Feinstein AR. The measurement of dyspnea. Contents, interobserver agreement, and physiologic correlates of two new clinical indexes. Chest. 1984;85:751–758. doi: 10.1378/chest.85.6.751.
    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. Radloff L. The CES-D scale: A self-report depression scale for research in the general population. Appl Psychological Measurement. 1977;1:385–401. doi: 10.1177/014662167700100306.
    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. Cochrane LM, Clark CJ. Benefits and problems of a physical training programme for asthmatic patients. Thorax. 1990;45:345–351. doi: 10.1136/thx.45.5.345.
    1. Mohsenin V, Dubois AB, Douglas JS. Effect of ascorbic acid on response to methacholine challenge in asthmatic subjects. Am Rev Respir Dis. 1983;127:143–147.
    1. Robinson DM, Egglestone DM, Hill PM, Rea HH, Richards GN, Robinson SM. Effects of a physical conditioning programme on asthmatic patients. N Z Med J. 1992;105:253–256.
    1. Schachter EN, Schlesinger A. The attenuation of exercise-induced bronchospasm by ascorbic acid. Ann Allergy. 1982;49:146–151.
    1. Spector SL, Surette ME. Diet and asthma: has the role of dietary lipids been overlooked in the management of asthma? Ann Allergy Asthma Immunol. 2003;90:371–377. doi: 10.1016/S1081-1206(10)61817-0. quiz 377-378, 421.
    1. Broughton KS, Johnson CS, Pace BK, Liebman M, Kleppinger KM. Reduced asthma symptoms with n-3 fatty acid ingestion are related to 5-series leukotriene production. Am J Clin Nutr. 1997;65:1011–1017.
    1. Block G. A review of validations of dietary assessment methods. Am J Epidemiol. 1982;115:492–505.
    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. 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. Netzer NC, Stoohs RA, Netzer CM, Clark K, Strohl KP. Using the Berlin Questionnaire to identify patients at risk for the sleep apnea syndrome. Ann Intern Med. 1999;131:485–491.
    1. Rothman M, Farup C, Stewart W, Helbers L, Zeldis J. Symptoms associated with gastroesophageal reflux disease: development of a questionnaire for use in clinical trials. Dig Dis Sci. 2001;46:1540–1549. doi: 10.1023/A:1010660425522.
    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. 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. Tuomilehto J, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001;344:1343–1350. doi: 10.1056/NEJM200105033441801.
    1. Appel LJ, Champagne CM, Harsha DW, Cooper LS, Obarzanek E, Elmer PJ, Stevens VJ, Vollmer WM, Lin PH, Svetkey LP. Effects of comprehensive lifestyle modification on blood pressure control: main results of the PREMIER clinical trial. Jama. 2003;289:2083–2093. doi: 10.1001/jama.289.16.2083.
    1. Stevens VJ, Obarzanek E, Cook NR, Lee IM, Appel LJ, Smith D West, Milas NC, Mattfeldt-Beman M, Belden L, Bragg C. Long-term weight loss and changes in blood pressure: results of the Trials of Hypertension Prevention, phase II. Ann Intern Med. 2001;134:1–11.
    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. 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;37:505–511. doi: 10.1016/j.amepre.2009.07.020.
    1. Littell RC, Milliken GA. SAS System for Mixed Models. Cary, NC: SAS Institute Inc; 1996.
    1. Siddique J, Brown CH, Hedeker D, Duan N, Gibbons RD, Miranda J, Lavori PW. Missing Data in Longitudinal Trials - Part B, Analytic Issues. Psychiatr Ann. 2008;38:793–801. doi: 10.3928/00485713-20081201-09.
    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. Dixon JB, O'Brien PE. Changes in comorbidities and improvements in quality of life after LAP-BAND placement. Am J Surg. 2002;184:51S–54S. doi: 10.1016/S0002-9610(02)01181-9.
    1. Simard B, Turcotte H, Marceau P, Biron S, Hould FS, Lebel S, Marceau S, Boulet LP. Asthma and sleep apnea in patients with morbid obesity: outcome after bariatric surgery. Obes Surg. 2004;14:1381–1388. doi: 10.1381/0960892042584021.
    1. Spivak H, Hewitt MF, Onn A, Half EE. Weight loss and improvement of obesity-related illness in 500 U.S. patients following laparoscopic adjustable gastric banding procedure. Am J Surg. 2005;189:27–32. doi: 10.1016/j.amjsurg.2004.06.038.
    1. Johnson JB, Summer W, Cutler RG, Martin B, Hyun DH, Dixit VD, Pearson M, Nassar M, Telljohann R, Maudsley S. Alternate day calorie restriction improves clinical findings and reduces markers of oxidative stress and inflammation in overweight adults with moderate asthma. Free Radic Biol Med. 2007;42:665–674. doi: 10.1016/j.freeradbiomed.2006.12.005.
    1. Eneli IU, Skybo T, Camargo CA Jr. Weight loss and asthma: a systematic review. Thorax. 2008;63:671–676. doi: 10.1136/thx.2007.086470.
    1. Nathan RA, Sorkness CA, Kosinski M, Schatz M, Li JT, Marcus P, Murray JJ, Pendergraft TB. Development of the asthma control test: a survey for assessing asthma control. J Allergy Clin Immunol. 2004;113:59–65. doi: 10.1016/j.jaci.2003.09.008.

Source: PubMed

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

3
Suscribir