Design considerations and rationale of a multi-center trial to sustain weight loss: The weight loss maintenance trial

Clinical Trials

Volumn 5, Issue 5, 2008, Pages 546-556

  Brantley, Phillip ^a   Appel, Lawrence ^b   Hollis, Jack ^c   Stevens, Victor ^c   Ard, Jamy ^d   Champagne, Catherine ^a   Elmer, Patricia ^c   Harsha, David ^a   Myers, Valerie ^a   Proschan, Michael ^e   William, Vollmer ^c   Svetkey, Laura ^f  

^a PENNINGTON BIOMEDICAL RESEARCH CENTER   (United States)

^b JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c CENTER FOR HEALTH RESEARCH   (United States)

^d UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^e NATIONAL HEART LUNG AND BLOOD INSTITUTE   (United States)

^f DUKE UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL RESEARCH; DATA ANALYSIS; FEEDING BEHAVIOR; HEALTH BEHAVIOR; HEALTH PROGRAM; HUMAN; INFORMATION PROCESSING; INTERNET; LIFESTYLE MODIFICATION; OBESITY; PATIENT ATTITUDE; PATIENT CARE; PATIENT COMPLIANCE; PHYSICAL ACTIVITY; PRIORITY JOURNAL; PROCESS DESIGN; PROCESS MONITORING; REVIEW; SOCIAL BEHAVIOR; SOCIAL SUPPORT; SUPPORT GROUP; TREATMENT DURATION; WEIGHT LOSS MAINTENANCE TRIAL; WEIGHT REDUCTION;

CARDIOVASCULAR DISEASES; HUMANS; OBESITY; OUTCOME AND PROCESS ASSESSMENT (HEALTH CARE); OVERWEIGHT; RESEARCH DESIGN; UNITED STATES; WEIGHT LOSS;

EID: 59349097703     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774508096315     Document Type: Review

References (59)

1. National Institutes of Health. NHLBI clinical guidelines on the identification, evaluation, and treatment of overweight and obesity in adults, executive summary U.S. Department of Health and Human Services, 1998.
2. Flegal KM, Carroll MD, Ogden CL, Johnson CL Prevalence and trends in obesity among US adults, 1999-2000. JAMA 2002; 288 (14): 1723-27.
3. Ford ES, Giles WH, Dietz WH Prevalence of the metabolic syndrome among US adults: Findings from the Third National Health and Nutrition Examination Survey. JAMA 2002; 287: 356-59.
4. Seidel JC, Visscher TLS, Hoogeveen RT Overweight and obesity in the mortality rate data: Current evidence and research issues. Med Sci Sports Exerc 1999; 31 (Suppl): S597-S601.
5. Allison DB, Fontaine KR, Manson JE et al. Annual deaths attributable to obesity in the United States. JAMA 1999; 282: 1530-38.
6. Fontaine KR, Redden DT, Wang C. et al. Years of life lost due to obesity. JAMA 2003; 289: 187-93.
7. Olshansky SJ, Passaro DJ, Hershow RC et al. A potential decline in life expectancy in the United States in the 21st Century. New Engl J Med 2005; 352: 1138-45.
8. Kannel WB, D'Agostino RB, Cobb JL Effect of weight on cardiovascular disease. Am J Clin Nutr 1996; 63 (Suppl. 3): 419S-22S.
9. Pi-Sunyer FX Medical hazards of obesity. Ann Intern Med 1993; 119 (7 Pt 2): 655-60.
10. King AC, Haskell WL, Young DR et al. Long-term effects of varying intensities and formats of physical activity on participation rates, fitness, and lipoproteins in men and women aged 50 to 65 years. Circulation 1995; 91 (10): 2596-604.
11. Must A., Spadano J., Coakley EH et al. The disease burden associated with overweight and obesity. JAMA 1999; 282 (16): 1523-29.
12. Colditz GA, Willett WC, Rotnitzky A., Manson JE Weight gain as a risk factor for clinical diabetes mellitus in women. Ann Intern Med 1995; 122: 481-86.
13. Dickey RA, Janick JJ Lifestyle modifications in the prevention and treatment of hypertension. Endocr Pract 2001; 7: 392-99.
14. Dubbert PM, Carithers T., Sumner AE et al. Obesity, physical inactivity, and risk for cardiovascular disease. Am J Med Sci 2002; 324: 116-26.
15. Mann JI Diet and risk of coronary heart disease and type 2 diabetes. Lancet 2002; 360 (9335): 783-89.
16. Visscher TLS, Seidell JC The public health impact of obesity. Annu Rev Public Health 2001; 22: 355-75.
17. Thompson D., Brown JB, Nichols GA et al. Body mass index and future health-care costs: A retrospective cohort study. Obes Res 2001; 9 (3): 210-18.
18. Allison DB, Zannolli R., Narayan KM The direct health care costs of obesity in the United States. Am J Public Health 1999; 89 (8): 1194-99.
19. Musich SA, Lu C., McDonals T. et al. Association of additional health risks on medical charges and prevalence of diabetes within body mass index categories. Am J Health Promot 2004; 18 (3): 264-68.
20. Finkelstein EA, Fiebelkorn IC, Wang G. State-level estimates of annual medical expenditures attributable to obesity. Obes Res 2004; 12 (1): 18-24.
21. Mokdad AH, Serdula MK, Dietz WH et al. The spread of the obesity epidemic in the United States, 1991-1998. JAMA 1999; 282 (16): 1519-22.
22. Kuczmarski RJ, Flegal KM, Campbell SM, Johnson CL Increasing prevalence of overweight among U.S. adults. The national health and nutrition examination surveys, 1960 to 1991. JAMA 1994; 272 (3): 205-11.
23. Elmer PJ, Grimm J. r, R, Laing B. et al. Lifestyle intervention: Results of the Treatment of Mild Hypertension Study (TOMHS). Prev Med 1995; 24 (4): 378-88.
24. Whelton PK, Appel LJ, Espeland MA et al. Sodium reduction and weight loss in the treatment of hypertension in older persons: A randomized controlled trial of nonpharmacologic interventions in the elderly (TONE). TONE Collaborative Research Group [published erratum appears in JAMA 1998 Jun 24; 279 (24): 1954]. JAMA 1998; 279 (11): 839-46.
25. The Trials of Hypertension Prevention Collaborative Research Group. The effects of nonpharmacologic interventions on blood pressure of persons with high normal levels. Results of the Trials of Hypertension Prevention, Phase I [published erratum appears in JAMA 1992 May 6; 267 (17): 2330]. JAMA 1992; 267 (9): 1213-20.
26. The Trials of Hypertension Prevention Collaborative Research Group. Effects of weight loss and sodium reduction intervention on blood pressure and hypertension incidence in overweight people with high-normal blood pressure. The Trials of Hypertension Prevention, phase II. Arch Intern Med 1997; 157 (6): 657-67.
27. Wood PD, Stefanick ML, Dreon DM et al. Changes in plasma lipids and lipoproteins in overweight men during weight loss through dieting as compared with exercise. N Engl J Med 1988; 319 (18): 1173-79.
28. Wing RR Maintenance of behavior change in cardiorespiratory risk reduction: Introduction to proceedings from the National Heart, Lung, and Blood Institute conference. Health Psychol 2000; 19 (Suppl. 3-4): 3-4.
29. Orleans CT Promoting the maintenance of health behavior change: Recommendations for the next generation of research and practice. Health Psychol 2000; 19: 76-83.
30. Marcus BH, Dubbert PM, Forsyth LH et al. Physical activity behavior change: Issues in adoption and maintenance. Health Psychol 2000; 19 (Suppl. 1): 32-41.
31. Berkel LA, Carlos Poston WS, Foreyt JP Behavioral interventions of obesity. J Am Diet Assoc 2005; 105 (5 Pt 2): 35-43.
32. King AC, Frey-Hewitt B., Dreon DM, Wood PD The effects of minimal intervention strategies on long-term outcomes in men. Arch Intern Med 1989; 149: 2741-46.
33. Wing RR, Jeffery RW, Hellerstedt WL, Burton L. Effect of frequent phone contacts and optional food provision on maintenance of weight loss. Annals Behav Med 1996; 18: 172-76.
34. Meneghini LF, Albisser AM, Goldberg RB, Mintz DH An electronic case manager for diabetes control. Diabetes Care 1998; 21 (4): 591-96.
35. U.S. Department of Health and Human Services. Science Panel on Interactive Communication and Health. In Eng TR, Gustafson DH. (eds). Wired for Health and Well-Being: The Emergence of Interactive Health Communication. U.S. Government Printing Office, Washington, DC, 1999, pp. i-41.
36. Revere D., Dunbar PJ Review of computer-generated outpatient health behavior interventions: Clinical encounters "in Absentia". J Am Med Inform Assoc 2001; 8 (1):62-79.
37. Jimison H., Adler L., Coye M. et al. Health care providers and purchasers and evaluation of interactive health communication applications. Science Panel on Interactive Communication and Health. Am J Prev Med 1999; 16 (1): 16-22.
38. Harvey-Berino J., Pintauro S., Buzzell P., Gold EC Effect of internet support on long-term maintenance of weight loss. Obes Res 2004; 12 (2): 320-29.
39. Harvey-Berino J., Pintauro SJ, Gold EC The feasibility of using Internet support for the maintenance of weight loss. Behav Modif 2002; 26 (1): 103-16.
40. Wing RR, Tate DF, Gorin AA et al. STOP regain: Are there negative effects of daily weighing ? J Consult Clin Psychol 2007; 75 (4): 652-56.
41. Weinstein PK A review of weight loss programs delivered via the Internet. J Cardiovasc Nurs 2006; 21 (4): 251-58.
42. Svetkey LP, Stevens VJ, Brantley PJ et al. for the Weight Loss Maintenance Collaborative Research Group. Comparison of strategies for sustaining weight loss: The Weight Loss Maintenance randomized controlled trial. JAMA 2008; 299 (10): 1139-48.
43. Writing Group of the PREMIER Collaborative Research Group. Effects of comprehensive lifestyle modification on blood pressure control: Main results of the PREMIER clinical trial. JAMA 2003; 289 (16): 2083-93.
44. Bandura A. Social foundations of thought and action: A social cognitive theory. Prentice Hall, Englewood Cliffs, NJ, 1986.
45. Watson DL, Tharp RG Self-directed behavior: Self-modification for personal adjustment (7 th edn). Brooks/Cole, Belmont, CA, 1997.
46. Prochaska JO, DiClemente CC Stages and processes of self-change of smoking: Toward an integrative model of change. J Consult Clin Psychol 1983; 51 (3): 390-95.
47. Bock BC, Marcus BH, Pinto BM, Forsyth LH Maintenance of physical activity following an individualized motivationally tailored intervention. Ann Behav Med 2001; 23 (2): 79-87.
48. Rollnick S., Mason P., Butler C. Health Behavior Change: A Guide for Practitioners. Churchill Livingston, London, 1999.
49. Miller WR, Rollnick S. Motivational Interviewing: Preparing People to Change Addictive Behavior. The Guilford Press, New York, 1991.
50. Appel LJ, Moore TJ, Obarzanek E. et al. A clinical trial of the effects of dietary patterns on blood pressure. DASH Collaborative Research Group. N Engl J Med 1997; 336 (16): 1117-24.
51. Working Group on Primary Prevention of Hypertension. National High Blood Pressure Education Program: Working Group Report on Primary Prevention of Hypertension; 1993(NIH Publication No. 93-2669).
52. Harris J., Benedict F. A biometric study of basal metabolism in man. Carnegie Institution, Washington, DC, 1919.
53. Klem ML, Wing RR, McGuire MT et al. A descriptive study of individuals successful at long-term maintenance of substantial weight loss. Am J Clin Nutr 1997; 66 (2): 239-246.
54. Wadden TA, Butryn ML, Byrne KJ Efficacy of lifestyle modification for long-term weight control. Obes Res 2004; 12 (Suppl. 32): 151S-162S.
55. Jeffery RW, Drewnowski A., Epstein LH et al. Long-term maintenance of weight loss: Current status. Health Psychol 2000; 19 (Suppl. 1): 5-16.
56. Wagner EH, Glasgow RE, Davis C. et al. Quality improvement in chronic illness care: A collaborative approach. J Comm J Qual Improv 2001; 27 (2): 63-80.
57. Medicare medical nutrition therapy amendment act of 2001. 6-7-2001. HR 2117.
58. Stevens VJ, Obarzanek E., Cook NR et al. 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.
59. Aickin M., Gensler H. Adjusting for multiple testing when reporting research results: The Bonferroni vs Holm methods. Am J Public Health 1996; 86 (5): 726-28.