A Gym-Based Wellness Challenge for People With Type 2 Diabetes: Effect on Weight Loss, Body Composition, and Glycemic Control

Transcription

1 A Gym-Based Wellness Challenge for People With Type 2 Diabetes: Effect on Weight Loss, Body Composition, and Glycemic Control Richard M. Tucker, MD; Casey May, RN; Richard Bennett, RN, MA; Jenny Hymer, BS, ACSM; and Blair McHaney Abstract Context. Modification of diet and exercise is known to be effective in treating diabetes and obesity, but options for practical, effective interventions are few. Objective. To assess the effectiveness of a gym-based fitness competition with financial incentives in weight loss and diabetes control in adults with type 2 diabetes. gym attendance, body composition improvement, participation in patient education sessions, and adherence to the diabetes care regimen. Main outcome measures. The primary outcomes were weight loss and body composition improvement. Secondary outcomes included quality of life assessment and improvements in hemoglobin A 1c (A1C) and lipid levels. 176 Address correspondence and requests for reprints to: Richard M. Tucker, MD, Associate Medical Director, Department of Quality Improvement and Education, Wenatchee Valley Medical Center, 820 N Chelan St., Wenatchee, WA Design. Retrospective analysis of outcomes of a quality improvement initiative in diabetes care. Analysis was made from comparisons of measurements made of participants before enrollment to those of the subset of enrolling participants who finished the challenge. Setting. Outpatient multispecialty group practice clinic and private gym in rural eastern Washington State. Participants. Sixty-nine adults with type 2 diabetes who were followed by the participating clinic. Participants were recruited from diabetes disease management registries and from newspaper and posted advertisements. Interventions. Participants competed in a 5.5-month, gym-based structured exercise and diet program with close clinical monitoring. Substantial financial awards were made at the end of the program based on a point system that included credits for diet tracking, Results. Thirty participants (45%) finished the program and could be evaluated. Significant (P < 0.05) improvements were seen for A1C results; weight loss; decrease in body fat; inches lost from abdomen, thigh, and hips; and physical component score from a quality-of-life scale (the Short- Form 8 [SF-8] health survey). Weight loss was seen in 28 of the 30 patients who completed the program (mean loss = 15.9 lb; median = 14.5 lb; range = lb). A1C reductions were seen in 86% of these participants (mean = 1.52%; median = 1.6%; range = +0.8 to 5.0%). Physiciandirected reduction of one or more diabetes, lipid-lowering, or anti-hypertensive medications occurred in 28%, and discontinuation of one more medications occurred in 28%. Conclusion. Structured financial incentives are highly effective in achieving weight loss and improved clinical outcomes in some adults with type 2 diabetes.

2 Feature Article/Tucker et al. The rates of overweight and obesity have exploded in the United States and worldwide in the past several decades. 1 3 Inextricably linked through the correlation of adiposity and insulin has been a parallel and equally striking increase in incidence and prevalence of type 2 diabetes. 4 These twin epidemics have affected all age-groups, races, and countries. 5 7 Multiple possible causes have been postulated for these increases, but it is clear that the proximal cause is a concurrent increase in daily caloric intake and a decrease in expended energy. 8 If unaddressed, the public health implications of these trends for the United States are dire. 1,3,8,9 Clearly, addressing the adverse effects of Western culture on healthful patterns of diet and exercise is of paramount importance. Effective, sustainable methods of effecting change in affected populations of patients are sadly limited. The Wenatchee Valley Medical Center (WVMC) is a multi-specialty group practice in eastern Washington State. Since, it has been involved in disease management and quality improvement initiatives in diabetes care, women s health, cardiovascular disease, and preventive health. In these initiatives, WVMC health professionals have used the principles of the Chronic Care Model (CCM) developed by the MacColl Institute 10,11 and Group Health Cooperative of Puget Sound and the Model for Change developed by the Institute for Healthcare Improvement. 12 Central to the use of the CCM in disease management, although undeveloped in most systems, is a close collaboration with available community resources. Gold s Gym International has had a successful track record in the conduct of fitness competitions for its members, wherein financial incentives are offered to contestants based on achievement of improvement in established fitness measures. Gold s Gym Wenatchee is a recognized innovator in these initiatives. In the interest of expanding the community resource component of the CCM, the WVMC and Gold s Gym Wenatchee designed a proof-of-concept pilot using these methods in diabetes disease management. METHODS Patients Potential participants were recruited from diabetes disease management registries maintained by the parent clinic and its commercial insurance partner (Premera Blue Cross). Patients were eligible at the discretion of their primary physician if they had been diagnosed with type 2 diabetes. Participants were required to join the gym to participate. Primary care physicians at WVMC were informed of the challenge and encouraged to avail patients of the opportunity for involvement. Potential participants were notified of the existence of the competition by registry-based mailings from their primary physicians. The competition was also advertised at the participating gym and on its website. 13 Patient Confidentiality WVMC has chain-of-trust agreements with Gold s Gym and Premera Blue Cross in compliance with Health Insurance Portability and Accountability Act regulations. No patient-specific medical records, such as clinic notes or laboratory studies, were shared with Gold s Gym. Participants signed a consent and release-of-information form before involvement. All information collected by Gold s Gym was shared by patients consent with WVMC and included in their medical records and/or diabetes registry. Because this was a quality improvement initiative analyzed retrospectively, the study did not require institutional review board approval from the medical center. Clinical Procedures Participants had a physician visit and clearance for participation before entry. All other clinical procedures were recommended but not required. However, point scores were contingent on completion. Physician visits were repeated at the conclusion of the trial. Weight; percent body fat; pounds of fat; pounds of lean tissue; abdominal, hip, and thigh girths; and laboratory tests including A1C and LDL cholesterol were requested before and at completion of the trial. Body composition measurements were made by skin-fold caliper method. 14 All measurements for weight, percent body fat, and girth measurements were performed by an experienced American College of Sports Medicine (ASCM)-certified trainer for both preand post-contest data. Weight was taken on a standard scale in pounds. Girth measurements were taken in inches using standard ACSM guidelines regarding technique and site. Percent body fat was determined by using Harpenden calipers and ACSM s current standard three-site protocol: for men, chest, abdomen, and thigh in millimeters; for women, tricep, suprailiac, and thigh in millimeters. Quality-of-life assessments were made before and at the completion of the trial. Measurements of physical function, pain, social function, general health, vitality, social function, emotional state and mental health, as well as summary mental component and physical component score calculations were made using the SF-8 psychometric tool according to standard procedures. 15 Gym Procedures Gym exercise sessions included cardiovascular exercise, weight training (selective use of weight machines and free weights), stretching, and balance work. Each exercise program was developed by certified trainers designed according to participants individual abilities and goals. Participants had full access to the trainers during regular gym hours. Entrants received points for participating in a supervised group exercise class one time per week consisting of 1 hour of functional exercise and movement. Other Elements of the Challenge Participants were encouraged to raise funds for and compete in an American Diabetes Association (ADA) fundraising walk/run on September 21, Bimonthly evening patient education sessions were held at the gym meeting room. Participation in a community Diabetes Awareness Day 2002 on September 14, 2002, was suggested. Submission of a low-fat, low-calorie apple recipe and participation in a group recipe-tasting event was encouraged. Point-Scoring System and Financial Awards Participants were awarded weighted points for primary physician visits, 177

3 laboratory studies, dilated retinal exams, daily diet and medication diaries, gym attendance, participation in the ADA fundraising walk, educational seminar attendance, gym attendance, cardiovascular exercise units, knowledge self-test completion, number of apples consumed, blood pressure monitoring, fat loss, lean tissue gain, and completion of a personal essay on their experience in the trial. Points were tallied by gym and clinic staff at the conclusion of the trial, and awards were announced at a ceremony at the gym on December 12, The participant deemed Most Inspirational was selected by gym staff. The participant with best compliance with clinical measures was named Best Patient by clinic staff. The winner of a Best Essay award was selected by gym and clinic staff. Winning categories and cash prizes were: $3,000 each for 1st place male and $1,000 each for 2nd place male and $500 each for 3rd place male and $750 for Most Inspirational award winner $750 for Best Essay award winner $250 for Best Patient award winner In addition, the low-fat, low-calorie apple recipe contest and tasting occurred mid-trial on October 25, 2002, and included a $1,000 award for Best Recipe judged by gym staff. An interim award of $500 to the man and woman with the most fat pounds lost to date was awarded at month 2 of the trial (August 19, 2002). Statistical Analysis All data are expressed as the mean ± standard deviation. Parametric statistical comparisons of pre-trial and posttrial variables (e.g., A1C) were made by paired and unpaired two-tailed Student s t test. Nonparametric comparisons were made with the Fisher exact test on dropout rates, LDL, and A1C goal achievement. An alpha level of significance was set at P < RESULTS The trial began on June 24 and ended on November 31, Sixty-nine participants (32 women, 37 men; mean age = 56 years) underwent initial screening and began the trial. Thirty participants (45%) finished the 5.5-month program. There was no significant difference in dropout between sexes: 13 of 32 (41%) of women and 17 of 37 (46%) of men completed the challenge. Thirteen of 69 were prior gym members; for the remaining 56 (81%), this was their first gym experience. Of finishers, 26 continued their gym membership for 6 months, 25 for 1 year, 24 for 2 years, and 13 are still members as of June Table 1 shows a comparison of characteristics of participants who finished to those of participants who did not finish the challenge. Initially, patients were similar in A1C and sex. Finishers were significantly older than non-finishers. The average exercise session lasted ~ 1 hour and was performed three times per week with the recommendation to engage in outdoor/indoor physical activity the other 4 days of the week (i.e., walking, biking, hiking, swimming). The finishers averaged 4.5 days/week of some form of the above exercise. Cumulative gym visits declined during the course of the trial; 915 visits were recorded during the first month, 592 during the second, 474 during the third, 470 during the fourth, and 345 during the fifth. These decreases reflect attrition of participants, most of which occurred in month 2. Table 2 describes measures at initiation and completion of the trial for the 30 finishers. Significant (P < 0.05) improvements were seen for A1C results; weight loss; decrease in body fat; inches lost from abdomen, thigh, and hips; and physical component score from the SF-8. Weight loss and body mass index (BMI) reduction was seen in 28 of 30 (93%) of patients (mean loss = 15.9 lb; median = 14.5 lb; range = lb). A1C reductions were seen in 25 of 29 (86%) of finishing participants (mean = 1.52%; SD = 0.3%). Before the trial, 4 of 29 (14%) of eventual finishers who provided pre- and post-measurements had A1C results within normal for our laboratory ( 6.2%); at completion, 23 of these 29 (79%) were within normal range. Improvement in lipid measurements was less pronounced. Mean scores for LDL cholesterol dropped from mg/dl at the start to 99.4 mg/dl at program s end. This result failed to reach statistical significance (P = 0.22). The ADA s recommended goal for LDL (< 100 mg/dl) was achieved at the challenge start by 9 of 23 (39%) participants who provided pre- and post-measurements of lipids and by 13 of these participants (57%) by the program s finish (non-significant; Fisher s exact test). Quality-of-life assessment revealed a significant improvement in physical function. There were small but nonsignificant increases in mental functioning on quality-of-life assessment and scores on diabetes self-knowledge tests. Patients reported multiple physiciandirected medication changes during the trial. Diabetes, lipid lowering, or antihypertensive medications were reduced in 28% of patients and stopped in 28%. At month 2, the participants initiated a diabetes trial exercise group stressing functional aerobic training. At the conclusion of the trial, 7 of 30 finishing participants related strong interest in serving as mentors for participants in future trials. DISCUSSION Exercise has been shown in experimental and observational studies to have multiple beneficial effects. 16 In population-based studies, low cardiopulmonary fitness correlates strongly with cardiovascular mortality. 17,18 While the correlation was strong in all groups, it was particularly strong in the subset of obese patients. Large population surveys of women have Table 1. Comparison of Competition Finishers and Non-Finishers Parameter Finishers (n = 30) Non-Finishers (n = 37) P Mean age (years) 59.5 (± 4.5) 54.4 (± 5.0 ) Female (%) NS Initial A1C (%) 7.26 (± 1.24 ) (± 1.41) NS 178

4 Feature Article/Tucker et al. Table 2. Beginning and Ending Measures in 30 Finishers Beginning Ending Measure Mean Range STD Mean Range STD P A1C (%) Weight (lb) < LDL cholesterol (mg/dl) Lean weight (lb) Fat weight (lb) < Body fat (%) < Abdominal girth (inches) < Hip girth (inches) < Thigh girth (inches) < SF-8 PCS SF-8 MCS % correct on knowledge test MCS, mental component score; PCS, physical component score also shown a major correlation of adherence to recommended diet and exercise guidelines to reductions of cardiovascular and diabetes complications. 19,20 Despite these clear benefits, we as a population are trending against recommendations. While physicians exert a considerable influence on patients decisions about lifestyle change, they uncommonly address these issues when treating obese patients. 21,22 We postulate that physicians lack sufficient tools to implement lifestyle change. In addition, blanket recommendations for exercise carry some risk in patients with chronic illness. 23,24 People with diabetes in particular face potential risk of glycemic and cardiovascular complications while exercising. Our trial involved close integration of gym-based exercise with primary physician care. Each participant had at least one detailed training session with a member of the training staff. Gym staff freely recommended physician input on difficulties with exercise. Although mild hypoglycemic reactions were common, especially in early months, there were no events requiring emergency medical intervention. Patients were referred to their physician, and medication adjustments were made frequently and accordingly. The mild events were not quantified during the study and therefore were unobtainable retrospectively. Participants were generally cautioned to check glucose before and after exercise, and foods with a high glycemic index were made freely available at the gym. Detailed glucose monitoring protocols with exercise were not required. Given the potential adverse effects of exercise on glucose levels (both hyperglycemia and hypoglycemia), such protocols will be applied and results monitored in future challenges. We measured multiple parameters of body composition in addition to weight. Weight measurement alone has deficiencies and the inability to distinguish lean body mass from body fat and therefore is deficient in assessing fitness. Abdominal girth and percent body fat each are correlated with decreased insulin sensitivity and proclivity to diabetes. 25 We saw strong evidence of this in the significant concurrent decreases in A1C, abdominal girth, and weight in this trial. Lean muscle mass and skeletal muscle strength correlate independently with insulin sensitivity and longevity in older individuals. 26,27 We actually noted a small, near-significant decrease in lean weight, despite a point reward for a gain in lean weight. An optimal exercise program for people with diabetes would emphasize loss of fat and gain of lean mass. Measurement of complete body composition allows for this; weight measurements alone do not. Figure 1. The Chronic Care Model. Reprinted with permission from Diabetes Spectrum 17: 95,

5 The effect of obesity on quality of life is equivocal. Elevated BMI correlates with an enhanced overall quality of life, but abdominal obesity does not. Meanwhile, both elevated BMI and abdominal obesity correlate with low physical fitness and bodily pain. 28 BMI reductions were seen in 94% of patients finishing in this trial. We also noticed substantial, significant physical component quality-of-life scores and lesser increases in mental component scores. This trial was designed as a test of concept in the context of a larger diabetes quality improvement and disease management project of the sponsoring clinic and insurance partner. Completing the challenge was difficult and rewarding, as our patients noted in their essays. Those who entered and those who finished may not represent the norm of type 2 diabetic patients. Indeed, their baseline A1C and lipid test results, although abnormal, were substantially better than those noted in our diabetes registry population in general. Future trials will emphasize testing the effect of intermediate goals and alternative incentives to motivate those individuals less prone to diehard commitment. The CCM 11 implies that constructive use of community resources is essential in dealing with chronic illness (Figure 1). The lack of ability of the U.S. health care sector to stem the negative tide of obesity and poor fitness may come from a lack of these community connections. Alternative approaches are needed. 8 We present the methodology used in this trial as an example of such an alternative. Acknowledgments The program described in this article was supported by unrestricted educational grants from Bristol-Myers Squibb, Aventis, Pfizer, Novartis, and GlaxoSmithKline. References 1 Must A, Spadano J, Coakley EH: The disease burden associated with overweight and obesity. JAMA 282: , 2 Rosenbaum M, Leibel RL, Hirsch J: Obesity. N Engl J Med 337: , Allison DB, Fontaine KR, Manson JE, Stevens J, VanItallie TB: Annual deaths attributable to obesity in the United States. JAMA 282: , 4 Mokdad AH, Bowman BA, Ford ES, Vinicor F: The continuing epidemics of obesity and diabetes in the United States. JAMA 286: , Clark CM: How should we respond to the worldwide diabetes epidemic? Diabetes Care 21: , Rocchini AP: Childhood obesity and the diabetes epidemic. N Engl J Med 346: , Rosenbloom CA, Joe JR, Young RS, Winter WE: Emerging epidemic of type 2 diabetes in youth. Diabetes Care 22: , 8 Koplan JP, Dietz WH: Caloric imbalance and public health policy. JAMA 282: , 9 Kenchaiah S, Evans JC, Levy D, Wilson PWF, Benjamin EJ, Larson MG, Kannel WB, Vasan RS: Obesity and the risk of heart failure. N Engl J Med 347: , Improving Chronic Illness Care: The Chronic Care Model. Available online at improvingchroniccare.org. Accessed 12/29/02 11 Bodenheimer T, Wagner EH, Grumbach K: Improving primary care for patients with chronic illness: The Chronic Care Model, Part 2. JAMA 288: , Institute for Healthcare Improvement: IHI quality improvement resources: a model for accelerating improvement. Available online at Accessed 12/29/ Gold s Gym Wenatchee: Diabetes Challenge 2002: What is it? Available online at Accessed 12/27/02 14 Jackson AS, Pollock ML: Practical assessment of body compsition. Physician Sport Med 13:76 90, Ware JE, Kosinski M, Dewey JE, Gandek B: How to score and interpret single-item health status measures: a manual for users of the SF- 8(TM) Health Survey. Lincoln, R.I., QualityMetric, Stewart KJ: Exercise training and the cardiovascular consequences of type 2 diabetes and hypertension. JAMA 288: , Wei M, Kampert JB, Barlow CE, Nichamen MZ, Gibbons LW, Paffenbarger RS, Blair SN: Relationship between low cardiorespiratory fitness and mortality in normal-weight, overweight and obese men. JAMA 282: , 18 Horton ES: Role and management of exercise in diabetes mellitus. Diabetes Care 11: , Stampfer MJ, Hu FB, Manson JE, Rimm EB: Primary prevention of coronary heart disease in women through diet and lifestyle. N Engl J Med 343:16 22, Hu FB, Manson JE, Stampfer MJ, Colditz G, Liu S, Solomon CG, Willett WC: Diet, lifestyle and the risk of type 2 diabetes mellitus in women. N Engl J Med 345: , Galuska DA, Will JC, Serdula MK, Ford ES: Are health care professionals advising obese patients to lose weight? JAMA 282: , 22 Fontarosa PB: Patients, physicians, and weight control. JAMA 282: , 23 Maron BJ: The paradox of exercise. N Engl J Med 343: , Tall AR: Exercise to reduce the cardiovascular risk: how much is enough? N Engl J Med 347: , Colman E, Toth MJ, Katzel LI, Gardner AW, Poehlman ET: Body fatness and waist circumference are independent predictors of the age-associated increase in fasting insulin levels in healthy men and women. Int J Obes Relat Metab Disord 19: , Lazarus R, Sparrow D, Weiss ST: Handgrip strength and insulin levels: cross-sectional and prospective associations in the Normative Aging Study. Metabolism 46: , Metter EJ, Talbot LA, Schrager M, Conwit R: Skeletal muscle strength as a predictor of allcause mortality in healthy men. J Gerontol Biol Sci Med Sci 57:B359 B365, Rosmond R, Bjorntorp P: Quality of life, overweight, and body fat distribution in middle-aged men. Behav Med 26:90 94, 2000 Richard M. Tucker, MD, is the associate medical director; Casey May, RN, is the quality coordinator; and Richard Bennett, RN, MA, is the manager in the Department of Quality Improvement and Education of the Wenatchee Valley Medical Center in Wenatchee, Wash. Jenny Hymer, BS, ACSM, is a certified trainer, and Blair McHaney is co-owner at Gold s Gym Wenatchee in Wenatchee, Wash. 180