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  1. Lifestyle Medicine Evidence-based Medicine for the 21st Century Intensive Lifestyle Intervention (ILI) in the management and treatment of chronic disease (e.g. CHD, DM2, Obesity, HTN, Metabolic syndrome) Presented byJohn Kelly, MD, MPH

  2. Presentation Agenda • Causes of death & lifestyle-related risk factors • Overview of intensive lifestyle intervention (ILI) and Lifestyle Medicine (LM) • Review selected LM studies and clinical trials • Cardiovascular disease (CVD) • Diabetes type-2 (DM2) • Comments • Need for future LM studies • Summary • Review questions

  3. DM2: Major CHD Risk Factor • Steno-2 examined lifestyle intervention in secondary prevention of CVD in pts with DM2 – diseases closely connected • We now turn to lifestyle intervention as primary & secondary prevention for type-2 diabetes

  4. Melbourne • 200 IGT women (GDM) randomized to • intensive vs routine dietary advice • DM2 incidence rates Controls 7.3% Intervention 6.1% (16.4% reduction) Aust NZ J Obstet Gynaecol 1999 May;39(2):162-6.

  5. China Da Qing IGT Study • 577 IGT subjects randomized by clinic for 6 years to • control group • diet only • exercise only • diet plus exercise Diabetes Care 1997 Apr;20(4):537-44.

  6. China Da Qing IGT Study … • Proportional hazards analysis (adjusted for baseline BMI and fasting glucose) reductions in risk of DM2: • Diet 31% p <0.03 • Exercise 46% p <0.0005 • Diet-plus-exercise 42% p <0.005 Diabetes Care 1997 Apr;20(4):537-44.

  7. Japan DM2 Study (JDCS ) • 2,205 DM2 from 59 Japanese diabetes care institutes randomized for 3 yr to • intensive lifestyle management and frequent telephone counseling (materials on importance of lifestyle & behavioral changes, diary to record progress of lab & other data, pedometer) (Given tools but not treatment) • vs standard care Horm Metab Res 2002 Sep;34(9):509-15.

  8. Japan DM2 Study (JDCS ) … • HbA1c baseline at 3 yr Control 7.80 +/-1.42 7.78 +/-1.27 ILI 7.68 +/-1.28 7.62 +/-1.20 • Small difference statistically significant but not clinically significant Horm Metab Res 2002 Sep;34(9):509-15.

  9. Italian Group Care • 112 DM2 randomized for 51 months to • systematic group education (intervention) • individual consultation education (controls) Diabetologia 2002 Sep;45(9):1231-9.

  10. Italian Group Care … ControlsGroup patients HbA1c increased no incr p<0.001 BMI - decr p<0.001 HDL - incr p<0.001 QOL, DM knowledge, health behaviors worsened improved (p=0.004 to p<0.001) (p<0.001, all) Diabetologia 2002 Sep;45(9):1231-9.

  11. Italian Group Care … ControlsGroup patients Dosage - decr p<0.001 Retinopathy - less p<0.009 DBP decr p<0.001 decr p<0.001 RR CVD decr p<0.05 decr p<0.05 Time 150 min 196 min Cost $665.77 $756.54 (add’l $2.12 per point gained in QOL) Diabetologia 2002 Sep;45(9):1231-9.

  12. Danish Steno Diabetes Centre • 160 DM2 (45-65 y) randomized over 4-years to • intensive group focusing on change of behavior and polypharmacological (diet focused on dietary fat and CHO) • control group receiving conventional treatment Diabet Med 2001 Feb;18(2):104-8.

  13. Denmark … • Fat (%E) baseline at 3.8 yr Controls 41.9 (6.5)% 38.3 (6.4)% ILI 41.2 (6.2)% 34.2 (6.0)% • Fat (%sat) baseline at 3.8 yr Controls 45 (5)% 46 (6)% ILI 47 (4)% 44 (6)% • Significant improvement (p <0.001) Diabet Med 2001 Feb;18(2):104-8.

  14. International Diabetes Center Minneapolis, MN • 170 DM2 subjects randomized to • group (n = 87) or individual (n = 83) standardized educational settings. (received education in 4 sessions at consistent time intervals over a 6-month period) • Outcomes assessed at baseline and 2-week, 3-month, and 6-month education sessions. • changes in knowledge, self-management behaviors, weight, BMI, HbA1c, health-related QOL, patient attitudes, and medication regimen. Diabetes Care 2002 Feb;25(2):269-74.

  15. IDC Minneapolis, MN … • Similar improvements in knowledge, BMI, health-related QOL, attitudes, and all other measured indicators. HbA1cBaseline6 months Overall 8.5 +/-1.8% 6.5 +/-0.8% p <0.01 Individual -1.7 +/-1.9% p <0.01 Group -2.5 +/-1.8% p <0.01 Group > individual -2.5 > -1.7 p =0.05 Diabetes Care 2002 Feb;25(2):269-74.

  16. IDC Minneapolis, MN … • CONCLUSIONS: “This study demonstrates that diabetes education delivered in a group setting compared with an individual setting is equally effective at providing equivalent or slightly greater improvements in glycemic control.” • Group diabetes education is effective in delivering key educational components and may allow more efficient and cost-effective methods in diabetes education programs. Diabetes Care 2002 Feb;25(2):269-74.

  17. Finland (FDPS) • 522 middle-aged, overweight IGT subjects (55 y, 172 men and 350 women, BMI 31) randomized for 3.2 y to • individualized counseling (reducing weight, total intake of fat and intake of saturated fat, and increasing intake of fiber and physical activity) • vs control (standard care) NEJM 2001 May 3;344(18):1343-50.

  18. Finland (FDPS) … • weight loss from baseline at 1 year • Controls 0.8+/-3.7 kg • ILI 4.2+/-5.1 kg • weight loss at 2 years • Controls 0.8+/-4.4 kg • ILI 3.5+/-5.5 kg (p <0.001 ) NEJM 2001 May 3;344(18):1343-50.

  19. Finland (FDPS) … • 4-year incidence DM2 • Controls 23% (CI 17-29%) • ILI 11% (CI 6-15%) • DM2 risk reduced 58% (p<0.001) • A very clinically and statistically significant improvement NEJM 2001 May 3;344(18):1343-50.

  20. Diabetes Prevention Program • 3,234 IGT (51 y, BMI 34, 68% female, 45% minority) randomized for 2.8 y (study stopped early) to • placebo, or • metformin (850mg bid), or • lifestyle-modification (³7% weight loss and ³150 minutes physical activity per week) NEJM 2002 Feb 7;346(6):393-403.

  21. US DPP • DM2 incidence (per 100 person-yrs) • 11.0 placebo reference • 7.8 metformin -31% (CI 17-43%) • 4.8 ILI -58% (CI 48-66%) • A very clinically and statistically significant improvement NEJM 2002 Feb 7;346(6):393-403.

  22. ALL Pts in DPP Trial Received Some Lifestyle Intervention … • Standard lifestyle recommendations for themedication groups were provided in written information and annual 20-to-30-minute individual sessions emphasizing importance of healthy lifestyle. • Participants were encouraged to: • Follow the Food Guide Pyramid and NCEP Step 1 diet • Reduce their weight and increase their physical activity More intensive than typical medical care NEJM 2002 Feb 7;346(6):393-403.

  23. Adverse Events in DPP TrialReduction in the Incidence of Type 2 Diabetes with Lifestyle Intervention or Metformin(NEJM. 2002 Feb 7;346:393-403.) RR Lifestyle vs Placebo 0.42 1.14 0.97 1.01 1.00 0.63 • Significantly lower risk of adverse events with lifestyle than placebo (RR 0.42 - 1.14) • Comparisons of medications to placebo only may underestimate true magnitude of adverse effects

  24. RCT of "talking computer" to improve adults' eating habits • PURPOSE: To assess efficacy of an intervention delivered by an interactive, computer-controlled telephone system to improve individuals' diets. • DESIGN: RCT in a convenience sample. • SETTING: Large multi-specialty group practice. • SUBJECTS: 298 adults who were both sedentary and had sub-optimal diet quality. Mean age 45.9 years, 72% women, 45% white, and 45% African-American. • INTERVENTION: Weekly communication for 6 months via a totally automated, computer-based voice system. Am J Health Promot 2001 Mar-Apr;15(4):215-24.

  25. RCT of "talking computer" … Among intervention group subjects, the system monitored dietary habits and provided educational feedback, advice, and behavioral counseling. Control group subjects received physical activity promotion counseling. • MEASURES: Daily intake of fruits, vegetables, red and processed meats, whole fat dairy foods, and whole grain foods estimated from a food frequency questionnaire. Am J Health Promot 2001 Mar-Apr;15(4):215-24.

  26. RCT of "talking computer" … • RESULTS: Among participants who completed diet assessments, compared with the control group, the intervention raised fruit intake a mean of 1.1 servings per day (95% confidence interval [CI] .4, 1.7). • On a 0 to 100 global diet quality score combining all five food groups, intervention participants improved their mean score 9 points (95% CI 4, 13) more than the control group. • The intervention raised dietary fiber intake 4.0 g/d (95% CI .1, 7.8) and decreased saturated fat, as % of energy intake, by 1.7% (95% CI -2.7 to -0.7). Am J Health Promot 2001 Mar-Apr;15(4):215-24.

  27. Intensive Lifestyle Change is Needed • (Diabetes Care. 2002;25:445-452.) • The extent to which lifestyle must be altered to improve insulin sensitivity has not been well established. • Study compared the effect on insulin sensitivity of current dietary and exercise recommendations with a more intensive intervention in normoglycemic, insulin-resistant individuals.

  28. Insulin Sensitivity, Design • (Diabetes Care. 2002;25:445-452.) • 79 normoglycemic, insulin-resistant men and women randomized to control group or one of two combined dietary and exercise programs for 4 months • Modest level group was based on current recommendations • A more intensive dietary and exercise program • Insulin sensitivity measured by euglycemic insulin clamp, body composition measured using DEXA (dual-energy X-ray absorptiometry), anthropometry & aerobic fitness assessed before and after intervention • Four daily dietary intakes were recorded and fasting glucose, insulin, and lipids were measured

  29. Insulin Sensitivity, Results • (Diabetes Care. 2002;25:445-452.) • Only the intensive group showed significant improvement in insulin sensitivity +23% in intensive group (p=0.006) vs +9% in modest group (p=0.23, not significant) • Significant improvement in aerobic fitness +11% in intensive group (p=0.02) vs +1% in modest group (p=0.94, not significant) • Also, greater fiber intake • No difference in self-reported total fat or saturated dietary fat.

  30. Insulin Sensitivity, Conclusion • (Diabetes Care. 2002;25:445-452.) • Current clinical dietary and exercise recommendations, even when vigorously implemented, do not significantly improve insulin sensitivity. • A more intensive program does. • Improved aerobic fitness was the major difference between the intervention groups. • Weight loss and diet composition may have also played an important role in determining insulin sensitivity.

  31. Exercise less controversial • Unpublished results found interval training (IT) more effective than continuous training (CT) (Mayer H, et al.) • IT varies exertion level over wider range during exercise, rather than maintaining constant exertion (CT: THR 80% MHR) • Fitness increased more rapidly with IT than with CT, with greater lipid improvement • Hypothesized metabolism more aerobic with IT, especially in less fit subjects

  32. Exercise less controversial … • Pritikin's original intervention utilized frequent, brief, gentle, aerobic exercise • Walking often used for aerobic exercise • Strength training aids in maintaining muscle mass during weight loss

  33. Comments • A common argument against use of LM is poor compliance (typical medication compliance ~60%) • ILI treatment is proven effective - standard dietary/exercise advice is not • CVD, diabetes and obesity are growing epidemics around the world and we have >90% of the answer

  34. Comments … • Making lifestyle change is not easy • Adherence to diet and exercise is poor • Recidivism rates are high • More intensive intervention - more effect • Follow-up intervention is weak link • Studies underway to identify best, most cost-effective, long-term intervention • Community-based vs institution-based • Professional-led vs laymen

  35. Comments … • All lifestyle intervention is not created equal • Adherence better with “less invasive” diet and exercise plans - least amount change • Mediterranean diet less radical to many than no-fat or very low-fat diets • IT more accepted and adherence better • Busy lives leave little time for exercise • Modern conveniences (golf cart, elevator) make us less active

  36. Comments … • Fast-food marketing appeals to appetite, not health • Disincented to produce healthy foods unless public wants them • Serving sizes have grown as competition heightens (JAMA 2003 Jan 22/29;289:450-3.) • Need a value-based motivation for permanent lifestyle change

  37. Comments … • Value-based motivation for permanent lifestyle change • Body is the temple for God’s presence • Created in the image of God • Reverence and protect that gift • Many leaders in movement focusing on this spiritual piece (Ornish, Segal, etc.) • Love, self-worth, self-esteem, SELF • A missing piece in the N-E-W-S-T-A-R • T rust in God and dependence on Him

  38. Renaissance Happening in Lifestyle Medicine • Rising multidisciplinary approach to managing health care • Direct-to-consumer drug advertising (DTCA) • Growing use of complimentary and alternative medicine (CAM) • New NIH support for lifestyle intervention research (not just NCCAM) • NIDDK PA 02-153, 8/22/02 - 10/05

  39. Objectives and Scope • The NIDDK, the NEI, the NINR, the OBSSR, AHRQ, the CDC-DDT, and the ADA seek to enhance diabetes prevention and control research. • The overall objective of this announcement is to support research to develop and test intervention strategies that will enhance health promotion, diabetes self control and reduction in risk … • Trials proposed under this program should test 1) improved methods of health care delivery to patients with or at risk of diabetes, 2) improved methods of diabetes self management, and 3) cost effective community-based strategies to promote healthy lifestyles that will reduce the risk of diabetes and obesity.

  40. Rich SDA History in Lifestyle Medicine • Roots in the Garden of Eden • Resurgence in 19th century • Battle Creek Sanitarium • College of Medical Evangelists • Pioneering studies in SDAs (e.g. AHS) • LLU motto: “To Make Man Whole”

  41. Must investigate ALL aspects of healthy lifestyle • Air pollution recognized as major health risk (e.g. lung cancer and asthma trigger) • Water recently found to cut CHD risk in half (Jacky Chen) • Other aspects such as Rest, Sunshine, Abstemiousness and Spiritual influences, all need study • Sleep deficit found to impair glucose metabolism and cognition, may promote obesity

  42. Sleep effects not all in head • Sleep has traditionally been viewed from its effects on brain activity and function. • New research shows its effects on other organs may be more significant to health. • Is sleep deficit a risk factor for DM and obesity?

  43. Sleep, IGT and obesity? • Even moderate sleep debt causes altered metabolic state in healthy young males comparable to that of diabetics, with 30% impairment in glucose metabolism • The growing epidemic of sleep deprivation “may be causally linked to the coincident epidemic of obesity.” Spiegel K,Leproult R, Van Cauter E. Impact of sleep debt on metabolic and endocrine function. Lancet 1999;354:1435-9.

  44. Health Risks of Short Sleeping • After 4 hours of sleep for 6 nights, healthy young men had blood tests that nearly matched those of diabetics • Ability to process blood sugar cut by 30% • Huge drop in insulin response • Elevated levels of stress hormone cortisol which can lead to hypertension and memory impairment Spiegel K,Leproult R, Van Cauter E. Impact of sleep debt on metabolic and endocrine function. Lancet 1999;354:1435-9.

  45. Health Risks of Short Sleeping • Sleep debt decreases the entire brain's ability to function • Most significantly impairs areas responsible for • attention, • complex planning, • complex mental operations, and • judgement. Belenky, J Sleep Res. 2000;9(4):335-52. Belenky. J Sleep Res. 1999;8(4): 237-45. Review.

  46. Health Risks of Short Sleeping • After four 8-hour recovery nights’ sleep, • subjects were still making more errors than when they started. Belenky, J Sleep Res. 2000;9(4):335-52. Belenky. J Sleep Res. 1999;8(4): 237-45. Review.

  47. Don’t feel much need of sleep • Studies show that sleep deprivation decreases objective measures of performance, and • Yet sleep deprived college students subjectively rated their alertness higher than did their well-rested colleagues. Pilcher, et al. Effects of sleep deprivation on performance: a meta-analysis. Sleep 1996 May;19(4):318-26.

  48. Sleep deprivation can kill • It not only can... it does! • Sleep deprivation has been shown to place EM residents at over 6 times the risk of motor vehicle collisions as before beginning residency. • MVCs are documented occupational risk for medical residents. Steele, et al. The occupational risk of motor vehicle collisions for emergency medicine residents. Academic Emergency Medicine 1999;610:1050-1053. Geer, et al. Incidence of automobile accidents involving anesthesia residents after on-call duty cycles. Anesthesiology 1997;87(3A):A938.

  49. Motor Vehicle Collisions • Wayne State University researchers concluded “Emergency medicine residents are 6.7 times more likely to have a MVC due to falling asleep at the wheel during their residency” than before residency. Academic Emergency Medicine 2000;7(5):451.

  50. Need Systematic LM Studies • What are the sub-types and susceptible populations for these chronic disease epidemics? • What are the specific risk factors? • For which sub-populations is LM most effective? • For which is LM not effective (or less effective)? • What are the causes/determinants of these differences?