Transcript Lifestyle Medicine

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 by
John Kelly, MD, MPH
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)
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Comments
Need for future LM studies
Summary
Review questions
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
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.
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.
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.
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.
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.
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.
Italian Group Care …
Controls
Group 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.
Italian Group Care …
Controls
Group 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.
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.
Denmark …
 Fat (%E)
Controls
ILI
baseline
at 3.8 yr
41.9 (6.5)%
41.2 (6.2)%
38.3 (6.4)%
34.2 (6.0)%
 Fat (%sat) baseline
Controls
45 (5)%
ILI
47 (4)%
at 3.8 yr
46 (6)%
44 (6)%
 Significant improvement (p <0.001)
Diabet Med 2001 Feb;18(2):104-8.
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.
IDC Minneapolis, MN …
 Similar improvements in knowledge, BMI,
health-related QOL, attitudes, and all other
measured indicators.
HbA1c
Baseline 6 months
Overall
8.5 +/-1.8% 6.5 +/-0.8%
Individual
-1.7 +/-1.9%
Group
-2.5 +/-1.8%
Group > individual
-2.5 > -1.7
Diabetes Care 2002 Feb;25(2):269-74.
p <0.01
p <0.01
p <0.01
p =0.05
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.
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.
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.
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.
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 (7% weight loss
and 150 minutes physical activity
per week)
NEJM 2002 Feb 7;346(6):393-403.
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.
ALL Pts in DPP Trial Received
Some Lifestyle Intervention …
 Standard lifestyle recommendations for the
medication 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.
Adverse Events in DPP Trial
Reduction 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
RCT of "talking computer" to
improve adults' eating habits
 PURPOSE: To assess efficacy of an intervention
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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% AfricanAmerican.
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.
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.
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.
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.
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
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.
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.
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
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
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
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
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
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
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
Renaissance Happening in
Lifestyle Medicine
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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
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.
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”
Must investigate ALL aspects
of healthy lifestyle
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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
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?
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.
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.
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, et.al. J Sleep Res. 2000;9(4):335-52.
Belenky. J Sleep Res. 1999;8(4): 237-45. Review.
Health Risks of Short Sleeping
 After four 8-hour recovery nights’ sleep,
 subjects were still making more errors
than when they started.
Belenky, et.al. J Sleep Res. 2000;9(4):335-52.
Belenky. J Sleep Res. 1999;8(4): 237-45. Review.
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.
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.
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.
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?
Future LM / ILI studies
 Need broader risk factor analyses
– Longitudinal interventional studies of
genotypic and phenotypic measures
– Measure susceptibility to disease
and response to lifestyle
interventions
• Health beliefs/attitudes, psychosocial
• Molecular epidemiology
• Pre-natal influences (& pre- pre-natal)
Summary
 Heart disease, diabetes and obesity
are major killers around globe, and we
have >90% of the answer.
 We must find methods and funding to
successfully implement Lifestyle
Medicine and lifestyle interventions.
 Group sessions combined with
individual visits (in person and by
phone) are currently most effective.
Summary …
 ILI treatment is proven effective, more
effective than usual care or meds.
 Evidence-based medicine uses most
effective and efficacious methods.
 Intensive lifestyle intervention is an
essential part of 21st century medicine.
 We must find methods of making it
available to the patients who need it.
Practicing evidence-based
medicine (EBM)?
 Two studies reviewed were stopped
early; considered unethical to deny the
control group access to intervention
received by the treatment group
(LDHT & DPP)
 Is it any more ethical to deny patients
access to these more effective
treatments and continue prescribing
treatments shown to be inferior?
Practicing evidence-based
medicine (EBM)?
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As clinicians, we are practicing EBM when
we prescribe those treatments shown to be
most effective and efficacious for our patient
If I prescribe a NCEP Step I or II diet
instead of Ornish’s low-fat or de Lorgeril’s
-linolenic rich Mediterranean diet, I am
simply not practicing EBM
Nor am I doing what is best for my patient!
We should write prescriptions for the best
treatments, and advocate until our patients
have access to them
Quick Review Question
 For pts with chronic disease (e.g. CAD,
IGT, DM2) true evidence-based*
medicine will do which of the following
a) not inform pt of LM Tx?
b) mention LM Tx but not prescribe it?
c) prescribe LM Tx?
(*Repeated multi-center, blind, placebo-controlled
studies show improved outcomes.)
c) prescribe LM Tx, and follow it up!
Lifestyle Intervention much
better than Prevention Clinics
Lyons Diet Heart Trial
vs
Scottish CHD Prevention Clinics
LDHT treatment group RR <0.5 vs Scottish treatment
Citations
1. CDC Burden of Chronic Disease Report 2000.
2. Ann Int Med 2001;134:1106-14.
3. Lancet 1998;352:1801-7.
4. BMJ 2002;324:1570-6.
5. The World Health Report 2002.
6. JAMA 1993 Nov 10;270:2207.
7. The Bible. Genesis and Daniel.
8. White, EG. Ministry of Healing. 1906.
9. Arch Intern Med 1992 Jul;152(7):1416-24.
10. NEJM 2001 Sep 13;345:790-7.
11. Lancet 1990 Jul 21;336:129-33.
12. JAMA 1998 Dec 16;280:2001-7.
13. Circulation. 1994 Mar;89:975-90.
14. Lancet 1994;343:1454-9.
15. Circulation. 1999;99:779-785.
16. BMJ 2003 JAN 11;326:84.
17. JAMA 2002 Nov 27;288(20):2569-78.
18. NEJM 2003 Jan 30;348:383-393.
19. Aust NZ J Obstet Gynaecol 1999
May;39(2):162-6.
20. Diabetes Care 1997 Apr;20(4):537-44.
21. Horm Metab Res 2002 Sep;34(9):509-15.
22. Diabetologia 2002 Sep;45(9):1231-9.
23. Diabet Med 2001 Feb;18(2):104-8.
24. Diabetes Care 2002 Feb;25(2):269-74.
25. NEJM 2001 May 3;344(18):1343-50.
26. NEJM 2002 Feb 7;346(6):393-403.
27. Am J Health Promot 2001 Mar-Apr;15(4):215-24.
28. Diabetes Care. 2002;25:445-452.
29. JAMA 2003 Jan 22/29;289:450-3.
30. Spiegel K, Leproult R, Van Cauter E. Impact of sleep
debt on metabolic and endocrine function. Lancet
1999;354:1435-9.
31. Belenky. J Sleep Res. 1999;8(4): 237-45. Review.
32. Belenky, et.al. J Sleep Res. 2000;9(4):335-52.
33. Pilcher, et al. Effects of sleep deprivation on
performance: a meta-analysis. Sleep 1996
May;19(4):318-26.
34. Geer, et al. Incidence of automobile accidents
involving anesthesia residents after on-call duty
cycles. Anesthesiology 1997;87(3A):A938.
35. Steele, et al. The occupational risk of motor vehicle
collisions for emergency medicine residents.
Academic Emergency Medicine 1999;610:10501053.
36. Academic Emergency Medicine 2000;7(5):451.