A RCT of the effect of individual PA

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Transcript A RCT of the effect of individual PA

Why employers should be doing more
to get employees more active?
Willem van Mechelen, MD, PhD, FACSM, FECSS
VU University Medical Centre Amsterdam
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www.bodyatwork.nl
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CONTENT
• Occupational Health Care
• Paradigm shift: occ. health ---> workers health
• What is the problem ?
• Cost of a physically inactive lifestyle
• Examples: one to one interventions/supportive environment
• Who is responsible? Self-regulation or the Nanny State?
number of benefits WAO 1968-2006
900,0
800,0
700,0
benefits
600,0
500,0
400,0
300,0
200,0
100,0
0,0
1967 1970 1973 1976 1979 1982 1985 1988 1991 1994 1997 2000 2003 2006
years
Source: UWV, calculations
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Paradigm shift:
from occupational health to workers health
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Health threats
• Noise
• Radiation
• Air – pollution (allergens)
• Chemicals
• Awkward postures
• Repetitive motions
• Heavy loads
etc.
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Solution
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‘Modern’ work conditions
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‘Modern’ labour conditions
• 24 hour economy
• Service industry
• Flexible, individualized labor contracts
• Mental demands
• Multi-tasking
etc.
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Health threats
• Job stress
• Sedentary job ‘performance’
• Inactive commuting
• ‘Double’ demands (‘juggling the kids’)
etc.
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Solution
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So, we have experienced change in work conditions ….
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Added to this, society has changed also………
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primary and secondary
prevention
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Major health problems
Lifestyle (health behaviour)
primary and secondary
prevention
Coping with complaints
secondary
prevention
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Major health problems
Lifestyle (health behaviour)
95% at
work
primary and secondary
prevention
Disability for work
5% off
work
secondary
prevention
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Paradigm shift
Lifestyle (health behaviour)
Disability for work
Workers
health
Occupational
health
presenteeism
absenteeism
primary and secondary
prevention
secondary
prevention
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What is the problem?
BMI
• weight/height2
• overweight > 25
• obesity
> 30
104 kg by 1,86 m
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Obesity Trends* Among U.S. Adults
BRFSS, 1985
(*BMI ≥30, or ~ 30 lbs. overweight for 5’ 4” person)
No Data
<10%
10%–14%
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Obesity Trends* Among U.S. Adults
BRFSS, 1990
(*BMI ≥30, or ~ 30 lbs. overweight for 5’ 4” person)
No Data
<10%
10%–14%
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Obesity Trends* Among U.S. Adults
BRFSS, 1995
(*BMI ≥30, or ~ 30 lbs. overweight for 5’ 4” person)
No Data
<10%
10%–14%
15%–19%
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Obesity Trends* Among U.S. Adults
BRFSS, 2000
(*BMI ≥30, or ~ 30 lbs. overweight for 5’ 4” person)
No Data
<10%
10%–14%
15%–19%
≥20%
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Obesity Trends* Among U.S. Adults
BRFSS, 2005
(*BMI ≥30, or ~ 30 lbs. overweight for 5’ 4” person)
No Data
<10%
10%–14%
15%–19%
20%–24%
25%–29%
≥30%
35
Obesity Trends* Among U.S. Adults
BRFSS, 2006
(*BMI ≥30, or ~ 30 lbs. overweight for 5’ 4” person)
No Data
<10%
10%–14%
15%–19%
20%–24%
25%–29%
≥30%
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Obesity prevalence across Europe, 1985-1989
% Obesity
<5%
5-9.9%
Males
1985-1989
10-14.9%
15-19.9%
20-24.9%
≥ 25%
© International Obesity TaskForce 2005
Obesity prevalence across Europe, 2000-2005
% Obesity
<5%
5-9.9%
10-14.9%
Males
2000-2005
15-19.9%
20-24.9%
≥ 25%
Self
Reported
data
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© International Obesity TaskForce 2005
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40
Obesity
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Obesity
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Obesity
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NL O&O trends 2024
• 6,6 million
36% & 12% = 48%
• 8,0 million
41% & 18% = 59%
• 8,7 million
35% & 30% = 65%
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Mixed-longitudinal development of overweight in the Netherlands, men
a) men
Mean BMI (kg/m 2) with 95% CL
28
27
26
Age of cohort
at baseline
25
20-29 y
30-39 y
24
40-49 y
50-59 y
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22
20
25
30
35
40
45
50
55
60
65
70
45
Average age of cohort during measurement (y)
Mixed-longitudinal development of overweight in the Netherlands, women
b) women
Mean BMI (kg/m 2) with 95% CL
28
27
26
Age of cohort
at baseline
25
20-29 y
30-39 y
24
40-49 y
50-59 y
23
22
20
25
30
35
40
45
50
55
60
65
Average age of cohort during measurement (y)
70
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Diabetes Trends* Among Adults in the U.S.,
(Includes Gestational Diabetes)
BRFSS 1990
No Data
<4%
4%-6%
6%-8%
8%-10%
Source: Mokdad et al., Diabetes Care 2000;23:1278-83.
>10%
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Diabetes Trends* Among Adults in the U.S.,
(Includes Gestational Diabetes)
BRFSS 1995
No Data
<4%
4%-6%
6%-8%
8%-10%
Source: Mokdad et al., Diabetes Care 2000;23:1278-83.
>10%
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http://www.cdc.gov/diabetes/statistics/maps/index.htm
Diabetes Trends* Among Adults in the U.S.,
(Includes Gestational Diabetes)
BRFSS 2000
No Data
<4%
4%-6%
6%-8%
Source: Mokdad et al ., J Am
8%-10%
Med Assoc 2001;286:10.
>10%
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http://www.cdc.gov/diabetes/statistics/maps/index.htm
Diabetes Trends* Among Adults in the U.S.,
(Includes Gestational Diabetes)
BRFSS 2001
No Data
<4%
4%-6%
6%-8%
Source: Mokdad et al ., J Am
8%-10%
Med Assoc 2001;286:10.
>10%
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http://www.cdc.gov/diabetes/statistics/maps/index.htm
Diabetes Mellitus: WHO regional estimates 1995-2025
Estimated prevalence (millions)
90
1995
2000
2025
80
70
64
80
60
50
48
43
40
35
33
31
30
20
35
33
28
14
17
10
10
3
4
0
Africa
E. Mediterranean
South-East Asia
Americas
Europe
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Source: King & Rewers. Diabetes Care, 1993; 16: 157-177
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Workers health
Cost of a physically inactive lifestyle
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Determinants of 2003 lifestyle-related
health care cost, 20 y. and older
Million Euro
% tot. health care cost
Smoking
2.129
3.7
Overweight
1.151
2.0
Inactivity
805
1.4
Too much sat. fat
115
0.2
Not enough fruit
460
0.8
Not enough vegetables
173
0.3
Not enough fish
518
0.9
Alcohol
230
0.4
59.529
100.0
Total health care cost
RIVM,
Van Baal et al 2007
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Projected loss of national income due to heart disease,
stroke and diabetes 2005-2015, billions of 1998 US$
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Obesity and lifestyle-related disease
are cost- drivers, so:
STOP these diseases,
f.i. by becoming physically active
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Life expectancy and projected health care cost of a
RIVM, Van Baal et al 2007
20 year old who has a:
healthy lifestyle
smokes
is obees
Life expectancy (years)
64,4
57,4
59,9
Health care cost due to
smoking & obesity related
disease
Euro
Euro
Euro
50.000
51.000
59.000
Euro
Euro
Euro
329.000
221.000
259.000
Euro
Euro
Euro
379.000
272.000
319.000
Health care cost due to other
disease
Total health care cost
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Elimination of overweight and smoking starting in 2003:
% effect on health care cost of causally related disease
overweight
Smoking
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Elimination of overweight and smoking starting in 2003:
% effect on health care cost of all disease
Smoking
overweight
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However:
people with an unhealthy lifestyle
also WORK !
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Work disability in Finns
2 .5
R e la t iv e r is k
2
1 .5
1
w om en
0 .5
m en
0
< 2 2 .5
2 2 .5 -2 4 .9
2 5 .0 -2 7 .4
2 7 .5 -2 9 .9
b o d y m a s s in d e x ( k g / m
3 0 .0 -3 2 .4
2
> 3 2 .5
)
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(Rissanen et al. BMJ 1990)
mean sick leave by frequency of vigorous PA
3
mean sick leave (in days)
2,5
2
OBiN
1,5
POLS
1
0,5
0
0
1
2
3
4
frequency (in x per week)
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65
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The Netherlands:
• direct cost:
• indirect cost:
Euro 0,5 billion per year
Euro 2,0 billion per year
RVZ, 2002
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It makes sense to introduce worksite health
promotion ………………..
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Evidence of effectiveness of
workplace interventions
Behaviour effects
Health-related effects
Work-related effects
Economic impact
++
++
+/?
(health care & indirect costs)
+/?
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Results from previous reviews
• Cost savings from absenteeism:
$2.5 to 4.9 for each dollar invested
• Cost savings from health care:
$2.5 to 4.5 for each dollar invested
Aldana, 2001
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Results from previous reviews
• Based on studies of WHP:
– Average 27% reduction in sick leave
– Average 26% reduction in health care costs
– Average 32% reduction in workers’
compensation and disability claim costs
– Average $5.81 to $1 savings-to cost ratio
Chapman et al. 2005
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To summarize
• There are indications for a favourable
effect on work-related outcomes and
reduced costs, but …
• Lack of high quality studies (RCTs) that
examined the effect of workplace PA/diet
interventions on work-related outcomes,
and evaluated the economic impact
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Risk factor identification should lead
to risk reduction by intervention----> RCT
followup
randomization
outcome
target population
intervention
vs. control
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Risk factor identification should lead
to risk reduction by intervention----> RCT
randomization
followup
outcome
target population
However, ‘true’ RCT not
always feasible.
intervention Other designs (cluster RCT,
vs. control CT, time trend) may be more
appropriate
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What causes the problem?
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Need for a common denominator
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Energy intake of 140 kcal/week
Glass of
beer
Croissant
Some
peanuts
Chocolate cookie
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Dia geleend van Seidell
Energy expenditure
= 21 min
= 14 min
= 19 min
= 35 min
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Dia geleend van Seidell
Trends in Energy-intake (Kilojoules)
in the Netherlands
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Dutch Health Council, Trends in Nutrition, report 2002/12
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Physical inactivity
Abnormal reaction to a
normal environment?
Normal reaction to an
abnormal environment?
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Determinants of behaviour
gender
attitude
age
social influence
behaviour
SES
etc.
self-efficacy
barriers
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De Vries, OU, 1993
The environment
individual behaviour
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….various kinds of influences
individual behaviour
physical
environment
Macro environment
Micro environment
economic
environment
socio-cultural
environment
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BMJ, Egger& Swinburn, 1997
Deteminants of health behaviour
(Aarts et al., 1997)
External
factors
awareness
behaviour
cognition
(A/S/E)
Behavioural
intention
habits
barriers
Social & physical
environment
89
Social Ecological Model of Physical Activity
ENVIRONMENTAL/
POLICY
Organizational PA
policies
Urban planning
policies
Active
transport
policies
Area-level SES
Connectivity of
streets
SOCIOCULTURAL
Social support
friends
Social support
family
Living in
cul-de-sac
Ethnicity
INDIVIDUAL
Gender
Sibling PA
Age
Social norms
Aesthetics of
environment
Cultural norms
Seasonality
Social capital
Topography
Education
level
Family rules
PA
SES
PHYSICAL
ACTIVITY
DIETARY
HABITS
SEDENTARY
BEHAVIOR
Crime rates &
neighborhood
safety
Someone to
be active with
Beliefs
Enjoyment
Physician
influence
Self-efficacy
Traffic
(volume/speed)
Parental PA
Barriers
Stranger danger
Access to
recreational facilities
Peer & sibling
interactions
Social isolation
Children same age
live nearby
Access to parks/
playgrounds
Walking/cycling tracks
Perceptions of
safety
Time spent
outdoors
90
(Adapted from Davison & Birch 2001)
Prevention Strategies
High Risk vs. Population
Truncate high risk end of
exposure distribution
Secondary & tertiary
prevention.
Reduce risk a little risk in most people
Primary & promiordial prevention
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Individual
environment
• Dutch PACE
• Alife@Work
• Foodsteps
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• Improvement of Quality of Life
• Reduction of risk factors for chronic disease
• Reduction in health care cost
• Reduction in work absenteeism
• Improvement in productivity
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Indirect cost should
also be taken into account
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Economical evaluation
research question
Is this intervention worth the investment,
compared to other things one could do with
similar means?
It is not: is this intervention cheaper than other
interventions for the same disease, complaint?
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Economical evaluation
identification of the perspective
• Society:
all costs (direct and indirect)
• Insurer:
cost of re-imbursement
• Health care provider:
cost of treatment
• Patient:
‘out-of-pocket’ costs
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Economical evaluation
• Cost minimalization analysis
similar effects, lower costs
• Cost effectiveness analysis
effect expressed in disease specific outcomes
• Cost utility analysis
effect expressed in utility (QALY)
• Cost benefit analysis
cost and benefit expressed in monetary units
97
Economical evaluation
Cost
•
•
•
•
Effect
Cost
Utility
Etc
98
99
Results: subjects
600 invited to attend information meeting
325 attended information meeting
312 randomised
299 baseline measurement, April '00
131 intervention group
168 reference group
110 post measurement, January '01 130 post measurement, January '01
Design cost-benefit analysis
Intervention
Effect measurements (T0, T1)
Work absenteeism (1)
mei 2000
januari 2001
Work absenteeism (2)
mei 2001
januari 2002
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Intervention
9 months: May January 2001
Intervention group
Control Group
7 consultations, 20 minutes,
x
trained counsellor
Written information
Written information
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Intervention
• Individualized Counselling
–Daily physical activity
–Healthy Nutrition
• PACE (stages of changes) protocols
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Results: primary outcomes
Beta
Energy expenditure (kcal.day-1)
(SE)
(95% CI)
182.7 (53.9) (76.5;289.0)
Physical activity, sport (1-5)
0.25 (0.07)
(0.12;0.38)
Physical activity, leisure time (1-5)
0.10 (0.05) (-0.00;0.19)
Fitness (beats.min-1)
-5.07 (1.21) (-7.46;-2.68)
Cost-benefit analysis
D mean
Intervention
mean
Control
mean
(sd)
(sd)
Intervention cost
430
0
430
Cost of work
absenteeism year 1
1915 (4813)
2040 (5030)
-125
Total cost year 1
2345
Costs (€)
(95% BI)
(-1386;1062)
2040
305
(-1029; 1419)
Total cost year 2
1830 (4666)
2465 (5568)
-635
(-1883; 814)
105
ALIFE@Work
Amsterdam Lifestyle Intervention on Food and
Exercise at Work
Marieke van Wier1, Caroline Dekkers1, Geertje Ariëns1, Tjabe
Smid1, Ingrid Hendriksen2, Nico Pronk3 & Willem van Mechelen1
Body@Work, Research Center Physical Activity, Work and Health, TNO-VUmc
1) Department of Public and Occupational Health/EMGO Institute, VU medical center, Amsterdam 2)
TNO Work and Employment, Hoofddorp en 3) Health Partners, Minneapolis, USA
Objectives
• To evaluate, among in an overweight working
population, the effectiveness of a lifestyle
intervention program on body weight, physical
activity and dietary habits.
• To compare the efficacy of two different
communication strategies, i.e. phone and
internet
• To evaluate the cost-effectiveness of this lifestyle
intervention program.
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Study population
• inclusion: employee, between 18 – 65 yrs, BMI ≥ 25 kg/m2,
adequate in Dutch, access to internet
• exclusion: pregnancy, diagnosis- or treatment of cancer, any
disorder that makes physical activity impossible
• 1386 employees were eligible and randomised to three
groups:
1. reference: brochures Dutch Heart Foundation (460)
2. phone: binder and counselling by phone (462)
3. internet: access to website and counselling by e-mail (464)
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Measurements
• anthropometrics (T0, T6, T24):
weight and length
20% in each group:
waist circumference, body fat%, blood pressure, total
blood-cholesterol and aerobic fitness
• questionnaire (T0, T6, T12, T18, T24)
weight
waist circumference
nutrition (fruit, vegetables, fat)
physical activity
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Timeline
Measurements
Intervention
Questionnaire
Anthropometrics
T0 - Baseline
Questionnaire
Anthropometrics
Process evaluation
T6 - 6 months
Questionnaire
T12 - 12 months
Questionnaire
T18 - 18 months
Questionnaire
Anthropometrics
T24 - 24 months
Intervention
• The ‘Leef je Fit’ intervention program takes six months and
comprises 10 interactive educational modules.
• In each module participants fill out assignments (in a binder,
respective, on internet), designed to assist them in changing
their behaviour.
• Trained counsellors provide feedback on the assignments 111
by either phone or e-mail.
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Body weight compared to control group,
Corrected for baseline differences
weight difference (kg) against
control group and baseline values
0
6 mnd
24 mnd
-0,5
-1
Telefoon
Internet
Kg
-1,5
-2
-2,5
time of measurement
114
BMI compared to control group,
Corrected for baseline differences
BMI difference against
control group and baseline values
0
6 mnd
24 mnd
-0,1
-0,2
-0,3
Telefoon
2
Kg/m -0,4
Internet
-0,5
-0,6
-0,7
-0,8
time of measurement
115
* Participants with complete cost data
Costs in Euros
Control*
Phone*
Internet*
(n=135)
(n=149)
(n=132)
Mean (SD) Mean (SD) Mean
difference
(95% CI)
Mean
(SD)
Mean
difference
(95% CI)
Intervention
0
273 (89)
-
277 (108)
-
Direct (incl.
interv.)
668
1006
338
859
191
(832)
(842)
(129 to 541)
(778)
(-12 to 379)
Indirect
1227
1558
332
1031
-196
(2904)
(3388)
(-485 to 974)
(2521)
(-774 to
480)
1895
2565
670
1890
-5
(3336)
(3782)
(-377 to
1390)
(2894)
Total
(-785 to116
753)
Incremental Cost-Effectiveness Ratios
Body weight
• Phone:
€735 per kg lost
• Internet:
€5 per kg lost
Quality of life
• Phone:
€128 575 per QALY gained
• Internet:
€-18 910 per QALY gained
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Reshaping an office environment.
Does it make sense?
Mireille van Poppel, Luuk Engbers, Willem van Mechelen
VU University Medical Center, Amsterdam
Department of Public and Occupational Health
Body@Work TNO-VUmc
Aim of FoodSteps
To assess the effects of environmental modifications on
 physical activity
 dietary behavior
 Body Mass Index
 Biological CVD risk indicators of office workers
119
Design
 controlled trial (1 intervention & 1 control site)
 duration of the intervention 12 months
 baseline and follow-up measurements at 3 & 12 months
 population of office workers:
 Body Mass Index >23
 able to take stairs
 contract until the last follow-up measurement
120
Intervention
121
Intervention physical activity
 ‘point-of-decision’-signs on elevator doors
 motivational texts in staircases
 slim making mirrors in staircases
 routing of people to the stairs
122
Intervention physical activity
Routing
Motivational texts
123
Intervention diet
 food labelling in canteen & vending machines
(every 4 weeks a different product group)
 information corner
(computers & brochures)
 FoodSteps buffet
(healthy product offerings, every 2 months)
124
Intervention diet
Food labelling:
caloric values of products
translated into number of minutes
of a certain activity
1 orange = 55 Kcal
≈ 6.9 minutes cycling
1 mars = 270 Kcal
≈ 30 minutes stair walking
≈ 2.5 hours sitting in a meeting
125
Outcomes physical activity
Total population:
 self-reported physical activity
(total PA, PA at work, stair use at work)
Subgroups:
 objectively measured stair use at work
(hands free detection system & chip cards)
 objectively measured physical activity
(MTI actigraph; total PA and PA at work)
126
Results
intervention
control
number of subjects
% female
316
37.4
325
41.7
age (mean)
45.3
45.5
hrs at work/week (mean)
35.3
36.6
% higher educated
BMI (mean)
69.9
26.4
63.9
26.6
127
Results stair use
median number stairs / week
self reported stair use
25
20
15
intervention
control
10
5
0
baseline
3 months
12 months
128
Results stair use
Intervention effect on self-reported stair use
 interaction with gender:
only statistically significant effect for men
self-reported: β = 1.41 (objectively measured: β = 1.34)
 interaction with BMI:
only statistically significant effect for subjects with BMI < 25
objective: β = 1.47
129
Results cholesterol
Intervention effects on cholesterol levels (interaction
with gender)
Total cholesterol
12 months men
β = - 0.41
LDL cholesterol
12 months men
β = - 0.31
12 months women
β = - 0.41
3 months men
β = 0.05
12 months men
β = 0.11
HDL cholesterol
130
Conclusion
Reshaping an office environment.
Does it make sense?
Yes, but ……
 more for men than women
 more for people with lower body mass index
 effects are modest
131
CONTENT
• Occupational Health Care
• Paradigm shift: occ. health ---> workers health
• What is the problem ?
• Cost of a physically inactive lifestyle
• Examples: one to one interventions/supportive environment
• Who is responsible? Self-regulation or the Nanny State?
133
134
The solution lies in self-regulation?
135
“Unless effective population-level
interventions to reduce obesity are
developed, the steady rise in life
expectancy observed in the modern era
may soon come to an end and the youth
of today may, on average, live less
healthy and possibly even shorter lives
than their parents.”
Olshansky et al. NEJM 352:1138-1145, 2005
136
Self-regulation or the Nanny State?
138
139
140
141
142
143
Food for thought
144
145
146
30 kg  approx. 90 minutes swimming
to get rid of 100 grams of Dutch cake
Three cakes: 3,1 * 3 * 1,5 (uur)
= 14 hours of swimming
147
Do all these interventions aiming
at ‘voluntary’ behavioral change
make Occupational Health sense??
Yes they do, but
perhaps more
Draconic action
is needed!!
148
Sanitation: pragmatism works
Johan P Mackenbach, BMJ 2006
149
Sanitation: pragmatism works
• effective intervention does not always need
accurate knowledge of disease causation
•
Obesity
prevention:
environmental measures may be more effective
than changing individual behaviour
pragmatism
may
work
also
• universal
measures may
be better
than
targeted
measures in reducing health inequalities
150
151
However, the future looks bright!
152
153