UK Society for Behavioural Medicine · NPRI UK Society for Behavioural Medicine 9th Annual...

NPRI

UK Society for Behavioural Medicine 9th Annual Scientific Meeting

“Behavioural Medicine: From Laboratory to Policy”

University of Oxford Examination Schools

Monday 9 and Tuesday 10 December 2013

NPRI

UK Society for Behavioural Medicine 9th Annual Scientific Meeting

“Behavioural Medicine: From Laboratory to Policy”

Parallel Session D Workshop

12.00-13.15

NPRI

UK Society for Behavioural Medicine 9th Annual Scientific Meeting

“Behavioural Medicine: From Laboratory to Policy”

NPRI: Natural experiments:

success and challenges

Gavin Malloch, Annie Anderson,

Frank Kee and Chris Owen

Annie S. Anderson, A.Craigie, S. Caswell, M. Macleod

The BeWEL team Centre for Research into Cancer Prevention and

Screening

University of Dundee

The impact of a weight loss

programme (BeWEL) initiated

through a national colorectal cancer

screening programme

• Prof Annie Anderson (PI)

• Prof Robert Steele

• Dr Shaun Treweek

• Prof Jill Belch

• Dr Fergus Daly

University of Dundee

• Prof Jane Wardle

University College London

• Prof Anne Ludbrook

University of Aberdeen

• Dr Martine Stead

University of Stirling

• Dr Alison Kirk

University of Strathclyde

National Prevention Research

Initiative (MRC)

• Joyce Thompson

• Jackie Rodger

NHS Tayside

• Tayside

• Prof Robert Steele

• Ayrshire & Arran

• Mr Robert Diament

• Forth Valley

• Mr Wilson Hendry

• Greater Glasgow and Clyde

• Mr Derek Gillon

NHS Site Collaborators

Preventability estimates (PAF%) for cancers

of the colon and rectum (UK) (WCRF, 2013)

and Parkin (2011)

Exposure WCRF PAF%

Parkin PAF%

Foods containing Fibre 12 12

Red meat 5 21 (combined)

Processed meat 10

Alcoholic drinks 7 12

Physical Activity 12 3

Body Fatness 14 13

Total estimate 47 48

Does weight loss reduce

incidence of CRC?

Changing Cancer Risk Byers & Sedjo (2011) Diabetes Obes Metab

Dietary RCT’s Site Populati

on

Body

weight

loss

Cancer

risk

reduction

Sjostrom et al

(2009)

All sites Women

Men

31.9%

19.3%

42%

3%

Adams et al (2009) All sites Women

Men

31.0% 24%

2%

Christou et al (2008) All sites Men &

Women

31.9% 78%

Bariatric Surgery Cohorts

Observational data suggest wt decreases incidence in CRC in men (Rapp et al. 2008)

The effect of Body Weight Reduction on

the incidence of Colorectal adenoma

Subjects Adenoma Incidence %

Weight gain/maintenance 2418 413 17.1 **

Weight loss 150 14 9.3

Total 2568 427 16.6

** p<0.01

Incidence after 1 year according to weight change:

Yamaji et al, (2008) Am J Gastroenterol (103) 2061-2067

Scottish Bowel Screening Programme

Colonoscopy

Removing the adenoma removes the immediate risk of disease

The underlying factors which might influence the development of adenoma remain

Study design

3.5 year study (start 1st Feb 2010)

Two-arm multi-centre RCT

Hospital setting across 4 sites

n=316 randomised (158 / group):

– 12 month BeWEL intervention

– Usual care

6 months 24 months 6 months

Pre-trial development

Recruitment, data collection & intervention

implementation

Final data collection, analysis &

interpretation

Formative research

Using the teachable moment…..

Patients need to

– Be aware of the risk factors for adenoma

– Be able to relate these to personal behaviours

– To have a shared and accepted understanding of lifestyle and CRC

Importance of consultant endorsement

Baseline assessments

Randomisation

Intervention Group Comparison Group

12 month follow up

Exit interview

Full invitation from research nurse:

Sent within next 2 weeks

3 month follow up

Colonoscopy results sent by post

+ “Teaser Letter” from consultant endorsing study

Study

Procedures

BeWEL

12-month

programme

Outcome measures

• Change in body weight (not adenoma recurrence)

Primary outcome

• Change in:

• Waist circumference

• Cardiovascular risk factors (BP, lipids)

• Metabolic risk factors (glucose, HbA1c, insulin)

• Dietary intake (DINE)

• Physical activity (Accelerometry)

• Self assessed general health (SFQ12)

• Self-efficacy

• Programme acceptability to participants and staff

• Intervention cost

Secondary outcomes

Intervention design

Based on Diabetes Prevention Programme:

Target 7% weight loss:

• -600 kcal/day deficit diet

• Red and processed meat portions (animal fats)

• Alcohol

• Portion sizes

• Increase wholegrains, vegetables and fruit

• Increased mod / vig activity to 150 mins / week

Intervention delivery

• Combine knowledge, motivation and

• Behavioural techniques

• Motivational interviewing

• Goal setting

• Implementation intentions

• Self monitoring and feedback

• Re-enforcement

Behavioural and Re-enforcement techniques

for promoting change weight management

Self monitoring record book Body weight scales

Remind about 12 month goal, self monitoring records,

telephone calls and visits

Demonstrate and also

discuss body fat Explain recording and reporting

Inclusion criteria

Colorectal adenoma detected following

national FOBT screening

Age 50 to 74 (screening age in Scotland)

BMI >25 kg/m2

NO known cancer, insulin dependent DM

or pregnancy

Dose

All face to face contacts in months 1 to 3

– Delivered by Lifestyle counsellor

Foster immediate changes

Take 3 months to establish initial changes and build on

Monthly Telephone contacts thereafter

Baseline 12 months 3 months

Face-to-face

consultations

9 telephone consultations

BeWEL Recruitment – people are interested in

lifestyle intervention

Adults screened positive for adenoma aged 50 to 74 years

(n=997)

Responded ‘No’ n= 345 (35%)

Did not respond n=160 (16%)

Responded ‘Yes’ n=492 (49%) Changed mind

n=42 (9%)

Ineligible

1. BMI <25kg/m2 n=108(22%)

2. ‘Yes’ ineligible as reply

received after study closing

to recruitment n=13(3%)

Randomised n=329

BeWEL Retention – people stay with the

lifestyle intervention (91% follow up) for 12m

Allocated to intervention (n=163) Allocated to control (n=166)

3 month follow-up (n=153) 3 month follow-up (n=161)

12 month loss to

follow-up (n=9) 12 month loss to

follow-up (n=15)

12 month follow-up

(n=148) 91%

12 month follow-up

(n=157) 95%

Baseline and Clinical Characteristics at Randomisation

Intervention

(n=163)

Control

(n=166)

All

(n=329)

Age (years)

Range

63.5 7.0

50 – 75

63.6 6.7

50 – 75

63.6 6.8

50 – 75

Male gender 120 (73.6%) 123 (74.1%) 243 (73.9%)

Employment status

Retired

Employed full-time

Employed part-time

Unemployed

Other

90 (55.2%)

45 (27.6%)

18 (11.0%)

2 (1.2%)

8 (4.9%)

97 (58.4%)

41 (24.7%)

14 (8.4%)

10 (6.0%)

4 (2.4%)

187 (56.8%)

86 (26.1%)

32 (9.7%)

12 (3.6%)

12 (3.6%)

SIMD* (quintiles)

1 (most deprived)

2

3

4

5 (least deprived)

25 (15.3%)

33 (20.2%)

26 (16.0%)

39 (23.9%)

40 (24.5%)

29 (17.5%)

28 (16.9%)

33 (19.9%)

45 (27.1%)

31 (18.7%)

54 (16.4%)

61 (18.5%)

59 (17.9%)

84 (25.5%)

71 (21.6%)

Data are mean ± SD or number (%) unless stated otherwise. *Scottish Index of Multiple Deprivation

Primary Outcome

Intervention

Group

Control Group

P

n Mean ± SD n Mean ± SD

Bodyweight (kg)

Baseline 163 90.2± 14.9 166 88.4± 14.3

<0.0001 12 months 148 87.2± 15.7 157 88.1± 14.2

Difference 148 -3.50 ± 4.9 157 -0.78 ± 3.8

Weight loss (%) 12 months 148 -3.92 ± 5.4 157 -0.83 ± 4.1 <0.001

Waist

Circumference (cm)

Baseline 163 104.7 ± 10.9

166 103.9 ± 10.9

<0.0001

12 months 145 100.2 ± 12.0 157 102.1 ± 11.1

Difference 145 -4.91 ± 5.4 157 -2.16 ± 4.4

Changes in anthropometric measures from

baseline at 12 months by treatment group

Body Weight Reduction

% achieving 5% body weight loss

– Significantly higher in the intervention group

than the control group (36% vs. 12%)

% achieving 7% body weight loss

– Also higher in the intervention group (22% vs.

9%)

Weight change in intervention

and control groups at 12 months

Secondary Outcomes

Intervention

Group

Control Group

P

n Mean ± SD n Mean ± SD

Glucose

(mmol/l)

Baseline 142 6.11± 2.0 149 6.12± 1.9

0.05 12 months 125 5.68± 1.4 132 6.08± 1.7

Difference 125 -0.27± 1.9 132 -0.07± 1.0

Insulin

(mmol/l)

Baseline 104 11.12± 8.3 110 10.17± 8.8

0.82 12 months 74 12.77± 11.1 79 13.48± 10.2

Difference 66 2.77± 9.00 73 2.58± 7.1

HbA1c (%)

Baseline 149 6.02± 1.2 151 6.03± 1.2

0.06 12 months 120 5.84± 0.8 129 6.03± 1.0

Difference 120 -0.13± 0.9 129 -0.02± 0.6

Glucose metabolism biomarkers

Intervention

Group

Control Group

P

n Mean± SD n Mean± SD

Fat

consumption

score*

Baseline 163 30± 10.6 166 32± 10.6

<0.0001 12 months 146 24± 7.4 156 28±10.3

Difference 146 -7.3± 10.2 156 -3.8± 8.0

Fruit and

vegetable

(p/day)

Baseline 163 4± 2.2 166 4± 2.2

0.0004 12 months 148 5± 2.4 157 4± 2.4

Difference 148 0.6± 2.3 157 0.0± 2.1

Changes in dietary intake

*Based on intakes of foods which contribute substantially to fat intake i.e. dairy

foods, meat, processed meat, fish, fried foods, sweet and savoury snacks and fat

spreads. . A score of less than 30 is equivalent to around 83g fat (estimate 35% of total energy intake for an average woman).

Intervention Group Control Group

P n Mean± SD n Mean± SD

Daily average

time spent

active (mins)

Baseline 156 82± 62.3 157 79± 55.9

0.02 12 months 140 89± 65.3 148 74± 62.0

Difference 140 6.23± 60.1 148 -5.53± 40.0

Daily average

time spent in

moderate

activity (mins)

Baseline 153 81± 58.0 153 77± 53.7

0.05 12 months 137 86± 63.4 144 73± 60.7

Difference 137 6.27± 54.5 144 -3.67± 38.5

Daily average

step count

Baseline 156 8429± 3995 157 7734± 3538

0.03 12 months 140 8697± 4404 148 7460± 3873

Difference 140 239.6± 3118.3 148 -310.2± 2263.6

Changes in Physical Activity

Participant experience

spoke highly of the study + counselling staff

feeling of being understood as an individual

(encouraging and maintaining involvement)

several felt they would not have engaged so

well in a group setting

motivations varied: small "scare“/ adenoma

+ other triggers/ “if not now, when”?

successful weight loss - sustained

commitment/strategies to deal with relapse

triggers.

Conclusions

There is interest in lifestyle change in people

with CRC adenomas

Study participants show commitment to lifestyle

change over a 12 month period

Study participants respond favourably to lifestyle

interventions

Considerable potential for disease risk reduction

in older adults

Colorectal cancer screening and prevention

programme?

NPRI

UK Society for Behavioural Medicine 9th Annual Scientific Meeting

“Behavioural Medicine: From Laboratory to Policy”

• The Connswater Community Greenway

• The elements of the evaluation

• The best laid plans.....

• The importance of theory and the challenges for analysis

• Collateral KE benefits of PARC

The PARC Study: a case study of a natural experiment

Health • 5 wards within the top 10% most disadvantaged

Education • 7 wards within the top 10% most disadvantaged

Environment • 3 of the 10 most deprived living environments in

NI

Employment • 5 wards within the top 20% most disadvantaged

• Before and after household survey (1200x2)

• Regional comparison survey (SportNI)

• Network and social capital analysis

• Process evaluation

• Economic and behavioural economics analysis

• Built environment

• Primary care based exercise referral

• Walking schemes and other community - led physical activity initiatives

• Employer and school based initiatives

• “Loyalty schemes”

What makes complex public health interventions complex ?

Questions to ask about evaluability

• CMO configurations/ “realist evaluation”

• Testing theories rather than interventions

• Seeing the “big picture”

• How will an evaluation affect policy?

• What are the plausible sizes and distribution of hypothesized impacts?

• How will the findings add value to the evidence?

• Is it practical within the time available ?

An ecological model of 4 domains of physical activity.

Sallis J F et al. Circulation 2012;125:729-737 Copyright © American Heart Association

`

Preliminary analysis of PARC Survey

• Structural Equation Model based on hypothesised pathways from socio-ecological model (Mplus)

• Tested a series of relationships through which environmental (objective and subjective), social and individual factors potentially interact to influence PA

• Perceived environment factors (attractiveness and supportive infrastructure) predict overall and travel related PA; but not recreational PA

• Perceived social support for PA moderates this relationship

• Suggests possible pathway between the built environment and PA

The importance of theory - added value from concept mapping-

Benches, lighting

•Quality of surface •Signage

Somewhere to go

Green space Graffiti, Noise

•Stamina •Mastery

Social capital Dog ownership Police presence

The importance of theory - added value from concept mapping in PARC-

Index of Activities: 1 = Being out and

about,

2= Being Active.

Index of Facilitators: 3=Physical

Infrastructure, 4 = Good weather, 5= Other

People, 6 = Being Safe, 7 = Greenery and

Open Space, 8 = Organizational

Infrastructure.

Index of Inhibitors: 9 = Current demands

of work and daily life, 10 = Vandalism &

Anti-social behaviour, 11 = Territoriality, 12

= Bad Weather, 13 = Urban Infrastructure.

The importance of theory

• Are there any unblocked back-door paths from exposure to outcome?

• Are mediators themselves “confounded” ?

• Are any associations induced by selection bias?

• Perfectly even distributions of causal factors do not prevent confounding

• Confounding without confounders

• DAG may not always correctly identify the presence of confounding

The importance of theory Manski’s typology

• effects of aggregate outcomes at the group-level on individual-level outcomes (“endogenous” effects)

• contextual effects of group composition

• environmental effects.

Infectious disease Social capital/norms

Challenges for “experiments” on Nature and Neighbourhoods

• Spatial resolution and boundary issues

• Synergies between physical and social environments

• Individual-level variables may simultaneously be confounders and mediators

• Migration and selection

Where’s the evidence ?

“The highway from one merchant town to another shall be cleared so that no cover for malefactors should be allowed for a width of two hundred feet on either side; landlords who do not effect this clearance will be answerable for robberies committed in consequence of their default, and in case of murder they will be in the king’s mercy”.

17 June 1239 – 7 July 1307) Statute of Winchester, 1285

• Even RCTs need mechanistic insights

• eg to help with the interpretation of external validity

– distinguishing behavioural effect modification from biological effect modification”

• Methodology has a rather weak influence on research use by policy makers;

• We need to consider information needs and intended use of new information

– only then consider added value in the context of precision, bias and generalisability

• Be honest in considering how ambiguous results will be used in decision making

Existing research on walkability

• mostly from US and Australia • different urban form

• cultural and demographic differences

• subjective versus objective measures

• data availability

• Most indices based on • Residential density

• Land use mix

• Street connectivity

• Retail area ratio

Special thanks to

• Dr Mark Tully

• Dr Ruth Hunter

• Prof Geraint Ellis

• Prof Margaret Cupples; Prof Lindsay Prior

• Dr Mary Dallat; Prof George Hutchinson;

• Dr Michael Donnelly, Dr Helen McEneney, Mike Stevenson

• CCG Team

THANKYOU

NPRI

UK Society for Behavioural Medicine 9th Annual Scientific Meeting

“Behavioural Medicine: From Laboratory to Policy”

Natural experiments:

success and challenges

Operational experiences

from ENABLE London

Christopher Owen

Population Health Research Centre,

St George’s, University of London, UK

Will moving into social and intermediate

housing in the East Village increase

family physical activity levels?

Christopher Owen, Bina Ram, Billie Giles-Corti †, Ashley Cooper ‡, Anne Ellaway §, Alicja Rudnicka, Peter Whincup, Derek Cook Population Health Research Centre, St George’s,

University of London, UK

† McCaughey Centre, University of Melbourne, Australia

‡ Department of Exercise, Nutrition & Health Sciences, University of Bristol, UK

§ MRC Social and Public Health Unit, Glasgow, UK

Objectives

What is ENABLE London?

Progress to date

Recruitment rates

Data collected

Questionnaire, activity / GPS data

Challenges ahead

Decisions made / to be made

Future work

How to increase physical activity

- evidence to date Interventions to increase physical activity

levels

have shown limited effects

poorly maintained in the longer-term

The built environment may be key constraint limited evidence on the effect of the built

environment on physical activity

Need for studies examining impact of

marked changes in the built environment on

physical activity levels (‘natural experiment’)

ENABLE London aims

Do families moving to East Village show a

sustained change in PA levels compared

with non-movers?

Is the change in PA attributable to use of

elements of the local built environment?

What factors influence the change in PA

levels? (e.g., age, gender, social factors)

Do other health indicators (e.g., body fat

levels) change – if so, does this reflect

changes in physical activity?

1200 families

recruited from EV

applications

600 families

(1 adult, 1 child)

1200 subjects

East Village

600 families

(1 adult, 1 child)

1200 subjects

Living elsewhere

420 adults

(320 children)

420 adults

(320 children)

1 YEAR FOLLOW-UP

Evaluating the impact of the EV development

Control families matched to those moving into the Village

Powered to detect

500 step difference

5% daily steps

AF

TE

R M

OV

E

BE

FO

RE

MO

VE

Types of East Village housing

East Village

housing (E20)

N=2818 units

Social Housing

Intermediate Rent

Shared Ownership

Shared Equity

N=675

(290 3+beds,

49 2 beds)

N=704

(356 IMR,

269 SO, 79 SE)

TRIATHLON HOMES

Private Rent

N=1439

All owned by

QDD

QDD

Target recruitment

January 2013 January 2014

600 Social

Households

600 Intermediate

Households

300 Social

EV households

300 households

elsewhere

300 Intermediate

EV households

300 households

elsewhere

Social housing recruitment

634 interviewed

at East Thames

321 (80%) agreed

to participate:-

272 (85%) seen

49 (15%) pending

426 (67%)

forms received

105 (20%) refusals

23 snowballs:-

7 refusals

16 seen

598 school

questionnaires:

90 (15%) forms:-

32 refusals

52 seen

6 pending

539 forms:

144 (27%) refusals

340 (63%) seen

55 (10%) pending

Opportunities to recruit

634 interviewed

at East Thames

215 to be

allocated by

mid-November

460 allocated EV

social housing

Snowballs may

yield 10% 395 social

households so far

need to recruit

205 more

Control

East

Village

School

recruitment

could be

maximised but

select group

Social housing recruitment

Control

0

100

200

300

400

500

600

700

Target

Forms Received

Recruited

Visits Completed

OR

Intermediate progress

Intermediate recruitment

96/150 Triathlon

EV Intermediate

homes allocated

44 (77%) agreed

to participate:-

38 (86%) seen

6 (14%) pending

57 (59%)

forms received

13 (23%) refusals

7 snowballs:-

0 refusals

7 seen 64 forms:

13 (20%) refusals

45 (70%) seen

6 (9%) pending

Less suited to

school

recruitment?

Intermediate recruitment

0

100

200

300

400

500

600

700

Target

Forms Received

Recruited

Visits Completed

East Village not fully open

Access / move postponed

Recruitment process for EV Intermediate (IMR, SO, SE) homes

Step 1

• Eligible

• Online application

Step 2 • Financial assessment

Step 3 • Invited to Interview

Step 4

• Accommodation offered

• Deposit paid (circa £15K+)

Further

recruitment

opportunities,

especially

for controls

Current

recruitment

Phase 1

N=150

Phase 2

N=200

Phase 3

N=200

Phase 4

N=150

Questionnaire sources

ENABLE London

Census 2011

HSE 1995, 2004

General Household

Survey 1994

SURESTART

EQ-5D, 2009

NEWS, IPAQ

RESIDE, TREK,

HABITAT

CHASE & NOVEL Qs

Item Main / partner / adult Parent Child

Demographics

Household

Qualifications

Employment

Travel to work / study

Household income

General health

Health outcomes

Satisfaction scores

Smoking / drinking

Local neighbourhood

Activities / IPAQ

Cost of activities

Attitudes to exercise

TV & computers

Eating / sleeping

Maximum items 219 / 174 20 52

Median duration (mins) 49 / 38 / 26 Included with main 19

17.8

36.3

21.4

14.9

9.5

0

10

20

30

40

50

Pe

rce

nt

(%)

1 2 3 4 5

Enjoy living in area

39.4

48.7

5.73.9

2.3

0

10

20

30

40

50

1 2 3 4 5

Good local transport

16.0

35.8

21.118.8

8.2

0

10

20

30

40

50

1 2 3 4 5

Good leisure services

10.6

20.1

25.8

31.7

11.9

0

10

20

30

40

50

1 2 3 4 5

Problems due to vandalism

5.2

36.9

19.6

26.0

12.4

0

10

20

30

40

50

Pe

rce

nt

(%)

1 2 3 4 5

Area free from litter

11.9

28.125.826.5

7.7

0

10

20

30

40

50

1 2 3 4 5

Too much traffic

8.8

28.6

22.2

27.6

12.9

0

10

20

30

40

50

1 2 3 4 5

Area attractive to look at

12.1

39.2

21.9

17.3

9.5

0

10

20

30

40

50

1 2 3 4 5

Enjoy walking in area

1: Strongly agree, 2: Agree, 3: Neither agree or disagree, 4: Disagree, 5: Strongly disagree

Missing data: 0 out of 388 records

Actigraph data

From 480 individuals

312 (65%) have good Actigraph data

Defined as 4 days at 540 mins

Re-testing 10% with borderline data

Defined as at least 3 to <4 days at 540

mins

Of 20 re-issued, 8/16 good data

GPS data

Preliminary analyses on small sample

73% of Actigraph wear time matches

GPS data

26% of GPS data was outdoors

Data cleaned by applying criterion of

60 minutes of zero values, allowing for

2 minute blips

Wear time is the amount of valid

accelerometer data after this

Points to consider

Electronic surveys

Third party recruitment

Delay in East Village opening

Social housing recruitment on target

Numbers from intermediate housing will

increase

Staffing issues

Future funding: extension, further work

http://www.enable.sgul.ac.uk/

National Prevention

Research Initiative

NPRI

UK Society for Behavioural Medicine 9th Annual Scientific Meeting

“Behavioural Medicine: From Laboratory to Policy”