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 E Weight mangagement, and

physical activity, part 2

14.25-15.40

Chaired by Jamie Hartmann-Boyce

NPRI

UK Society for Behavioural Medicine 9th Annual Scientific Meeting

“Behavioural Medicine: From Laboratory to Policy”

The impact of a weight loss intervention

(BeWEL) initiated through a national

colorectal cancer screening programme

Annie Anderson

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”