Clinical and Cost-effectiveness of a Co-developed, Evidence-based Physical Activity Referral Scheme for the Treatment and Prevention of Health Conditions: a Pragmatic Trial
Phase: NA
Conditions: Cardiovascular Risk Factor, Diabetes Mellitus, Type 2, Anxiety, Depression, Musculoskeletal Injury, Cardiovascular Diseases, Cancer, Obesity, Metabolic Syndrome, Physical Activity
Sponsor: Paula Watson

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Research Protocol 
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Research Protocol        
        
The proposed research study is part of a PhD that is taking a phased approach (MRC, 2008) to develop, pilot, 
and evaluate an exercise referral scheme (ERS) for inactive individuals with health conditions. Study 1 [REF 
16/EM/0157] involved the co-development of the intervention in collaboration with a multidisciplinary 
steering group (e.g. researchers, GP’s, commissioners etc.). Study 2 (REF 16/WA/0231) explored the feasibility 
of the ERS and tested potential outcome measures to inform a subsequent evaluation trial. Study 3 (this 
application) will be a pragmatic, quasi-experimental trial to test the effectiveness of the ERS. The research 
will be conducted in collaboration with Liverpool NHS Clinical Commissioning Group (CCG) and Liverpool City 
Council (LCC).  This protocol relates to study 3 only.  
 
Formal study title: “Clinical and cost-effectiveness of a co-developed, evidence-based physical activity referral 
scheme for the treatment and prevention of health conditions: a pragmatic trial” 
 
Lay study title: “Evaluation of a co-developed physical activity referral scheme” 
 
Aim: To test the pragmatic effectiveness and cost-effectiveness of a co-developed, evidence-based physical 
activity referral scheme, with embedded process evaluation. 
 
Objectives: 
• 
To investigate the relative effectiveness (for improving cardiorespiratory fitness at 12 weeks) and cost-
effectiveness (PA levels at 6 months) of two delivery modes of ERS (1. co-developed physical activity 
referral scheme; 2. standard ERS)  
• 
To explore who each intervention reaches, patient adherence levels, fidelity of intervention delivery 
and acceptability of the intervention to patients and staff.  
 
Study Design 
A three-arm quasi-experimental trial involving: 1. co-developed physical activity referral scheme (intervention); 
2. standard ERS (usual care); and 3. no treatment control. Process evaluation will be embedded to establish 
reach, adherence, fidelity and acceptability of the intervention and usual care conditions.       
 
 

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Participants and recruitment  
There are two types of participants within the study design:  
1. Patients 
Inclusion Criteria: 
> 18 years old and have a health-related risk factor (e.g. high blood pressure, hyperglycaemia, obesity etc.) 
or a health condition (diabetes, cardiovascular disease, anxiety, depression etc.) that may be alleviated by 
increasing current PA levels. 
Exclusion Criteria: 
• 
Uncontrolled health-conditions (Cardiac, metabolic, respiratory etc.) and/or any recent traumatic 
events (e.g. myocardial infarction). 
• 
Unstable angina or aortic stenosis. 
• 
Severe psychological or neurological conditions. 
• 
Participation in an ERS at any location other than the research centres (at the time of recruitment).  
 
2. ERS staff 
Inclusion Criteria: 
• 
Qualified exercise referral practitioner (ERP) 
• 
Involvement in the delivery of the ERS at Centre A (intervention) or Centre B (usual care) 
Exclusion Criteria: 
• 
None 
 
Recruitment 
 
Intervention and usual care conditions 
Eligible patients will be recruited from Centre A and Centre B (after they have been referred to the ERS by a 
health professional).  Once referred, it is standard protocol that ERS patients visit their chosen Lifestyles fitness 
centre to book an ERS induction with administrative staff. During this initial contact, administrative staff will 
introduce the study briefly and provide the individual with a summary poster (attached). If the patient is 
interested, administrative staff will gain verbal consent to pass the patient’s contact details to the researcher 
(NB this is consent for sharing details only, the participant will still have the opportunity to opt out before full 
research consent is sought). Administrative staff will then provide patients with the participant information 
sheet to take away and have some time to consider. Patients will be informed that the researcher will contact 
them within one week to discuss the study and check if they want to take part. Researcher contact details will 
be provided on the poster and information sheet in case the participant has any questions in the meantime. 

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For patients who consent to speak to the researcher, the administrative staff will book an ERS induction 2-3 
weeks later (to allow time for the patient to undergo baseline testing prior to starting the ERS). The researcher 
will then contact the patient to arrange a visit to Liverpool John Moores University (LJMU) laboratories for 
baseline collection of health measures.  
Patients who opt out of the study at this stage will continue with the ERS as usual. 
No treatment control condition 
Participants in the no treatment control group will be recruited via posters placed around LJMU, electronic 
invitations on LJMU research recruitment websites, email communications to LJMU staff and students, and 
LJMU social media output (see attached documents). Interested participants will contact the researcher for 
further information, who will e-mail them a full participant information sheet. If the participant then decides 
to take part the researcher will arrange a date and time to visit LJMU laboratories for baseline collection of 
health measures.   
Participant blinding. Due to the nature of the study, it will not be possible to fully blind patients to their study 
condition (as they will know whether they are signed up to attend an ERS or not) or to blind ERS staff (who 
will know whether their centre is the intervention or the usual care condition).  Patients within the two active 
conditions (intervention and usual care) will not however be informed whether their centre is the intervention 
or the usual care condition. 
 
Conditions 
Intervention (Centre A) 
Both the co-developed scheme and standard ERS offer subsidised access to a fitness centre for 12 weeks.  
However, in addition to this the co-developed intervention (centre A) will offer:  
- more physical activity options that include both daily opportunities to increase PA and activities available at 
the fitness centre;  
- more individual progress meetings, during which the GP exercise referral practitioner will provide behaviour 
change support (Week 0, 4, 8, 12 and 18); and 
- more efforts to refer patients to optional additional support from a 'Health Trainer' service qualified to 
provide advice on multiple health-related behaviours. 
These adaptations are in line with the current NICE guidelines as well as a local evaluation study that fed into 
the development of the scheme. The aim of the co-developed ERS is a person-centred approach to improve 
overall well-being and quality of life through PA. As the intervention is drawing on an existing scheme, 
delivered/guided by qualified ERPs, and has been developed by a multidisciplinary stakeholder group involved 
with the existing scheme, it is deemed that there are no additional risks to the users compared to the existing 

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scheme in operation. The key aspect of the intervention is that the participant has choice but is supported 
through the process.  
It was found during the pilot study that some patients were referred inappropriately to the ERS who 
were already active or were seeking subsidised access to certain activities (e.g. swimming) without a need for 
additional behaviour change support. In an attempt to provide more targeted support, patient eligibility for 
the ERS will be explored through the patient-centred induction. If it is deemed by both the instructor and 
patient that the intensive 18-week intervention is not the most appropriate for the patient’s needs, alternative 
options will be offered (see figure 1).  Since this study aims to investigate the real-world effectiveness of an 
ERS that is tailored to patient needs, patients referred to the ERS at Centre A who opt not to take part in the 
18-week intervention will remain in the research study (i.e. an intention to treat approach).  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 1. Co-developed referral scheme that will run at Centre A (intervention centre). 

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Theoretical underpinning and behaviour change support.  All behaviour change support is underpinned by self-
determination theory (SDT, Ryan and Deci, 2000) and aimed at supporting patients to feel autonomously 
motivated to keep up physical activity in the long-term.  
Usual care (Centre B)  
The usual care arm will follow a standard ERS model of 12-week access to a Lifestyles fitness centre. Patients 
referred from a health professional (GP, physiotherapist, nurse etc.) will meet an ERP at the leisure centre for 
an initial induction (week 1). A personalised exercise intervention will be provided to the patient based on 
their referral reason/health condition. The patient will have 12 weeks of subsidised access to the gymnasium 
and group classes. This system is already in place and is considered standard exercise referral care for the local 
area.  
No treatment control 
These participants will receive a lifestyle advice booklet only (provided to all groups at the baseline data 
collection point).  
 
 
 
 
 
 
 
 
 
 
 
Figure 2. Overview of intervention measure time points for each arm. 
2. Usual Care  
(Standard ERS) 
Centre B 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
        = subsidised access to Lifestyles sessions 
ER = exercise referral; EFH = Exercise-for-Health; Wk = week 
Patients referred by health professional 
1. Intervention  
(Co-developed ERS) 
Centre A 
 
 
Wk 4 1-to-1 
 
Alternative 
options as 
appropriate 
Wk 8 1-to-1 
Wk 12 1-to-1 
 
 
Wk 18 1-to-1 
 
 
3. Control group 
(no treatment) 
Participants recruited 
from comparable  
population 
Wk 1 induction 
Wk 1 induction 
Baseline measures 
12 week measures 
6 month measures 

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Sample size estimation 
Between-group effects (intervention vs usual care) 
Required sample size was estimated by using effect sizes of a previous pilot study that demonstrated a mean 
change in CRF 3.6 ± 3.2 ml.kg.min-2 (REF 16/WA/0231) and existing epidemiological evidence. A change in 
cardiorespiratory fitness of 3.5 ml.kg.min-2 has been deemed clinically meaningful with an associated 
reduction in all-cause mortality (13%) and cardiovascular disease risk (15%; Lee et al., 2010). Yet, it has also 
been demonstrated that small increases in fitness (Males: 0.5 ml.kg.min-2; Females 1.0 ml.kg.min-2) are 
associated with significant reductions in clustered-cardiometabolic risk in at-risk individuals (Simmons et al., 
2008).  
Therefore, we decided a moderate-large effect size (based on pilot baseline CRF SD of 3.2 ml.kg.min-2) 
equivalent to a change of 1.98 ml.kg.min-2, would be clinically meaningful. This is between the clinically 
meaningful change of 3.5 units reported by Lee et al. (2010) and the smaller increases of 0.5 to 1 unit reported 
by Simmons et al. (2008) in at-risk individuals. Thus, to detect a difference of 1.98 units (ml.kg.min-2) between 
groups, it was estimated that a total sample of 84 would be needed (f=0.25, p=0.05, power = 0.8). Factoring 
for dropout witnessed in the pilot study (40%) this yields a sample of 140 patients (70 per ERS arm).  
 
Between-group effects (ERS arms vs no treatment control) 
It is estimated that a larger effect size would occur between the ERS arms and the no treatment control, it was 
therefore decided we did not need to recruit as many participants. To identify a difference of 3.2 units 
(ml.kg.min-2; 0.3 units smaller than the within-subjects change seen in the previous pilot for fitness to allow 
for some variance) between the ERS arms and a no treatment control arm a sample of 17 would be required 
(f=0.5, p=0.05, power = 0.8). Factoring for dropout witnessed in the pilot study (40%) this yields a sample of 
30 patients for the no treatment control arm. 
 In summary, the study will aim to recruit 70 patients for the intervention condition, 70 for the usual care 
condition and 30 for the no treatment control.  
ERPs. All ERPs responsible for delivering the ERS at Centre A (n=4-5) and Centre B (n=2-3) will be invited to 
take part.      
 
Measures 
Demographic measures 
Demographic measures collected at baseline will include: date of birth, sex, postcode, employment status, 
ethnicity, referral reason, referring professional, and number of previous referrals. 
 
Outcome measures 

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a All patient outcome data will be collected at two time-points: pre-intervention (prior to an induction with an 
ERP) and at Week 12 (post 12-week consultation with an ERP). b At 6-month follow-up, questionnaire-based 
measures and PA levels (determined by an accelerometer worn for 7 days), only will be collected. All data will 
be collected and analysed by a researcher at LJMU.  All outcome measures were piloted in a previous study 
(REF 16/WA/0231) and were deemed acceptable by patients and demonstrated adequate sensitivity to detect 
change. 
 
a Collected at Baseline and week 12 
b Collected at Baseline, week 12 and 6-month follow-up 
 
a Cardiorespiratory Fitness. A sub-maximal VO2 test (Astrand Rhyming test) will be carried out to estimate 
cardiorespiratory fitness. The Astrand Rhyming test allows you to predict VO2max from work intensity and 
heart rate. Following a warm-up (unloaded cycling 3-5 minutes at 50-60 rpm) the procedure will begin. Using 
a Polar Heart Rate Monitor to measure heart rate, the individual will begin cycling at 60 rpm with a workload 
of 60 watts (female) or 90 watts (male). The participant will then cycle at this workload for 6 minutes. Heart 
rate will be measured each minute; blood pressure will be measured at each 3-minute period as well as pre- 
and post-test. If the mean heart rate is between 125 and 170 beats per minute at minute 5 and 6, the test can 
be terminated. If the mean heart rate is less than 125 beats per minute, the workload will be increased by 30 
watts (0.5 kg). If the mean heart rate is less than 125 beats per minute at minute 5 and 6 the test will be 
continued for a further 3 minutes.  This procedure will be repeated until the required heart rate is achieved. 
The test will be stopped if the participant experiences any adverse effects, their heart rate exceeds 
recommended max heart rate values for this test, or if the participant wants to stop. 
 
b Objective PA levels. Objective PA will be analysed using an accelerometer (ActiGraph software), which will 
be fitted during baseline testing at LJMU. A baseline 7-day monitoring period will occur before participants 
engage with the scheme. During the 7-day monitoring period, each participant will complete a diary to record 
hours of use as well as distinguish between work and leisure hours.  
 
a Endothelial function. Flow-mediated dilation (FMD) and carotid vasoreactivity (cold pressor test) will 
measure artery function. These tests have been deemed non-invasive and strong predictors of CVD risk 
(Cunningham & Gotlieb, 2005; Rubenfire et al., 2000). The primary researcher will conduct these ultrasound 
tests with assistance and training from experts in the field of cardiovascular physiology (Prof Dick Thijssen).  
Flow mediated dilation. Endothelium dependent vasodilatation of the brachial arteries will be 
examined using ultrasound. Brachial artery baseline diameter and blood flow will be assessed in one arm. An 
ultrasound probe is placed on the bicep for 1 minute before a blood pressure cuff (placed around the forearm) 

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is inflated to suprasystolic pressure (~220 mmHg) for 5 minutes. Immediately after the cuff is deflated, changes 
in arterial diameter and flow will be assessed continuously for 3 minutes using the ultrasound probe.  
Carotid vasoreactivity. The carotid vasoreactivity (cold pressor) test will measure the carotid artery's 
response to a stimulus. Similar to the method above, an ultrasound probe will be placed on the patient's left 
side of their neck, positioned in such a way to allow a clear image of the right common carotid artery to be 
displayed on the ultrasound monitor screen. The cold pressor procedure involves submersion of the left hand 
to wrist in ice slush for 180-seconds. Ultrasound data will then be analysed post hoc. 
 
a Blood Profiles. A 15ml blood sample will be taken. The primary researcher for this study will complete all 
phlebotomy and has completed the relevant LJMU training as well as having previous experience working as 
a physiologist collecting blood samples among other health-related measures. Blood profiles will be analysed 
as a measure of cardiometabolic health. Analysis will be conducted at LJMU. Patients will be made aware of 
the storage and use of their tissue. Blood analysis will include: glucose, insulin, cholesterol (Total, HDL and 
LDL), lipids, triglycerides, CRP and homocysteine.  
 
b Lifestyle questionnaire. Information regarding patients’ lifestyle will be collected via questions related to 
dietary habits (e.g. number of fizzy drinks per week, amount of processed meat etc.), alcohol consumption, 
smoking status, as well as any services the patient may be receiving lifestyle support from. 
 
b Self-reported PA. Patients’ perceived PA levels will be recorded with the short version of the International 
Physical Activity Questionnaire (IPAQ, Craig et al., 2003). The short-IPAQ is a 7-day recall self-administered 
tool that measures intensity, frequency and duration of PA and provides a total estimate of energy expenditure.  
A total score of MET-minutes/day/week and sedentary behaviour minutes/day/week will be calculated 
according to the IPAQ scoring protocol.  
 
b Psychological wellbeing. Psychological wellbeing will be measured using the Warwick-Edinburgh Mental 
Well-being Scale (WEMWBS, Tennant et al., 2007). WEMWBS is a 14-item positively worded instrument 
containing items related to psychological functioning (e.g. “I’ve been thinking clearly”) and subjective well-
being (e.g. “I’ve been feeling cheerful”).  Participants are asked to rate on a Likert scale of 1 (none of the time) 
to 5 (all of the time) how well each statement describes their experiences over the last two weeks. 
 
b PA motivation. The Behavioural Regulation in Exercise Questionnaire (BREQ-2, Markland & Tobin, 2004) plus 
4 additional items (Wilson et al., 2006a) will be used to assess PA motivation. The BREQ-2 is a widely-used 
instrument comprised of 19 items describing reasons why people exercise (e.g. “I think exercising is a waste 

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of time”; “I feel ashamed when I miss an exercise session”; “I exercise because it’s fun”).  Participants answer 
on a likert scale of 0 (not true for me) to 4 (very true to me) to indicate how true each item is for them.  
b Psychological needs satisfaction. Psychological need satisfaction will be measured using the Psychological 
Need Satisfaction in Exercise Scale (PNSE, Wilson et al., 2006b). The PNSE is an 18-item instrument designed 
to measure participants’ perceived autonomy (e.g. “I feel free to exercise in my own way”), competence (e.g. 
“I feel capable of completing exercises that are challenging to me”) and relatedness (e.g. “I feel connected to 
the people who I interact with while we exercise together”) in an exercise context.  Participants are asked to 
answer on a 6-point likert scale (1 = false, 6 = true) to indicate how they typically feel when they exercise.  
b Perceived needs support. Needs support will be measured using a 15-item needs support (NS) tool developed 
by Markland and Tobin (2010) to measure the extent to which participants perceive their exercise instructors 
provide support for autonomy, structure (linked to competence) and involvement (linked to relatedness). 
b Intentions to engage in PA.  Three items developed by Edmunds et al. (2007) will be used to assess patients’ 
intentions to engage in PA (e.g. “I plan to regularly engage in PA during the next 3 months”).   
 
Process Measures (intervention and usual care groups, unless otherwise noted)  
 
Attendance at consultations. Patient attendance records will be collected by ERPs at the following time-points:   
- Intervention centre: induction, 4,8,12 and 18 weeks;  
- Usual care centre: induction and 12 weeks. 
 
Attendance at fitness centre. The number of times patients sign in at the leisure centre to go to either the 
gym or a class will be recorded on a weekly basis for weeks 1 to 12, then on a monthly basis up to 6 months. 
This information is automatically recorded at leisure centres when patients visit.  
 
Patient focus groups. Focus groups will be conducted with a purposeful subsample of patients after 
approximately 6-12 weeks of attending the scheme (e.g. those with low attendance, high attendance, 
significant health changes, no change etc.). Two focus groups will be conducted with patients attending the 
intervention centre (approx 5-8 participants per group) and two focus groups will be conducted with patients 
attending the usual care centre (approx 5-8 participants per group) (20-32 participants in total). Focus groups 
will be conducted at the individual fitness centres and will last approximately 60 minutes. Discussion will focus 
on the extent to which, and how, patients feel each ERS is facilitative (or not) in helping them become more 

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physically active, with questions about staff interactions, activities on offer, and the impact of the scheme on 
their likely continuation with PA.    
ERP interviews (intervention group only).  ERPs from the intervention centre only will take part in a semi-
structured interview (after over half of patients have reached the 18-week point) to explore the acceptability 
of the co-developed intervention and any challenges of delivery, areas that require further development etc.    
Fidelity. Fidelity of intervention delivery will be measured in two ways: 
1. ERPs from both intervention and usual care centres will be asked to monitor the number of 
consultations offered (measured by appointment bookings or records of appointments offered but 
declined by participants), and the number of consultations conducted for each patient.   
2. A random sample of ERS inductions from both intervention and usual care centres (approx 10 per 
centre) plus a random sample of 4, 8, 12 and 18-week consultations from the intervention centre only 
will be audio-recorded and coded for the use of “needs-supportive” communication strategies (using 
a coding manual developed through a previous pilot study (REF 16/WA/0231)). In addition, all 
intervention centre recordings will be coded for fidelity to an agreed protocol, e.g. asking required 
questions about physical activity, setting an action plan, giving out patient log book etc.     
 
Economic evaluation measures 
Please refer to the detailed economic evaluation information sheet attached if you require more information. 
Methods 
A trial- and model-based economic evaluation will be conducted from the public sector perspective, which will 
include the costs and consequences to the: local authority, NHS and PSS, and local authority leisure centre. 
Results from all analyses will be reported in the form of an incremental cost-effectiveness ratio. Firstly, a cost-
utility analysis will be carried out with the results being presented as cost per quality adjusted life year. 
Secondly, a cost-effectiveness analysis will be carried out with the results being presented as cost per active 
participant. Lastly, a cost-consequence analysis will be conducted from a broader perspective, which will 
highlight relevant public sector and participant costs and consequences. More specifically, the main analysis 
will be done by exploring the costs and effects over a lifetime horizon, using a decision-analytic model. All 
costs and effects over the lifetime horizon will be discounted at a rate of 3.5% as recommended in the NICE 
reference case (NICE, 2017). The 6-month effectiveness data for change in physical activity level, as well as 
published secondary data sources on change in disease state will be input into the model. The extrapolated 
analysis will aim to estimate the relative risk of participants being in one of the following six health states 10 
years after the intervention: healthy, dead, has had a stroke, has coronary heart disease (CHD), or has type 2 
diabetes (T2D). The 10-year duration of effect period is a conservative approach, which has been based on a 
recently published study (Campbell et al. 2015) that was identified in the systematic review. All 

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epidemiological data along with additional published secondary data on the life expectancy, health-related 
quality of life and treatment costs associated with each of the six health states will be input into a Markov 
Model. Uncertainty will be assessed through deterministic and probability sensitivity analyses. 
 
Data collection 
Resource use measures. Direct costs to the local authority will be measured, these will include the annual cost 
of operating the intervention, and the set up costs. A breakdown of these costs will be requested from the 
local authority. Any additional costs will be captured through a questionnaire completed by key staff 
coordinating the Exercise Referral Scheme at the local authority, local authority leisure centre, and research 
institute delivering the training. Indirect short-term cost savings to the NHS and PSS will be captured via health 
care utilisation questionnaires completed by the participants at baseline, and at 6 months follow up. The long-
term indirect cost savings to the NHS and PSS through a reduction in coronary heart disease, stroke and type 
2 diabetes will be sources from secondary data. A short telephone interview will be conducted with the leisure 
centre manager to identify whether the centre experienced a loss in revenue as a result of providing the 
Exercise Referral Scheme. Participant out of pocket and productivity costs will be captured through self-
reported questionnaires at baseline, 12 weeks, and 6 months from baseline. All questionnaires and telephone 
interview questions are adapted from validated measurement tools from the Database of Instruments for 
Resource Use Measurement. Apart from room hire, primary data will not be collected for common overhead 
operating costs, such as lighting and heating; however, these costs will be explored in the sensitivity analysis, 
for instance by estimating the hours of the intervention and increasing the salary rates of staff by 10% to 
include overheads. Unit cost prices will be sources from secondary sources. 
 
b Economic evaluation measures (attached: located at the end of Booklet 2): 
 
Health-related quality of life measure. Participants’ change in health-related quality of life (HRQoL) will be 
measured at baseline, 12 weeks, and 6 months. The EQ-5D will be used, this is a validated tool for measuring 
HRQoL. This tool has been applied successfully in a recent UK trial-based economic evaluation of exercise 
referral schemes (Edwards et al. 2013).  
 
Intervention operating and set up costs. Captured via telephone interview with Exercise Referral Scheme 
Personnel from (organisation e.g. local authority/ leisure centre/ research institute; questions adapted from 
validated questionnaire). 
 

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Loss in revenue costs. Captured via telephone interview with leisure centre manager and/or coordinators 
(questions have been used in previous research).  
 
Patient costs. Captured via patient questionnaire during lab testing (questions adapted from validated 
questionnaire).  
 
Patient Health care utilisation costs. Captured via questionnaire (questions adapted from validated 
questionnaire). 
 
Patient procedure  
LJMU lab-based measures. Written informed consent will be gained prior to the commencement of testing, 
when patients arrive at LJMU for baseline testing with a researcher. Patients will need to be rested for 20 
minutes prior to initiation of the ultrasound techniques. During this period, demographic data will be collected 
in addition to information about PA levels, mental wellbeing, diet, smoking and alcohol habits, psychological 
questionnaires and economic-related questions (~30 minutes; see attached Booklet 1 and Booklet 2). 
Ultrasound measures will then be conducted (FMD and CAR): 25 minutes. A 15ml blood sample will be taken 
from the antecubital fossa (5 minutes). The participant will then be able to drink and eat, if they wish, prior to 
completing a sub-maximal fitness test (20 minutes). The patient will then be informed about the 
accelerometry protocol and given the Actigraph monitor with accompanying diary to be completed over a 
seven-day period (5 minutes). For the ERS arms, the accelerometer and accompanying diary will be returned 
to the ERP when the patient attends their referral induction at Centre A or Centre B to begin their programme. 
The control group participants will return the monitors to LJMU in person or by pre-paid mail. The expected 
period to complete baseline testing is ∼90-120-minutes.  
Lab based testing will be repeated at week 12 as per the protocol for baseline data collection described above. 
At 6 months from baseline, participants will be sent (by mail) a questionnaire pack (booklet 2) and an activity 
monitor. These will be returned via pre-paid mail or as otherwise organised with the researcher.  
 
Protocol for incidental disclosures or abnormal test results 
Disclosure of unhealthy lifestyle – Whilst it is not deemed appropriate for researchers to pass on lifestyle 
information disclosed in confidence, or to provide individual advice, it is recognised that the research team 
have a responsibility to provide evidence-based information to allow patients to make informed decisions 
about their health. Therefore, after completing their baseline assessments at LJMU participants will each be 
given a simple information sheet that outlines the recommended guidance on PA and diet as well as risks 
associated with smoking and alcohol. On the sheet participants will be signposted to relevant government 

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websites for further information and will be advised to contact their GP if they have any concerns about their 
own lifestyle.   
Abnormal test results. 
The laboratory-based testing is not diagnostic in nature and is therefore not likely to find anything alarming. 
However, if any abnormal blood results (analysed following week 12 testing) are identified, the researcher will 
write to the individual participant and ask them to see their GP. Refer to attached patient letter. 
 
Analyses 
Statistical analysis of the primary and secondary outcomes will be conducted using linear mixed models in 
SPSS Statistics Version 23 (SPSS Inc., IBM Corp., Armonk, NY), with alpha levels set at P < .05. The models will 
be used to assess the impact of treatment (co-developed ERS, usual care ERS, and no treatment control), time 
(baseline and post-tests), and Group × Time interactions. Mixed models are robust to the biases of missing 
data and provide appropriate balance of Type 1 and Type 2 errors. Mixed-model analyses are consistent with 
the intention-to-treat principle, assuming the data are missing at random. Appropriate variables including 
baseline values will be included as covariates in the models. The data will be screened for skewness and 
kurtosis prior to commencing any analyses. Magnitude-based inferences will be used to investigate ‘clinical 
meaningfulness’ of results  (Batterham and Hopkins 2006).  
 
Focus groups and interviews will be recorded and transcribed verbatim (where they will be anonymised). They 
will then be analysed using NVivo electronic software using a thematic approach to allow common themes to 
arise from the data collected. Members of the research team will review the data independently and meet to 
reflect on the emerging themes, discuss rationale for coding decisions, areas of disagreement and theoretical 
concepts that emerge. 
 
REFERENCES: 
Anokye, N., Lord. J.,  Fox-Rushby. J. (2012). National Institute for Health and Clinical Excellence Public Health 
 
Intervention Guidance on Physical Activity- Brief advice for adults in primary care: Economic 
 
Analysis. Available at:  https://www.nice.org.uk/guidance/ph44/chapter/about-this-guidance 
 
Accessed 01.11.2017 
Batterham, A.M., Hopkins, W.G. (2006) ‘Making meaningful inferences about magnitudes.’, International 
 
journal of sports physiology and performance, 1(1), 50–7. 
Beecham, 
J., 
and 
Knapp. 
M. 
(1997). 
Client 
Service 
Receipt 
Inventory. 
Available 
at: 
 
http://www.dirum.org/assets/downloads/634462388066137028-CSRI.pdf Accessed 01.11.2017 

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Beck, F., Gillison, F., Koseva, M., Standage, M. (2016) ‘The systematic identification of content and delivery 
 
style of an exercise intervention’, Psychology & Health, 31(5), 605–621. 
Craig, P., Dieppe, P., Macintyre, S., Michie, S., Nazareth, I., & Petticrew, M. (2008). Developing and evaluating 
complex interventions: the new Medical Research Council guidance. BMJ, 337, a1655. 
Cunningham, K., & Gotlieb, A. (2005) ‘The role of shear stress in the pathogenesis of 
 
atherosclerosis.’, Laboratory investigation; a journal of technical methods and pathology, 85(1),9-23. 
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