Motivate: A Web Based Intervention to Increase Attendance at an Eating Disorder Service
Phase: NA
Conditions: Eating Disorders
Sponsor: Bournemouth University

MOTIVATE: A WEB-BASED INTERVENTION 
Registration: NCT02777944 
Date of document: 23.07.2018 
 
 
 

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Impact of a web based intervention (Motivate) to increase attendance at an eating disorder 
service assessment appointment: a zelen randomised control trial 
 
James Denison-Day1, Sarah Muir1, Ciaran Newell2, Katherine M Appleton1 
Affiliations:  
1. Research Centre for Behaviour Change, Psychology Department, Bournemouth University  
2. Dorset Healthcare University NHS Foundation Trust 
 
Methods 
Design 
 
The research was conducted using a two arm single-consent Zelen randomised control trial. 
A zelen randomised consent design (Zelen, 1979), which involves randomising participants 
prior to consent and then only collecting consent from those in the active condition, was 
proposed as the most ethical and appropriate approach for answering the research question 
for several reasons. Firstly people with eating disorders are often highly ambivalent about 
recovery (Leavey, Vallianatou, Johnson-Sabine, Rae & Gunputh, 2011), and as such adding 
trial consent, particularly with the knowledge that they may not receive the active 
condition, at a time that might be challenging for this group could be deemed unethical. The 
addition of full consent prior to randomisation ran the risk of resentful demoralization 
within the control group, potentially increasing the rate of non-attendance at assessment 
appointments. Hawthorne effects, which result in participants changing their behaviour as a 
result of knowing they are being observed may also occur (Payne & Payne, 2004). These 

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would not only have implications for the validity of the study, it may also pose significant 
risks to the health and wellbeing of the patient and their loved ones. As such the use of a 
Zelen design reduces biases such as those caused by resentful demoralization and 
Hawthorne effects. It also allowed for a trial that more closely replicates what would 
happen in usual clinical practice.  
 
Recruitment 
 
No active recruitment took place for the study. All adult referrals to the Kimmeridge Court 
Eating Disorders service, Dorset, UK, over the period of one year (24/10/17 - 23/10/18) 
were identified for potential inclusion in the study. This time period was chosen to ensure 
that results were not affected by seasonal variations. No power calculations were done due 
to limited previous literature directly relating to this research, however a post-hoc power 
analysis was conducted and is presented in the discussion section. Participants were 
referred to the eating disorder service by a health professional as part of the usual referral 
process. Upon referral to the service, patient information was checked by the eating 
disorders service staff against the following inclusion/exclusion criteria:  
Inclusion criteria  
 
1) Referrals to the eating disorders service during the study period. 
Exclusion criteria 
 
1) Inpatients or emergency and urgent cases. 
2) Patients who have already been randomised into the study. 

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3) Non English speakers 
 
All eligible referrals were then randomised into the study using the randomisation 
procedure outlined below.   
 
 
Control Condition (Treatment As Usual) 
 
Participants randomized to the control condition received standard care. This consisted of a 
phone call from service centre staff, with details of participants' assessment appointments, 
a letter, plus a compliments, comments, concerns and complaints leaflet sent to their home 
address.  
 
Intervention Condition (MotivATE) 
 
Participants randomized to the intervention condition received standard care, plus the 
opportunity to access MotivATE (Muir et al, 2017). MotivATE is delivered via four 15-20 
minute web-based modules designed to be used prior to an assessment appointment. The 
content and aims of these modules is briefly outlined in table 1. Screenshots of different 
sections of MotivATE can be found in the supplementary materials. 
Table 1: Content of MotivATE 
Module 
Aim 
Description 

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1 – What happens at 
the first appointment? 
Address 
expectations about 
the assessment 
appointment 
Provides an interactive quiz to explore 
common misconceptions about 
assessment, information about the 
assessment appointment and stories and 
videos about others’ experiences.   
2 – How motivated 
are you? 
Introduce the idea 
of change 
Introduces people to the stages of change 
model with stories of others’ experiences. 
User can choose their stage of change. 
3 – Arming yourself 
with information 
Help with 
recognising 
problematic 
behaviours (pre-
contemplation).  
Address 
ambivalence  
Information about eating disorders that 
relate to the pros and cons of eating 
disorders. Those who have selected a 
contemplation or preparation stage of 
change can complete their own pros and 
cons table and complete exercises 
designed to address ambivalence. Again, 
stories of others’ experiences of an eating 
disorder are included. 
4 – Preparing for your 
assessment 
Improve 
confidence to 
attend 
Includes a video of a clinician welcoming 
them to the assessment and allows users to 
make plans to attend their appointment.  
 
Access to Motivate was offered in addition to treatment as usual via an invitation letter to 
access MotivATE. The MotivATE invitation letter included a brief outline of MotivATE, the 

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participant’s ID number to be used at registration and the URL to access the intervention 
online.  
 
Outcomes 
 
Our primary outcome was attendance at initial assessment appointment. This was assessed 
using NHS audit data from the eating disorders service, to result in the number of DNA's 
(Did Not Attends) in the MotivATE group versus the control group.  
Secondary outcomes were: 
 a) engagement with the intervention, which was examined using data on the number of 
sessions completed by each participant and time spent accessing them generated by the 
intervention.  
b) Participants’ perceptions of MotivATE and the perceived impact of MotivATE on their 
motivation to attend assessment. This was assessed using qualitative data collected from 
participants from the MotivATE group in semi-structured interviews. Participants in were 
given the opportunity to opt-in to take part in a semi-structured qualitative interview upon 
registering with the intervention. This triggered an automated email following the 
participants assessment appointment which outlined the details of the interview and invited 
participants to take part. At the midpoint of the study, a second follow up email, sent out 
two weeks after the initial invitation was also added in an attempt to improve uptake. 
 Due to the nature of the study design, no baseline measures or demographics were 
collected. 
 

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Initial Assessment Appointment 
The initial assessment for both conditions was the same, constituting usual care, with 
attendance at this appointment being assessed using routine audit data which will be added 
to the secure participant database by service staff. All treatment following the initial 
assessment was usual care and beyond the scope of this study. 
 
Randomisation, Allocation Concealment and Blinding 
 
Study relevant information were placed in blank envelopes labelled with participant ID 
numbers. Participants were pre-randomised using block randomisation into the intervention 
or control arms by a member of the research team not directly involved in conducting the 
study (KMA). This was achieved by generating a random number string from Random.org 
which was then broken down into consecutive blocks of eight digits, and manually balanced 
to ensure even allocation in each block. The number sequence was then followed 
sequentially for each batch of participant invitation envelopes, which were numbered 
sequentially with ascending participant ID numbers, in order to assign the relevant study 
arm. 
As participants were referred to the service they were assigned a participant ID 
incrementally by the service centre staff.  Opaque envelopes containing the relevant 
information for each condition were appropriately labelled with participant numbers, 
allowing them to be included with the invitation to assessment letter by service staff.  
Service staff maintained a single, secure record linking the participant’s name to their 
unique participant ID. Once all participants had passed through the study, outcome data 

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was added to the secure record by service staff and any personal identifiers removed prior 
to this document being delivered to the research team.  
 
 
Analysis  
 
Initial analysis was conducted on an intention-to-treat basis with all data categorised 
according to the original allocation using a 2-sided 5% significance level. To examine the 
research question, a logistic regression was conducted.  The independent variable for this 
analysis was the allocated condition (MotivATE/Treatment as usual); the dependent variable 
was attendance at assessment ('attended' and 'did not attend').  Additionally a follow up 
analysis was conducted to compare attendance between those who registered, or did not 
register, with MotivATE amongst participants within the MotivATE condition. 
Usage data from the MotivATE condition was analysed using descriptive statistics in order to 
explore the number of participants who registered with the intervention, as well as how 
many of the intervention modules were accessed by users. 
Qualitative data were originally to be analysed using thematic analysis (Braun & Clarke, 
2006). However as a result of poor recruitment to this aspect of the study it was not 
possible to complete a full analysis of the data. Data were analysed as case studies instead. 
 
Ethical Approval 
 
The research gained HRA approval (Ref: 16/SC/0431) from the Hampshire A Ethics 
Committee, and was registered on Clinicaltrials.gov (Trial number: NCT02777944 
(19/05/2016)) prior to commencement .