Eating DisordersNCT02777944
Motivate: A Web-based Intervention
A study testing Motivate: a web-based intervention in people with Eating Disorders, run by Bournemouth University.
Trial summary
The aim of this study is to test whether MotivATE can increase attendance at assessment. This will be done using a single-consent Zelen randomised control trial, with all non-emergency adult clients referred to the Kimmeridge Courte Eating Disorder Service over a one year period being randomised to either treatment as… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Eating Disorders
- What is being tested?
- Motivate: a web-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 313 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Sep 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1) Referrals to the eating disorders service during the study period.
Who cannot join
- Inpatients or emergency and urgent cases.
- Patients who have already been randomised into the study.
- Non English speakers
About this study
Official title: Motivate: A Web Based Intervention to Increase Attendance at an Eating Disorder Service
The aim of this study is to test whether MotivATE can increase attendance at assessment. This will be done using a single-consent Zelen randomised control trial, with all non-emergency adult clients referred to the Kimmeridge Courte Eating Disorder Service over a one year period being randomised to either treatment as usual (TAU) or TAU plus access to the MotivATE intervention prior to their assessment appointment.
Read the detailed description
MotivATE is a web-based intervention intended to be delivered at the point of referral to an Eating Disorder (ED) service. The intervention focuses on managing expectations of assessment, addressing ambivalence and increasing users' motivation and confidence to attend their initial appointment. This is achieved through the use of information, motivational tools, interactive activities and stories from other individuals with EDs spread across four 15-20 minute modules. These modules have been evaluated by service-users who have an ED.
The aim of this study is to test whether MotivATE can increase attendance at assessment. This will be done using a single-consent Zelen randomised control trial, with all non-emergency adult clients referred to the Kimmeridge Courte Eating Disorder Service over a one year period being randomised to either treatment as usual (TAU) or TAU plus access to the MotivATE intervention prior to their assessment appointment.
Routine audit data will be collected to compare the number of people who attend their assessment appointment in the MotivATE group verses the control group. Usage data generated by the intervention will also be assessed. Twenty participants from the MotivATE group will be invited to give qualitative feedback about their experience of the intervention.
- Conditions
- Eating Disorders
- Being tested
- Motivate: a web-based intervention
- Keywords
- motivation, attendance
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivate: a web-based interventionBehavioural
A web-based intervention focuses on managing expectations of assessment, addressing ambivalence and increasing users' motivation and confidence to attend their initial appointment. This is achieved through the use of information, motivational tools, interactive activities and stories from other individuals with EDs spread across four 15-20 minute modules.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Access to Motivate: a web-based intervention, in addition to Usual Care Receives: Behavioral: Motivate: a web-based intervention |
| Control | No intervention | Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Attended Initial Assessment Appointment
Attendance at initial assessment appointment
Measured: 3 months
Secondary outcomes (2)
Number of Participants Who Accessed the Intervention Program
Number of participants who accessed the intervention program
Measured: 3 months
Number of Participants Who Volunteered to Provide Qualitative Feedback on the Motivate Program
Number of participants who volunteered to provide qualitative feedback on the Motivate Program
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study startOct 2016
- Primary completionFeb 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 313 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bournemouth University
- Sponsor type
- University, hospital or other
- Collaborators
- Dorset HealthCare University NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Katherine M Appleton, PhD, Study director, Bournemouth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02777944
- Sponsor's protocol ID
- PhDDay
- Status last verified
- Aug 2019
- First submitted
- 17 May 2016
- Last updated
- 29 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Group data will be publicly available on completion
Publications
Denison-Day J, Muir S, Newell C, Appleton KM. A Web-Based Intervention (MotivATE) to Increase Attendance at an Eating Disorder Service Assessment Appointment: Zelen Randomized Controlled Trial. J Med Internet Res. 2019 Feb 27;21(2):e11874. doi: 10.2196/11874.
PubMed 30810533
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivate: A Web Based Intervention to Increase Attendance at an Eating Disorder Service
- ClinicalTrials.gov ID
- NCT02777944
- Acronym / sponsor ID
- PhDDay
- Conditions
- Eating Disorders
- Keywords
- motivation, attendance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 313 participants (actual)
- Lead sponsor
- Bournemouth UniversityUniversity, hospital or other
- Collaborators
- Dorset HealthCare University NHS Foundation Trust
- Study start
- Oct 2016 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 19 May 2016 (estimated)
- Results
- Posted 31 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to test whether MotivATE can increase attendance at assessment. This will be done using a single-consent Zelen randomised control trial, with all non-emergency adult clients referred to the Kimmeridge Courte Eating Disorder Service over a one year period being randomised to either treatment as usual (TAU) or TAU plus access to the MotivATE intervention prior to their assessment appointment.
Detailed description
MotivATE is a web-based intervention intended to be delivered at the point of referral to an Eating Disorder (ED) service. The intervention focuses on managing expectations of assessment, addressing ambivalence and increasing users' motivation and confidence to attend their initial appointment. This is achieved through the use of information, motivational tools, interactive activities and stories from other individuals with EDs spread across four 15-20 minute modules. These modules have been evaluated by service-users who have an ED.
The aim of this study is to test whether MotivATE can increase attendance at assessment. This will be done using a single-consent Zelen randomised control trial, with all non-emergency adult clients referred to the Kimmeridge Courte Eating Disorder Service over a one year period being randomised to either treatment as usual (TAU) or TAU plus access to the MotivATE intervention prior to their assessment appointment.
Routine audit data will be collected to compare the number of people who attend their assessment appointment in the MotivATE group verses the control group. Usage data generated by the intervention will also be assessed. Twenty participants from the MotivATE group will be invited to give qualitative feedback about their experience of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Motivate: a web-based interventionAccess to Motivate: a web-based intervention, in addition to Usual Care |
| Control | No intervention | –Usual Care |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 1) Referrals to the eating disorders service during the study period.
Key exclusion criteria (3 listed)
- Inpatients or emergency and urgent cases.
- Patients who have already been randomised into the study.
- Non English speakers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivate: a web-based interventionA web-based intervention focuses on managing expectations of assessment, addressing ambivalence and increasing users' motivation and confidence to attend their initial appointment. This is achieved through the use of information, motivational tools, interactive activities and stories from other individuals with EDs spread across four 15-20 minute modules. | Behavioural | Intervention |
Primary outcome
Number of Participants Who Attended Initial Assessment Appointment
Time frame: 3 months
Attendance at initial assessment appointment
2 secondary outcomes
Number of Participants Who Accessed the Intervention Program
Time frame: 3 months
Number of Participants Who Volunteered to Provide Qualitative Feedback on the Motivate Program
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30810533Denison-Day J, Muir S, Newell C, Appleton KM. A Web-Based Intervention (MotivATE) to Increase Attendance at an Eating Disorder Service Assessment Appointment: Zelen Randomized Controlled Trial. J Med Internet Res. 2019 Feb 27;21(2):e11874. doi: 10.2196/11874.
- Individual participant dataSharing planned: No. Group data will be publicly available on completion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine M Appleton, PhD study director
Bournemouth University
Questions about this trial
What is this clinical trial studying?
A study testing Motivate: a web-based intervention in people with Eating Disorders, run by Bournemouth University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Attended Initial Assessment Appointment (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02777944, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2019.