Feeding and Eating Disorders of ChildhoodL-FEDNCT03946540
Longitudinal Follow Up of Eating Disorder Treatment
An observational study of Feeding and Eating Disorders of Childhood and Anorexia Nervosa, run by South London and Maudsley NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The research proposed here seeks to delineate the outcomes of people who have received treatment for an eating disorder at a specialist eating disorder service in childhood or adolescence (hereafter 'former patients'). Read more about this study
- Who is it for?
- Ages 16 to 30 years
- Conditions the study is for
- Feeding and Eating Disorders of Childhood, Anorexia Nervosa, Bulimia Nervosa
- How many people
- 159 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Jul 2019to 28 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: People who were assessed and offered treatment at the National and Specialist CAMHS Eating Disorder Service, South London and Maudsley NHS Foundation Trust between 1/8/2009 and 31/1/2014
Who may be able to join
- People who were assessed and offered treatment at the National and Specialist CAMHS Eating Disorder Service, South London and Maudsley NHS Foundation Trust between 1/8/2009 and 31/1/2014.
Who cannot join
- young people who were referred for treatment but did not attend assessment
- young people who were referred for treatment but did not meet criteria for an eating disorder
- young people who were referred for treatment but did not accept treatment (or attended for fewer than 3 sessions).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Maudsley Centre for Child and Adolescent Eating Disorders
London, SE5 8AZ
About this study
Official title: Follow up of Young People Treated in CAEDS 2009-2014. Longitudinal Follow Up of Eating Disorder Treatment
The research proposed here seeks to delineate the outcomes of people who have received treatment for an eating disorder at a specialist eating disorder service in childhood or adolescence (hereafter 'former patients'). This will inform our understanding of the maintenance of treatment effects beyond initial trial follow-ups, and together with data collected during treatment will allow for identification of factors predicting chronicity which will inform further treatment development.
Read the detailed description
Research Questions
- Is recovery from an eating disorder in adolescence maintained and associated with good socio-economic outcomes?
- Is poor outcome from eating disorder treatment in adolescence associated with a chronic course of illness?
- Are there factors measured during treatment that predict maintenance of outcome or relapse?
This study will use a longitudinal follow up design, contacting former patients of the National and Specialist Child and Adolescent Mental Health Service (CAMHS) Eating Disorder Service, South London and Maudsley National Health Service (NHS) Foundation Trust (CAEDS) between 1/8/2009 and 31/1/2014. These former patients are now aged 16-27. The study will thus provide the longest and largest follow up of treated adolescents to date (n = 358 over a 4-8 year follow up). Former patients will be asked a series of questions by phone/post/email about their health and socio-economic well-being since discharge from the service. This data will be analysed together with assessment and outcome data collected while they were patients of CAEDS.
Measures Data will be collected using a data collection tool developed for this project, as well as the Eating Disorders Examination Questionnaire and the Work and Social Adjustment Scale.
Data collected will comprise:
- Age now
- Employment/education
- Any help sought for eating disorder
- Any help sought for other mental health difficulties
- Current weight
- Current binge/purge symptoms
- Current general well being All data will be self-reported by participants.
Statistical power The primary analysis will be descriptive. We will recruit as many of our original treatment group as possible.
A secondary analysis will be to predict who continues to require mental health care following discharge from CAEDS. Power has been calculated following Babyak's (2004) advice for power calculation for logistic regression of 13 events (continuing mental health care needs) per variable. We have taken figures from the original audit in which 24.1% (n = 69.89) had a poor outcome to hypothesise that a similar proportion of the sample at follow up will have a poor outcome. This is a conservative estimate given the chronicity of eating disorders in adulthood and the longitudinal data of on-going mental health difficulties even in the absence of diagnosable eating disorders. In order to run a logistic regression with 5 predictor variables will require 65 cases with on-going eating disorder symptoms. This will require recruitment of the majority of the original sample assuming the % of on-going difficulties remains the same. Depending on recruitment rate we will adjust analysis accordingly, and reduce the number of predictors in the model.
Data analysis
Planned analyses:
- Descriptive analysis of key health and socio-economic outcomes for all young people who received treatment in the audited timeframe and split by treatment outcome and diagnosis for between group analysis.
- Regression analysis to identify predictors of long term outcome from clinical variables measured at baseline assessment and service discharge (including weight, mood, anxiety, eating disorder symptoms)
- Medical subject headings
- Feeding and Eating Disorders of Childhood, Anorexia Nervosa, Bulimia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| L-FED sample | All young people treated in Maudsley Child and Adolescent Eating Disorder Service between 1/8/2009 and 31/1/2014. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receipt of further treatment for an eating disorder in the first four years after discharge from treatment
Self report of whether subsequent treatment for an eating disorder has been received since discharge. Self report of treatment received in the period between discharge and research follow up - including number and duration of outpatient treatment, hospital admission and day patient treatment. The four year outcome is the primary outcome as it allows for the most complete dataset for follow up.
Measured: From discharge from service to L-FED research assessment. Discharges between 2009 and 2014 (4-10) year follow up. Proportion of sample needing treatment in the first four years post discharge will be reported
Eating Disorder Examination Questionnaire (EDEQ). Fairburn & Beglin, 1994
Self reported eating disorder symptoms. This is a 28 item self report questionnaire which is scored using a 7 - point (0-6) rating scale. Four subscales are derived through adding together relevant items and diving by the number of items to give a score range for each subscale of 0-6. A total score is derived by adding together the subscales and diving by the number of subscales (ie 4) also giving a score range of 0-6. Higher scores indicate greater impairment.
Measured: 28 days prior to L-FED research assessment
Work and social adjustment scale (WSAS) Mundt, J. C., I. M. Marks, et al. (2002).
Self reported impact of symptoms on functioning. This is a self report measure of the impact of illness on work and social functioning. It is a five item questionnaire with each item scored 0-8 giving a total score range of 0-40 where high scores indicate greater impairment.
Measured: At time of L-FED research assessment. Discharges between 2009 and 2014 (4-10) year follow up. Variation in time since discharge will be stratified in analysis.
Secondary outcomes (2)
Receipt of treatment for an eating disorder >4 years after discharge from treatment
Self report of whether subsequent treatment for an eating disorder has been received since discharge. Self report of treatment received in the period between discharge and research follow up - including number and duration of outpatient treatment, hospital admission and day patient treatment. >4 years post treatment is a secondary outcome because for some participants will not have been out of treatment for more that 5 years. We will report on the proportion of those who have been discharged for each time period who have required subsequent treatment (eg % of those discharged for 8+ years who have required further treatment)
Measured: From four years post discharge from service to L-FED research assessment. Proportion
Psychosocial wellbeing
Self report questionnaire assessing function and well-being. This is a study specific tool which measures education, employment, and subjective experience of well-being.
Measured: At time of L-FED assessment.Discharges between 2009 and 2014 (4-10) year follow up. Variation in time since discharge will be stratified in analysis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start14 Jul 2019
- Primary completion27 Jul 2020
- Study completion28 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding and Eating Disorders of ChildhoodStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- South London and Maudsley NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Catherine Stewart, South London and Maudsley NHS Foundation Trust
- Investigators
- Catherine s Stewart, }hD DClinPsy, Principal investigator, South London and Maudsley NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03946540
- Sponsor's protocol ID
- L-FED2019
- Acronym
- L-FED
- Status last verified
- Jan 2021
- First submitted
- 10 Apr 2019
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow up of Young People Treated in CAEDS 2009-2014. Longitudinal Follow Up of Eating Disorder Treatment
- ClinicalTrials.gov ID
- NCT03946540
- Acronym / sponsor ID
- L-FED / L-FED2019
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 159 participants (actual)
- Lead sponsor
- South London and Maudsley NHS Foundation TrustUniversity, hospital or other
- Study start
- 14 Jul 2019 (actual)
- Primary completion
- 27 Jul 2020 (actual)
- Study completion
- 28 Feb 2021 (estimated)
- First posted
- 10 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The research proposed here seeks to delineate the outcomes of people who have received treatment for an eating disorder at a specialist eating disorder service in childhood or adolescence (hereafter 'former patients'). This will inform our understanding of the maintenance of treatment effects beyond initial trial follow-ups, and together with data collected during treatment will allow for identification of factors predicting chronicity which will inform further treatment development.
Detailed description
Research Questions
- Is recovery from an eating disorder in adolescence maintained and associated with good socio-economic outcomes?
- Is poor outcome from eating disorder treatment in adolescence associated with a chronic course of illness?
- Are there factors measured during treatment that predict maintenance of outcome or relapse?
This study will use a longitudinal follow up design, contacting former patients of the National and Specialist Child and Adolescent Mental Health Service (CAMHS) Eating Disorder Service, South London and Maudsley National Health Service (NHS) Foundation Trust (CAEDS) between 1/8/2009 and 31/1/2014. These former patients are now aged 16-27. The study will thus provide the longest and largest follow up of treated adolescents to date (n = 358 over a 4-8 year follow up). Former patients will be asked a series of questions by phone/post/email about their health and socio-economic well-being since discharge from the service. This data will be analysed together with assessment and outcome data collected while they were patients of CAEDS.
Measures Data will be collected using a data collection tool developed for this project, as well as the Eating Disorders Examination Questionnaire and the Work and Social Adjustment Scale.
Data collected will comprise:
- Age now
- Employment/education
- Any help sought for eating disorder
- Any help sought for other mental health difficulties
- Current weight
- Current binge/purge symptoms
- Current general well being All data will be self-reported by participants.
Statistical power The primary analysis will be descriptive. We will recruit as many of our original treatment group as possible.
A secondary analysis will be to predict who continues to require mental health care following discharge from CAEDS. Power has been calculated following Babyak's (2004) advice for power calculation for logistic regression of 13 events (continuing mental health care needs) per variable. We have taken figures from the original audit in which 24.1% (n = 69.89) had a poor outcome to hypothesise that a similar proportion of the sample at follow up will have a poor outcome. This is a conservative estimate given the chronicity of eating disorders in adulthood and the longitudinal data of on-going mental health difficulties even in the absence of diagnosable eating disorders. In order to run a logistic regression with 5 predictor variables will require 65 cases with on-going eating disorder symptoms. This will require recruitment of the majority of the original sample assuming the % of on-going difficulties remains the same. Depending on recruitment rate we will adjust analysis accordingly, and reduce the number of predictors in the model.
Data analysis
Planned analyses:
- Descriptive analysis of key health and socio-economic outcomes for all young people who received treatment in the audited timeframe and split by treatment outcome and diagnosis for between group analysis.
- Regression analysis to identify predictors of long term outcome from clinical variables measured at baseline assessment and service discharge (including weight, mood, anxiety, eating disorder symptoms)
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| L-FED sample | – | –All young people treated in Maudsley Child and Adolescent Eating Disorder Service between 1/8/2009 and 31/1/2014. |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- People who were assessed and offered treatment at the National and Specialist CAMHS Eating Disorder Service, South London and Maudsley NHS Foundation Trust between 1/8/2009 and 31/1/2014
Key inclusion criteria (1 listed)
- People who were assessed and offered treatment at the National and Specialist CAMHS Eating Disorder Service, South London and Maudsley NHS Foundation Trust between 1/8/2009 and 31/1/2014.
Key exclusion criteria (3 listed)
- young people who were referred for treatment but did not attend assessment
- young people who were referred for treatment but did not meet criteria for an eating disorder
- young people who were referred for treatment but did not accept treatment (or attended for fewer than 3 sessions).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Receipt of further treatment for an eating disorder in the first four years after discharge from treatment
Time frame: From discharge from service to L-FED research assessment. Discharges between 2009 and 2014 (4-10) year follow up. Proportion of sample needing treatment in the first four years post discharge will be reported
Self report of whether subsequent treatment for an eating disorder has been received since discharge. Self report of treatment received in the period between discharge and research follow up - including number and duration of outpatient treatment, hospital admission and day patient treatment. The four year outcome is the primary outcome as it allows for the most complete dataset for follow up.
Eating Disorder Examination Questionnaire (EDEQ). Fairburn & Beglin, 1994
Time frame: 28 days prior to L-FED research assessment
Self reported eating disorder symptoms. This is a 28 item self report questionnaire which is scored using a 7 - point (0-6) rating scale. Four subscales are derived through adding together relevant items and diving by the number of items to give a score range for each subscale of 0-6. A total score is derived by adding together the subscales and diving by the number of subscales (ie 4) also giving a score range of 0-6. Higher scores indicate greater impairment.
Work and social adjustment scale (WSAS) Mundt, J. C., I. M. Marks, et al. (2002).
Time frame: At time of L-FED research assessment. Discharges between 2009 and 2014 (4-10) year follow up. Variation in time since discharge will be stratified in analysis.
Self reported impact of symptoms on functioning. This is a self report measure of the impact of illness on work and social functioning. It is a five item questionnaire with each item scored 0-8 giving a total score range of 0-40 where high scores indicate greater impairment.
2 secondary outcomes
Receipt of treatment for an eating disorder >4 years after discharge from treatment
Time frame: From four years post discharge from service to L-FED research assessment. Proportion
Psychosocial wellbeing
Time frame: At time of L-FED assessment.Discharges between 2009 and 2014 (4-10) year follow up. Variation in time since discharge will be stratified in analysis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Individual participant dataSharing planned: No
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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.
Catherine s Stewart, }hD DClinPsy principal investigator
South London and Maudsley NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Feeding and Eating Disorders of Childhood and Anorexia Nervosa, run by South London and Maudsley NHS Foundation Trust at 1 site in United Kingdom.
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: status not confirmed, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Receipt of further treatment for an eating disorder in the first four years after discharge from treatment (time frame: From discharge from service to L-FED research assessment. Discharges between 2009 and 2014 (4-10) year follow up. Proportion of sample needing treatment in the first four years post discharge will be reported). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2021.