Eating Disorders in AdolescenceNCT04552639
Evaluation of Compulsive Exercise Group Therapy for Eating Disorders
A study testing Newbridge Eating disorders Activity Treatment group and Newbridge House treatment as usual in people with Eating Disorders in Adolescence, run by Newbridge House at 1 site in United Kingdom.
Trial summary
The study aims to generate hypotheses about whether a group intervention is effective in reducing motivation to compulsive exercise and/or eating disorder psychopathology when compared with a control group. This will be explored through a Randomized Control Trial. Read more about this study
- Who is it for?
- Ages 11 to 18 years, women only
- Conditions the study is for
- Eating Disorders in Adolescence
- What is being tested?
- Newbridge Eating disorders Activity Treatment group and Newbridge House treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2020to 31 Dec 2022
- Phase
- Interventional
- 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 11 to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Inpatients at Newbridge House
- Aged 11-18
- Primary diagnosis of any form of eating disorder
- Females
Who cannot join
- Previously received NEAT group at Newbridge House
- Aged under 10 years
- Severe learning disability
- Inpatients without compulsive exercise behaviours
- Day patients
- Co-morbid psychosis
- Males
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Newbridge House
Birmingham, B74 3NE
Rachel Matthews, 01212273891 ext. 01212273891, rachel.matthews@newbridge-health.org.uk
Hubert Professor Lacey, 01212273891 ext. 01212273891, jhubertlacey@hotmail.com
About this study
Official title: A Randomized Control Trial Study Evaluating a Compulsive Exercise Group for Adolescent Inpatients With Eating Disorders
The study aims to generate hypotheses about whether a group intervention is effective in reducing motivation to compulsive exercise and/or eating disorder psychopathology when compared with a control group. This will be explored through a Randomized Control Trial.
- Conditions
- Eating Disorders in Adolescence
- Being tested
- Newbridge Eating disorders Activity Treatment group, Newbridge House treatment as usual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Newbridge Eating disorders Activity Treatment groupBehavioural
A compulsive exercise cognitive-behavioural based group, for children and adolescents diagnosed with an eating disorder. It was devised for eating disorders including Anorexia Nervosa, Bulimia Nervosa and Other Specified Feeding or Eating Disorder. This treatment is semi-structured and problem-oriented, which focuses on tackling the factors and processes that maintain compulsive exercise behaviour.
Newbridge House treatment as usualBehavioural
Multi-disciplinary eating disorder treatment (including; psychiatry, individual therapy, group therapy, dietetic support, occupation therapy and nursing excluding NEAT group).
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual | Active comparator | Treatment as usual is offered. This includes; individual therapy, group therapy, dietetic support, occupational therapy, nursing and psychiatry, excluding the NEAT group. Receives: Behavioral: Newbridge House treatment as usual |
| Treatment as usual and NEAT group | Experimental | Treatment as usual is offered. This includes; individual therapy, group therapy, dietetic support, occupational therapy, nursing and psychiatry, alongside NEAT group. Receives: Behavioral: Newbridge Eating disorders Activity Treatment group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Compulsive Exercise Test
Measured: Week 1 and week 7
Secondary outcomes (1)
Change in Eating Disorder Examination Questionnaire
Measured: Week 1 and week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start1 Oct 2020
- Primary completion1 Oct 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating Disorders in AdolescenceStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Newbridge House
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gurdeep Aulakh, Newbridge House
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04552639
- Sponsor's protocol ID
- 281456
- Status last verified
- Sep 2021
- First submitted
- 21 Aug 2020
- Last updated
- 2 Sep 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 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial Study Evaluating a Compulsive Exercise Group for Adolescent Inpatients With Eating Disorders
- ClinicalTrials.gov ID
- NCT04552639
- Acronym / sponsor ID
- 281456
- Conditions
- Eating Disorders in Adolescence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Newbridge HouseUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 17 Sep 2020 (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 study aims to generate hypotheses about whether a group intervention is effective in reducing motivation to compulsive exercise and/or eating disorder psychopathology when compared with a control group. This will be explored through a Randomized Control Trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | Active comparator | Behavioral: Newbridge House treatment as usualTreatment as usual is offered. This includes; individual therapy, group therapy, dietetic support, occupational therapy, nursing and psychiatry, excluding the NEAT group. |
| Treatment as usual and NEAT group | Experimental | Behavioral: Newbridge Eating disorders Activity Treatment groupTreatment as usual is offered. This includes; individual therapy, group therapy, dietetic support, occupational therapy, nursing and psychiatry, alongside NEAT group. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Inpatients at Newbridge House
- Aged 11-18
- Primary diagnosis of any form of eating disorder
- Females
Key exclusion criteria (7 listed)
- Previously received NEAT group at Newbridge House
- Aged under 10 years
- Severe learning disability
- Inpatients without compulsive exercise behaviours
- Day patients
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 |
|---|---|---|
| Newbridge Eating disorders Activity Treatment groupA compulsive exercise cognitive-behavioural based group, for children and adolescents diagnosed with an eating disorder. It was devised for eating disorders including Anorexia Nervosa, Bulimia Nervosa and Other Specified Feeding or Eating Disorder. This treatment is semi-structured and problem-oriented, which focuses on tackling the factors and processes that maintain compulsive exercise behaviour. | Behavioural | Treatment as usual and NEAT group |
| Newbridge House treatment as usualMulti-disciplinary eating disorder treatment (including; psychiatry, individual therapy, group therapy, dietetic support, occupation therapy and nursing excluding NEAT group). | Behavioural | Treatment as usual |
Primary outcome
Change in Compulsive Exercise Test
Time frame: Week 1 and week 7
1 secondary outcome
Change in Eating Disorder Examination Questionnaire
Time frame: Week 1 and week 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 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.
Newbridge House
Birmingham, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Newbridge Eating disorders Activity Treatment group and Newbridge House treatment as usual in people with Eating Disorders in Adolescence, run by Newbridge House 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 4 inclusion and 7 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 2 Sep 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Compulsive Exercise Test (time frame: Week 1 and week 7). 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 2 Sep 2021.