Disordered EatingNCT01872169
Investigating Prevalence of Disordered Eating in Children With GI Disorders
A study testing Disordered eating screening questionnaire in people with Disordered Eating, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Gastroenterological disorders are disorders affecting the stomach, intestines and associated organs. Symptoms of these types of disorders vary but often include vomiting, diarrhoea, weight loss and loss of appetite. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Disordered Eating
- What is being tested?
- Disordered eating screening questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2013to Nov 2014
- 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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children/adolescents between the age of 5-17 and their parents who are attending the Gastroenterological Clinic. We will recruit all patients that fall within the age range, including both new patients and existing patients.
Who cannot join
- Parents/ adolescents unable to communicate English will be excluded from the current study.
- Children under the age of 5 and over the age of 17 will also be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Prevalence of Disordered Eating in Children and Adolescents Attending the Great Ormond Street Gastroenterology Clinic
Gastroenterological disorders are disorders affecting the stomach, intestines and associated organs. Symptoms of these types of disorders vary but often include vomiting, diarrhoea, weight loss and loss of appetite. Due to the nature and symptomatology of these disorders research has suggested that sufferers may be vulnerable to developing disordered eating behaviours. Treatment of such disorders often requires dietary restriction which has been found to lead to an obsessive preoccupation with food and in some cases to an increase in binge eating. Further to this, symptoms of Gastroenterological disorders such as vomiting have also been suggested to be linked with disordered eating. At the present there is limited research in this area and as such evidence is inconclusive. Particularly little research has looked at this area in relation to adolescents, who have been recognised as being at increased risk for the development of disordered eating . Gastroenterological disorders are likely to affect the typical development of eating habits and therefore it seems plausible they may also predispose adolescents to developing abnormal eating behaviours /weight concerns.
The aim of this study is to further investigate the possibility that Gastroenterological disorders may be a risk factor for disordered eating in children and adolescents. This study will recruit children/ adolescents aged 5-17 and their parents, who are attending Great Ormond Street Gastroenterology Clinic and ask them to complete a screening questionnaire. The recruitment process will be on going for around 5 months until the study has around 300 participants. Following this initial questionnaire, participants who are categorised as screening positively for disordered eating and a 10% sample of participants that screen negatively, will be contacted to complete a further questionnaire interview that will look more specifically into this area.
- Conditions
- Disordered Eating
- Being tested
- Disordered eating screening questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disordered eating screening questionnaireOther
| Study group | Role | What they receive |
|---|---|---|
| Disordered eating screening questionnaire | Other | Not described Receives: Other: Disordered eating screening questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disordered eating screening questionnaire
Measured: Questionnaire administered once after recruitment
Secondary outcomes (1)
Developmental and Well Being Assessment
Measured: Administered once following inital screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startJul 2013 (estimated)
- Primary completionNov 2014 (estimated)
- Study completionNov 2014 (estimated)
Why it stopped: Study was withdrawn prior to commencement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disordered EatingStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01872169
- Sponsor's protocol ID
- 13BS03
- Status last verified
- Jun 2013
- First submitted
- 29 May 2013
- Last updated
- 24 Jan 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Prevalence of Disordered Eating in Children and Adolescents Attending the Great Ormond Street Gastroenterology Clinic
- ClinicalTrials.gov ID
- NCT01872169
- Acronym / sponsor ID
- 13BS03
- Conditions
- Disordered Eating
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was withdrawn prior to commencement
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation TrustUniversity, hospital or other
- Study start
- Jul 2013 (estimated)
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 7 Jun 2013 (estimated)
- 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.
Gastroenterological disorders are disorders affecting the stomach, intestines and associated organs. Symptoms of these types of disorders vary but often include vomiting, diarrhoea, weight loss and loss of appetite. Due to the nature and symptomatology of these disorders research has suggested that sufferers may be vulnerable to developing disordered eating behaviours. Treatment of such disorders often requires dietary restriction which has been found to lead to an obsessive preoccupation with food and in some cases to an increase in binge eating. Further to this, symptoms of Gastroenterological disorders such as vomiting have also been suggested to be linked with disordered eating. At the present there is limited research in this area and as such evidence is inconclusive. Particularly little research has looked at this area in relation to adolescents, who have been recognised as being at increased risk for the development of disordered eating . Gastroenterological disorders are likely to affect the typical development of eating habits and therefore it seems plausible they may also predispose adolescents to developing abnormal eating behaviours /weight concerns.
The aim of this study is to further investigate the possibility that Gastroenterological disorders may be a risk factor for disordered eating in children and adolescents. This study will recruit children/ adolescents aged 5-17 and their parents, who are attending Great Ormond Street Gastroenterology Clinic and ask them to complete a screening questionnaire. The recruitment process will be on going for around 5 months until the study has around 300 participants. Following this initial questionnaire, participants who are categorised as screening positively for disordered eating and a 10% sample of participants that screen negatively, will be contacted to complete a further questionnaire interview that will look more specifically into this area.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Disordered eating screening questionnaire | Other | Other: Disordered eating screening questionnaire |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children/adolescents between the age of 5-17 and their parents who are attending the Gastroenterological Clinic. We will recruit all patients that fall within the age range, including both new patients and existing patients.
Key exclusion criteria (2 listed)
- Parents/ adolescents unable to communicate English will be excluded from the current study.
- Children under the age of 5 and over the age of 17 will also be excluded.
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 |
|---|---|---|
| Disordered eating screening questionnaire | Other | Disordered eating screening questionnaire |
Primary outcome
Disordered eating screening questionnaire
Time frame: Questionnaire administered once after recruitment
1 secondary outcome
Developmental and Well Being Assessment
Time frame: Administered once following inital screening
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Disordered eating screening questionnaire in people with Disordered Eating, run by Great Ormond Street Hospital for Children 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 2 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: withdrawn, as of the sponsor's last update on 24 Jan 2022. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Disordered eating screening questionnaire (time frame: Questionnaire administered once after recruitment). 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 24 Jan 2022.