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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01872169
Other study ID # 13BS03
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date July 2013
Est. completion date November 2014

Study information

Verified date June 2013
Source Great Ormond Street Hospital for Children NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date November 2014
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender All
Age group 5 Years to 17 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Disordered eating screening questionnaire


Locations

Country Name City State
United Kingdom Great Ormond Street Hospital London

Sponsors (1)

Lead Sponsor Collaborator
Great Ormond Street Hospital for Children NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Disordered eating screening questionnaire Questionnaire administered once after recruitment
Secondary Developmental and Well Being Assessment Administered once following inital screening
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