- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01872169
Investigating Prevalence of Disordered Eating in Children With GI Disorders
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
-
London, Verenigd Koninkrijk, WC1N 3JH
- Great Ormond Street Hospital
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Screening
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Ander: Disordered eating screening questionnaire
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Disordered eating screening questionnaire
Tijdsspanne: Questionnaire administered once after recruitment
|
Questionnaire administered once after recruitment
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Developmental and Well Being Assessment
Tijdsspanne: Administered once following inital screening
|
Administered once following inital screening
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Verwacht)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 13BS03
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .