NCT01872169

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 7, 2013

Completed
24 days until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

January 24, 2022

Status Verified

June 1, 2013

Enrollment Period

1.3 years

First QC Date

May 29, 2013

Last Update Submit

January 7, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Disordered eating screening questionnaire

    Questionnaire administered once after recruitment

Secondary Outcomes (1)

  • Developmental and Well Being Assessment

    Administered once following inital screening

Study Arms (1)

Disordered eating screening questionnaire

OTHER
Other: Disordered eating screening questionnaire

Interventions

Disordered eating screening questionnaire

Eligibility Criteria

Age5 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Great Ormond Street Hospital

London, WC1N 3JH, United Kingdom

Location
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2013

First Posted

June 7, 2013

Study Start

July 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

January 24, 2022

Record last verified: 2013-06

Locations