search
Back to results

Bariatric Surgery and Guided Self-help for Binge Eating Disorder (BED)

Primary Purpose

Obesity

Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Guided Self Help
Treatment As Usual
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Bariatric surgery, Binge eating, Self help

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Obese (BMI >28 kg/m2)
  • Pursuing bariatric surgery

Exclusion Criteria:

  • Any illnesses which make the patient unsuitable
  • If the patient is taking any medication which makes them unsuitable
  • If the patient is pregnant or breast feeding
  • If the patient has donated blood in the last three months
  • If the patient has a history of alcoholism or substance dependency within the last 5 years
  • If the patient has a history of major haematological, renal, gastrointestinal, hepatic, respiratory, cardiovascular or psychiatric disease or other illness or use of any medications, including over the counter products, which, in the opinion of the investigators would either interfere with the study or potentially cause harm to the volunteer
  • If the patient has any medical or psychological condition or social circumstances which would interfere with their ability to participate reliably in the trial
  • If the patient is without access to a telephone
  • If the patient is currently receiving or intends to receive treatment with an investigational drug within the next 2 months If the patient is currently receiving or intends to receive treatment for binge eating
  • If the patient currently suffers with severe depression, as indicated by a Beck Depression Inventory Score greater than 28

Sites / Locations

  • Obesity, Endocrine and Medical Clinics at Imperial College Healthcare NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Guided Self Help

Treatment As Usual

Arm Description

Guided Self Help intervention to reduce binge eating

No intervention for binge eating (treatment as usual in the form of bariatric surgery)

Outcomes

Primary Outcome Measures

Change in body mass index point

Secondary Outcome Measures

Binge episodes
-Number of binge episodes per 28 days
Complication or reversal of surgery
Surgical complication or reversal of bariatric surgery as per case notes
Quality of life
Score on SF-36, IQoL-lite, Hospital anxiety and depression scale (HADS), and PANAS (positive and negative affect scale)
Eating behaviour
Emotional, externally driven, disinhibited, restrained eating patterns and weight and shape concerns as measured by Eating disorders examination questionnaire (EDE-Q), Dutch Eating Behaviour Questionnaire (DEBQ), Three factor eating questionnaire (TFEQ)
Drug and alcohol misuse
As measured by AUDIT drug and alcohol assessment tool

Full Information

First Posted
March 5, 2014
Last Updated
December 16, 2016
Sponsor
Imperial College London
Collaborators
National Institute for Health Research, United Kingdom
search

1. Study Identification

Unique Protocol Identification Number
NCT02094027
Brief Title
Bariatric Surgery and Guided Self-help for Binge Eating Disorder
Acronym
BED
Official Title
The Role of Self-help in the Pre-surgical Treatment of Binge Eating Disorder in Bariatric Surgery Candidates: Implications for Weight-related and Psychological Outcome.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Terminated
Why Stopped
New evidence came to light to indicate that study was no longer relevant
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
Collaborators
National Institute for Health Research, United Kingdom

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To demonstrate the effectiveness of an easily administered intervention (guided self help) aimed at reducing binge eating in patients undergoing bariatric surgery. The investigators hypothesize that patients who have guided self help pre-operatively will have reduced episodes of bingeing pre-operatively compared to those having treatment as usual (bariatric surgery), which will be maintained in the post-operative period, and will be associated with improved weight loss and psychological outcomes after surgery.
Detailed Description
Binge eating disorder (BED) is distressing and common in patients who present for treatment for obesity. Despite this, it is often undiagnosed. Patients who have bariatric surgery have improvements in their eating patterns, including binge eating. However there is variability in the degree of weight loss and post-operative complications following bariatric surgery, associated with disordered eating. Guided self help for BED (GSH) is a treatment which, like bariatric surgery, is effective in reducing the number of binge episodes in people who binge eat. It is not known whether GSH prior to surgery, in patients undergoing bariatric surgery has any additional benefit for reducing bingeing, or improving weight loss in these patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Bariatric surgery, Binge eating, Self help

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Guided Self Help
Arm Type
Experimental
Arm Description
Guided Self Help intervention to reduce binge eating
Arm Title
Treatment As Usual
Arm Type
Placebo Comparator
Arm Description
No intervention for binge eating (treatment as usual in the form of bariatric surgery)
Intervention Type
Behavioral
Intervention Name(s)
Guided Self Help
Intervention Description
A behaviourally orientated guided self help book designed to reduce binge eating prior to surgery
Intervention Type
Other
Intervention Name(s)
Treatment As Usual
Intervention Description
Binge eating disordered participants receive treatment as usual in the form of bariatric surgery (i.e. no pre-operative intervention to reduce binge eating)
Primary Outcome Measure Information:
Title
Change in body mass index point
Time Frame
baseline, pre-operatively, 3 month, 6 month and 1 year follow up
Secondary Outcome Measure Information:
Title
Binge episodes
Description
-Number of binge episodes per 28 days
Time Frame
baseline, pre-operatively, 3 month, 6 month and 1 year follow up
Title
Complication or reversal of surgery
Description
Surgical complication or reversal of bariatric surgery as per case notes
Time Frame
3 month, 6 month and 1 year follow up
Title
Quality of life
Description
Score on SF-36, IQoL-lite, Hospital anxiety and depression scale (HADS), and PANAS (positive and negative affect scale)
Time Frame
baseline, pre-operative, 3 month, 6 month and 1 year follow up
Title
Eating behaviour
Description
Emotional, externally driven, disinhibited, restrained eating patterns and weight and shape concerns as measured by Eating disorders examination questionnaire (EDE-Q), Dutch Eating Behaviour Questionnaire (DEBQ), Three factor eating questionnaire (TFEQ)
Time Frame
baseline, pre-operatively, 3 month, 6 month and 1 year follow up
Title
Drug and alcohol misuse
Description
As measured by AUDIT drug and alcohol assessment tool
Time Frame
pre-operatively, baseline, 3 month, 6 month and 1 year follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Obese (BMI >28 kg/m2) Pursuing bariatric surgery Exclusion Criteria: Any illnesses which make the patient unsuitable If the patient is taking any medication which makes them unsuitable If the patient is pregnant or breast feeding If the patient has donated blood in the last three months If the patient has a history of alcoholism or substance dependency within the last 5 years If the patient has a history of major haematological, renal, gastrointestinal, hepatic, respiratory, cardiovascular or psychiatric disease or other illness or use of any medications, including over the counter products, which, in the opinion of the investigators would either interfere with the study or potentially cause harm to the volunteer If the patient has any medical or psychological condition or social circumstances which would interfere with their ability to participate reliably in the trial If the patient is without access to a telephone If the patient is currently receiving or intends to receive treatment with an investigational drug within the next 2 months If the patient is currently receiving or intends to receive treatment for binge eating If the patient currently suffers with severe depression, as indicated by a Beck Depression Inventory Score greater than 28
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samantha Scholtz, MRCPsych
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Obesity, Endocrine and Medical Clinics at Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The IPD has been shared with Prof. Alex Blakemore as planned, who was conducting the genetic part of the study and who is using the data in wider analysis.

Learn more about this trial

Bariatric Surgery and Guided Self-help for Binge Eating Disorder

We'll reach out to this number within 24 hrs