Bariatric Surgery and Guided Self-help for Binge Eating Disorder

NCT02094027 | Terminated

• 1 other identifier: 10/H0707/67
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Obesity; Bariatric surgery; Binge eating; Self help

Outcome Measures

Primary Outcomes (1)

• Change in body mass index point

  baseline, pre-operatively, 3 month, 6 month and 1 year follow up

Secondary Outcomes (5)

• Binge episodes

  baseline, pre-operatively, 3 month, 6 month and 1 year follow up

• Complication or reversal of surgery

  3 month, 6 month and 1 year follow up

• Quality of life

  baseline, pre-operative, 3 month, 6 month and 1 year follow up

• Eating behaviour

  baseline, pre-operatively, 3 month, 6 month and 1 year follow up

• Drug and alcohol misuse

  pre-operatively, baseline, 3 month, 6 month and 1 year follow up

Study Arms (2)

Guided Self Help

EXPERIMENTAL

Guided Self Help intervention to reduce binge eating

Behavioral: Guided Self Help

Treatment As Usual

PLACEBO COMPARATOR

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

Other: Treatment As Usual

Interventions

Guided Self Help BEHAVIORAL

A behaviourally orientated guided self help book designed to reduce binge eating prior to surgery

Guided Self Help

Treatment As Usual OTHER

Binge eating disordered participants receive treatment as usual in the form of bariatric surgery (i.e. no pre-operative intervention to reduce binge eating)

Treatment As Usual

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

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

London, W6 8RF, United Kingdom

Location

MeSH Terms

Conditions

Obesity; Bulimia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperphagia; Signs and Symptoms, Digestive

Study Officials

• Samantha Scholtz, MRCPsych

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2014
• First Posted: March 21, 2014
• Study Start: July 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 19, 2016

Record last verified: 2014-03

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)