Condition category
Digestive System
Date applied
07/01/2015
Date assigned
23/02/2015
Last edited
23/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Gastric bypass surgery can help individuals who are overweight and cannot lose weight through non-surgical ways. The surgery reduces weight and increases patients’ quality of life, but some patients start to gain weight after some years or do not lose as much weight as expected. The reasons are usually poor health, shame and feelings of loss of control. Our study aims to reduce these problems and improve the effects of gastric bypass in women.

Who can participate?
Women who are overweight, can speak Swedish and are planning to have a gastric bypass surgery at any of our four hospitals (Ersta, Uppsala, Örebro or Danderyds) from January 2015 to November 2015.

What does the study involve?
Women will be randomly allocated to receive four 1 hour sessions of group therapy about 2 months after surgery or usual care after surgery. The group sessions comprise discussions with a small task to be done at home. All women will be given an accelerometer (an instrument to measure movement) and questionnaires about eating habits, social life, happiness of life and self-esteem every 6 months until 2 years after surgery.

What are the possible benefits and risks of participating?
No known risks

Where is the study run from?
Hospitals Ersta Sjukhus, Danderyds sjukhus, Universitetssjukhuset Örebro and Akademiska sjukhuset (Sweden)

When is the study starting and how long is it expected to run for?
From December 2013 to January 2018

Who is funding the study?
Karolinska Institutet (Sweden)

Who is the main contact?
Fanny Sellberg

Trial website

Contact information

Type

Scientific

Primary contact

Professor Finn Rasmussen

ORCID ID

http://orcid.org/0000-0002-7579-3098

Contact details

Tomteboda vägen 18A
Stockholm
171 77
Sweden

Type

Public

Additional contact

PhD student Fanny Sellberg

ORCID ID

Contact details

Tomteboda vägen 18A
Stockholm
171 77
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Can a dissonance-based intervention improve quality of life, social adjustment, eating behaviour and physical activity in women after gastric bypass surgery? A randomised controlled study

Acronym

WELG (study of well-being after gastric bypass)

Study hypothesis

1. Quality of life and social adjustment will be higher at follow-up in the intervention group than before surgery and higher than in the control group.
2. Fewer symptoms of disordered eating behaviours and higher body satisfaction will be noted at follow-up in the intervention group than before surgery and fewer than in the control group.
3. Physical activity and weight loss will be higher at follow-up in the intervention group than in the control group.

Ethics approval

Stockholm Ethical Review Board, on 10 December 2013, Dnr: 2013/1847-31/2

Study design

Randomised controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a patient information sheet (in Swedish).

Condition

Prevention of unwanted mental and physical outcomes after gastric bypass surgery

Intervention

50% of the recruited patients will be randomly allocated to the intervention group after surgery and 50% to the control group (usual post-operative follow-up). The first intervention session will start about 2 months after surgery. The group sessions will consist of 1 hour discussions, role plays and other activities and will be led by a researcher. We will use a dissonance-based group setting with four 1 hour sessions (one session per week) in the intervention group, covering eating behaviour, physical activity and social and intimate relations. Other versions of this intervention have been successfully used in other settings with the same structure, for example, for the prevention of eating disorders in non-obese individuals. The theory is that the participants will discuss difficult situations that might occur after surgery and propose approaches and solutions in a group setting. It is suggested that individuals will then tend to use these approaches themselves if they face difficulties in the future.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Quality of life, measured with a validated questionnaire (SF-36)
2. Eating behaviour, measured with the Three-Factor Eating Questionnaire and the Disordered Eating after Bariatric Surgery
3. Body esteem, measured with the Body Esteem Scale
4. Social adjustment, measured with the Social Adjustment Scale
5. Physical activity, measured with an accelerometer at before surgery and at 6 months, 1 year and 2 years after surgery; the accelerometers will be posted to the participants and returned in the post

All questionnaires (except SF-36) will be completed at home and emailed to the research group before surgery and at 6 months, 12 months, 18 months and 24 months after surgery. SF-36 will be measured at the same timepoints with a national register as a part of the usual care.

Secondary outcome measures

1. Weight
2. Height
3. Waist circumference

The secondary outcomes will be measured before surgery and at 6 months, 12 months, 18 months and 24 months after surgery by the nurses at the hospital where the surgery is done.

Overall trial start date

01/12/2013

Overall trial end date

01/01/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Eligible for gastric bypass surgery: body-mass index >35 kg/m2, usually between 18–65 (with some exceptions)
2. Age: over 18 years old
3. Able to speak and read Swedish
4. Women

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

240

Participant exclusion criteria

Current diagnosis of depression

Recruitment start date

15/01/2015

Recruitment end date

01/11/2015

Locations

Countries of recruitment

Sweden

Trial participating centre

Ersta Sjukhus
Fjällgatan 44
Stockholm
116 91
Sweden

Trial participating centre

Danderyds sjukhus
Mörbygårdsvägen, Danderyd
Stockholm
182 88
Sweden

Trial participating centre

Universitetssjukhuset Örebro
Södra Grev Rosengatan
Örebro
703 62
Sweden

Trial participating centre

Akademiska sjukhuset
Akademiska sjukhuset
Uppsala
751 85

Sponsor information

Organisation

Karolinska Institute

Sponsor details

Karolinska institutet
Stockholm
171 77
Sweden

Sponsor type

University/education

Website

http://ki.se

Funders

Funder type

Not defined

Funder name

Karolinska Institutet

Alternative name(s)

Karolinska Institute, KI

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Sweden

Funder name

Centrum for epidmeiology and social medicine

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The study will be a part of a 4 year PhD student project with at least two publications.

Intention to publish date

01/01/2019

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes