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. The aim of this study is 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?
Participants are 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 participants are 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?
December 2013 to January 2018
Who is funding the study?
Karolinska Institutet (Sweden)
Who is the main contact?
Fanny Sellberg
Study website
Additional identifiers
EudraCT/CTIS number
IRAS 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(s)
Stockholm Ethics Review Board, 10/12/2013, Dnr: 2013/1847-31/2
Study design
Randomised controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study 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
Primary outcome measure
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 study start date
01/12/2013
Overall study end date
01/08/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Eligible for gastric bypass surgery: body-mass index >35 kg/m2, usually between 18–65 (with some exceptions)
2. Aged over 18 years old
3. Able to speak and read Swedish
4. Women
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Female
Target number of participants
240
Total final enrolment
259
Participant exclusion criteria
Current diagnosis of depression
Recruitment start date
15/01/2015
Recruitment end date
01/11/2015
Locations
Countries of recruitment
Sweden
Study participating centre
Ersta Sjukhus
Fjällgatan 44
Stockholm
116 91
Sweden
Study participating centre
Danderyds sjukhus
Mörbygårdsvägen, Danderyd
Stockholm
182 88
Sweden
Study participating centre
Universitetssjukhuset Örebro
Södra Grev Rosengatan
Örebro
703 62
Sweden
Study participating centre
Akademiska sjukhuset
Akademiska sjukhuset
Uppsala
751 85
Sweden
Sponsor information
Organisation
Karolinska Institute
Sponsor details
Karolinska institutet
Stockholm
171 77
Sweden
Sponsor type
University/education
Website
ROR
Funders
Funder type
Government
Funder name
Karolinska Institutet
Alternative name(s)
Karolinska Institute, KI
Funding Body Type
government organisation
Funding Body Subtype
Local government
Location
Sweden
Funder name
Centre for epidimeology 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
Individual participant data (IPD) sharing plan
Not provided at registration
IPD sharing plan summary
Not expected to be made available
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 09/05/2018 | Yes | No | |
| Results article | 04/11/2021 | 05/11/2021 | Yes | No | |
| Results article | 05/02/2019 | 07/03/2023 | Yes | No |