Can group therapy improve well-being and mental health of overweight women after gastric bypass surgery?
| ISRCTN | ISRCTN16417174 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16417174 |
| Secondary identifying numbers | N/A |
- Submission date
- 07/01/2015
- Registration date
- 23/02/2015
- Last edited
- 07/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
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
Contact information
Scientific
Department of Public Health Sciences
Karolinska Institutet
Solnavägen
Stockholm
113 65
Sweden
Public
Tomteboda vägen 18A
Stockholm
171 77
Sweden
Study information
| Study design | Randomised controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a patient information sheet (in Swedish). |
| 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 |
| Study acronym | WELG (study of well-being after gastric bypass) |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 01/08/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 240 |
| Total final enrolment | 259 |
| Key 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 |
| Key exclusion criteria | Current diagnosis of depression |
| Date of first enrolment | 15/01/2015 |
| Date of final enrolment | 01/11/2015 |
Locations
Countries of recruitment
- Sweden
Study participating centres
Stockholm
116 91
Sweden
Stockholm
182 88
Sweden
Örebro
703 62
Sweden
Uppsala
751 85
Sweden
Sponsor information
University/education
Karolinska institutet
Stockholm
171 77
Sweden
| Website | http://ki.se |
|---|---|
"ROR" |
https://ror.org/056d84691 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Karolinska Institute, KI
- Location
- Sweden
No information available
Results and Publications
| Intention to publish date | 01/01/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | The study will be a part of a 4 year PhD student project with at least two publications. |
| IPD sharing plan | Not provided at registration |
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 |
Editorial Notes
07/03/2023: Publication reference added.
05/11/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
14/01/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The overall trial end date was changed from 01/01/2018 to 01/08/2021.
