WELCOME: improving WEight controL and CO-Morbidities in children with obesity via Executive function training
| ISRCTN | ISRCTN14722584 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14722584 |
| Secondary identifying numbers | 150179 |
- Submission date
- 10/05/2017
- Registration date
- 16/06/2017
- Last edited
- 09/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
As the prevalence and negative consequences of childhood obesity are severe, this problem needs to be tackled as soon as possible. The current treatments for obesity are successful but only moderately and in the short term. Improving executive functioning may be an answer to the question "why is it still so difficult for obese youngsters to lose weight and to control it on a long term?" Executive functioning is an umbrella term to represent brain processes that allow people to control themselves. This process can be crucial in the origins and maintenance of obesity. Obese youngsters often have more difficulty with self-control when confronted with unhealthy temptations. More specifically, they seem to have an inhibition and attention bias. Inhibition is the capacity to suppress the impulsive urge to react, in this case when tempted towards unhealthy food (i.e., not grasping food when seeing hamburger advertisements). Next, they also seem to have attentional biases. Attention is the capacity to (re)direct focus, in this case away from unhealthy food (i.e., not thinking about eating when seeing hamburger advertisements). Obese children and adults with obesity, in comparison to normal-weight persons, have more inhibition and attention problems, and are more impulsive and distracted when confronted with those temptations. There is a lot of evidence to support this. Unfortunately, there hasn't been a lot of evidence for youngsters, and these insights are not used in current treatment. The aim of this study is to find out whether executive function training results in better weight control and less illness.
Who can participate?
Obese youngsters aged 8 to 18 who are already receiving treatment
What does the study involve?
Participants are randomly allocated to receive one of two forms of executive function training on top of their usual treatment. One group receives the training tasks with all active components (inhibiting responses toward unhealthy food and refocusing attention away from unhealthy). The other group receives the same training tasks but without the 'active ingredients' (stimuli are equally divided towards neutral or unhealthy food). This training lasts 14 weeks, and the participants are followed up until 6 months afterwards to measure their executive functioning, weight and eating behaviours.
What are the possible benefits and risks of participating?
Youngsters who receive the active elements of the training are expected to gain more self-control, lose more weight and have more healthy eating behaviour in comparison to the other group. If this extra treatment is found to work, the goal is to use this treatment in a larger group of treatment centres. There are no known risks from the brain fitness tasks. The data collection is carried out and supervised by trained medical personnel and has no extra health risks.
Where is the study run from?
1. Zeepreventorium (Belgium)
2. Jan Palfijn Hospital (Belgium)
3. University Hospital of Antwerp (Belgium)
When is the study starting and how long is it expected to run for?
January 2017 to December 2020
Who is funding the study?
Fonds Wetenschappelijk Onderzoek (Belgium)
Who is the main contact?
Mrs Tiffany Naets
Tiffany.Naets@UGent.be
Contact information
Scientific
Henri Dunantlaan 2
Gent
9000
Belgium
 ORCID ID |
0000-0002-9560-5613 |
|---|---|
| Phone | +32 (0)9 264 91 08 |
| Tiffany.Naets@UGent.be |
Study information
| Study design | Interventional longitudinal multicentre blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Improving weight control and co-morbidities in children with obesity via executive function training: a randomised controlled trial |
| Study acronym | WELCOME |
| Study objectives | Active executive function (EF) training results in better weight control and less co-morbidities than active-control EF training. |
| Ethics approval(s) | Pilot study: Commissie voor Medische Ethiek UGent/UZ Gent, 03/05/2017, ref: 2017/0305 Full study: approval pending |
| Health condition(s) or problem(s) studied | Childhood obesity |
| Intervention | Participants are randomized to either an experimental group or an active control group (50/50, 30/10 in pilot) via the OPEN CLINICA computer program. The executive function training consists of two tasks (Go-No-Go inhibition task and Dot-Probe attention task) on top of care as usual (Multidisciplinary Obesity Treatment [MOT]). Both groups do both tasks. The experimental group receives the tasks with all active components (inhibiting responses toward unhealthy food and refocusing attention away from unhealthy). The active control group receives the same tasks that last as long, but without the 'active ingredients' (equally divided stimuli towards neutral or unhealthy food). Participants are followed up at 2 and 6 months. |
| Intervention type | Behavioural |
| Primary outcome measure | Weight index (BMI, adjusted, calibrated) measured at T0-T4 Timepoints: T0 = baseline (at the intake in the treatment centre) T1 = start training (in between there is approximately 4-6 months, depending on the treatment centre) T2 = end of the intensive training (after 6 weeks intensive training and when the follow-up and booster starts) T3 = after 2 months/8 weeks follow up and performing the tasks once a week in booster sessions T4 = after 6 months follow up |
| Secondary outcome measures | 1. IQ, measured using Raven Progressive Matrices (task for the participant) at T0-T4, except for the outpatient centers that don’t measure them at T1 2. Depression and anxiety, measured using ASEBA questionnaires: Youth Self Report (YSR) and Child Behavior Checklist (CBCL) and the Children Depression Inventory (CDI) self-report at T0-T4, except for the outpatient centers that don’t measure them at T1 3. Self-worth, measured using CBSA and CBSK, translated version of Self-Perception Profile at T0-T4, except for the outpatient centers that don’t measure them at T1 4. Executive functioning, measured using: 4.1. A questionnaire (Effortful Control Scale (ECS) self-report, BRIEF (Behavior Rating Inventory of Executive Function) = BRIEF-Parent version and BRIEF-teacher version [for the educators at the Zeepreventorium]) at all timepoints, with exclusion of the T1 measurements for the outpatient settings 4.2. Inhibition and attention measurements from the EF tasks (Go-No-Go and Dot Probe Task), errors and reaction times at T0, T1, T2, T3 and T4 5. Eating behaviors, measured using Ch-EDE-Q self-report and Dutch Eating Behavior Questionnaire (“NVE” in Dutch) at T0-T4, except for the outpatient centers that don’t measure them at T1 Added 21/06/2017: Medical variables: 1. Waist and hip measurements at T1 + T3 2. Blood and pulse pressure, measured with automatic meters 3. Puberty status: clinical stages (Tanner) 4. Tonsillar hypertrophy: clinical stages (Brodsky) 5. Blood measurements (venipuncture) 6. Urine (urine sample) 7. Lung function, measured with spirometry and full body plethysmography 8. Vascular function, measured with ENDO-Pat 9. Sleep pattern, measured with ApneaLink and questionnaire 10. Body composition, measured with a Body Composition Monitor (BCM) Timepoints: T0 = baseline (at the intake in the treatment centre) T1 = start training (in between there is approximately 4-6 months, depending on the treatment centre) T2 = end of the intensive training (after 6 weeks intensive training and when the follow-up and booster starts) T3 = after 2 months/8 weeks follow up and performing the tasks once a week in booster sessions T4 = after 6 months follow up |
| Overall study start date | 01/01/2017 |
| Completion date | 31/12/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 8 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | Pilot N = 40 (Zeepreventorium) + N = 200 (100 Zeepreventorium, 50 Jan Palfijn, 50 UZA) |
| Total final enrolment | 302 |
| Key inclusion criteria | 1. Obese youngsters ((a)BMI > 120) 2. Age 8 - 18 3. Both male and female 4. Following treatment (outpatient or inpatient) |
| Key exclusion criteria | Comorbid medical disorders that cause (a part of) the weight gain (i.e. serious thyroid problems) |
| Date of first enrolment | 01/04/2017 |
| Date of final enrolment | 28/02/2020 |
Locations
Countries of recruitment
- Belgium
Study participating centres
De Haan
8420
Belgium
Ghent
9000
Belgium
Edegem
2650
Belgium
Sponsor information
University/education
Faculty of Psychology and Educational Sciences
Department of Developmental, Personality and Social Psychology
Henri Dunantlaan 2
Gent
9000
Belgium
| Website | https://www.vopspsy.ugent.be/en/ |
|---|---|
"ROR" |
https://ror.org/00cv9y106 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Research Foundation Flanders, Flemish Research Foundation, FWO
- Location
- Belgium
Results and Publications
| Intention to publish date | 31/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | First year (2017) next to data collection: 1. Pilot study: writing information for participants and their parents (in the form of education folders and flyers) for the pilot 2. Website introduction 3. Manuscripts of the pilot study Second year (2018) next to data collection and analysis: 1. Protocol paper 2. Information for the participants and their parents (in the form of education folders and flyers) 3. Teaching PowerPoints Third year (2019) next to data collection and analysis: 1. Feasibility analyses 2. Writing guidelines and a manual 3. Train the trainer materials 4. Educational videos for website 5. Distributing knowledge newsletter 6. Information for partners 7. Press communications 8. Manuscript on executive functioning (after training and 2-month follow-up) Fourth year (2020): 1. Manuscripts on executive functioning and comorbidities (after training and 2-month follow-up) 2. Manuscript on 6-month follow-up |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Tiffany Naets (primary researcher), Dr Leentje Vervoort (co-promotor) and Prof. Dr Caroline Braet (promotor). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | Adherence and barriers | 01/01/2020 | 17/08/2022 | Yes | No |
| Results article | 23/12/2021 | 17/08/2022 | Yes | No | |
| Protocol article | 29/08/2018 | 23/08/2022 | Yes | No | |
| Results article | 05/06/2023 | 19/06/2023 | Yes | No | |
| Results article | 05/06/2023 | 17/07/2023 | Yes | No | |
| Other publications | Reliability of the dot probe task using an obese subset from this study and a convenience non-obese subset | 03/03/2021 | 09/07/2025 | Yes | No |
| Results article | Risk factors for dropouts and treatment outcomes | 13/06/2022 | 09/07/2025 | Yes | No |
Editorial Notes
09/07/2025: Publication references added.
17/07/2023: Publication reference added.
19/06/2023: Publication reference added.
23/08/2022: Publication reference added.
17/08/2022: Publication references added.
05/01/2022: A contact email was removed.
23/12/2021: The intention to publish date was changed from 31/12/2021 to 31/12/2022.
16/04/2020: The final enrolment number has been added.
19/12/2019: The following changes have been made:
1. The Public title has been changed from Executive function training for obese youngsters to improve weight control and other co-morbidities to WELCOME: improving WEight controL and CO-Morbidities in children with obesity via Executive function training.
2. The recruitment end date has been changed from 01/10/2019 to 28/02/2020.
3. The intention to publish date has been changed from 01/12/2017 to 31/12/2021.
