Condition category
Nutritional, Metabolic, Endocrine
Date applied
10/05/2017
Date assigned
16/06/2017
Last edited
21/06/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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@hotmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Tiffany Naets

ORCID ID

http://orcid.org/0000-0002-9560-5613

Contact details

Henri Dunantlaan 2
Gent
9000
Belgium
+32 (0)9 264 91 08
Tiffany.Naets@hotmail.com

Type

Scientific

Additional contact

Mrs Tiffany Naets

ORCID ID

http://orcid.org/0000-0002-9560-5613

Contact details

Henri Dunantlaan 2
Gent
9000
Belgium

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

150179

Study information

Scientific title

Improving weight control and co-morbidities in children with obesity via executive function training: a randomised controlled trial

Acronym

WELCOME

Study hypothesis

Active executive function (EF) training results in better weight control and less co-morbidities than active-control EF training.

Ethics approval

Pilot study: Commissie voor Medische Ethiek UGent/UZ Gent, 03/05/2017, ref: 2017/0305
Full study: approval pending

Study design

Interventional longitudinal multicentre blinded randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/01/2017

Overall trial end date

31/12/2020

Reason abandoned

Eligibility

Participant inclusion criteria

1. Obese youngsters ((a)BMI > 120)
2. Age 8 - 18
3. Both male and female
4. Following treatment (outpatient or inpatient)

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Pilot N = 40 (Zeepreventorium) + N = 200 (100 Zeepreventorium, 50 Jan Palfijn, 50 UZA)

Participant exclusion criteria

Comorbid medical disorders that cause (a part of) the weight gain (i.e. serious thyroid problems)

Recruitment start date

01/04/2017

Recruitment end date

01/10/2019

Locations

Countries of recruitment

Belgium

Trial participating centre

Zeepreventorium
Koninklijke Baan 5
De Haan
8420
Belgium

Trial participating centre

Jan Palfijn Hospital ("Jan Palfijn")
Watersportbaan 5
Ghent
9000
Belgium

Trial participating centre

University Hospital of Antwerp ("UZA")
Wilrijkstraat 10
Edegem
2650
Belgium

Sponsor information

Organisation

Ghent University

Sponsor details

Faculty of Psychology and Educational Sciences
Department of Developmental
Personality and Social Psychology
Henri Dunantlaan 2
Gent
9000
Belgium

Sponsor type

University/education

Website

https://www.vopspsy.ugent.be/en/

Funders

Funder type

Government

Funder name

Fonds Wetenschappelijk Onderzoek

Alternative name(s)

Research Foundation Flanders, Flemish Research Foundation, FWO

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Belgium

Results and Publications

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 statement
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).

Intention to publish date

01/12/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes