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ObesityTOuCHNCT03615274

Executive Function Training in Childhood Obesity: Food Choice, Quality of Life and Brain Connectivity

A study testing Executive function training and Psychoeducation in people with Obesity, run by University of Barcelona at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study evaluates if executive function training in obese children can improve food-related choices and produce cognitive and neuroimaging changes, but also improve psychological and physical status and quality of life measures. Read more about this study

Who is it for?
Ages 9 to 12 years
Conditions the study is for
Obesity
What is being tested?
Executive function training and Psychoeducation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
46 participants
Where
1 siteSpain
Study dates
5 Feb 2018to 27 Jan 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Being obese according to the criteria by Cole et al., (2000)

Who cannot join

  • Neurological, psychiatric or developmental disorder.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Neuroscience Institute. Department of Clinical Psychology and Psychobiology

    Barcelona, 08035

Other trials in Spain

About this study

This study evaluates if executive function training in obese children can improve food-related choices and produce cognitive and neuroimaging changes, but also improve psychological and physical status and quality of life measures.

Read the detailed description

Based on the limited success of current behavioural weight-loss programmes and coupled with data on executive function deficiencies in obesity, this study aims to explore the impact of executive function training on food-related choices, cognitive and neuroimaging outcomes, but also on the psychological and physical status and quality of life measures.

The specific hypotheses are:

  1. Obese children undergoing the training programme will perform better than those receiving the control programme in cognitive, emotional state, physical activity and quality of life measures at the end of the intervention and follow-up at 12 months.
  2. Obese children receiving the training programme will take better food-related decisions at the end of the intervention and follow-up at 12 months.
  3. Obese children receiving the training programme will show changes in brain connectivity, which will be observable immediately at the end of the intervention and during the follow up period at 12 months.
  4. There will be an association between changes in neuroimaging biomarkers and food choice, cognitive, emotional, physical and quality of life outcomes in individuals receiving training.
Conditions
Obesity
Being tested
Executive function training, Psychoeducation, Placebo non-adaptive training
Keywords
childhood obesity, cognitive training, executive function, quality of life, neuroimaging, magnetic resonance, connectivity, decision making
Medical subject headings
Obesity, Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Executive function trainingDevice

    Home-based executive function training with adaptive difficulty, through Cogmed and Cognifit systems over 6 weeks (30-45 minuts/day, 5 days per week). Cognitive training will consist on working memory training (Cogmed, www.cogmed.com) and executive/inhibitory function training (Cognifit, www.cognifit.com).

  • PsychoeducationOther

    Learning basic healthy habits through daily Prezi presentations that include healthy food recommendations, funny receipts to families, ideas for exercising, emotion and behavioral management strategies, etc.

  • Placebo non-adaptive trainingDevice

    Executive function training with non-adaptive difficulty through Cognifit system over 6 weeks (30-45 minuts/day, 5 days per week). Exercices will be the same as the ones in the experimental group but minimizing the executive/working memory component and without incresing difficulty.

Study groups in NCT03615274
Study groupRoleWhat they receive
ExperimentalExperimentalChildren in the training group must complete home-based executive function training by iPad. At the same time, they are asked to learn basic psychoeducational contents and send pictures of their daily meals. Furthermore, physical activity and sleep patterns are registered over the training period.
Receives: Device: Executive function training; Other: Psychoeducation
Placebo non-adaptive trainingActive comparatorChildren in the control group must complete cognitive control tasks. They are also asked to learn basic psychoeducational contents and send pictures of their daily meals. Furthermore, physical activity and sleep patterns are registered over the training period.
Receives: Other: Psychoeducation; Device: Placebo non-adaptive training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline estimated verbal intelligence quotient (IQ) at 12 months

    Vocabulary subtest (Wechsler intelligence scale for children - Fifth edition, WISC-V). 29 items. Each item is scored 0 or 1 (0=incorrect; 1=correct), yielding a total between 0 and 54.

    Measured: Baseline (T0; 1 week before intervention); follow-up (T2; 12 months after intervention finished)

  2. Change from baseline estimated visuospatial intelligence quotient (IQ) at 12 months

    Matrix Reasoning subtest (WISC- V). 32 items. Each item is scored 0 or 1 (0=incorrect; 1=correct), yielding a total between 0 and 32.

    Measured: Baseline (T0; 1 week before intervention); follow-up (T2; 12 months after intervention finished)

  3. Change from baseline immediate verbal attention at 8 weeks and at 12 months

    Forward Digit Span (WISC-V). 9 items. Each item is scored 0 or 1 (0=incorrect; 1=correct), yielding a total between 0 and 18.

    Measured: Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)

  4. Change from baseline immediate visuospatial attention at 8 weeks and at 12 months

    Forward Spatial Span (Wechsler Nonverbal Scale of Ability; WNV). 8 items. Each item is scored 0 or 1 (0=incorrect; 1=correct), yielding a total between 0 and 16.

    Measured: Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)

  5. Change from baseline speed and selective verbal attention at 8 weeks and at 12 months

    Reading and counting (Five Digits Test). Total expended time.

    Measured: Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)

  6. Change from baseline speed and selective visual attention at 8 weeks and at 12 months

    Children Color Trail Test - I. Total expended time.

    Measured: Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)

  7. Change from baseline sustained visual attention at 8 weeks and at 12 months

    Continuous Performance Test -III. Detectability: number of correct responses to non-targets (i.e., the letter X) and to targets (i.e., all other letters). Omissions: number of failures to respond to targets. Comissions: number of incorrect responses to non-targets. Perseverations: number of random or anticipatory responses.

    Measured: Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)

  8. Change from baseline verbal digit working memory at 8 weeks and at 12 months

    Backward Digit Span (WISC-V). 9 items. Each item is scored 0 or 1 (0=incorrect; 1=correct), yielding a total between 0 and 18.

    Measured: Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)

  9. Change from baseline visuospatial working memory at 8 weeks and at 12 months

    Backward Spatial Span (WNV). 8 items. Each item is scored 0 or 1 (0=incorrect; 1=correct), yielding a total between 0 and 16.

    Measured: Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)

  10. Change from baseline verbal working memory at 8 weeks and at 12 months

    N-back. It consists of indicating when the current stimulus matches the one from n steps earlier in the sequence. The load factor n can be adjusted (0-1-2-3). Correct responses : number of correct responses to targets. Omissions: number of failures to respond to targets. Comissions: number of incorrect responses to non-targets. Mean Reaction Time: mean response speed of correct responses for the whole administration.

    Measured: Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)

  11. Change from baseline cognitive flexibility at 8 weeks and at 12 months

    Children Color Trail Test - II. Total expended time.

    Measured: Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)

  12. Change from baseline set-shifting at 8 weeks and at 12 months

    Shifting (Five Digits Test). Total expended time.

    Measured: Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)

  13. Change from baseline attentional inhibition at 8 weeks and at 12 months

    Choosing (Five Digits Test). Total expended time.

    Measured: Baseline (T0; 1 week before intervention); postest (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)

  14. Change from baseline behavioral inhibition at 8 weeks and at 12 months

    Go/No Go: it requires to perform an action given a letter stimuli ("p"- Go) and inhibit that action under a different set of stimuli ("r"- No-Go). After several trials the instructions are reversed ("r"-Go; "p"- No Go).

    Measured: Baseline (T0; 1 week before intervention); postest (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)

  15. Change from baseline planning/reasoning at 8 weeks and at 12 months

    Tower of London consists of two boards with pegs and several beads with different colors. The examiner uses the beads and the boards to present the examinee with problem-solving tasks.

    Measured: Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)

  16. Change from baseline neuroimaging (T1-weighted 3D sequence) at 8 weeks and at 12 months

    MPRAGE sequence: TR=2300 ms, TE=2.98 ms, TI 900 ms, 240 slices, FOV=256 mm; matrix size=256x256; 1 mm isotropic voxel

    Measured: Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)

  17. Change from baseline neuroimaging (T2-weighted 3D sequence) at 8 weeks and at 12 months

    TR=3200 ms, TE=298 ms, 256 slices, FOV=224 mm; matrix size=256x256; 0.9 mm isotropic voxel

    Measured: Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)

  18. Change from baseline neuroimaging (Diffusion Tensor Imaging sequence) at 8 weeks and at 12 months

    Singleshot diffusion weighted EPI sequence, two adquisitions AP and PA: b=1000mm2/s, 30 directions, TR=7700 ms, TE=89 ms, flip angle 90o, slice thickness=2 mm, 1.97 mm in-plane resolution

    Measured: Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)

  19. Change from baseline neuroimaging (resting-state fMRI sequence) at 8 weeks and at 12 months

    gradient-echo echo-planar imaging-EPI sequence: 200 volumes of 40 axial slices, TR=2500ms; TE=28ms; matrix=80x80; field of view=24cm; slice thickness=3mm; 15% interslice gap; flip angle= 80o

    Measured: Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)

  20. Change from baseline neuroimaging (clinical sequences) at 8 weeks and at 12 months

    clinical T2 (TR/TE=5150/99 ms; 512x307 matrix, flip angle 120o, slice thickness 5 mm with a 1.5-mm interslice gap) and FLAIR sequences (TR/TE=9040/85 ms; TI= 2500; 250X171 matrix, flip angle 150o, slice thickness 5 mm)

    Measured: Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)

  21. Food-choices

    Photographs of participants' meals (breakfast, lunch, dinner).

    Measured: Daily, over 6 weeks (training period)

  22. Change from baseline Body Mass Index (BMI) and waist circumference at 8 weeks and at 12 months

    Pediatric evaluation:

    Height (m) and weight (kg) measures will be collected and combined to report BMI (kg/m^2).

    Additionally, waist circumference (m) will be assessed.

    Measured: Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)

Secondary outcomes (5)

  1. Change from baseline self-report quality of life at 8 weeks and at 12 months

    Pediatric Quality of Life Inventory (parents' version and children's version). 23 items. Each item is scored from 0 to 4 (0=never; 4=almost always), yielding a total between 0 and 92. Higher scores mean worse quality of life.

    Measured: Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)

  2. Change from baseline social support and self-steem at 8 weeks and at 12 months

    The Self-Perception Profile for Children (SPPC). 70 items. Each item is scored from 0 to 4 (0=never; 4=almost always), yielding a total between 0 and 280. Higher scores mean better social support and self-steem.

    Measured: Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)

  3. Change from baseline internalising and externalising problems at 8 weeks and at 12 months

    Child Behavior Checklist. 113 items. Each item is scored from 0 to 2 (0=not true; 2= true very often or quite often). Higher scores mean more psychological and behavioral problems.

    Measured: Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished).

  4. Change from baseline behavioral executive function at 8 weeks and at 12 months

    Behavior Rating Inventory of Executive Function - II (Parents' version and Schools' version). 63 items. Higher scores mean more executive problems.

    Measured: Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished).

  5. Activity and sleep patterns

    Fitbit tracker. Number of steps and number of sleep hours.

    Measured: Daily, during 6 weeks (the training period)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2018
  2. Study start5 Feb 2018
  3. Primary completion27 Jan 2021
  4. Study completion27 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03615274
Sponsor's protocol ID
2016-16-10
Acronym
TOuCH
Status last verified
Apr 2021
First submitted
18 Jul 2018
Last updated
29 Apr 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Sanchez-Castaneda C, Luis-Ruiz S, Ramon-Krauel M, Lerin C, Sanchez C, Miro N, Martinez S, Garolera M, Jurado MA. Executive Function Training in Childhood Obesity: Food Choice, Quality of Life, and Brain Connectivity (TOuCH): A Randomized Control Trial Protocol. Front Pediatr. 2021 Feb 24;9:551869. doi: 10.3389/fped.2021.551869. eCollection 2021.

    PubMed 33718294

Questions about this trial

What is this clinical trial studying?

A study testing Executive function training and Psychoeducation in people with Obesity, run by University of Barcelona at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline estimated verbal intelligence quotient (IQ) at 12 months (time frame: Baseline (T0; 1 week before intervention); follow-up (T2; 12 months after intervention finished)). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03615274, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.

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