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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Executive function training
Psychoeducation
Placebo non-adaptive training
Sponsored by
University of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring childhood obesity, cognitive training, executive function, quality of life, neuroimaging, magnetic resonance, connectivity, decision making

Eligibility Criteria

9 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Neurological, psychiatric or developmental disorder.

Sites / Locations

  • Neuroscience Institute. Department of Clinical Psychology and Psychobiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental

Placebo non-adaptive training

Arm Description

Children 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.

Children 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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
Change from baseline speed and selective verbal attention at 8 weeks and at 12 months
Reading and counting (Five Digits Test). Total expended time.
Change from baseline speed and selective visual attention at 8 weeks and at 12 months
Children Color Trail Test - I. Total expended time.
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.
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.
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.
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.
Change from baseline cognitive flexibility at 8 weeks and at 12 months
Children Color Trail Test - II. Total expended time.
Change from baseline set-shifting at 8 weeks and at 12 months
Shifting (Five Digits Test). Total expended time.
Change from baseline attentional inhibition at 8 weeks and at 12 months
Choosing (Five Digits Test). Total expended time.
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).
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.
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
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
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
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
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)
Food-choices
Photographs of participants' meals (breakfast, lunch, dinner).
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.

Secondary Outcome Measures

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

Full Information

First Posted
July 18, 2018
Last Updated
April 28, 2021
Sponsor
University of Barcelona
Collaborators
Fundació La Marató de TV3
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1. Study Identification

Unique Protocol Identification Number
NCT03615274
Brief Title
Executive Function Training in Childhood Obesity: Food Choice, Quality of Life and Brain Connectivity
Acronym
TOuCH
Official Title
Executive Function Training in Childhood Obesity: Food Choice, Quality of Life and Brain Connectivity
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
February 5, 2018 (Actual)
Primary Completion Date
January 27, 2021 (Actual)
Study Completion Date
January 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Barcelona
Collaborators
Fundació La Marató de TV3

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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: 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. Obese children receiving the training programme will take better food-related decisions at the end of the intervention and follow-up at 12 months. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
childhood obesity, cognitive training, executive function, quality of life, neuroimaging, magnetic resonance, connectivity, decision making

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Children 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.
Arm Title
Placebo non-adaptive training
Arm Type
Active Comparator
Arm Description
Children 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.
Intervention Type
Device
Intervention Name(s)
Executive function training
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Psychoeducation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Placebo non-adaptive training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline estimated verbal intelligence quotient (IQ) at 12 months
Description
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.
Time Frame
Baseline (T0; 1 week before intervention); follow-up (T2; 12 months after intervention finished)
Title
Change from baseline estimated visuospatial intelligence quotient (IQ) at 12 months
Description
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.
Time Frame
Baseline (T0; 1 week before intervention); follow-up (T2; 12 months after intervention finished)
Title
Change from baseline immediate verbal attention at 8 weeks and at 12 months
Description
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.
Time Frame
Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
Title
Change from baseline immediate visuospatial attention at 8 weeks and at 12 months
Description
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.
Time Frame
Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
Title
Change from baseline speed and selective verbal attention at 8 weeks and at 12 months
Description
Reading and counting (Five Digits Test). Total expended time.
Time Frame
Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
Title
Change from baseline speed and selective visual attention at 8 weeks and at 12 months
Description
Children Color Trail Test - I. Total expended time.
Time Frame
Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
Title
Change from baseline sustained visual attention at 8 weeks and at 12 months
Description
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.
Time Frame
Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
Title
Change from baseline verbal digit working memory at 8 weeks and at 12 months
Description
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.
Time Frame
Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
Title
Change from baseline visuospatial working memory at 8 weeks and at 12 months
Description
Backward Spatial Span (WNV). 8 items. Each item is scored 0 or 1 (0=incorrect; 1=correct), yielding a total between 0 and 16.
Time Frame
Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
Title
Change from baseline verbal working memory at 8 weeks and at 12 months
Description
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.
Time Frame
Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
Title
Change from baseline cognitive flexibility at 8 weeks and at 12 months
Description
Children Color Trail Test - II. Total expended time.
Time Frame
Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
Title
Change from baseline set-shifting at 8 weeks and at 12 months
Description
Shifting (Five Digits Test). Total expended time.
Time Frame
Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
Title
Change from baseline attentional inhibition at 8 weeks and at 12 months
Description
Choosing (Five Digits Test). Total expended time.
Time Frame
Baseline (T0; 1 week before intervention); postest (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
Title
Change from baseline behavioral inhibition at 8 weeks and at 12 months
Description
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).
Time Frame
Baseline (T0; 1 week before intervention); postest (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
Title
Change from baseline planning/reasoning at 8 weeks and at 12 months
Description
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.
Time Frame
Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
Title
Change from baseline neuroimaging (T1-weighted 3D sequence) at 8 weeks and at 12 months
Description
MPRAGE sequence: TR=2300 ms, TE=2.98 ms, TI 900 ms, 240 slices, FOV=256 mm; matrix size=256x256; 1 mm isotropic voxel
Time Frame
Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
Title
Change from baseline neuroimaging (T2-weighted 3D sequence) at 8 weeks and at 12 months
Description
TR=3200 ms, TE=298 ms, 256 slices, FOV=224 mm; matrix size=256x256; 0.9 mm isotropic voxel
Time Frame
Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
Title
Change from baseline neuroimaging (Diffusion Tensor Imaging sequence) at 8 weeks and at 12 months
Description
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
Time Frame
Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
Title
Change from baseline neuroimaging (resting-state fMRI sequence) at 8 weeks and at 12 months
Description
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
Time Frame
Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
Title
Change from baseline neuroimaging (clinical sequences) at 8 weeks and at 12 months
Description
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)
Time Frame
Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
Title
Food-choices
Description
Photographs of participants' meals (breakfast, lunch, dinner).
Time Frame
Daily, over 6 weeks (training period)
Title
Change from baseline Body Mass Index (BMI) and waist circumference at 8 weeks and at 12 months
Description
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.
Time Frame
Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
Secondary Outcome Measure Information:
Title
Change from baseline self-report quality of life at 8 weeks and at 12 months
Description
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.
Time Frame
Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
Title
Change from baseline social support and self-steem at 8 weeks and at 12 months
Description
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.
Time Frame
Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
Title
Change from baseline internalising and externalising problems at 8 weeks and at 12 months
Description
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.
Time Frame
Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished).
Title
Change from baseline behavioral executive function at 8 weeks and at 12 months
Description
Behavior Rating Inventory of Executive Function - II (Parents' version and Schools' version). 63 items. Higher scores mean more executive problems.
Time Frame
Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished).
Title
Activity and sleep patterns
Description
Fitbit tracker. Number of steps and number of sleep hours.
Time Frame
Daily, during 6 weeks (the training period)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Being obese according to the criteria by Cole et al., (2000) Exclusion Criteria: Neurological, psychiatric or developmental disorder.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Angeles Jurado Luque, PhD
Organizational Affiliation
Institute of Neuroscience. Department of Clinical Psychology and Psychobiology, University of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neuroscience Institute. Department of Clinical Psychology and Psychobiology
City
Barcelona
ZIP/Postal Code
08035
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33718294
Citation
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.
Results Reference
derived

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

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