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

Obesity Clinical Trial

— TOuCH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03615274
• Other study ID #: 2016-16-10
• Status: Completed
• Phase: N/A
• Start date: February 5, 2018
• Est. completion date: January 27, 2021

Study information

• Verified date: April 2021
• Source: University of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: January 27, 2021
• Est. primary completion date: January 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 12 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Neurological, psychiatric or developmental disorder.

Related Conditions & MeSH terms

• Obesity
• Pediatric Obesity

Intervention

Device:
• Executive function training
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).

Other:
• Psychoeducation
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.

Device:
• Placebo non-adaptive training
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.

Locations

Country	Name	City	State
Spain	Neuroscience Institute. Department of Clinical Psychology and Psychobiology	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
University of Barcelona	Fundació La Marató de TV3

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (T0; 1 week before intervention); follow-up (T2; 12 months after intervention finished)
Primary	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.	Baseline (T0; 1 week before intervention); follow-up (T2; 12 months after intervention finished)
Primary	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.	Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
Primary	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.	Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
Primary	Change from baseline speed and selective verbal attention at 8 weeks and at 12 months	Reading and counting (Five Digits Test). Total expended time.	Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
Primary	Change from baseline speed and selective visual attention at 8 weeks and at 12 months	Children Color Trail Test - I. Total expended time.	Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
Primary	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.	Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
Primary	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.	Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
Primary	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.	Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
Primary	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.	Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
Primary	Change from baseline cognitive flexibility at 8 weeks and at 12 months	Children Color Trail Test - II. Total expended time.	Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
Primary	Change from baseline set-shifting at 8 weeks and at 12 months	Shifting (Five Digits Test). Total expended time.	Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
Primary	Change from baseline attentional inhibition at 8 weeks and at 12 months	Choosing (Five Digits Test). Total expended time.	Baseline (T0; 1 week before intervention); postest (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
Primary	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).	Baseline (T0; 1 week before intervention); postest (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
Primary	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.	Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
Primary	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	Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
Primary	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	Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
Primary	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	Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
Primary	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	Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
Primary	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)	Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
Primary	Food-choices	Photographs of participants' meals (breakfast, lunch, dinner).	Daily, over 6 weeks (training period)
Primary	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.	Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
Secondary	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.	Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
Secondary	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.	Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
Secondary	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.	Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished).
Secondary	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.	Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished).
Secondary	Activity and sleep patterns	Fitbit tracker. Number of steps and number of sleep hours.	Daily, during 6 weeks (the training period)