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

NCT03615274 | Completed

• 1 other identifier: 2016-16-10
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

childhood obesity; cognitive training; executive function; quality of life; neuroimaging; magnetic resonance; connectivity; decision making

Outcome Measures

Primary Outcomes (22)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• Food-choices

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

  Daily, over 6 weeks (training period)

• 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 Outcomes (5)

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

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

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

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

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

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

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

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

• Activity and sleep patterns

  Daily, during 6 weeks (the training period)

Study Arms (2)

Experimental

EXPERIMENTAL

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.

Device: Executive function training; Other: Psychoeducation

Placebo non-adaptive training

ACTIVE COMPARATOR

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.

Other: Psychoeducation; Device: Placebo non-adaptive training

Interventions

Executive function training DEVICE

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).

Experimental

Psychoeducation OTHER

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.

Experimental; Placebo non-adaptive training

Placebo non-adaptive training DEVICE

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.

Placebo non-adaptive training

Eligibility Criteria

• Age: 9 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Neurological, psychiatric or developmental disorder.

Sponsors & Collaborators

• University of Barcelona: lead
• Fundació La Marató de TV3: collaborator

Study Sites (1)

Neuroscience Institute. Department of Clinical Psychology and Psychobiology

Barcelona, 08035, Spain

Location

Related Publications (1)

• 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.

  PMID: 33718294 DERIVED

MeSH Terms

Conditions

Obesity; Pediatric Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria Angeles Jurado Luque, PhD

  Institute of Neuroscience. Department of Clinical Psychology and Psychobiology, University of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: August 3, 2018
• Study Start: February 5, 2018
• Primary Completion: January 27, 2021
• Study Completion: January 27, 2021
• Last Updated: April 29, 2021

Record last verified: 2021-04

Locations

ES (1)