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

NCT ID: NCT03615274

Last Updated: 2021-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-05

Study Completion Date

2021-01-27

Brief Summary

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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

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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

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Executive function training

Intervention Type 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).

Psychoeducation

Intervention Type 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.

Placebo non-adaptive training

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.

Group Type ACTIVE_COMPARATOR

Psychoeducation

Intervention Type 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.

Placebo non-adaptive training

Intervention Type 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.

Interventions

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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).

Intervention Type DEVICE

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.

Intervention Type OTHER

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Neurological, psychiatric or developmental disorder.
Minimum Eligible Age

9 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundació La Marató de TV3

OTHER

Sponsor Role collaborator

University of Barcelona

OTHER

Sponsor Role lead

Responsible Party

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María Ángeles Jurado Luque

Full professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria Angeles Jurado Luque, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Neuroscience Institute. Department of Clinical Psychology and Psychobiology

Barcelona, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 33718294 (View on PubMed)

Other Identifiers

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2016-16-10

Identifier Type: -

Identifier Source: org_study_id

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