Clinical trial NCT03615274: Executive Function Training in Childhood Obesity: Food Choice, Quality of Life and Brain Connectivity
Official title: Executive Function Training in Childhood Obesity: Food Choice, Quality of Life and Brain Connectivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: childhood obesity
cognitive training
executive function
quality of life
neuroimaging
magnetic resonance
connectivity
decision making
Lead sponsor: University of Barcelona
Sponsor class: OTHER
Collaborators: name: Fundació La Marató de TV3
First posted: 2018-08-03
Enrollment: 46
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Neurological, psychiatric or developmental disorder.

Primary outcomes:
measure: Change from baseline estimated verbal intelligence quotient (IQ) at 12 months
timeFrame: Baseline (T0; 1 week before intervention); follow-up (T2; 12 months after intervention finished)
measure: Change from baseline estimated visuospatial intelligence quotient (IQ) at 12 months
timeFrame: Baseline (T0; 1 week before intervention); follow-up (T2; 12 months after intervention finished)
measure: Change from baseline immediate verbal attention at 8 weeks and at 12 months
timeFrame: Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
measure: Change from baseline immediate visuospatial attention at 8 weeks and at 12 months
timeFrame: Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
measure: Change from baseline speed and selective verbal attention at 8 weeks and at 12 months
timeFrame: Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
measure: Change from baseline speed and selective visual attention at 8 weeks and at 12 months
timeFrame: Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
measure: Change from baseline sustained visual attention at 8 weeks and at 12 months
timeFrame: Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
measure: Change from baseline verbal digit working memory at 8 weeks and at 12 months
timeFrame: Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
measure: Change from baseline visuospatial working memory at 8 weeks and at 12 months
timeFrame: Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
measure: Change from baseline verbal working memory at 8 weeks and at 12 months
timeFrame: Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
measure: Change from baseline cognitive flexibility at 8 weeks and at 12 months
timeFrame: Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
measure: Change from baseline set-shifting at 8 weeks and at 12 months
timeFrame: Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
measure: Change from baseline attentional inhibition at 8 weeks and at 12 months
timeFrame: Baseline (T0; 1 week before intervention); postest (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
measure: Change from baseline behavioral inhibition at 8 weeks and at 12 months
timeFrame: Baseline (T0; 1 week before intervention); postest (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
measure: Change from baseline planning/reasoning at 8 weeks and at 12 months
timeFrame: Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
measure: Change from baseline neuroimaging (T1-weighted 3D sequence) at 8 weeks and at 12 months
timeFrame: Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
measure: Change from baseline neuroimaging (T2-weighted 3D sequence) at 8 weeks and at 12 months
timeFrame: Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
measure: Change from baseline neuroimaging (Diffusion Tensor Imaging sequence) at 8 weeks and at 12 months
timeFrame: Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
measure: Change from baseline neuroimaging (resting-state fMRI sequence) at 8 weeks and at 12 months
timeFrame: Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
measure: Change from baseline neuroimaging (clinical sequences) at 8 weeks and at 12 months
timeFrame: Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
measure: Food-choices
timeFrame: Daily, over 6 weeks (training period)
measure: Change from baseline Body Mass Index (BMI) and waist circumference at 8 weeks and at 12 months
timeFrame: Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
Secondary outcomes:
measure: Change from baseline self-report quality of life at 8 weeks and at 12 months
timeFrame: Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
measure: Change from baseline social support and self-steem at 8 weeks and at 12 months
timeFrame: Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished)
measure: Change from baseline internalising and externalising problems at 8 weeks and at 12 months
timeFrame: Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished).
measure: Change from baseline behavioral executive function at 8 weeks and at 12 months
timeFrame: Baseline (T0; 1 week before intervention); postraining (T1; 1 week after intervention); follow-up (T2; 12 months after intervention finished).
measure: Activity and sleep patterns
timeFrame: Daily, during 6 weeks (the training period)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Neuroscience Institute. Department of Clinical Psychology and Psychobiology
Study officials:
affiliation: Institute of Neuroscience. Department of Clinical Psychology and Psychobiology, University of Barcelona
name: Maria Angeles Jurado Luque, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.