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

University of Barcelona

Status: Completed

Conditions: Obesity

Treatments: Device: Placebo non-adaptive training; Device: Executive function training; Other: Psychoeducation

Study type: Interventional

Funder types: Other

Identifiers

NCT03615274

2016-16-10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 9 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Neurological, psychiatric or developmental disorder.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 2 patient groups

Experimental

Experimental group

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.

Treatment:

Other: Psychoeducation

Device: Executive function training

Placebo non-adaptive training

Active Comparator group

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.

Treatment:

Other: Psychoeducation

Device: Placebo non-adaptive training