Executive Function Training in Childhood Obesity: Food Choice, Quality of Life, and Brain Connectivity (TOuCH): A Randomized Control Trial Protocol

Cristina Sanchez-Castañeda, Sandra Luis-Ruiz, Marta Ramon-Krauel, Carles Lerin, Consuelo Sanchez, Núria Miró, Sònia Martínez, Maite Garolera, Maria Angeles Jurado, Cristina Sanchez-Castañeda, Sandra Luis-Ruiz, Marta Ramon-Krauel, Carles Lerin, Consuelo Sanchez, Núria Miró, Sònia Martínez, Maite Garolera, Maria Angeles Jurado

Abstract

Background: Individuals with obesity are known to present cognitive deficits, especially in executive functions. Executive functions play an important role in health and success throughout the whole life and have been related to food decision-making and to the ability to maintain energy balance. It is possible to improve executive functions through targeted training. This would involve brain plasticity changes that could be studied through connectivity MRI. The general hypothesis of this study is that executive functions training in children with obesity can improve food choices and produce cognitive and neuroimaging changes (structural and functional connectivity), as well as improve emotional state and quality of life. Methods: Randomized controlled double-blind trial with 12-month follow-up. Thirty children with obesity will be randomly allocated into "executive training" (Cognifit with adaptive difficulty + Cogmed) or "control task" group (Cognifit without adaptive difficulty). Both groups will attend 30-45 min of individual gamified training (Cogmed and/or Cognifit systems) by iPad, five times per week during 6 weeks. Cogmed and Cognifit software are commercially available from Pearson and Cognifit, respectively. Participants will receive an iPad with both apps installed for a 6-week use. Participants will also receive counseling diet information via presentations sent to the iPad and will wear a Fitbit Flex 2 tracker to monitor daily activity and sleep patterns. Main outcomes will be cognitive, emotional, food decision, and quality-of-life measures, as well as neuroimaging measures. Participants are evaluated at baseline (T0), after treatment (T1), and 12 months since baseline (T2). Discussion: Longitudinal study with active control group and 3 time points: baseline, immediately after treatment, and 1 year after baseline. Threefold treatment: executive function training, psychoeducation, and feedback on activity/sleep tracking. We will evaluate the transfer effects of the intervention, including emotional and functional outcomes, as well as the effects on neural plasticity by connectivity MRI. Trial registration: This project has been registered in ClinicalTrials.gov (trial registration number NCT03615274), August 3, 2018.

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

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2021 Sanchez-Castañeda, Luis-Ruiz, Ramon-Krauel, Lerin, Sanchez, Miró, Martínez, Garolera and Jurado.

Figures

Figure 1
Figure 1
Diagram of the study protocol methods.
Figure 2
Figure 2
CONSORT flow diagram of study recruitment.
Figure 3
Figure 3
Materials provided to participants to follow the home-based training.
Figure 4
Figure 4
Screenshots of a Prezi daily presentation.

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