Clinical trial NCT02077387: Promoting Child Inhibitory Control Skills Around Food
Official title: Promoting Child Inhibitory Control Skills Around Food
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Inhibitory control
executive functioning
childhood obesity
preschool
snack foods
caloric intake
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2014-03-04
Enrollment: 72
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Today's environment provides many hedonic stimuli that promote consumption of unhealthy energy-dense snack foods. It is widely recognized that a systems approach is required to deal with this complex problem. However, individuals, particularly children, also need to develop the personal capacity to deal with tempting stimuli and inhibit responses to these energy-dense foods. Therefore in this proposal, we will focus on enhancing higher level executive functions, particularly inhibitory control, which is needed to counterbalance impulsive behavior and is crucial for growth and development. We have chosen to focus on developing inhibitory control in preschool-age children because executive functioning/inhibitory control and eating habits are developing at this time. Among preschool-age children, inhibitory control is fostered through social play-based curriculums and has been found to be related to greater school readiness and academic skills. Therefore, the goal of this proposal is to adapt a play-based curriculum, the Tools of the Mind program, to promote greater inhibitory control skills in preschool children and decrease consumption of energy-dense snack foods. In Phase I, we will develop and pilot a Child Inhibitory Control Play-based Program (CHIC Play) among children age 4- to 6-years old. We will adapt the learning tools used in the Tools of the Mind curriculum and employ naturalistic play scenarios, drawings (visual support), and games to teach children to inhibit their responses to energy-dense snack foods. Once developed, we will test the efficacy of CHIC Play in the preschool setting. Parent groups will also be conducted to support the adoption of these skills at home. The primary outcome of interest is caloric intake and age- and gender-adjusted percent of daily caloric intake as measured by the Eating in the Absence of Hunger (EAH) free access procedure and a snack time procedure. Inhibitory control skills will also be measured using executive functioning tasks. Feasibility and acceptability of this program will be determined from parent, child, and teacher surveys. The purpose of this study is to develop a new innovative method of decreasing energy-dense snack food consumption by promoting the development of inhibitory control or impulse control. If successful, this program has the potential to play a role in the treatment and prevention of childhood obesity.


Eligibility criteria: Inclusion Criteria:

* 1) child age between 4 and 6 years
* 2) child BMI ≥5th %ile (Children below this BMI percentile may have an underlying biological mechanism that influences eating behaviors.)
* 3) active parental consent

Exclusion Criteria:

* 1) child with major psychological diagnosis, developmental delay, or other medical disorder that affects weight, eating behaviors, and cognition
* 2) food allergies to the foods used in the study
* 3) plans to leave the preschool within the timeframe of the study

Primary outcomes:
measure: Caloric intake in the Eating in the Absence of Hunger (EAH) paradigm
timeFrame: week 4
Secondary outcomes:
measure: Executive functioning
timeFrame: week 4
Other outcomes:
measure: BRIEF
timeFrame: week 4
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
Study officials:
References:
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citation: Nederkoorn C, Jansen E, Mulkens S, Jansen A. Impulsivity predicts treatment outcome in obese children. Behav Res Ther. 2007 May;45(5):1071-5. doi: 10.1016/j.brat.2006.05.009. Epub 2006 Jul 7.
citation: Rhee KE, Manzano M, Goffin S, Strong D, Boutelle KN. Exploring the relationship between appetitive behaviours, executive function, and weight status among preschool children. Pediatr Obes. 2021 Aug;16(8):e12774. doi: 10.1111/ijpo.12774. Epub 2021 Feb 2.
citation: Rhee KE, Kessl S, Manzano MA, Strong DR, Boutelle KN. Cluster randomized control trial promoting child self-regulation around energy-dense food. Appetite. 2019 Feb 1;133:156-165. doi: 10.1016/j.appet.2018.10.035. Epub 2018 Nov 1.