Promoting Child Inhibitory Control Skills Around Food

NCT ID: NCT02077387

Last Updated: 2016-02-03

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

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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CHild Inhibitory Control Play (CHIC) Play

CHIC Play paradigm: Children will exposed to several play paradigms that enhance inhibitory control around snack foods. Children will receive the intervention in the preschool setting over a 3 week period.

Group Type EXPERIMENTAL

CHild Inhibitory Control (CHIC) Play

Intervention Type BEHAVIORAL

CHIC Play paradigm: Children will exposed to several play paradigms that enhance inhibitory control around snack foods. Children will receive the intervention in the preschool setting over a 3 week period.

Attention control

Children will receive information regarding other healthy behaviors: brushing teeth, sunscreen use, being physically active

Group Type ACTIVE_COMPARATOR

Attention control

Intervention Type BEHAVIORAL

Children will receive an equal amount of time with the RA, but focus on other healthy behaviors and not use inhibitory control skills training techniques

Interventions

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CHild Inhibitory Control (CHIC) Play

CHIC Play paradigm: Children will exposed to several play paradigms that enhance inhibitory control around snack foods. Children will receive the intervention in the preschool setting over a 3 week period.

Intervention Type BEHAVIORAL

Attention control

Children will receive an equal amount of time with the RA, but focus on other healthy behaviors and not use inhibitory control skills training techniques

Intervention Type BEHAVIORAL

Other Intervention Names

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Inhibitory control training Executive functioning training Tools of the Mind Curriculum Control group

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Kay Rhee

Assistant Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of California, San Diego

San Diego, California, United States

Site Status

Countries

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United States

References

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Nederkoorn C, Braet C, Van Eijs Y, Tanghe A, Jansen A. Why obese children cannot resist food: the role of impulsivity. Eat Behav. 2006 Nov;7(4):315-22. doi: 10.1016/j.eatbeh.2005.11.005. Epub 2005 Nov 22.

Reference Type BACKGROUND
PMID: 17056407 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16828053 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33530135 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30391226 (View on PubMed)

Other Identifiers

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HD074987

Identifier Type: -

Identifier Source: org_study_id

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