NCT02077387

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 4, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

February 3, 2016

Status Verified

February 1, 2016

Enrollment Period

1.4 years

First QC Date

February 27, 2014

Last Update Submit

February 2, 2016

Conditions

Keywords

Inhibitory controlexecutive functioningchildhood obesitypreschoolsnack foodscaloric intake

Outcome Measures

Primary Outcomes (1)

  • Caloric intake in the Eating in the Absence of Hunger (EAH) paradigm

    Eating in the Absence of Hunger paradigm: Children in the full state will be presented with 8 snack foods and allowed to eat ad libitum for 10 minutes. Caloric intake and age- and gender-adjusted percent of daily caloric intake will be assessed.

    week 4

Secondary Outcomes (1)

  • Executive functioning

    week 4

Other Outcomes (1)

  • BRIEF

    week 4

Study Arms (2)

CHild Inhibitory Control Play (CHIC) Play

EXPERIMENTAL

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.

Behavioral: CHild Inhibitory Control (CHIC) Play

Attention control

ACTIVE COMPARATOR

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

Behavioral: Attention control

Interventions

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.

Also known as: Inhibitory control training, Executive functioning training, Tools of the Mind Curriculum
CHild Inhibitory Control Play (CHIC) Play

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

Also known as: Control group
Attention control

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Diego

San Diego, California, 92093, United States

Location

Related Publications (4)

  • 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.

    PMID: 17056407BACKGROUND
  • 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.

    PMID: 16828053BACKGROUND
  • 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.

  • 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.

MeSH Terms

Conditions

ObesityPediatric Obesity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics

Study Record Dates

First Submitted

February 27, 2014

First Posted

March 4, 2014

Study Start

June 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

February 3, 2016

Record last verified: 2016-02

Locations