- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02077387
Promoting Child Inhibitory Control Skills Around Food (CHIC Play)
February 2, 2016 updated by: Kay Rhee, University of California, San Diego
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
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San Diego, California, United States, 92093
- University of California, San Diego
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 6 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
|
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.
Other Names:
|
ACTIVE_COMPARATOR: Attention control
Children will receive information regarding other healthy behaviors: brushing teeth, sunscreen use, being physically active
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Caloric intake in the Eating in the Absence of Hunger (EAH) paradigm
Time Frame: week 4
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Executive functioning
Time Frame: week 4
|
Several tasks of Executive functioning will be assessed including a go/no-go task, backward digit span, and delay of gratification
|
week 4
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BRIEF
Time Frame: week 4
|
Parents will be asked to report on their child's executive functioning ability using the BRIEF (Behavior Rating Inventory of Executive Functioning)
|
week 4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2014
Primary Completion (ACTUAL)
November 1, 2015
Study Completion (ACTUAL)
November 1, 2015
Study Registration Dates
First Submitted
February 27, 2014
First Submitted That Met QC Criteria
February 28, 2014
First Posted (ESTIMATE)
March 4, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
February 3, 2016
Last Update Submitted That Met QC Criteria
February 2, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HD074987
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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