ObesityCHIC PlayNCT02077387
Promoting Child Inhibitory Control Skills Around Food
A study of Obesity, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
San Diego, California, 92093
About this study
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.
- Conditions
- Obesity
- Being tested
- CHild Inhibitory Control (CHIC) Play, Attention control
- Keywords
- Inhibitory control, executive functioning, childhood obesity, preschool, snack foods, caloric intake
- Medical subject headings
- Obesity, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHild Inhibitory Control (CHIC) PlayBehavioural
Also called Inhibitory control training, Executive functioning training, Tools of the Mind Curriculum
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 controlBehavioural
Also called Control group
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: Attention control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: week 4
Secondary outcomes (1)
Executive functioning
Several tasks of Executive functioning will be assessed including a go/no-go task, backward digit span, and delay of gratification
Measured: week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startJun 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Kay Rhee, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02077387
- Sponsor's protocol ID
- HD074987
- Acronym
- CHIC Play
- Status last verified
- Feb 2016
- First submitted
- 27 Feb 2014
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 17056407Nederkoorn 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.
PubMed 16828053Rhee 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.
PubMed 33530135Rhee 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.
PubMed 30391226
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Child Inhibitory Control Skills Around Food
- ClinicalTrials.gov ID
- NCT02077387
- Acronym / sponsor ID
- CHIC Play / HD074987
- Conditions
- Obesity
- Keywords
- Inhibitory control, executive functioning, childhood obesity, preschool, snack foods, caloric intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jun 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 4 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHild Inhibitory Control Play (CHIC) Play | Experimental | Behavioral: CHild Inhibitory Control (CHIC) PlayCHIC 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 | Active comparator | Behavioral: Attention controlChildren will receive information regarding other healthy behaviors: brushing teeth, sunscreen use, being physically active |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHild Inhibitory Control (CHIC) PlayAlso: Inhibitory control training, Executive functioning training, Tools of the Mind CurriculumCHIC 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. | Behavioural | CHild Inhibitory Control Play (CHIC) Play |
| Attention controlAlso: Control groupChildren will receive an equal amount of time with the RA, but focus on other healthy behaviors and not use inhibitory control skills training techniques | Behavioural | Attention control |
Primary outcome
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.
1 secondary outcome
Executive functioning
Time frame: week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
- Background: PubMed 17056407Nederkoorn 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.
- Background: PubMed 16828053Nederkoorn 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.
- Derived from this study: PubMed 33530135Rhee 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.
- Derived from this study: PubMed 30391226Rhee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Obesity, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caloric intake in the Eating in the Absence of Hunger (EAH) paradigm (time frame: week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02077387, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2016.