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Completed

NCT Number: NCT02077387

Promoting Child Inhibitory Control Skills Around Food

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.

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Key information

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Diego

San Diego, California, 92093, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CHild Inhibitory Control (CHIC) Play

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.

Other names: Inhibitory control training, Executive functioning training, Tools of the Mind Curriculum

Attention Control

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

Other names: Control group

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Other outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

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

Registry information

Acronym: CHIC Play

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 4, 2014
Registry last updated
Feb 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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