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NCT Number: NCT07011602

INTEGRATED CHILDHOOD ACTIVITY AND NUTRITION (ICAN) STUDY

This study is a multi-functional integrated research and education project to prevent losses in academic achievement, cognitive function, and behavioral health among at-risk youth. The study tests the effects of a 8-week nutrition and physical activity-based program (Integrated Childhood Activity and Nutrition [ICAN]) to prevent summer learning loss. Outcomes include standardized academic achievement as well as executive function among 6-10-year-olds affected by poverty. The nutrition component of the intervention involves daily consumption of a snack containing the carotenoid lutein, typically found in high quantities in green leafy vegetables. The physical activity components will involve group games or activities.

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Key information

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bloomington Public Schools District 87

Bloomington, Illinois, 61701, United States

Location status: Recruiting

Location contact

Nicole Rummel, Ed.D.

CONTACT

[email protected]

3098276031

About this study

During the summer period it is estimated that children, especially those from impoverished settings, could lose up to 30% of learning gained during the school year. Additionally, the loss in learning accompanied by increased risk for obesity. Children's dietary intake, particularly of nutrient-dense dark green leafy vegetables, has persistently fallen below dietary recommendations. Similarly, there has been a decline in children's aerobic fitness since the 1970s. Despite consistent and widespread efforts, there has been limited progress in improving children's dietary habits, habitual physical activity engagement, and reducing child obesity. One reason for this perpetual challenge is that educational and intervention efforts typically occur during the school year. However, it is the summer, not the school year, when accelerated increases in body fat and decline in diet quality and physical activity tend to occur. Student summer learning loss, a phenomenon commonly referred to as the summer slide, is the loss of academic knowledge and/or skills during the summer. Students' achievement scores decline over the summer by one month's worth of school-year learning instruction. Additionally, these effects are more pronounced black and Latino students who not only tend to gain less over the school year but exhibit greater learning loss in the summer, compared to white students. This is at least in part because during summer, fewer opportunities exist for children from low-income households to access healthy structured programs. Therefore, efficacious nutrition and physical activity-based programs are critically needed, especially during summer, a period of vulnerability among children affected by poverty.

This work will conduct an 8-week physical activity and nutrition randomized controlled trial among children during the summer period. The specific aims are outlined below.

Specific Aim 1: To investigate the effects of combining an 8-week lutein intervention (6mg lutein/day) with a social emotional learning (SEL)-framed physical activity summer intervention (ICAN) on improving academic achievement and cognition among school children (6-11-year-olds) affected by poverty.

Specific Aim 2: To investigate the effects of the ICAN program on improvement in carotenoid status and implications for academics and cognition in 6-11-year-olds from impoverished settings.

Specific Aim 3: To investigate ICAN intervention effects on weight status and adiposity.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Parental/guardian consent
  • Child assent
  • Child participant is between the chronological age of 6-11 years.
  • Child participant is considered economically or educationally disadvantaged (e.g., eligible for Supplemental Nutritional Assistance Program [SNAP] and/or qualifies for free-and-reduced lunch.
  • Child participant must have 20/20 or corrected 20/20 vision.
  • Child participant absent of cognitive or neurological disorder (e.g., autism spectrum disorder)

Exclusion criteria

  • Parental/guardian does not provide consent
  • Child non-assent
  • Child participant chronological age when enrolling into the iCANS program falls below 6 or above 11 years of age
  • Child participant is not eligible for SNAP or does not qualify for free-and-reduced lunch.
  • Child participant does not have 20/20 or corrected 20/20 vision.
  • Presence of cognitive or neurological disorder (e.g., autism spectrum disorder)

Treatment and study plan

8-week Physical Activity and Nutrition Program

Behavioral

Participants will be enrolled in an 8-week (Monday-Friday) daily physical activity program where treatment group participants will receive daily physical activity via organized games and daily lutein (6mg/d) snacks.

Primary outcomes

  1. Academic Achievement

    Time frame: Baseline vs. 8 week Post-test

    Composite score on the standardized Kaufman Test of Academic and Educational Achievement 3-(KTEA-3)

Secondary outcomes

  1. Attentional Inhibition

    Time frame: Baseline vs. 8-week Post-test

    Flanker Task Accuracy (%)

  2. Attentional Inhibition

    Time frame: Baseline vs. 8-week Post-test

    Flanker Reaction Time (ms)

  3. Attentional Resource Allocation

    Time frame: Baseline vs. 8 week Post-test

    P3 Event-related potential amplitude (mv)

  4. Processing Speed

    Time frame: Baseline vs. 8 week Post-test

    P3 Event-related potential latency (ms)

  5. Retinal Xanthophylls

    Time frame: Baseline vs. 8 week Post-test

    Macular Pigment Optical Density

  6. Skin Carotenoids

    Time frame: Baseline vs. 8 week Post-test

    Veggiemeter Score

  7. Weight status

    Time frame: Baseline vs. 8 week Post-test

    BMI-for-age Percentile

  8. Adiposity

    Time frame: Baseline vs. 8 week Post-test

    %Fat assessed by bioelectric impedance

  9. Nutrition Literacy

    Time frame: Baseline vs. 8 week Post-test

    Nutrition Literacy Survey

Study contacts

Contact information is provided by the study sponsor or research team.

Naiman Khan, PhD, RD

CONTACT

[email protected]

2173002197

Sponsors and collaborators

Lead sponsor

University of Illinois at Urbana-Champaign

Other

Collaborators

  • United States Department of Agriculture (USDA)

Registry information

Acronym: ICAN

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 9, 2025
Registry last updated
Jun 9, 2025

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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