Recruiting

ICAN

Sponsor:

University of Illinois at Urbana-Champaign

Code:

NCT07011602

Conditions

Achievement

Weight Change

Cognition

Fitness

Nutrition Status

Eligibility Criteria

Sex: All

Age: 6 - 11

Healthy Volunteers: Accepted

Interventions

8-week Physical Activity and Nutrition Program

Study Details

Brief summary:

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.

Conditions

Achievement

Weight Change

Cognition

Fitness

Nutrition Status

Study ID

NCT07011602

Start date

Jun 4, 2025

Status verified date

Jun, 2025

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 11

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Treatment Group

8-week Physical Activity and Nutrition

no intervention: Control

Waitlist Control

Interventions

8-week Physical Activity and Nutrition Program

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 outcome measure

  • Academic Achievement [ Time Frame: Baseline vs. 8 week Post-test ]

Central Contacts and Locations

Central contacts

Locations

Bloomington Public Schools District 87

Recruiting

Bloomington, Illinois, United States, 61701

Contacts

More Information

Sponsor

University of Illinois at Urbana-Champaign

Last update posted

Jun 9, 2025

Last verified

Jun, 2025

Keywords

  • brain, exercise, carotenoids, body composition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Illinois at Urbana-Champaign on 2025-06-09.