NCT07011602

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
15mo left

Started Jun 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress43%
Jun 2025Jul 2027

Study Start

First participant enrolled

June 4, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 5, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 9, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

June 9, 2025

Status Verified

June 1, 2025

Enrollment Period

2.2 years

First QC Date

June 5, 2025

Last Update Submit

June 5, 2025

Conditions

Keywords

brain, exercise, carotenoids, body composition

Outcome Measures

Primary Outcomes (1)

  • Academic Achievement

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

    Baseline vs. 8 week Post-test

Secondary Outcomes (9)

  • Attentional Inhibition

    Baseline vs. 8-week Post-test

  • Attentional Inhibition

    Baseline vs. 8-week Post-test

  • Attentional Resource Allocation

    Baseline vs. 8 week Post-test

  • Processing Speed

    Baseline vs. 8 week Post-test

  • Retinal Xanthophylls

    Baseline vs. 8 week Post-test

  • +4 more secondary outcomes

Study Arms (2)

Treatment Group

EXPERIMENTAL

8-week Physical Activity and Nutrition

Behavioral: 8-week Physical Activity and Nutrition Program

Control

NO INTERVENTION

Waitlist Control

Interventions

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.

Treatment Group

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bloomington Public Schools District 87

Bloomington, Illinois, 61701, United States

RECRUITING

MeSH Terms

Conditions

Body Weight ChangesMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Naiman Khan, PhD, RD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2025

First Posted

June 9, 2025

Study Start

June 4, 2025

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

June 9, 2025

Record last verified: 2025-06

Locations