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RecruitingNCT07011602ICANUpdated Jun 9, 2025

INTEGRATED CHILDHOOD ACTIVITY AND NUTRITION (ICAN) STUDY

An interventional study of 8-week Physical Activity and Nutrition Program in Achievement, Weight Change and Cognition, sponsored by University of Illinois at Urbana-Champaign. Recruiting at 1 site in United States. Open to participants aged 6 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-09.

Sponsored by University of Illinois at Urbana-Champaign · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Jun 2025; still recruiting 1 year 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
6 Years to 11 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Achievement
  • Weight Change
  • Cognition
  • Fitness
  • Nutrition Status

Keywords

  • brain, exercise, carotenoids, body composition
03

In context

Body Weight Changes

231 studies on the registry are indexed under Body Weight Changes; 30 are open to participants now.

This study's planned enrollment of 100 is above the median of 80 across 179 interventional studies indexed under Body Weight Changes.

Browse Body Weight Changes studies →

Lead sponsor

University of Illinois at Urbana-Champaign is the lead sponsor of 191 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Treatment Group

    8-week Physical Activity and Nutrition

    Behavioral: 8-week Physical Activity and Nutrition Program

  • No intervention
    Control

    Waitlist Control

Interventions

  • Behavioral8-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.

06

What researchers measure

Primary outcomes

  1. Academic Achievement

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

    Time frame: Baseline vs. 8 week Post-test

Secondary outcomes

  1. Attentional Inhibition

    Flanker Task Accuracy (%)

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

  2. Attentional Inhibition

    Flanker Reaction Time (ms)

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

  3. Attentional Resource Allocation

    P3 Event-related potential amplitude (mv)

    Time frame: Baseline vs. 8 week Post-test

  4. Processing Speed

    P3 Event-related potential latency (ms)

    Time frame: Baseline vs. 8 week Post-test

  5. Retinal Xanthophylls

    Macular Pigment Optical Density

    Time frame: Baseline vs. 8 week Post-test

  6. Skin Carotenoids

    Veggiemeter Score

    Time frame: Baseline vs. 8 week Post-test

  7. Weight status

    BMI-for-age Percentile

    Time frame: Baseline vs. 8 week Post-test

  8. Adiposity

    %Fat assessed by bioelectric impedance

    Time frame: Baseline vs. 8 week Post-test

  9. Nutrition Literacy

    Nutrition Literacy Survey

    Time frame: Baseline vs. 8 week Post-test

07

Study locations

1 of 1 sites recruiting
  • Bloomington Public Schools District 87
    Bloomington, Illinois 61701, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07011602
Collaborators
United States Department of Agriculture - National Institute of Food and Agriculture (USDA-NIFA)
Responsible party
Sponsor
First posted
Jun 9, 2025
Start date
Jun 4, 2025
Primary completion
Jul 31, 2027 (estimated)
Completion
Jul 31, 2027 (estimated)
Last update
Jun 9, 2025

Study contacts

Naiman Khan, PhD, RD
Contact
nakhan2@illinois.edu
2173002197

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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