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Recruiting NCT07011602

INTEGRATED CHILDHOOD ACTIVITY AND NUTRITION (ICAN) STUDY

No phase Interventional Achievement Weight Change Cognition Fitness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 8-week Physical Activity and Nutrition Program.
Who it may be relevant to
Registry conditions: Achievement, Weight Change, Cognition, Fitness. Basic parameters: 6 years — 11 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

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.

Interventions

  • Behavioral 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 measures

  • Academic Achievement [Time frame: Baseline vs. 8 week Post-test]
Secondary outcome measures (9)
  • Attentional Inhibition [Time frame: Baseline vs. 8-week Post-test]
  • Attentional Inhibition [Time frame: Baseline vs. 8-week Post-test]
  • Attentional Resource Allocation [Time frame: Baseline vs. 8 week Post-test]
  • Processing Speed [Time frame: Baseline vs. 8 week Post-test]
  • Retinal Xanthophylls [Time frame: Baseline vs. 8 week Post-test]
  • Skin Carotenoids [Time frame: Baseline vs. 8 week Post-test]
  • Weight status [Time frame: Baseline vs. 8 week Post-test]
  • Adiposity [Time frame: Baseline vs. 8 week Post-test]
  • Nutrition Literacy [Time frame: Baseline vs. 8 week Post-test]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Bloomington Public Schools District 87 — Bloomington

Publications

  • Kinder CJ, Liu R, McCabe E, Madson J, Keye S, Hodge K, Richards KA, Khan NA. Integrated Childhood Activity and Nutrition (ICAN) study: Protocol for a randomized controlled trial to prevent summer learning loss and promote child health. Contemp Clin Trials. 2026 Jul;166:108350. doi: 10.1016/j.cct.2026.108350. Epub 2026 May 14. PMID 42140347

Identifiers

NCT: NCT07011602 · 24-0625

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗