Physical Activity and Nutrition Program for Cognition

(ICAN Trial)

Overseen By Naiman Khan, PhD, RD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Urbana-Champaign

Disqualifiers: Autism, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how an 8-week program focused on nutrition and physical activity can enhance learning and thinking skills in children facing economic challenges. The program, Integrated Childhood Activity and Nutrition (ICAN), includes daily snacks with lutein (a nutrient from green vegetables) and engaging group games to keep children active. It targets children aged 6-11 who qualify for programs like free lunch at school and do not have cognitive issues such as autism. As an unphased trial, this study provides a unique opportunity for children to benefit from a program designed to enhance cognitive skills through improved nutrition and physical activity.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this program is safe for children?

Research has shown that the Integrated Childhood Activity and Nutrition (ICAN) program combines physical activities with healthy eating. The nutrition component includes a daily snack containing lutein, a nutrient found in leafy greens. Studies have demonstrated that lutein is safe and well-tolerated in children.

The physical activities resemble group games, which are generally safe for kids. No evidence indicates serious side effects from these activities or the snacks. This program promotes healthy habits, and current research suggests it is safe for children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Integrated Childhood Activity and Nutrition (ICAN) program because it takes a holistic approach by combining physical activity and nutrition to enhance cognitive function. Unlike traditional treatments that may focus solely on dietary changes or medication, ICAN integrates exercise and healthy eating habits over an 8-week period, potentially offering a more sustainable and natural way to boost brain health. This approach is particularly promising for long-term cognitive improvement in children, as it promotes lifestyle changes that can be maintained beyond the program's duration.

What evidence suggests that the Integrated Childhood Activity and Nutrition (ICAN) program is effective for preventing summer learning loss?

Research has shown that improving children's diets can greatly enhance their thinking and learning abilities, especially when they lack sufficient nutrients. For instance, nutrients in green leafy vegetables can help the brain grow and function better. Exercise also plays a crucial role in boosting learning and thinking skills. This trial will test the Integrated Childhood Activity and Nutrition (ICAN) program, which combines good nutrition with physical activity. Studies suggest that such combined efforts can improve children's ability to learn and perform well in school, helping to prevent learning setbacks, particularly during summer breaks for children from low-income families. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

The ICAN study is for children aged 6-11 who are economically or educationally disadvantaged, such as those eligible for SNAP or free-and-reduced lunch programs. Participants need parental consent, their own assent, and must have normal or corrected-to-normal vision. Children with cognitive or neurological disorders cannot participate.

Inclusion Criteria

Parental/guardian consent

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

Child non-assent

Presence of cognitive or neurological disorder (e.g., autism spectrum disorder)

Parental/guardian does not provide consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in an 8-week nutrition and physical activity program, including daily consumption of a snack containing lutein and participation in group games or activities.

8 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for changes in academic achievement, cognition, and health metrics after the intervention.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Integrated Childhood Activity and Nutrition (ICAN)

Trial Overview This trial tests an 8-week program combining nutrition and physical activity to prevent summer learning loss in at-risk youth. It includes daily snacks rich in lutein and group activities aimed at improving academic achievement, executive function, and behavioral health among participants.

How Is the Trial Designed?

Group I: Treatment Group Experimental Treatment 1 Intervention

8-week Physical Activity and Nutrition

Group II: Control Active Control 1 Intervention

Waitlist Control

Who Is Running the Clinical Trial?

University of Illinois at Urbana-Champaign

Lead Sponsor

Trials

203

Recruited

40,600+

United States Department of Agriculture - National Institute of Food and Agriculture (USDA-NIFA)

Collaborator

Trials

2

Recruited

60+

Citations

1. portal.nifa.usda.gov portal.nifa.usda.gov/web/crisprojectpages/1032079-integrated-childhood-activity-and-nutrition-ican-study.html

Integrated Childhood Activity and Nutrition (ICAN) 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8839299/

The Effects of Nutritional Interventions on the Cognitive ... This review suggests nutritional interventions significantly improve cognitive outcomes of undernourished preschool-age children. Trials ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3607807/

The role of nutrition in children's neurocognitive development ... This review examines the current evidence for a possible connection between nutritional intake (including micronutrients and whole diet) and neurocognitive ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2161831323001291

Integrating Nutrition and Child Development Interventions Data from LMICs have shown that parenting and preschool interventions early in life have beneficial effects on children's cognitive performance and schooling ( ...

5. mdpi.com mdpi.com/2072-6643/11/8/1953

How Lifestyle Factors Affect Cognitive and Executive ... Although both nutrition and physical activity have been associated with enhanced cognition and learning in children, few data have examined the independent and ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1499404625002994

Integrated Childhood Activity and Nutrition (ICAN) Study ICAN is a 3-year project, and we are in the process of recruiting study participants to initiate program implementation and data collection in the summer of ...

7. cdn.nutrition.org cdn.nutrition.org/article/S2475-2991(25)02805-7/fulltext

Protocol for the Integrated Childhood Activity and Nutrition ... The ICAN curriculum will focus on physical activity, nutrition education, SEL, and life skill enrichment. Additionally, a lutein-rich (6mg/day) snack will be ...

8. publish.illinois.edu publish.illinois.edu/ipals-program/files/2024/12/ICANS-Informed-Consent_Revised-2_Clean-Stamped-1.pdf

Integrated Childhood Physical Activity and Nutrition (ICAN ... The primary aims of the ICAN study coincides with the program, which is to conduct research to determine whether your child's participation in the ICAN program ...

9. trial.medpath.com trial.medpath.com/clinical-trial/70b791fd7e275190/nct07011602-integrated-childhood-activity-nutrition-study

INTEGRATED CHILDHOOD ACTIVITY AND NUTRITION ... The study tests the effects of a 8-week nutrition and physical activity-based program (Integrated Childhood Activity and Nutrition \[ICAN\]) to ...