AchievementICANNCT07011602
INTEGRATED CHILDHOOD ACTIVITY AND NUTRITION (ICAN) STUDY
A study testing 8-week Physical Activity and Nutrition Program in people with Achievement and Weight Change, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Achievement, Weight Change, Cognition
- What is being tested?
- 8-week Physical Activity and Nutrition Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2025to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Bloomington Public Schools District 87
Bloomington, Illinois, 61701
Nicole Rummel, Ed.D., 3098276031, rummeln@district87.org
About this study
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.
- Conditions
- Achievement, Weight Change, Cognition, Fitness, Nutrition Status
- Being tested
- 8-week Physical Activity and Nutrition Program
- Keywords
- brain, exercise, carotenoids, body composition
- Medical subject headings
- Body Weight Changes, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8-week Physical Activity and Nutrition ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | 8-week Physical Activity and Nutrition Receives: Behavioral: 8-week Physical Activity and Nutrition Program |
| Control | No intervention | Waitlist Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Academic Achievement
Composite score on the standardized Kaufman Test of Academic and Educational Achievement 3-(KTEA-3)
Measured: Baseline vs. 8 week Post-test
Secondary outcomes (9)
Attentional Inhibition
Flanker Task Accuracy (%)
Measured: Baseline vs. 8-week Post-test
Attentional Inhibition
Flanker Reaction Time (ms)
Measured: Baseline vs. 8-week Post-test
Attentional Resource Allocation
P3 Event-related potential amplitude (mv)
Measured: Baseline vs. 8 week Post-test
Processing Speed
P3 Event-related potential latency (ms)
Measured: Baseline vs. 8 week Post-test
Retinal Xanthophylls
Macular Pigment Optical Density
Measured: Baseline vs. 8 week Post-test
Skin Carotenoids
Veggiemeter Score
Measured: Baseline vs. 8 week Post-test
Weight status
BMI-for-age Percentile
Measured: Baseline vs. 8 week Post-test
Adiposity
%Fat assessed by bioelectric impedance
Measured: Baseline vs. 8 week Post-test
Nutrition Literacy
Nutrition Literacy Survey
Measured: Baseline vs. 8 week Post-test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2025
- Study start4 Jun 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AchievementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011602
- Sponsor's protocol ID
- 24-0625
- Acronym
- ICAN
- Status last verified
- Jun 2025
- First submitted
- 5 Jun 2025
- Last updated
- 9 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 42140347
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INTEGRATED CHILDHOOD ACTIVITY AND NUTRITION (ICAN) STUDY
- ClinicalTrials.gov ID
- NCT07011602
- Acronym / sponsor ID
- ICAN / 24-0625
- Conditions
- Achievement, Weight Change, Cognition, Fitness, Nutrition Status
- Keywords
- brain, exercise, carotenoids, body composition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Study start
- 4 Jun 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 9 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Behavioral: 8-week Physical Activity and Nutrition Program8-week Physical Activity and Nutrition |
| Control | No intervention | –Waitlist Control |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 8-week Physical Activity and Nutrition ProgramParticipants 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. | Behavioural | Treatment Group |
Primary outcome
Academic Achievement
Time frame: Baseline vs. 8 week Post-test
Composite score on the standardized Kaufman Test of Academic and Educational Achievement 3-(KTEA-3)
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2025.
- Derived from this study: PubMed 42140347Kinder 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.
- Individual participant dataSharing planned: Undecided
Related trials for Achievement
Recruiting
SBIR/ STTR Family Check-up Online
Mental Health, Parenting Stress
Not yet recruiting
Effect of Manual and Mechanical Glide Path Preparation on Working Length Accuracy.
Achievement of Working Length After Manual Versus Mechanical Glide Path
Active, not recruitingObservational study
Long-term Academic and Psychosocial Impact of Child's Sleep: Parental Influences
Parents, School-age Children
Not yet recruiting
Predictors of Trifecta Achievement After HoLEP
HoLEP, Trifecta Achievement
Enrolling by invitation
Ultrasound Guided Retroclavicular Infraclavicular Versus Axillary Block as Regional Anesthesia in Obese Patients
Achievement of High-quality Analgesia in Elbow Surgeries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 8-week Physical Activity and Nutrition Program in people with Achievement and Weight Change, run by University of Illinois at Urbana-Champaign at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Naiman Khan, PhD, RD (2173002197, nakhan2@illinois.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Academic Achievement (time frame: Baseline vs. 8 week Post-test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07011602, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2025; AzTrials last refreshed its copy on 31 Oct 2026.