AzTrials
AzTrials

Health Status DisparitiesPhase 2NCT05880901

Healthy Kids Beyond the Bell: Investigating the Impact of After-School and Summer Programs

A Phase 2 study testing After school program and Summer day camp in people with Health Status Disparities and Pediatric Obesity, run by University of South Carolina at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Nearly one in five children are obese, and disparities in overweight and obesity between children from low- and middle-to-high-income households persist despite a multitude of school-based interventions. Read more about this study

Who is it for?
Ages 5 to 12 yearsHealthy volunteers can take part
What is being tested?
After school program and Summer day camp
Could I receive a placebo?
No, everyone receives an active treatment
How many people
480 participants
Where
1 siteUnited States
Study dates
1 Mar 2024to 31 Aug 2028
Phase
Phase 2
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 5 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • k-4th grader in a partner school
  • eligible for free and reduced price lunch (a widely recognized indicator of
  • socioeconomic level and poverty status)
  • parent that indicates "yes' on an informed consent document for participation in the study

Who cannot join

  • Diagnosis of an intellectual disability, such as Down Syndrome, Fragile X, Fetal Alcohol
  • a physical disability, such as wheelchair use, that prevents the ability to ambulate without assistance.
  • Families who plan to enroll their children in a summer camp or after school program or relocate (i.e., move) during the 14-month period that they participate

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of South Carolina

    Columbia, South Carolina, 29205

Other trials in United States

About this study

Official title: Increasing Low-income Children's Access to Healthy Structured Programming to Reduce Obesity

Nearly one in five children are obese, and disparities in overweight and obesity between children from low- and middle-to-high-income households persist despite a multitude of school-based interventions. The structured days hypothesis posits that structure within a school day plays a protective role for children against obesogenic behaviors, and, ultimately, prevents the occurrence of excessive weight gain, thus, past school-based efforts are misplaced. This study will provide access to healthy structured programming via vouchers to afterschool programs and summer day camps during two "windows of vulnerability" (ie afterschool and summer) for low-income children.

Read the detailed description

Despite the public health field's best efforts, disparities in overweight and obesity (OWOB) prevalence between children (6-11) from low- and middle-to-high-income families persist. Previous interventions to address disparate rates of childhood OWOB have focused almost exclusively on school settings. Given that disparities in OWOB persist, current school-based efforts may be misplaced because children engage in more unhealthy behaviors outside of school (e.g., afterschool during weekdays and during the summer). The structured days hypothesis posits that a structure within a day, defined as a pre-planned, segmented, and adult-supervised compulsory environment (like a school day), plays a protective role for children against obesogenic behaviors, and, ultimately, prevents the occurrence of negative health-outcomes, such as, excessive weight gain. Essentially, the structured days hypothesis draws upon concepts in the 'filled-time perspective' literature which posits that time filled with favorable activities cannot be filled with unfavorable activities. There are at least two "windows of vulnerability" for children outside of the school day. These critically important windows include the hours immediately following school (i.e., 3-6pm school days) and the 10 weeks of summer vacation. Programs that can provide a healthy structured environment and prevent unhealthy weight gains exist for both of these time periods (i.e., afterschool programs and summer day camps). Unfortunately, these programs are too expensive for children from low-income families to attend. Thus, this study will rigorously test the impact of providing access to existing, community-operated afterschool and summer programs on weight status (i.e., BMI z-score) and obesogenic behaviors (i.e., physical activity, screen use, diet, and sleep) of elementary children from low-income households. The study will employ a 2x2 full factorial design. The two factors will be access, through vouchers, to structured programming. The four groups will be a no treatment control, afterschool program voucher only, summer day camp voucher only, and vouchers for afterschool and summer day camp combined. The study will accomplish the following specific aims: AIM 1 (Primary): Compare changes in z-BMI among children in the no treatment control, afterschool only, summer camp only, and afterschool and summer day camp combined groups. AIM 2 (Secondary): Compare differences in obesogenic behaviors during the school year and the summer among children in the no treatment control, school only, summer camp only, and afterschool and summer day camp combined intervention groups. AIM 3 (Secondary): Evaluate the cost-effectiveness of delivering the afterschool only, summer camp only, and combined interventions. This study is significant because nearly one in five children are obese, and disparities in OWOB between children from low- and middle-to-high-income households persist despite past school-based interventions. This study is innovative because it represents one of the first attempts to provide access to healthy structured programming during two "windows of vulnerability" for children outside of the school day. Should the proposed intervention strategy prove effective it has the potential to mitigate disparities in OWOB prevalence.

Being tested
After school program, Summer day camp
Medical subject headings
Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • After school programBehavioural

    The after school program are existing community-based programs that take place immediately after the regular school day (typically 3:00-6:00pm); are located in a school; are available daily throughout the academic year (Monday through Friday); and provide a combination of scheduled activities, which include a snack, homework assistance/tutoring, enrichment activities (e.g., arts and crafts, music), and opportunities for children to be physically active.

  • Summer day campBehavioural

    The summer day camp programs are existing camps which take place at schools from which children will be recruited. The camps are not singularly focused, such as sport camps or academic only camps. Rather, the camps provide indoor and outdoor opportunities for children to be physically active each day, provide enrichment and academic programming, as well as provide breakfast, lunch, and snacks.

Study groups in NCT05880901
Study groupRoleWhat they receive
ControlNo interventiondoes not attend afterschool or summer programing
After schoolExperimentalAttends after school programming for 32 weeks during the school year
Receives: Behavioral: After school program
Summer campExperimentalAttends summer day camp programming for 8 weeks during the summer vacation from school
Receives: Behavioral: Summer day camp
After school and Summer CampExperimentalAttends after school programming for 32 weeks during the school year and summer day camp programming for 8 weeks during the summer vacation from school
Receives: Behavioral: After school program; Behavioral: Summer day camp

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Body Mass Index

    BMI translated into BMI z-scores based on Centers for Disease Control age-sex-specific zBMI growth charts

    Measured: End of school year (0 months, start of summer), beginning of school year (3 months, end of summer) and end of following school year (12 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2023
  2. Study start1 Mar 2024
  3. Primary completion31 Mar 2028 (estimated)
  4. Study completion31 Aug 2028 (estimated)

Resources

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
480 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05880901
Sponsor's protocol ID
Pro00125471
Status last verified
Sep 2026
First submitted
17 May 2023
Last updated
22 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Eglitis EK, Savidge M, Adams EL, Beets MW, Kaczynski AT, Chen B, Armstrong B, Burkart S, Kiely KP, White JW 3rd, Finnegan O, Parker H, Randolf GAT, Maher C, Weaver RG. "I feel better as a parent" - summer programs help support children's health behaviors and parent wellbeing. Res Sq [Preprint]. 2026 Apr 23:rs.3.rs-9125988. doi: 10.21203/rs.3.rs-9125988/v1.

    PubMed 42078904
  • Weaver RG, Beets MW, Adams EL, Kaczynski AT, Chen B, Armstrong B, Burkart S, Kiely K, Cepni AB, White JW 3rd, Finnegan O, Savidge M, Parker H, Randolph GAT. Rationale and design of Healthy Kids Beyond the Bell: a 2x2 full factorial study evaluating the impact of summer and after-school programming on children's body mass index and health behaviors. Trials. 2024 Oct 24;25(1):714. doi: 10.1186/s13063-024-08555-2.

    PubMed 39449089

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing After school program and Summer day camp in people with Health Status Disparities and Pediatric Obesity, run by University of South Carolina 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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2026. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Body Mass Index (time frame: End of school year (0 months, start of summer), beginning of school year (3 months, end of summer) and end of following school year (12 months)). 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 NCT05880901, which also lists 2 linked publications.

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 22 Sep 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in