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.
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
- Conditions the study is for
- Health Status Disparities, Pediatric Obesity, Ethnic Group
- What is being tested?
- After school program and Summer day camp
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| Control | No intervention | does not attend afterschool or summer programing |
| After school | Experimental | Attends after school programming for 32 weeks during the school year Receives: Behavioral: After school program |
| Summer camp | Experimental | Attends summer day camp programming for 8 weeks during the summer vacation from school Receives: Behavioral: Summer day camp |
| After school and Summer Camp | Experimental | Attends 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.
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.
- First posted30 May 2023
- Study start1 Mar 2024
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Health Status DisparitiesStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, R. Glenn Weaver, University of South Carolina
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 42078904Weaver 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Low-income Children's Access to Healthy Structured Programming to Reduce Obesity
- ClinicalTrials.gov ID
- NCT05880901
- Acronym / sponsor ID
- Pro00125471
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 30 May 2023 (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.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –does not attend afterschool or summer programing |
| After school | Experimental | Behavioral: After school programAttends after school programming for 32 weeks during the school year |
| Summer camp | Experimental | Behavioral: Summer day campAttends summer day camp programming for 8 weeks during the summer vacation from school |
| After school and Summer Camp | Experimental | Behavioral: After school program, Behavioral: Summer day campAttends after school programming for 32 weeks during the school year and summer day camp programming for 8 weeks during the summer vacation from school |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| After school programThe 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. | Behavioural | After school, After school and Summer Camp |
| Summer day campThe 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. | Behavioural | After school and Summer Camp, Summer camp |
Primary outcome
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)
BMI translated into BMI z-scores based on Centers for Disease Control age-sex-specific zBMI growth charts
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 22 Sep 2026.
- Derived from this study: PubMed 42078904Eglitis 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.
- Derived from this study: PubMed 39449089Weaver 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.