- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05880901
Healthy Kids Beyond the Bell: Investigating the Impact of After-School and Summer Programs
March 9, 2024 updated by: R. Glenn Weaver, University of South Carolina
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.
Study Overview
Status
Recruiting
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
480
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Robert Weaver
- Phone Number: 8037775605
- Email: weaverrg@mailbox.sc.edu
Study Locations
-
-
South Carolina
-
Columbia, South Carolina, United States, 29205
- Recruiting
- University of South Carolina
-
Contact:
- Robert G Weaver
- Email: weaverrg@mailbox.sc.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
does not attend afterschool or summer programing
|
|
Experimental: After school
Attends after school programming for 32 weeks during the school year
|
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.
|
Experimental: Summer camp
Attends summer day camp programming for 8 weeks during the summer vacation from school
|
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.
|
Experimental: After school and Summer Camp
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
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2024
Primary Completion (Estimated)
March 31, 2028
Study Completion (Estimated)
August 31, 2028
Study Registration Dates
First Submitted
May 17, 2023
First Submitted That Met QC Criteria
May 25, 2023
First Posted (Actual)
May 30, 2023
Study Record Updates
Last Update Posted (Actual)
March 12, 2024
Last Update Submitted That Met QC Criteria
March 9, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00125471
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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