Recruiting
Phase 2

Observational Study

Sponsor:

University of South Carolina

Code:

NCT05880901

Conditions

Health Status Disparities

Pediatric Obesity

Ethnic Group

Socioeconomic Factors

Eligibility Criteria

Sex: All

Age: 5 - 12

Healthy Volunteers: Accepted

Interventions

After school program

Summer day camp

Study Details

Brief 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. 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.

Conditions

Health Status Disparities

Pediatric Obesity

Ethnic Group

Socioeconomic Factors

Study ID

NCT05880901

Start date

Mar 1, 2024

Status verified date

Mar, 2024

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 12

Healthy Volunteers: Accepted

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 Design

Enrollment

480 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Control

does not attend afterschool or summer programing

experimental: After school

Attends after school programming for 32 weeks during the school year

experimental: Summer camp

Attends summer day camp programming for 8 weeks during the summer vacation from school

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

Interventions

After school program

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 camp

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.

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) ]

Central Contacts and Locations

Central contacts

Robert Weaver

8037775605weaverrg@mailbox.sc.edu

Locations

University of South Carolina

Recruiting

Columbia, South Carolina, United States, 29205

Contacts

Robert G Weaver

weaverrg@mailbox.sc.edu

More Information

Sponsor

University of South Carolina

Last update posted

Mar 12, 2024

Last verified

Mar, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Carolina on 2024-03-12.