Recruiting
Phase 2

Observational Study

Sponsor:

University of South Carolina

Code:

NCT06158594

Conditions

Health Status Disparities

Pediatric Obesity

Ethnic Groups

Socioeconomic Factors

Eligibility Criteria

Sex: All

Age: 5 - 12

Healthy Volunteers: Accepted

Interventions

Summer day camp

Study Details

Brief summary:

Studies show that virtually all increases in children's (5-12yrs) BMI occur during the summer, no matter children's' weight status (i.e., normal weight, overweight, or obese) at summer entry. Recent preliminary studies show that children engage in healthier behaviors on days that they attend summer day camps, and that BMI gain does not accelerate for these children. The proposed randomized dose-response study will identify the dose-response relationship between amount of summer programming and summer BMI gain.

Conditions

Health Status Disparities

Pediatric Obesity

Ethnic Groups

Socioeconomic Factors

Study ID

NCT06158594

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 relocate (i.e., move) during the 14-month period that they participate

Study Design

Enrollment

360 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Control

Children in this group will not receive a voucher to attend a pre-existing summer program

experimental: 4-week voucher

Children in this group will receive a voucher to attend 4-weeks of a pre-existing summer program

experimental: 6-week voucher

Children in this group will receive a voucher to attend 6-weeks of a pre-existing summer program

experimental: 8-week voucher

Children in this group will receive a voucher to attend 8-weeks of a pre-existing summer program

Interventions

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.