Determining the Optimal Amount of Structured Environments for Healthy Kids

NCT06158594 | Recruiting Phase 2 DMC

• 1 other identifier: Pro00125467
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Body Mass Index

  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)

Study Arms (4)

Control

NO INTERVENTION

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

4-week voucher

EXPERIMENTAL

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

Behavioral: Summer day camp

6-week voucher

EXPERIMENTAL

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

Behavioral: Summer day camp

8-week voucher

EXPERIMENTAL

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

Behavioral: Summer day camp

Interventions

Summer day camp BEHAVIORAL

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.

4-week voucher; 6-week voucher; 8-week voucher

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Carolina: lead

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29205, United States

RECRUITING

Related Publications (1)

• Kiely KP, Beets MW, Adams EL, Pate RR, Brian C, Bridget A, Sarah B, Cepni AB, Holmes AJ, White JW, Olivia F, Meghan S, Hannah P, Randolph GAT, Xuanxuan Z, Weaver RG. Protocol for a randomized controlled dose response trial to combat accelerated summer BMI gain in children: The Determining the Optimal amount of Structured Environments (DOSE) study. Contemp Clin Trials. 2025 Apr;151:107840. doi: 10.1016/j.cct.2025.107840. Epub 2025 Feb 10.

  PMID: 39938613 DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Robert Weaver

CONTACT

8037775605; weaverrg@mailbox.sc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 6, 2023
• Study Start: March 1, 2024
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)