NCT06158594|Active Not RecruitingPhase 2DMC
Determining the Optimal Amount of Structured Environments for Healthy Kids
DOSE
Identifying the Ideal Dose of Structured Summer Programming for Mitigating Accelerated Summer BMI Gain
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Sponsor study identifier
interventional
360
1 country
1
Study Start
March 1, 2024
Actual (reported)Primary Completion
March 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 27, 2023
Actual (reported)December 6, 2023
Actual (reported)March 1, 2024
Actual (reported)March 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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)
Children in this group will not receive a voucher to attend a pre-existing summer program
Children in this group will receive a voucher to attend 4-weeks of a pre-existing summer program
Children in this group will receive a voucher to attend 6-weeks of a pre-existing summer program
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of South Carolina
Columbia, South Carolina, 29205, United States
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.
First Submitted
November 27, 2023
First Posted
December 6, 2023
Study Start
March 1, 2024
Actual (reported)Primary Completion
March 31, 2028
EstimatedPhentermine's Impact on Treatment in Teens
A Novel Obesity Prevention Program for High-Risk Infants in Primary Care
Children in this group will receive a voucher to attend 8-weeks of a pre-existing summer program
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 22, 2026
Record last verified: 2026-09
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Source: ClinicalTrials.gov.
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