Determining the Optimal Amount of Structured Environments for Healthy Kids
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age5-12
SponsorUniversity of South Carolina
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Summer day camp
BehavioralThe 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.
Treatment groups
360 Participants
are divided into 4 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: 4-week voucherExperimental treatment 1 intervention
Group C: 6-week voucherExperimental treatment 1 intervention
Group D: 8-week voucherExperimental treatment 1 intervention
Trial outcomes
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
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)Sponsors and contacts
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Source ClinicalTrials.gov