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Clinical Trials/NCT04608188
NCT04608188
Completed
Not Applicable

An Intervention to Prevent Weight Gain and Unhealthy Behaviors in Children From Economically Disadvantaged Circumstances

University of South Carolina1 site in 1 country89 target enrollmentNovember 15, 2020
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
University of South Carolina
Enrollment
89
Locations
1
Primary Endpoint
Change in Body Mass Index Z-score
Status
Completed
Last Updated
last year

Overview

Brief Summary

This study will address engagement in unhealthy behaviors, low levels of self-regulation, and unhealthy weight gain for children from low-income households.

Detailed Description

Evidence suggests that components within structured days (e.g., school days) have a positive influence on children's obesogenic behaviors (i.e., diet, sleep, physical activity, sedentary behaviors) and self-regulation. In this pilot study children will be randomized to two arms: attend a structured summer camp, not attend a camp. The investigators hypothesize that children attending the summer camp will engage in more healthy obesogenic behaviors, display higher levels of self-regulation, and subsequently will experience less weight gain than children not attending the summer camp. To test this hypothesis the following specific aims will be accomplished: Aim 1 (Primary): Compare changes in BMI z-scores and fitness among children from low-income households attending a structured summer day camp and those not attending a structured summer day camp. Aim 2 (Secondary): Compare changes in obesogenic behaviors among children attending a structured summer day camp and those not attending a structured summer day camp. Aim 3 (Exploratory): Explore changes in self-regulation and the moderating effect of these changes on primary and secondary outcomes among children attending and not attending a structured summer day camp.

Registry
clinicaltrials.gov
Start Date
November 15, 2020
End Date
November 30, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

R. Glenn Weaver

Assistant Professor

University of South Carolina

Eligibility Criteria

Inclusion Criteria

  • participants will be boys and girls that attend one of the participating schools
  • 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 and/or a physical disability, such as wheelchair use, that prevents the ability to ambulate without assistance.
  • children who plan to enroll in a summer camp during the year that they participate in the study will also be excluded from the study.
  • No other exclusion criteria will be used.

Outcomes

Primary Outcomes

Change in Body Mass Index Z-score

Time Frame: End of school year (start of summer - baseline), beginning of the following school year (3 month)

Measure Description: Centers for Disease Control age and sex-specific Body Mass Index z-scores. A z-score of 0 represents the population mean. Higher or lower z-scores could represent better or worse outcomes as too low could be underweight and too high could indicate overweight or obesity. Children above the 85th percentile are considered overweight while children above the 95th percentile are considered obese

Secondary Outcomes

  • Change in Monitor BRIEF Subscale(End of school year (start of summer - baseline), beginning of the following school year (3 month))
  • Change in Inhibit BRIEF Subscale(End of school year (start of summer - baseline), beginning of the following school year (3 month))
  • Change in Emotional Control BRIEF Subscale(End of school year (start of summer - baseline), beginning of the following school year (3 month))

Study Sites (1)

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