Clinical trial NCT04608188: Preventing Weight Gain and Unhealthy Behaviors in Children
Official title: An Intervention to Prevent Weight Gain and Unhealthy Behaviors in Children From Economically Disadvantaged Circumstances
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University of South Carolina
Sponsor class: OTHER
First posted: 2020-10-29
Enrollment: 89
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Body Mass Index Z-score
timeFrame: End of school year (start of summer - baseline), beginning of the following school year (3 month)
Secondary outcomes:
measure: Change in Inhibit BRIEF Subscale
timeFrame: End of school year (start of summer - baseline), beginning of the following school year (3 month)
measure: Change in Monitor BRIEF Subscale
timeFrame: End of school year (start of summer - baseline), beginning of the following school year (3 month)
measure: Change in Emotional Control BRIEF Subscale
timeFrame: End of school year (start of summer - baseline), beginning of the following school year (3 month)
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
Study officials:
References:
citation: Weaver RG, Armstrong B, Adams E, Beets M, White J, Flory K, Wilson D, Mclain A, Tennie B. Feasibility &amp; Preliminary Efficacy of Structured Programming and a Parent Intervention to Mitigate Accelerated Summer BMI Gain: A pilot study. Res Sq [Preprint]. 2022 Mar 29:rs.3.rs-1466063. doi: 10.21203/rs.3.rs-1466063/v1.