Viewing Study NCT05880901



Ignite Creation Date: 2024-05-06 @ 7:04 PM
Last Modification Date: 2024-10-26 @ 2:59 PM
Study NCT ID: NCT05880901
Status: RECRUITING
Last Update Posted: 2024-03-12
First Post: 2023-05-17

Brief Title: Healthy Kids Beyond the Bell Investigating the Impact of After-School and Summer Programs
Sponsor: University of South Carolina
Organization: University of South Carolina

Study Overview

Official Title: Increasing Low-income Childrens Access to Healthy Structured Programming to Reduce Obesity
Status: RECRUITING
Status Verified Date: 2024-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Nearly one in five children are obese and disparities in overweight and obesity between children from low- and middle-to-high-income households persist despite a multitude of school-based interventions The structured days hypothesis posits that structure within a school day plays a protective role for children against obesogenic behaviors and ultimately prevents the occurrence of excessive weight gain thus past school-based efforts are misplaced This study will provide access to healthy structured programming via vouchers to afterschool programs and summer day camps during two windows of vulnerability ie afterschool and summer for low-income children
Detailed Description: Despite the public health fields best efforts disparities in overweight and obesity OWOB prevalence between children 6-11 from low- and middle-to-high-income families persist Previous interventions to address disparate rates of childhood OWOB have focused almost exclusively on school settings Given that disparities in OWOB persist current school-based efforts may be misplaced because children engage in more unhealthy behaviors outside of school eg afterschool during weekdays and during the summer The structured days hypothesis posits that a structure within a day defined as a pre-planned segmented and adult-supervised compulsory environment like a school day plays a protective role for children against obesogenic behaviors and ultimately prevents the occurrence of negative health-outcomes such as excessive weight gain Essentially the structured days hypothesis draws upon concepts in the filled-time perspective literature which posits that time filled with favorable activities cannot be filled with unfavorable activities There are at least two windows of vulnerability for children outside of the school day These critically important windows include the hours immediately following school ie 3-6pm school days and the 10 weeks of summer vacation Programs that can provide a healthy structured environment and prevent unhealthy weight gains exist for both of these time periods ie afterschool programs and summer day camps Unfortunately these programs are too expensive for children from low-income families to attend Thus this study will rigorously test the impact of providing access to existing community-operated afterschool and summer programs on weight status ie BMI z-score and obesogenic behaviors ie physical activity screen use diet and sleep of elementary children from low-income households The study will employ a 2x2 full factorial design The two factors will be access through vouchers to structured programming The four groups will be a no treatment control afterschool program voucher only summer day camp voucher only and vouchers for afterschool and summer day camp combined The study will accomplish the following specific aims AIM 1 Primary Compare changes in z-BMI among children in the no treatment control afterschool only summer camp only and afterschool and summer day camp combined groups AIM 2 Secondary Compare differences in obesogenic behaviors during the school year and the summer among children in the no treatment control school only summer camp only and afterschool and summer day camp combined intervention groups AIM 3 Secondary Evaluate the cost-effectiveness of delivering the afterschool only summer camp only and combined interventions This study is significant because nearly one in five children are obese and disparities in OWOB between children from low- and middle-to-high-income households persist despite past school-based interventions This study is innovative because it represents one of the first attempts to provide access to healthy structured programming during two windows of vulnerability for children outside of the school day Should the proposed intervention strategy prove effective it has the potential to mitigate disparities in OWOB prevalence

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None