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Healthy Kids Beyond the Bell: Investigating the Impact of After-School and Summer Programs

Primary Purpose

Health Status Disparities, Pediatric Obesity, Ethnic Group

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
After school program
Summer day camp
Sponsored by
University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Health Status Disparities

Eligibility Criteria

5 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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 after school program or relocate (i.e., move) during the 14-month period that they participate

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    No Intervention

    Experimental

    Experimental

    Experimental

    Arm Label

    Control

    After school

    Summer camp

    After school and Summer Camp

    Arm Description

    does not attend afterschool or summer programing

    Attends after school programming for 32 weeks during the school year

    Attends summer day camp programming for 8 weeks during the summer vacation from school

    Attends after school programming for 32 weeks during the school year and summer day camp programming for 8 weeks during the summer vacation from school

    Outcomes

    Primary Outcome Measures

    Change in Body Mass Index
    BMI translated into BMI z-scores based on Centers for Disease Control age-sex-specific zBMI growth charts

    Secondary Outcome Measures

    Full Information

    First Posted
    May 17, 2023
    Last Updated
    May 28, 2023
    Sponsor
    University of South Carolina
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05880901
    Brief Title
    Healthy Kids Beyond the Bell: Investigating the Impact of After-School and Summer Programs
    Official Title
    Increasing Low-income Children's Access to Healthy Structured Programming to Reduce Obesity
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2024 (Anticipated)
    Primary Completion Date
    August 31, 2027 (Anticipated)
    Study Completion Date
    August 31, 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of South Carolina

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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 field's 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 (e.g., 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 (i.e., 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 (i.e., 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 (i.e., BMI z-score) and obesogenic behaviors (i.e., 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Health Status Disparities, Pediatric Obesity, Ethnic Group, Socioeconomic Factors

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Factorial Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    480 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    does not attend afterschool or summer programing
    Arm Title
    After school
    Arm Type
    Experimental
    Arm Description
    Attends after school programming for 32 weeks during the school year
    Arm Title
    Summer camp
    Arm Type
    Experimental
    Arm Description
    Attends summer day camp programming for 8 weeks during the summer vacation from school
    Arm Title
    After school and Summer Camp
    Arm Type
    Experimental
    Arm Description
    Attends after school programming for 32 weeks during the school year and summer day camp programming for 8 weeks during the summer vacation from school
    Intervention Type
    Behavioral
    Intervention Name(s)
    After school program
    Intervention Description
    The after school program are existing community-based programs that take place immediately after the regular school day (typically 3:00-6:00pm); are located in a school; are available daily throughout the academic year (Monday through Friday); and provide a combination of scheduled activities, which include a snack, homework assistance/tutoring, enrichment activities (e.g., arts and crafts, music), and opportunities for children to be physically active.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Summer day camp
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in Body Mass Index
    Description
    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)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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 after school program or relocate (i.e., move) during the 14-month period that they participate
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Robert Weaver
    Phone
    8037775605
    Email
    weaverrg@mailbox.sc.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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