NCT05880901

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
480

participants targeted

Target at P75+ for phase_2

Timeline
28mo left

Started Mar 2024

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Mar 2024Aug 2028

First Submitted

Initial submission to the registry

May 17, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 30, 2023

Completed
9 months until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

4.1 years

First QC Date

May 17, 2023

Last Update Submit

March 9, 2024

Conditions

Outcome Measures

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

    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)

Study Arms (4)

Control

NO INTERVENTION

does not attend afterschool or summer programing

After school

EXPERIMENTAL

Attends after school programming for 32 weeks during the school year

Behavioral: After school program

Summer camp

EXPERIMENTAL

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

Behavioral: Summer day camp

After school and Summer Camp

EXPERIMENTAL

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

Behavioral: After school programBehavioral: Summer day camp

Interventions

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.

After schoolAfter school and Summer Camp
Summer day campBEHAVIORAL

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.

After school and Summer CampSummer camp

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29205, United States

RECRUITING

Related Publications (1)

  • Weaver RG, Beets MW, Adams EL, Kaczynski AT, Chen B, Armstrong B, Burkart S, Kiely K, Cepni AB, White JW 3rd, Finnegan O, Savidge M, Parker H, Randolph GAT. Rationale and design of Healthy Kids Beyond the Bell: a 2x2 full factorial study evaluating the impact of summer and after-school programming on children's body mass index and health behaviors. Trials. 2024 Oct 24;25(1):714. doi: 10.1186/s13063-024-08555-2.

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 17, 2023

First Posted

May 30, 2023

Study Start

March 1, 2024

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

August 31, 2028

Last Updated

March 12, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations