Reducing Health Disparities in Childhood Obesity

Obesity Clinical Trial

Official title:

Reducing Health Disparities in Childhood Obesity Using Financial Incentives in Low-income Households

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04072549
• Other study ID #: Pro00086238
• Status: Completed
• Phase: N/A
• Start date: August 26, 2019
• Est. completion date: May 1, 2024

Study information

• Verified date: May 2024
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, we will address cost barriers to participating in summer programs and hypothesize this will lead to marked improvements in children's obesogenic behaviors and a reduction in excessive, unhealthy weight gain over summer.

Description:

For this study, we will rigorously test the impact of providing access to existing community-operated summer programs on weight status (i.e., BMI z-score) and obesogenic behaviors of 1st-3rd grade children from low-income households. Using a pragmatic, Type II hybrid effectiveness-implementation randomized design, we will compare changes in weight status and obesogenic behaviors of children from low-income households randomized to one of two conditions: free summer programming or comparison/control.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 651
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 10 Years

Eligibility

Inclusion Criteria:

1st through 3rd grade students in the participating schools.

Exclusion Criteria:

The only exclusion criteria will be the diagnosis of an intellectual disability, such as:

Autism Spectrum Disorder Down Syndrome Fragile X Fetal Alcohol and/or a physical disability, such as wheelchair use

This decision was made because of the added resources required to evaluate these children, as well as the inability to sample enough of these children to adequately draw conclusions.

No other exclusion criteria will be used.

Related Conditions & MeSH terms

• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• Free Summer Programming
The summer day 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. To standardize programming, the schools operate their camps on the same daily schedules which are developed by the same district-level personnel, with identical programmatic content delivered across all schools. The schools also provide the same meals to all children enrolled. The meals adhere to the Summer Food Service Program nutrition guidelines and are reimbursed through existing federal food programs.

Locations

Country	Name	City	State
United States	Michael Beets	Columbia	South Carolina
United States	University of South Carolina	Columbia	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI	Change in Body Mass Index - height and weight	Baseline and 3 months
Secondary	Physical Activity	Accelerometer-derived physical activity (minutes per day)	Baseline and 2 months
Secondary	Sleep	Accelerometer-derived sleep (minutes per day)	Baseline and 2 months
Secondary	Diet	Parent report of child dietary intake (healthy eating index)	Baseline and 2 months
Secondary	Screen Time	Parent report of screen time usage (minutes per day)	Baseline and 2 months