Reducing Health Disparities in Childhood Obesity

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Free Summer Programming

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 420
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Columbia, South Carolina, United States, 29201
      • Recruiting
      • University of South Carolina
    • Columbia, South Carolina, United States, 29208
      • Recruiting
      • Michael Beets

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 10 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	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.
NO_INTERVENTION: Comparison/Control; The children in the control group will be children enrolled in the same schools as those randomized to receive summer programming. The comparison/control group will not receive a voucher to attend a summer camp.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI	Change in Body Mass Index - height and weight	Baseline (month 0), 9 months, and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Activity	Accelerometer-derived physical activity (minutes per day)	7 months and 10 months
Sleep	Accelerometer-derived sleep (minutes per day)	7 months and 10 months
Diet	Parent report of child dietary intake (healthy eating index)	7 months and 10 months
Screen Time	Parent report of screen time usage (minutes per day)	7 months and 10 months

Collaborators and Investigators

• Sponsor: University of South Carolina

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 26, 2019
• Primary Completion (ANTICIPATED): June 30, 2024
• Study Completion (ANTICIPATED): June 30, 2024

Study Registration Dates

• First Submitted: August 26, 2019
• First Submitted That Met QC Criteria: August 27, 2019
• First Posted (ACTUAL): August 28, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 8, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: Pro00086238

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No