Reducing Health Disparities in Childhood Obesity

Sponsor
University of South Carolina (Other)
Overall Status
Recruiting
CT.gov ID
NCT04072549
Collaborator
(none)
420
2
2
58.2
210
3.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Free Summer Programming
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
420 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Reducing Health Disparities in Childhood Obesity Using Financial Incentives in Low-income Households
Actual Study Start Date :
Aug 26, 2019
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. BMI [Baseline (month 0), 9 months, and 12 months]

    Change in Body Mass Index - height and weight

Secondary Outcome Measures

  1. Physical Activity [7 months and 10 months]

    Accelerometer-derived physical activity (minutes per day)

  2. Sleep [7 months and 10 months]

    Accelerometer-derived sleep (minutes per day)

  3. Diet [7 months and 10 months]

    Parent report of child dietary intake (healthy eating index)

  4. Screen Time [7 months and 10 months]

    Parent report of screen time usage (minutes per day)

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 10 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of South Carolina Columbia South Carolina United States 29201
2 Michael Beets Columbia South Carolina United States 29208

Sponsors and Collaborators

  • University of South Carolina

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Michael Beets, Professor, University of South Carolina
ClinicalTrials.gov Identifier:
NCT04072549
Other Study ID Numbers:
  • Pro00086238
First Posted:
Aug 28, 2019
Last Update Posted:
Sep 28, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 28, 2021