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Reducing Health Disparities in Childhood Obesity

Primary Purpose

Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Free Summer Programming
Sponsored by
University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity

Eligibility Criteria

6 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of South CarolinaRecruiting
  • Michael BeetsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Summer Programming

Comparison/Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

BMI
Change in Body Mass Index - height and weight

Secondary Outcome Measures

Physical Activity
Accelerometer-derived physical activity (minutes per day)
Sleep
Accelerometer-derived sleep (minutes per day)
Diet
Parent report of child dietary intake (healthy eating index)
Screen Time
Parent report of screen time usage (minutes per day)

Full Information

First Posted
August 26, 2019
Last Updated
February 8, 2023
Sponsor
University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT04072549
Brief Title
Reducing Health Disparities in Childhood Obesity
Official Title
Reducing Health Disparities in Childhood Obesity Using Financial Incentives in Low-income Households
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 26, 2019 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (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
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
420 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Summer Programming
Arm Type
Experimental
Arm Description
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.
Arm Title
Comparison/Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Free Summer Programming
Intervention Description
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.
Primary Outcome Measure Information:
Title
BMI
Description
Change in Body Mass Index - height and weight
Time Frame
Baseline (month 0), 9 months, and 12 months
Secondary Outcome Measure Information:
Title
Physical Activity
Description
Accelerometer-derived physical activity (minutes per day)
Time Frame
7 months and 10 months
Title
Sleep
Description
Accelerometer-derived sleep (minutes per day)
Time Frame
7 months and 10 months
Title
Diet
Description
Parent report of child dietary intake (healthy eating index)
Time Frame
7 months and 10 months
Title
Screen Time
Description
Parent report of screen time usage (minutes per day)
Time Frame
7 months and 10 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Beets
Phone
8037773003
Email
beets@mailbox.sc.edu
Facility Information:
Facility Name
University of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael W Beets, PhD
Phone
803-777-3003
Email
beets@mailbox.sc.edu
Facility Name
Michael Beets
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Beets
Phone
803-777-3003
Email
beets@mailbox.sc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Reducing Health Disparities in Childhood Obesity

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