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Reducing Health Disparities in Childhood Obesity

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ClinicalTrials.gov Identifier: NCT04072549
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Michael Beets, University of South Carolina

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
Obesity Behavioral: Free Summer Programming Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : August 26, 2019
Estimated Primary Completion Date : August 26, 2023
Estimated Study Completion Date : August 26, 2024

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.



Primary Outcome Measures :
  1. BMI [ Time Frame: Baseline (month 0), 9 months, and 12 months ]
    Change in Body Mass Index - height and weight


Secondary Outcome Measures :
  1. Physical Activity [ Time Frame: 7 months and 10 months ]
    Accelerometer-derived physical activity (minutes per day)

  2. Sleep [ Time Frame: 7 months and 10 months ]
    Accelerometer-derived sleep (minutes per day)

  3. Diet [ Time Frame: 7 months and 10 months ]
    Parent report of child dietary intake (healthy eating index)

  4. Screen Time [ Time Frame: 7 months and 10 months ]
    Parent report of screen time usage (minutes per day)



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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04072549


Contacts
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Contact: Michael Beets 8037773003 beets@mailbox.sc.edu

Locations
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United States, South Carolina
University of South Carolina Recruiting
Columbia, South Carolina, United States, 29201
Contact: Michael W Beets, PhD    803-777-3003    beets@mailbox.sc.edu   
Michael Beets Recruiting
Columbia, South Carolina, United States, 29208
Contact: Michael Beets    803-777-3003    beets@mailbox.sc.edu   
Sponsors and Collaborators
University of South Carolina

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Responsible Party: Michael Beets, Professor, University of South Carolina
ClinicalTrials.gov Identifier: NCT04072549     History of Changes
Other Study ID Numbers: Pro00086238
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms