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Reducing Health Disparities in Childhood Obesity

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04072549
Enrollment
651
Registered
2019-08-28
Start date
2019-08-26
Completion date
2024-05-01
Last updated
2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

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.

Interventions

BEHAVIORALFree 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.

Sponsors

University of South Carolina
Lead SponsorOTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

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.

Eligibility

Sex/Gender
ALL
Age
6 Years to 10 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

The only

Design outcomes

Primary

MeasureTime frameDescription
BMI Age-Sex Specific Z-ScoreBaseline and 3 monthsChange in Body Mass Index age=sex specific z-score. 0 represents the 50th percentile. A reduction of 0.15 is considered clinically meaningful in an already obese population

Secondary

MeasureTime frameDescription
Moderate-to-Vigorous Physical Activity2 monthsAccelerometer-derived moderate-to-vigorous physical activity (minutes per day)
Sleep2 monthsAccelerometer-derived sleep (minutes per day)
Diet2 monthsParent report of child dietary intake
Screen Time2 monthsParent report of screen time usage (minutes per day)

Countries

United States

Participant flow

Pre-assignment details

This number reflects the number of parents who expressed interest in participating, completed the informed consent document, but who we were never able to recontact.

Baseline characteristics

Characteristic
Age, Continuous8.2 years
STANDARD_DEVIATION 1.5
BMI.704 z-score
STANDARD_DEVIATION 1.19
Diet
100% Fruit Juice
.522 items consumed
STANDARD_DEVIATION 0.499
Diet
Chips
.546 items consumed
STANDARD_DEVIATION 0.498
Diet
Dairy
.754 items consumed
STANDARD_DEVIATION 0.43
Diet
Desserts
.50 items consumed
STANDARD_DEVIATION 0.5
Diet
Fast Food
.199 items consumed
STANDARD_DEVIATION 0.399
Diet
Frozen Desserts
.243 items consumed
STANDARD_DEVIATION 0.4295
Diet
Fruit
.78 items consumed
STANDARD_DEVIATION 0.41
Diet
Soda
.151 items consumed
STANDARD_DEVIATION 0.359
Diet
Uncarbonated Flavored Drink
.477 items consumed
STANDARD_DEVIATION 0.499
Diet
Vegetables
.659 items consumed
STANDARD_DEVIATION 0.473
Physical Activity68.7 minutes per day
STANDARD_DEVIATION 34.9
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
215 Participants
Race (NIH/OMB)
More than one race
29 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
72 Participants
Screen Time123.3 minutes per day
STANDARD_DEVIATION 100.9
Sex: Female, Male
Female
101 Participants
Sex: Female, Male
Male
122 Participants
Sleep511.98 minutes per day
STANDARD_DEVIATION 43.88

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 2530 / 234
other
Total, other adverse events
0 / 2530 / 234
serious
Total, serious adverse events
0 / 2530 / 234

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026