NCT03595332

Addressing Health Disparities in Childhood Obesity, One Summer at a Time

Completed NA Results posted Last updated 5 October 2022

What this trial tests

NA trial testing Summer activity program in Obesity, Childhood in 222 participants. Completed in 22 April 2020.

Timeline

4 June 2018

Primary endpoint
22 April 2020

22 April 2020

Quick facts

Lead sponsor	Northern Arizona University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	prevention
Enrollment	222
Start date	4 June 2018
Primary completion	22 April 2020
Estimated completion	22 April 2020
Sites	1 location across United States

Drugs / interventions tested

• Summer activity program

Conditions studied

• Obesity, Childhood — all drugs for Obesity, Childhood →

Sponsor

Northern Arizona University

Who can join

Adults 5 to 13, any sex, with Obesity, Childhood. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Body Mass Index Percentile Score Change at 10 Weeks Primary · Measured at baseline and 10-weeks after baseline

Body mass index (BMI) will be calculated as kg/m2 and BMI-percentile score calculated using the L, M, S parameters published by the Centre for Disease Control and Prevention. BMI Percentile-score are measures of relative weight adjusted for child age and sex. The percentile indicates value relative to reference populations for age and sex, with at or below 5th percentile indicating the child being underweight, between 5 and 85th percentile as having a healthy weight, 85th to 95th percentile as being overweight and 95th percentile and above indicative of having obesity.

Group	Value	95% CI
Immediate Intervention	0.307	± 0.967
Delayed Intervention	1.755	± 1.560

Overweight Participants Body Mass Index Percentile Score Change Primary · Baseline to 10 weeks

Body mass index (BMI) will be calculated as kg/m2 and BMI percentile calculated using the L, M, S parameters published by the Centre for Disease Control and Prevention. BMI percentiles are measures of relative weight adjusted for child age and sex. This analysis includes only those children who were overweight by CDC standards (equal or greater to 85th percentile for age and sex), as they were the high-risk group of interest for the study.

Group	Value	95% CI
Immediate Intervention	-2.632	± 1.594
Delayed Intervention	-3.444	± 1.836

Body Mass Index Percentile Score Change at 1 Year Secondary · Measured 1-year after baseline

Body mass index (BMI) will be calculated as kg/m2 and BMI-Percentile score calculated using the L, M, S parameters published by the Centre for Disease Control and Prevention. BMI Percentile-score are measures of relative weight adjusted for child age and sex.

Group	Value	95% CI
Immediate Intervention	0.363	± 1.676

Change in Intention to Engage in Physical Activity From Baseline to 10 Weeks Secondary · Measured at baseline and at 10-weeks (after summer program)

During your free time on most days, how likely will you do physical activities? with Likert type 5-answer options (1,2,3,4 or 5) ranging from (1) "I will not be active" to (5) "For sure I will be active". The minimum score is 1, maximum score is 5. Higher scores mean greater intentions to engage in physical activity.

Group	Value	95% CI
Immediate Intervention	0.238	± 0.222
Delayed Intervention	0.311	± 0.154

Sponsor's own description

Almost 50% of Native American and Hispanic children are overweight or obese by the 5th grade. Research has demonstrated that the 'obesity gap' facing minority students is largely due to summer weight gain. However, very few summer programs have been tested among these populations. To encourage summer physical activity, the CDC developed a program that partners with local businesses to provide children with a 'scorecard' of subsidized or free local activities. The program has not been tested among Hispanic or Native American children. This study aims to test the impact of the scorecard program on Body Mass Index percentile, physical activity, sedentary behavior, barriers to physical activity and self-efficacy.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.