Who is sponsoring NCT03575884?

NCT03575884 is sponsored by Seattle Children's Hospital.

What drugs are being tested in NCT03575884?

Interventions in NCT03575884: Screen Time Reduction Curriculum.

What condition does NCT03575884 study?

NCT03575884 studies Obesity, Childhood, Physical Activity, Nutrition.

Is NCT03575884 still recruiting?

NCT03575884 is currently completed. Last updated 27 March 2025.

Are results published for NCT03575884?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-03-27 · How we verify

NCT03575884: Fit5Kids

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Fit 5 Kids Screen Time Reduction Curriculum for Latino Preschoolers

Completed NA Results posted Last updated 27 March 2025

What this trial tests

NA trial testing Screen Time Reduction Curriculum in Obesity, Childhood in 201 participants. Completed in 1 July 2023.

Timeline

18 September 2018

Primary endpoint
30 December 2022

1 July 2023

Quick facts

Lead sponsor	Seattle Children's Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	201
Start date	18 September 2018
Primary completion	30 December 2022
Estimated completion	1 July 2023
Sites	3 locations across United States

Drugs / interventions tested

Screen Time Reduction Curriculum

Conditions studied

Obesity, Childhood — all drugs for Obesity, Childhood →
Physical Activity — all drugs for Physical Activity →
Nutrition — all drugs for Nutrition →

Sponsor

Seattle Children's Hospital

Who can join

Adults 3 to 5, any sex, with Obesity, Childhood or Physical Activity. 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.

Screen Time Primary · Week 1-2, Week 11-12, and Week 34-36

Screen Time Pre-intervention vs Post-intervention, measured by Screen Time Diary (7-day)

Week 1-2 (Time 1)

Group	Value	95% CI
Screen Time Reduction Curriculum	122.6	96.75 – 148.44
Control	123.47	99.58 – 147.35

Weeks 11-12 (Time 2)

Group	Value	95% CI
Screen Time Reduction Curriculum	97.3	70.74 – 123.86
Control	129.34	104.39 – 154.28

Weeks 34-36 (Time 3)

Group	Value	95% CI
Screen Time Reduction Curriculum	122.85	96.06 – 149.64
Control	151.04	125.46 – 176.62

BMI Z-score Secondary · Week 1-2, Week 11-12, and Week 34-36

Measured Height and Weight Pre-intervention vs Post-intervention. Body Mass Index (BMI) Z-score, is the child's calculated standard deviation from the CDC's population reference for child's sex and age. The formula is: Z-score = ((BMI / M)L - 1) / (L × S) where BMI is body mass index, M is median, L is the transformation for normality, and S is the coefficient of variations. A Z-score of 0 represents the mean for the CDC's reference population. Z-scores above the mean generally represent a worse outcome. A Z-score of 1.645 is the 95th percentile, which is considered the threshold for obesity.

Group	Value	95% CI
Screen Time Reduction Curriculum Child	1.04	0.71 – 1.37
Control Child	0.85	0.48 – 1.22

Group	Value	95% CI
Screen Time Reduction Curriculum Child	1.05	.70 – 1.41
Control Child	0.87	0.49 – 1.25

Group	Value	95% CI
Screen Time Reduction Curriculum Child	1.33	.86 – 1.80
Control Child	0.55	0.09 – 1.02

Dietary Intake by Food Screener Data in Grams Secondary · Week 1-2, Week 11-12, and Week 34-36

Dietary Intake Pre-intervention vs Post-intervention, measured by Block Kids Food Screener (more details below) Block Food Screeners for Ages 2-17 2007: These screeners are designed to assess children's intake by food group, with outcomes measured in number of servings. The version the investigative team will use for this study is about food eaten "last week." The focus of this tool is on intake of fruit and fruit juices, vegetables, potatoes (including French fries), whole grains, meat/poultry/fish, dairy, legumes, saturated fat, "added sugars" (in sweetened cereals, soft drinks, and sweets)

T1 Saturated Fat in Grams

Group	Value	95% CI
Screen Time Reduction Curriculum Child	13.93	12.15 – 15.71
Control Child	14.08	12.50 – 15.66

T2 Saturated Fat in Grams

Group	Value	95% CI
Screen Time Reduction Curriculum Child	13.99	12.18 – 15.81
Control Child	12.85	11.20 – 14.50

T3 Saturated Fat in Grams

Group	Value	95% CI
Screen Time Reduction Curriculum Child	15.16	13.27 – 17.05
Control Child	13.47	11.73 – 15.20

T1 Sugar in Grams

Group	Value	95% CI
Screen Time Reduction Curriculum Child	4.97	4.17 – 5.76
Control Child	4.72	4.02 – 5.43

T2 Sugar in Grams

Group	Value	95% CI
Screen Time Reduction Curriculum Child	4.89	4.08 – 5.70
Control Child	4.38	3.65 – 5.12

T3 Sugar in Grams

Group	Value	95% CI
Screen Time Reduction Curriculum Child	5.01	4.17 – 5.85
Control Child	4.94	4.17 – 5.71

Fruit and Vegetable Intake and Skin Carotenoids Secondary · Week 1-2, Week 11-12, and Week 34-36

Fruit and Vegetable Intake/Skin Carotenoid levels Pre-intervention vs Post-intervention, measured by Pharmanex BioPhotonic Scanner. Skin carotenoids are measured using Raman spectroscopy, which returned results in units of Raman counts from 0 to 70,000. Greater Raman counts indicate greater skin carotenoids and greater fruit/vegetable intake.

Weeks 1-2 (Time 1) Skin Carotenoids

Group	Value	95% CI
Screen Time Reduction Curriculum Child	26760.15	16502.83 – 37017.48
Control Child	26590.89	16936.21 – 36245.57

Weeks 11-12 (Time 2) Skin Carotenoids

Group	Value	95% CI
Screen Time Reduction Curriculum Child	36853.57	26106.79 – 47600.36
Control Child	28673.47	18804.40 – 38542.54

Weeks 34-36

Group	Value	95% CI
Screen Time Reduction Curriculum Child	38017.93	19313.15 – 56722.71
Control Child	23030.60	10777.72 – 35283.48

Physical Activity and Sedentary Behavior Time Secondary · Week 1-2, Week 11-12, and Week 34-36

Physical Activity and Sedentary Behavior Time Pre-intervention vs Post-intervention, measured by ActiGraph Accelerometer GT3X+

T1 MVPA

Group	Value	95% CI
Screen Time Reduction Curriculum Child	57.21	47.57 – 66.86
Control Child	66.15	57.00 – 75.30

T2 MVPA

Group	Value	95% CI
Screen Time Reduction Curriculum Child	58.66	48.84 – 68.48
Control Child	57.21	47.81 – 66.61

T3 MVPA

Group	Value	95% CI
Screen Time Reduction Curriculum Child	47.97	37.55 – 58.40
Control Child	49.53	39.95 – 59.11

T1 Sedentary

Group	Value	95% CI
Screen Time Reduction Curriculum Child	647	534.96 – 760.78
Control Child	719.67	610.77 – 828.57

T2 Sedentary

Group	Value	95% CI
Screen Time Reduction Curriculum Child	617.68	503.79 – 731.58
Control Child	649.30	539.07 – 759.53

T3 Sedentary

Group	Value	95% CI
Screen Time Reduction Curriculum Child	530.60	413.01 – 648.20
Control Child	625.02	513.90 – 736.15

Dietary Intake by Food Screener Data in Cups Secondary · Week 1-2, Week 11-12, and Week 34-36

T1 Fruit and Fruit Juice in Cups

Group	Value	95% CI
Screen Time Reduction Curriculum Child	1.74	1.46 – 2.02
Control Child	1.57	1.31 – 1.83

T2 Fruits and Fruit Juice in Cups

Group	Value	95% CI
Screen Time Reduction Curriculum Child	1.62	1.33 – 1.90
Control Child	1.47	1.20 – 1.73

T3 Fruits and Fruit Juice in Cups

Group	Value	95% CI
Screen Time Reduction Curriculum Child	1.54	1.25 – 1.83
Control Child	1.54	1.27 – 1.81

T1 Vegetables Without Potatoes in Cups

Group	Value	95% CI
Screen Time Reduction Curriculum Child	0.64	0.51 – 0.77
Control Child	0.61	0.49 – 0.73

T2 Vegetables Without Potatoes in Cups

Group	Value	95% CI
Screen Time Reduction Curriculum Child	0.60	0.47 – 0.74
Control Child	0.52	0.40 – 0.65

T3 Vegetables Without Potatoes in Cups

Group	Value	95% CI
Screen Time Reduction Curriculum Child	0.60	0.46 – 0.74
Control Child	0.54	0.42 – 0.67

Sponsor's own description

Childhood obesity and metabolic risk are at record high levels in the US, and Latino children are at very high risk. This project will test an intervention called Fit 5 Kids, designed for Latino preschoolers to decrease their screen time in order to promote physical activity and healthy eating, and to prevent obesity. Ultimately, this line of research has the potential to provide an effective program to reduce risk of obesity for Latinos in the Head Start program and other preschool-based settings.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Healthy eating interventions delivered in early childhood education and care settings for improving the diet of children aged six months to six years.
Yoong SL, Lum M, Wolfenden L, Jackson J, et al · · 2023 · cited 29× · PMID 37306513 · DOI 10.1002/14651858.cd013862.pub2
Healthy eating interventions delivered in early childhood education and care settings for improving the diet of children aged six months to six years.
Yoong SL, Lum M, Wolfenden L, Jackson J, et al · · 2023 · cited 12× · PMID 37606067 · DOI 10.1002/14651858.cd013862.pub3
Interventions to prevent obesity in children aged 2 to 4 years old.
Phillips SM, Spiga F, Moore TH, Dawson S, et al · · 2025 · cited 3× · PMID 40494564 · DOI 10.1002/14651858.cd015326.pub2

Verify or expand the search:

Other recruiting trials for Obesity, Childhood

Currently open trials in the same condition.

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NCT06847373 — Efficacy and Safety of Vitamin D Supplementation in Pediatric Patients with Obesity · NA · recruiting
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Other Seattle Children's Hospital trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03575884 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Seattle Children's Hospital
Last refreshed: 27 March 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03575884.

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