Fit 5 Kids Screen Time Reduction Curriculum for Latino Preschoolers

Fit 5 Kids Screen Time Reduction Curriculum for Latino Preschoolers: A RCT

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03575884

Acronym

Fit5Kids

Enrollment

201

Registered

2018-07-03

Start date

2018-09-18

Completion date

2023-07-01

Last updated

2025-03-27

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

Conditions

Nutrition, Obesity, Childhood, Physical Activity

Brief summary

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.

Detailed description

Screen time is a major risk factor for childhood obesity and inadequate physical activity, both of which are determinants of type 2 diabetes (T2D), cardiovascular disease, and multiple cancers. Latinos are the largest and fastest growing minority in the US. Because US Latino children have more screen time and higher rates of obesity than their non-Latino White peers, interventions to reduce screen time adapted for Latino preschoolers are necessary to reduce health inequities related to obesity and T2D in the US. However, a systematic review reported no successful screen time reduction interventions among Latino preschoolers. The investigative team's pilot study tested the culturally adapted Fit 5 Kids screen time reduction curriculum among Latino preschoolers in Head Start. This short term cluster randomized controlled trial (RCT) is the only successful screen time reduction program for Latino preschoolers, having significantly reduced screen time by over 25 minutes/day. The investigative team's culturally adapted, multi-level intervention consists of lessons taught by study staff directly to preschoolers during Head Start, a weekly parent newsletter, and parenting tips via text messages several times/week. The investigative team will use a social ecological model and consider multiple levels of influences for analyses: (1) individual-level influences, e.g., acculturation and social cognitive theory, (2) families, e.g., screen time parenting practices, (3) schools, and (4) macro-environmental influences, e.g., neighborhood disorder. Building on this pilot work, the investigative team proposes a long term, efficacy, cluster RCT of the culturally adapted Fit 5 Kids among Latino preschoolers in Head Start from three US settings: Seattle, Houston, and the Central Valley of Washington State. Among 280 Latino 3-5 year olds at 20 Head Start centers, the investigative team's Specific Aims (SA) and Hypotheses (H) include: SA1) To conduct a cluster RCT of the culturally adapted Fit 5 Kids curriculum to evaluate its efficacy in reducing screen time and excessive weight gain over a school year (8-months) H1) Fit 5 Kids will decrease children's screen time, BMI z-scores and dietary energy intake, and increase fruit/vegetable intake, skin carotenoids, and moderate/vigorous physical activity (MVPA) compared to controls SA2) To examine mediators and moderators associated with reducing Latino preschoolers' screen time H2) Parents' outcome expectations, self-efficacy, and TV parenting practices will mediate the relationship between Fit 5 Kids and changes to preschoolers' screen time H3) Depressive symptoms, stress, and social support will moderate changes to preschoolers' screen time The proposed Fit 5 Kids RCT will confirm the pilot's promising results, and the larger sample will allow for mediation analyses to better understand mechanisms. This research will provide justification for a future community effectiveness trial with implementation by Head Start teachers, and the eventual widespread implementation of Fit 5 Kids in Head Start centers nationally.

Interventions

BEHAVIORALScreen Time Reduction Curriculum

Fit5Kids classroom curriculum, weekly parent newsletters, in-person (or by telephone) goal setting on their child's screen time, a lending library of resources (books, games, arts/crafts, etc), and text messages on screen time parenting practices offered over 7-8 weeks in the Fall semester. The classroom component will be taught by bilingual (English/Spanish) research staff interventionists. Parent newsletters, goal setting, and text messages will be offered in English and Spanish per parent preference. There will also be two booster weeks of classroom activities, daily parent newsletters, goal setting, and daily text messages on screen time parenting practices offered during the booster weeks in the Spring semester. The lending library of resources for parents/children will be available throughout the entire school year.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Years to 5 Years

Healthy volunteers

Yes

Inclusion criteria

* Latino children, 3-5 years old, enrolled from 1 of the 20 Head Start Centers. * Preschoolers do not require a minimum amount of screen time or devices in their household to enroll in the study, because it is preventive and population-based. * Parents must be able to complete forms in English or Spanish.

Exclusion criteria

* Any preschooler that is underweight or under medical supervision to gain weight. * Only one preschooler per family may be enrolled, to avoid clustering of variables by family. * Preschoolers may only enroll once in the study. * Children \<3 years and \>5 years of age. * Children whose parents do not identify them as Latino or Hispanic.

Design outcomes

Primary

Measure	Time frame	Description
Screen Time	Week 1-2, Week 11-12, and Week 34-36	Screen Time Pre-intervention vs Post-intervention, measured by Screen Time Diary (7-day)

Secondary

Measure	Time frame	Description
BMI Z-score	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. (info on the above can be found here: https://www.cdc.gov/growth-chart-training/hcp/computer-programs/sas.html)
Dietary Intake by Food Screener Data in Grams	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), glycemic load and glycemic index. A positive outcome would be to observe an increase in intake of fruit and vegetables, and reduced intake of saturated fats and added sugars.
Fruit and Vegetable Intake and Skin Carotenoids	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.
Physical Activity and Sedentary Behavior Time	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+
Dietary Intake by Food Screener Data in Cups	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), glycemic load and glycemic index. A positive outcome would be to observe an increase in intake of fruit and vegetables, and reduced intake of saturated fats and added sugars.

Countries

United States

Participant flow

Recruitment details

We recruited from Head Start centers in three different regions: 1) Central Valley of Washington 2) Seattle, Washington 3) Houston, Texas. Research staff recruited a total of N= 22 schools and N=201 parent-child dyads to participate in the study. But, children were the focus of the intervention study outcomes. We report results pertaining to the children only. Head Start organizations in the three regions found centers for recruitment and those centers assisted in publicizing the trial.

Pre-assignment details

Prior to randomization at Time 1, all assessments and surveys measuring mediating, moderating and outcome variables as well as covariates were assessed immediately pre-intervention at Time 1. Prior to randomization, we enrolled and consented 215 participants. Of those 215, 14 did not complete baseline assessments and/or were lost to follow -- these 14 participants were not randomized. Following Time 1, randomization occurred on a unit (Head Start school) level.

Participants by arm

Arm	Count
Screen Time Reduction Curriculum Child Fit5Kids curriculum, weekly parent newsletters, in-person (or by telephone) goal setting on their child's screen time, a lending library of resources (books, games, arts/crafts, etc), and text messages on screen time parenting practices. Screen Time Reduction Curriculum: Fit5Kids classroom curriculum, weekly parent newsletters, in-person (or by telephone) goal setting on their child's screen time, a lending library of resources (books, games, arts/crafts, etc), and text messages on screen time parenting practices offered over 7-8 weeks in the Fall semester. The classroom component will be taught by bilingual (English/Spanish) research staff interventionists. Parent newsletters, goal setting, and text messages will be offered in English and Spanish per parent preference. There will also be two booster weeks of classroom activities, daily parent newsletters, goal setting, and daily text messages on screen time parenting practices offered during the booster weeks in the Spring semester. The lending library of resources for parents/children will be available throughout the entire school year.	184
Control Child Students will be taught the standard preschool curriculum.	218
Total	402

Baseline characteristics

Characteristic	Screen Time Reduction Curriculum Child	Control Child	Total
Age, Continuous Child Age	4.6 years STANDARD_DEVIATION 0.72	4.77 years STANDARD_DEVIATION 0.64	4.69 years STANDARD_DEVIATION 0.68
Age, Continuous Parent Age	30.39 years STANDARD_DEVIATION 7.09	33.35 years STANDARD_DEVIATION 8.02	32.01 years STANDARD_DEVIATION 7.71
Ethnicity (NIH/OMB) Child Ethnicity Hispanic or Latino	87 Participants	95 Participants	182 Participants
Ethnicity (NIH/OMB) Child Ethnicity Not Hispanic or Latino	0 Participants	3 Participants	3 Participants
Ethnicity (NIH/OMB) Child Ethnicity Unknown or Not Reported	5 Participants	11 Participants	16 Participants
Ethnicity (NIH/OMB) Parent Ethnicity Hispanic or Latino	86 Participants	97 Participants	183 Participants
Ethnicity (NIH/OMB) Parent Ethnicity Not Hispanic or Latino	2 Participants	2 Participants	4 Participants
Ethnicity (NIH/OMB) Parent Ethnicity Unknown or Not Reported	4 Participants	10 Participants	14 Participants
Race (NIH/OMB) Child Race American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Child Race Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Child Race Black or African American	0 Participants	2 Participants	2 Participants
Race (NIH/OMB) Child Race More than one race	2 Participants	4 Participants	6 Participants
Race (NIH/OMB) Child Race Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Child Race Unknown or Not Reported	21 Participants	21 Participants	42 Participants
Race (NIH/OMB) Child Race White	69 Participants	82 Participants	151 Participants
Race (NIH/OMB) Parent Race American Indian or Alaska Native	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) Parent Race Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Parent Race Black or African American	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) Parent Race More than one race	3 Participants	3 Participants	6 Participants
Race (NIH/OMB) Parent Race Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Parent Race Unknown or Not Reported	20 Participants	24 Participants	44 Participants
Race (NIH/OMB) Parent Race White	69 Participants	80 Participants	149 Participants
Screen time	124.23 minutes/day STANDARD_DEVIATION 79.38	127.28 minutes/day STANDARD_DEVIATION 85.44	125.93 minutes/day STANDARD_DEVIATION 82.57
Sex/Gender, Customized Sex of Child Female	40 Participants	52 Participants	92 Participants
Sex/Gender, Customized Sex of Child Male	48 Participants	49 Participants	97 Participants
Sex/Gender, Customized Sex of Child Missing	4 Participants	8 Participants	12 Participants
Sex/Gender, Customized Sex of Parent Female	84 Participants	93 Participants	177 Participants
Sex/Gender, Customized Sex of Parent Male	4 Participants	7 Participants	11 Participants
Sex/Gender, Customized Sex of Parent Missing	4 Participants	9 Participants	13 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 92	0 / 109
other Total, other adverse events	0 / 92	0 / 109
serious Total, serious adverse events	0 / 92	0 / 109