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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK113005 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Fred Hutchinson Cancer Center | OTHER |
| Baylor College of Medicine | OTHER |
| USDA/ARS Children's Nutrition Research Center | UNKNOWN |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screen Time Reduction Curriculum | Experimental | 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. |
|
| Control | No Intervention | Students will be taught the standard preschool curriculum. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Screen Time Reduction Curriculum | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Screen Time | Screen Time Pre-intervention vs Post-intervention, measured by Screen Time Diary (7-day) | Week 1-2, Week 11-12, and Week 34-36 |
| Measure | Description | Time Frame |
|---|---|---|
| BMI Z-score | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason A Mendoza, MD, MPH | Seattle Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor College of Medicine | Houston | Texas | 77030 | United States | ||
| Seattle Children's Research Institute |
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.
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.
| ID | Title | Description |
|---|---|---|
| FG000 | Screen Time Reduction Curriculum | 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. |
| FG001 | Control | Students will be taught the standard preschool curriculum. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This data represents 92 parent child dyads in the intervention arm, and 109 parent child dyads in the control arm.11 schools were randomized into the Control Arm, likewise 11 schools were randomized into the Intervention Arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Screen Time | Screen Time Pre-intervention vs Post-intervention, measured by Screen Time Diary (7-day) | Posted | Mean | 95% Confidence Interval | minutes/day | Week 1-2, Week 11-12, and Week 34-36 |
|
Adverse events were collected over the course of the academic year, i.e., over ~9 months for each cohort of randomized centers and parent child dyads. This data represents 92 parent child dyads in the intervention arm, and 109 parent child dyads in the control arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Screen Time Reduction Curriculum | 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. |
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The randomized controlled trial was conducted in part during the COVID-19 Pandemic and the results may have limited generalizability.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jason Mendoza, MD, MPH | Seattle Children's Research Institute | 206.884.1261 | Jay.Mendoza@seattlechildrens.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 19, 2024 | May 24, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| NIH |
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|
|
| Week 1-2, Week 11-12, and Week 34-36 |
| Dietary Intake by Food Screener Data in Grams | 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. | Week 1-2, Week 11-12, and Week 34-36 |
| Fruit and Vegetable Intake and Skin Carotenoids | 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. | Week 1-2, Week 11-12, and Week 34-36 |
| Physical Activity and Sedentary Behavior Time | Physical Activity and Sedentary Behavior Time Pre-intervention vs Post-intervention, measured by ActiGraph Accelerometer GT3X+ | Week 1-2, Week 11-12, and Week 34-36 |
| Dietary Intake by Food Screener Data in Cups | 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. | Week 1-2, Week 11-12, and Week 34-36 |
| Seattle |
| Washington |
| 98145-5005 |
| United States |
| Fred Hutchinson Cancer Research Center - Center for Community Health Promotion | Sunnyside | Washington | 98944 | United States |
| BG001 | Control Child | Students will be taught the standard preschool curriculum. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Data represents parent-child dyads. They have been reported as child and parent respectively. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Data represents parent-child dyads. They have been reported as child and parent respectively. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Data represents parent-child dyads. They have been reported as child and parent respectively. | Count of Participants | Participants |
|
| Screen time | Unadjusted, children's screen time in minutes/day as measured by validated parent-reported screen time diaries | Mean | Standard Deviation | minutes/day |
|
| OG001 | Control | Students will be taught the standard preschool curriculum. |
|
|
|
| Secondary | BMI Z-score | 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) | Posted | Mean | 95% Confidence Interval | score on a scale | Week 1-2, Week 11-12, and Week 34-36 |
|
|
|
| Secondary | Dietary Intake by Food Screener Data in Grams | 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. | Posted | Mean | 95% Confidence Interval | Grams | Week 1-2, Week 11-12, and Week 34-36 |
|
|
|
| Secondary | Fruit and Vegetable Intake and Skin Carotenoids | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Week 1-2, Week 11-12, and Week 34-36 |
|
|
|
| Secondary | Physical Activity and Sedentary Behavior Time | Physical Activity and Sedentary Behavior Time Pre-intervention vs Post-intervention, measured by ActiGraph Accelerometer GT3X+ | Posted | Mean | 95% Confidence Interval | Minutes per Day | Week 1-2, Week 11-12, and Week 34-36 |
|
|
|
| Secondary | Dietary Intake by Food Screener Data in Cups | 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. | Posted | Mean | 95% Confidence Interval | Cups | Week 1-2, Week 11-12, and Week 34-36 |
|
|
|
| 0 |
| 92 |
| 0 |
| 92 |
| 0 |
| 92 |
| EG001 | Control | Students will be taught the standard preschool curriculum. | 0 | 109 | 0 | 109 | 0 | 109 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| Missing |
|
| Male |
|
| Missing |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| T3 |
|
| T3 Saturated Fat in Grams |
|
| T1 Sugar in Grams |
|
| T2 Sugar in Grams |
|
| T3 Sugar in Grams |
|
| Weeks 34-36 |
|
| T3 MVPA |
|
| T1 Sedentary |
|
| T2 Sedentary |
|
| T3 Sedentary |
|
| T3 Fruits and Fruit Juice in Cups |
|
| T1 Vegetables Without Potatoes in Cups |
|
| T2 Vegetables Without Potatoes in Cups |
|
| T3 Vegetables Without Potatoes in Cups |
|