- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT03111264
Building Blocks for Healthy Preschoolers
Building Blocks for Healthy Preschoolers: Child Care and Family Models
Pediatric obesity, a defining health problem of the century, leads to long-term health disparities. This application evaluates strategies to prevent health disparities early in life by developing environmental wellness-related interventions focused on child-care center staff and families.
Childcare centers provide an excellent opportunity to build healthy dietary and physical activity lifestyle habits and avoid the rapid weight gain that leads to health disparities. Building on a statewide survey among childcare centers and a pilot evaluation of an environmental intervention, this 3-cell randomized trial evaluates the impact of a staff-led wellness intervention and a staff-led and family-focused intervention, against a control condition.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
The intervention trial will be conducted in 48-55 childcare centers throughout Maryland, enrolling 864 children age 30-54 months from childcare centers serving low-income families. The aims are:
- to examine the impact of the wellness intervention individually and combined with the family intervention versus control on BMI z-score, food preferences and knowledge, and physical activity among children
- to examine the sustainability of the interventions
- to examine whether changes in outcomes measures for children's BMI z-score, gross motor skills, food preferences and knowledge, and physical activity are mediated by changes in the childcare staff wellness-related attitudes and behaviors and/or parent wellness-related attitudes and behaviors (exploratory).
Findings from the trial will inform programs and policies in childcare centers to prevent obesity and reduce disparities, and will be disseminated locally, regionally, and nationally through conferences, information briefs, social media, and peer-reviewed journal articles. The overall objective is to promote statewide strategies that reduce pediatric obesity and the long-term health disparities.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Maryland
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Baltimore, Maryland, Spojené státy, 21201
- University of Maryland Growth and Nutrition Division
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Preschooler 30-54 months
- Caregiver and childcare staff must be at least 18 years old
- Childcare center staff members willing to participate
- Licensed childcare centers serving low-income communities
- Children attending participating childcare centers (at least 3 days per week)
Exclusion Criteria:
- Caregivers and staff who do not speak or read English
- Childcare staff and preschoolers with health problems that would interfere with participation in physical activities
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Faktorové přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: CHAMP group
Childcare centers randomly assigned the CHAMP group will receive an intervention that promotes physical activity in the classroom by developing gross motor skills through movement and enhances the nutritional environment in the centers by exposing preschoolers to new foods.
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The CHAMP only group intervention is based on "Food Friends & Mighty Moves", a nutritional program designed to introduce new foods over the course of 12 weeks to preschoolers to create positive eating experiences.
In conjunction with the nutritional program, the intervention also consists of an 18 week physical activity program designed to develop gross motor skills.
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Experimentální: CHAMP+ group
These childcare centers, also randomly assigned, will have the same intervention as the CHAMP group in addition to a parenting intervention that promotes wellness and healthy behaviors within families.
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The CHAMP only group intervention is based on "Food Friends & Mighty Moves", a nutritional program designed to introduce new foods over the course of 12 weeks to preschoolers to create positive eating experiences.
In conjunction with the nutritional program, the intervention also consists of an 18 week physical activity program designed to develop gross motor skills.
The CHAMP+ component is comprised of a curriculum of parenting, wellness, physical activity, and feeding in the home environment.
The CHAMP+ intervention will span over the course of the CHAMP intervention.
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Žádný zásah: Control
This group will not receive theCHAMP intervention at the childcare center nor will this group receive the CHAMP+ parenting intervention.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Change of BMI Z-score for preschoolers
Časové okno: Baseline to 6 month (Midline) Follow-up or 1 year (Post Intervention) Follow-up
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Measured weight and height for the preschoolers, calculated as age and gender-specific BMI Z-score
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Baseline to 6 month (Midline) Follow-up or 1 year (Post Intervention) Follow-up
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Change of Physical Activity for preschoolers and childcare center staff
Časové okno: Baseline to 6 month (Midline) Follow-up or 1 year (Post Intervention) Follow-up
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Moderate to Vigorous Physical Activity (MVPA) based on anthropometrics
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Baseline to 6 month (Midline) Follow-up or 1 year (Post Intervention) Follow-up
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Change in Gross Motor Skills
Časové okno: Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
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Measured by Test of Gross Motor Development-2
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Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
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Change in Preschoolers to try new foods
Časové okno: Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
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Measured by Food Neophobia Scale (Caregiver report)
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Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
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Change in Preschoolers to try new foods
Časové okno: Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
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Measured by Fruit & Vegetable Knowledge & Preference Test
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Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
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Change in Preschoolers to try new foods
Časové okno: Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
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Measured by Food Tasting Assessment
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Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Maureen M Black, PhD, University of Maryland, Baltimore
Publikace a užitečné odkazy
Obecné publikace
- Rahmaty Z, Johantgen ME, Storr CL, Wang Y, Black MM. Preschoolers BMI: Associations with Patterns of Caregivers' Feeding Practices Using Structural Equation Models. Child Obes. 2022 Jun 1. doi: 10.1089/chi.2022.0026. Online ahead of print.
- Armstrong B, Trude ACB, Johnson C, Castelo RJ, Zemanick A, Haber-Sage S, Arbaiza R, Black MM. CHAMP: A cluster randomized-control trial to prevent obesity in child care centers. Contemp Clin Trials. 2019 Nov;86:105849. doi: 10.1016/j.cct.2019.105849. Epub 2019 Sep 13.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- HP-00065933
- 1R01DK107761-01 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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