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The Business of Childcare Homes & Child Health: Innovations for Nurturing Growth

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Qué se está evaluando

Keys to Healthy Family Child Care Homes

+ Keys to Healthy Family Child Care Homes

Conductual
Quiénes están siendo reclutados

Peso Corporal+3

+ Trastornos de la Nutrición

+ Enfermedades Nutricionales y Metabólicas

A partir de 18 meses
+6 Criterios de eligibilidad
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Prevención

Controlado con Placebo
Intervencional
Inicio del estudio: abril de 2013
Ver detalles del protocolo

Resumen

Patrocinador PrincipalUniversity of North Carolina, Chapel Hill
Última actualización: 8 de junio de 2016
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de abril de 2013

Fecha en la que se inscribió al primer participante.

Childhood obesity is a major public health problem and an important predictor of obesity later in life. Although early childhood is a formative period for dietary and activity habits, little research targeting this young age group has been conducted. Child care facilities are a prime setting for interventions targeting young children, given the number of families using some form of out-of-home care. Family child care homes (FCCH) are a particular type of child care facility in which the provider cares for children out of his/her own residence. FCCHs are generally less regulated than child care centers, and a significant percentage do not meet established recommendations for physical activity and nutrition practices. While there is a great need to intervene in these settings, there has been only one other published obesity prevention intervention in FCCHs to date. Interventions targeting FCCH providers could help promote healthy child weight by creating child care environments that provide and support active play opportunities and healthy food choices, while helping providers become role models for healthy lifestyles (physical activity and diet). However, the child care industry is faced with many challenges, including limited profitability. By incorporating strategies for overcoming some of these economic challenges, interventions may be able to more easily address barriers to implementing and sustaining the changes needed to promote regular physical activity and healthy dietary intakes in children. This project will use a cluster-randomized controlled trial (RCT) to test the efficacy of the 9-month intervention, Keys to Healthy Family Child Care Homes, which targets FCCHs. Keys will be delivered in three modules which are designed to promote (1) provider health and providers as healthy role models, (2) physical activity- and nutrition-supportive environments at the FCCH, and (3) healthy business practices. Each module will be delivered via group workshops, on-site visits and phone contacts using Motivational Interviewing-inspired coaching and educational toolkits. By combining these components, the ultimate objective is to create healthy and stable FCCHs that promote healthy physical activity and eating behaviors in children. The project will recruit and randomize 165 FCCHs (83 per arm). At each FCCH, subjects will include one child care provider and 3 children (we are targeting children between the ages of 1.5 and 4 years old, but one to two additional children who are younger than 18 months may also take part in height and weight measurements only). These 165 FCCHs and 825 children (495 children ages 1.5-4.9 years old and 330 children ages younger than 18 months) will be recruited in five waves over the course of 3 years, each wave enrolling 30 or more FCCHs (half assigned to each study arm). For recruitment, we will target areas with lower income households and with higher prevalence of child overweight/obesity within a 100 mile radius of the University of North Carolina at Chapel Hill (UNC) and Duke University. For each wave, potential FCCHs will be identified through the online database of licensed programs provided by the North Carolina Division of Child Development and Early Education (http://ncchildcaresearch.dhhs.state.nc.us/search.asp). Trained project staff will contact potential FCCH providers by mail/email (informational flyer/packets), telephone, and promotion at local professional meetings and community events. Informed consent will be obtained from providers and parents of participating children. Data collection will occur before and after the 9-month intervention, and each participating child care provider will receive up to $200 for completion of measures at both time points. At follow-up, we will also recruit newly enrolled children between the ages of 1.5 and 5 years old (one or two per home, thus about 210 additional children) to take part in all measures to allow additional cross-sectional analysis. Increased child physical activity and improved quality of child diet while at the FCCH will be the primary outcomes used to assess the impact of this innovative, theory-driven intervention. Secondary outcomes and mediators include child body mass index, provider body mass index, provider weight-related behaviors (dietary intake and physical activity), provider motivation, self-efficacy and social support, and obesogenic (nutrition- and physical activity-related) environmental characteristics of the FCCH (including policies, practices and communication between providers and parents). Primary analyses for primary aims will involve testing each of these hypotheses under the intent-to-treat principle using Generalized Linear Mixed Models (GLMM) that will account for the correlation induced by the clustering of children within FCCHs. Statistical analysis will employ Statistical Analysis System (SAS).

NCT01814215
Patrocinador PrincipalUniversity of North Carolina, Chapel Hill
Última actualización: 8 de junio de 2016
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 805 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Prevención

Los estudios de prevención buscan evitar que se desarrolle una enfermedad. A menudo incluyen a personas en riesgo y evalúan vacunas, cambios en el estilo de vida o medicamentos preventivos.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

A partir de 18 meses

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

Peso CorporalTrastornos de la NutriciónEnfermedades Nutricionales y MetabólicasSignos y SíntomasCondiciones Patológicas, Signos y SíntomasObesidad

Criterios

4 criterios de inclusión requeridos para participar
FCCH must have a working telephone number

FCCH must have at least 2 children between the ages of 1.5 and 4 years currently enrolled. * At least 2 children/families must agree to take part for the FCCH to remain eligible. (Note: Children ages 0-17 months may take part in height and weight measurements only)

FCCH must have been in business for at least 2 years

Provider must be able to read and speak English

2 criterios de exclusión impiden participar
FCCHs cannot close down during the summer months

FCCHs cannot serve exclusively special needs children

Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

2 grupos de intervención están designados en este estudio

50% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
The Experimental Arm will receive the Keys to Healthy Family Child Care Homes intervention to be delivered over 9 months in 3 modules (3 months/module). The intervention group will be asked to participate in 3 workshops on 3 content areas. Participants will be asked to meet with a coach 3 times in-person, as well 3-9 times by phone/email, over the course of the 9-months. Three content areas are designed to help providers:(1) modify their own weight-related behaviors so they can role model healthy behaviors for children in their care (Healthy You module), (2) create environments that support children's physical activity and healthy dietary intakes (Healthy Home module), and (3) adopt sound business practices that will help them sustain the changes introduced (Healthy Business module).

Grupo II

Placebo
The Control Arm will receive the Healthy Business Education and Coaching program to be delivered over 9 months in 3 modules (3 months/module). The control group will be asked to participate in 3 workshops and a similar number of coaching contacts about their business practices. The focus on business topics is relevant, but not directly related to physical activity or nutrition.

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene 2 ubicaciones

Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill

Chapel Hill, United StatesAbrir Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill en Google Maps

Duke University

Durham, United States
Completado2 Centros de Estudio