跳至主要内容
临床试验/NCT01814215
NCT01814215已完成不适用

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

University of North Carolina, Chapel Hill4 个研究点 分布在 1 个国家目标入组 805 人开始时间: 2013年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
805
试验地点
4
主要终点
Change in Child Physical Activity

研究概览

简要总结

The purpose of this project is to evaluate the efficacy of a 9-month Family Child Care Home (FCCH)-based intervention, Keys to Healthy Family Child Care Homes, to increase the physical activity and improve the diet quality of children (1.5 to 4.9 years).

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
18 Months 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.
  • FCCH must have a working telephone number.
  • Provider must be able to read and speak English.

排除标准

  • FCCHs cannot serve exclusively special needs children.
  • FCCHs cannot close down during the summer months.

结局指标

主要结局

Change in Child Physical Activity

时间窗: Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.

Child Physical Activity (Moderate to vigorous physical activity (MVPA)), will be assessed using Actigraph GT3X Accelerometers. Note: Child physical activity and dietary intake are linked in their relationship to child obesity prevention.

Change in Child Dietary Intake

时间窗: Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.

Child Dietary Intake will be assessed using the Dietary Observation for Child Care (DOCC). Note: Child physical activity and dietary intake are linked in their relationship to child obesity prevention.

次要结局

  • Change in Child Body Mass Index(Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.)
  • Change in Provider Physical Activity(Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.)
  • Change in Provider Dietary Intake(Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.)
  • Change in Provider Body Mass Index(Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.)
  • Change in Provider Self-Efficacy for Physical Activity and Healthy Eating(Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.)
  • Change in Provider Social Support(Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.)
  • Change in Physical Activity- and Nutrition-Related Environmental Characteristics of Family Child Care Home(Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.)
  • Change in Child Waist Circumference(Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.)
  • Change in Provider Motivation for Providing Children with Physical Activity and Healthy Eating Opportunities(Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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