Cluster Randomized Controlled Trial of a Multilevel Rural Community Engagement Model for Improving Children's Dietary Intake in Family Child Care Homes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Change in children's observed combined fruit and vegetable consumption [16 weeks]
研究概览
简要总结
The purpose of this study is to find out whether a program called "Healthy Children, Healthy Communities" can help young children in rural areas eat healthier and improve their health. The study focuses on children ages 3 to 5 who attend family childcare homes in rural communities.
The main goal is to see if the program can:
Help children eat healthier foods, like more fruits and vegetables.
Support childcare providers in using positive mealtime practices that encourage healthy eating.
The study will involve about 120 licensed family childcare providers in rural areas who participate in the Child and Adult Care Food Program (CACFP), along with about 240 children they care for.
Childcare providers will be randomly placed into one of two groups:
EAT Family Style Group (Intervention Group):
Complete 7 online training modules over 16 weeks about healthy mealtime practices.
Join 7 individual coaching sessions on Zoom.
Record short videos of their mealtimes to get personalized feedback from a coach.
Work with a coach to set goals and make plans to improve mealtimes.
Receive printed materials and conversation cards to use during meals.
Some providers may join Zoom interviews to share their experiences.
Better Kid Care Group (Comparison Group):
Complete 10 online modules about general childcare topics like child development, oral health, play, and managing a childcare home.
For both groups, the research team will:
Ask providers to fill out online surveys about how mealtimes work in their childcare homes.
Visit the childcare homes to observe and record children's mealtimes on two days at each data collection point.
Measure the height and weight of participating children.
Use a painless skin scanner (Veggie Meter) to check how many fruits and vegetables children have been eating.
Ask providers to complete surveys about the children's eating habits.
The study focuses on rural, low-income communities, where children are at higher risk of having poor diets and obesity compared to children in urban areas. Information will be collected at the start of the study, after 16 weeks, and again after 24 weeks to see if there are lasting changes.
详细描述
The primary objective of this study is to evaluate the effectiveness of a multilevel rural community engagement model in:
- improving children's dietary intake, and
- enhancing providers' feeding practices, within rural family childcare homes, using a cluster randomized controlled trial design.
Secondary objectives are to assess within these family childcare homes:
- child BMI z-scores and skin carotenoid levels (as a biomarker of fruit and vegetable intake), and
- the mealtime emotional climate.
This cluster randomized controlled trial uses the family childcare home as the unit of randomization (i.e., clusters), with both children and providers nested within each family childcare home.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •FCCH Settings:
- •Licensed family child care home-based early child care and education settings
- •Located in RURAL Nebraska or Kansas
- •Participate in the Child and Adult Care Food Program (CACFP)
- •Care for at least 2 preschool-aged children (3-5 years old) without feeding disorders or developmental delays
- •Provide meals and snacks to attending children
- •Located in a county designated as nonmetropolitan based on the 2023 rural urban continuum codes.
- •FCCH Providers:
- •Currently caring for at least two eligible 3-5 year old children who consume at least one meal and one snack in the program for at least two days per week.
- •Present with children during meals and snacks
- •Over the age of 19 years
- •Have not participated in the intervention before
- •Between 3 to 5 years old
- •Must consume at least one meal and one snack in the program for at least two days per week.
- •No dietary restrictions or feeding disorder that impact how they eat (lactose intolerance, egg/nut allergies, or vegetarian diet are acceptable)
- •Typically developing children (no diagnosis of developmental delays as identified by childcare providers)
- •Have a parent or guardian 19 years of age or older to consent for them
排除标准
- •FCCH Providers:
- •FCCH provider closes the business
- •FCCH provider stops serving meals to children
- •FCCH provider discontinues participation in CACFP and no longer adheres to CACFP meal pattern requirements
- •FCCH provider loses all eligible study children due to children leaving care, developing developmental delays or feeding disorders, or other reasons making them ineligible
- •Diagnosis of dietary restrictions or feeding disorder that impact how they eat (soft diet requirements or difficulty swallowing that impacts how they eat)
- •Diagnosis of developmental delays
研究组 & 干预措施
Arm 1: EAT Family Style
Arm 1: Rural family childcare home providers receive 7 online modules on responsive feeding practices over 16 weeks, plus 7 individual coaching sessions via Zoom with Extension agents. Providers record mealtime videos for personalized feedback, engage in goal-setting and action planning, and receive printed materials and conversation cards.
干预措施: EAT Family Style (Behavioral)
Arm 2. Better Kid Care
Arm 2: Rural family childcare home providers receive 10 online modules about general childcare topics unrelated to nutrition, including child development, block play, oral health, supervising children, and managing a family childcare home through the Better Kid Care platform.
干预措施: Better Kid Care (Behavioral)
结局指标
主要结局
Change in children's observed combined fruit and vegetable consumption [16 weeks]
时间窗: From baseline to 16 weeks post-intervention
Children's fruit and vegetable consumption (servings/day) will be assessed by trained research staff observing two consecutive days of meals and snacks in family child care homes (FCCHs), following the Dietary Observation in Child Care (DOCC) protocol, which allows one observer to record intake for up to three children with minimal disruption. Data will be entered into the Nutrition Data System for Research (NDSR) to convert observed foods into nutrient and food group values. Fruit and vegetable intake will be compared to Dietary Guidelines for Americans to determine each child's two-day average intake.
Change in children's observed combined fruit and vegetable consumption [24 weeks]
时间窗: From baseline to 24 weeks post-intervention
Children's fruit and vegetable consumption (servings/day) will be assessed by trained research staff observing two consecutive days of meals and snacks in family child care homes (FCCHs), following the Dietary Observation in Child Care (DOCC) protocol, which allows one observer to record intake for up to three children with minimal disruption. Data will be entered into the Nutrition Data System for Research (NDSR) to convert observed foods into nutrient and food group values. Fruit and vegetable intake will be compared to Dietary Guidelines for Americans to determine each child's two-day average intake.
次要结局
- Change in children's observed diet quality, measured by the Healthy Eating Index-2020 (HEI-2020) (16 weeks)(From baseline to 16 weeks post-intervention)
- Change in children's observed diet quality, measured by the Healthy Eating Index-2020 (HEI-2020) (24 weeks)(From baseline to 24 weeks follow-up)
- Change in the observed mealtime emotional climate(From baseline to 16 weeks post-intervention and 24-week follow-up)
- Change in family childcare home providers observed responsive feeding practices (16 weeks)(From baseline to 16 weeks post-intervention)
- Change in family childcare home providers observed responsive feeding practices (24 weeks)(From baseline to 24 weeks follow-up)
- Change in family childcare home providers' self-reported responsive feeding practices (16 weeks)(From baseline to 16 weeks post-intervention)
- Change in family childcare home providers' self-reported responsive feeding practices (24 weeks)(From baseline to 24-week follow-up)
- Change in family childcare home providers observed controlling feeding practices (16 weeks)(From baseline to 16 weeks post-intervention)
- Change in family childcare home providers observed controlling feeding practices (24 weeks)(From baseline to 24 weeks follow-up)
- Change in family childcare home providers' self-reported controlling feeding practices (16 weeks)(From baseline to 16 weeks post-intervention)
- Change in family childcare home providers' self-reported controlling feeding practices (24 weeks)(From baseline to 24 weeks follow-up)