ONE PATH: Optimizing Nutrition Education for Parents and Teachers for Healthy Growth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,461
- 试验地点
- 2
- 主要终点
- Child Appetite Regulation
研究概览
简要总结
This proposal uses an innovative methodological framework, the multiphase optimization strategy (MOST), to design an effective and efficient responsive feeding (RF) intervention that promotes child appetite self-regulation among a high-risk sample: families with preschoolers living in rural poverty. The principles of MOST emphasize efficiency, allowing identification of the most efficacious intervention components (i.e., components that contribute to treatment effects) while minimizing participant burden and cost. ONE PATH will intervene on ~768 dyads recruited from 56 classrooms serving largely low-income, rural populations.
详细描述
The ONE PATH: Optimizing Nutrition Education for Parents And Teachers for Healthy growth study will rigorously test the efficacy of responsive feeding (RF) and appetite regulation interventions. ONE PATH will intervene upon 3 unique targeted audiences, 1) Early Childhood Education providers (ECE), 2) preschool children, and 3) parents of the preschool children, to address childhood obesity in rural, under-served areas. ECE providers will receive online RF training and coaching. Preschool children will receive an experiential play-based curriculum delivered in the classroom focused on recognition of hunger and fullness cues and using attention control and mindfulness strategies to regulate food intake. Parents will receive RF and parenting guidance from ONE PATH educators through remote coaching. In addition to the three candidate interventions, all classrooms had the option to elect to participate in an existing evidence-based intervention (CORE intervention), the Nutrition and Physical Activity Self-Assessment of Child Care (Go NAP SACC) program. This component will not be tested as part of the optimized intervention.
Aim 1 is to identify which intervention components improve feeding practices and children's appetite regulation (primary), and BMI z-scores (secondary) over the 9-month school year. The 3 candidate intervention components include 1) RF interactive web-based training curriculum and coaching for ECE providers ("ECE provider intervention"), 2) classroom curriculum that teaches regulation strategies to preschool children ("child intervention"), and 3) responsive parenting (RP) curriculum and interactive activities for parents that provide opportunities to practice RF at home ("parent intervention"). The investigators will use the highly efficient multi-phase optimization (MOST) experimental strategy powered to detect main effects and all interactions.
Aim 2 is to improve understanding of the mechanisms by which the 3 candidate intervention components work, and determine if individuals respond differently to intervention components using the data from the experiment in Aim 1. The investigators will examine whether food security and child temperament explain the effects of the intervention on the outcomes (child appetite regulation, caregiver feeding practices, and child BMI z-score).
To investigate whether certain intervention components are more or less effective in certain subgroups, the investigators will explore moderation by child sex, race/ethnicity, and BMI categories.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Parents, educators and children will not be informed of their treatment factor status, but it will not be hidden from them either.
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •children must be enrolled in a participating Head Start or Pre-K Counts center
- •children must be between 2 and 6 years old
- •parent or primary caregiver must be 18 years or older
- •parent/child English speaking
- •ECE providers must be employed in participating Head Start or Pre-K Counts center
排除标准
- •Parents will not be eligible to participate if their child is not eligible and/or not enrolled in the study
- •ECE providers will not be eligible if they do not teach in a participating preschool classroom
结局指标
主要结局
Child Appetite Regulation
时间窗: Post intervention (~9 months)
Difference in mean COMPX score at post-intervention between intervention and control conditions: Child appetite regulation skills will be assessed using the gold standard caloric compensation score (COMPX). On 2 occasions, children will be served a smoothie \~20 minutes prior to lunch - on 1 occasion, they will receive a low-calorie smoothie, and on the other a high-calorie smoothie (order will be randomized by classroom). Children will then be served an ad-libitum lunch (same foods on both occasions), and intake will be determined by pre- and post-weighing of food. The difference in intake between the two conditions reflects the child's ability to compensate for the higher calorie preload, a measure of appetite regulation. Caloric compensation score (COMPX) will be calculated as a percentage score. A COMPX of 100% reflects perfect caloric compensation. A COMPX higher than 100% indicates overcompensation, whereas a COMPX lower than 100% indicates under-compensation.
Early childhood educator (ECE) feeding practices
时间窗: Post intervention (~9 months)
Difference in percentage of educators engaging in specific feeding practices between intervention and control conditions at post-study. Early childhood educators feeding practices will be assessed using the Mealtime Observation in Childcare Checklist (MOCC). This measure will capture whether educators engage in specific feeding styles and practices during meal time. Some of the behaviors observed will include: whether educators pressured children to eat their food, praised children for trying a certain food or finishing their food, or if they provided food- or non-food related rewards to children for eating food. Additionally, we will observe how educators handled food refusal and if they supported children's self-regulation. For each item on the check list, observers indicate if they did or did not observe the behavior.
Parent feeding practices
时间窗: Baseline and post intervention (~9 months)
Differences in baseline-post change in parent feeding practice scores between intervention and control conditions Parent feeding practices will be assessed using the Structure and Control in Parent Feeding (SCPF) questionnaire, a 34-item measure that assesses positive, structure based feeding practices (i.e., limit-setting, consistent routines) and controlling feeding practices (i.e., restriction, pressure to eat). Items are scored on a 5-point likert scale (0 = never- 4 = always), with higher scores indicating higher frequency of engagement in a specific feeding behavior.
次要结局
- BMI z-scores(Baseline and post intervention (~9 months))
- Classroom/school food environment(Post intervention (~9 months))
- Waist Circumference(Baseline and post intervention (~9 months))
- Weight Status(Post intervention (~9 months))
- Child Appetite Regulation and Satiety Responsiveness(Baseline and post intervention (~9 months))
研究者
Jennifer Savage Williams
Associate Professor of Nutritional Sciences
Penn State University