Clinical trial NCT03817021: ONE PATH: Optimizing Nutrition Education for Parents and Teachers for Healthy Growth
Official title: ONE PATH: Optimizing Nutrition Education for Parents and Teachers for Healthy Growth
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Childhood Obesity
Self-regulation
Appetite Regulation
Keywords: Responsive parenting
Early Childhood Education
Appetite Regulation
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2019-01-25
Enrollment: 768
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Using Multiphase Optimization (MOST) Strategy, we will examine 3 treatment factors and their interactions to determine a 'best' or optimum approach to education of the Early Childhood Environment (ECE), child and family.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Child Appetite Regulation
timeFrame: Post intervention (~9 months)
measure: Parent feeding practices
timeFrame: Baseline and post intervention (~9 months)
measure: Parent feeding practices
timeFrame: Baseline and post intervention (~9 months)
measure: Early childhood educator (ECE) feeding practices
timeFrame: Post intervention (~9 months)
measure: Parent feeding practices
timeFrame: Baseline and post intervention (~9 months)
Secondary outcomes:
measure: BMI z-scores
timeFrame: Baseline and post intervention (~9 months)
measure: Child Appetite Regulation and Satiety Responsiveness
timeFrame: Baseline and post intervention (~9 months)
measure: Child Appetite Regulation and Satiety Responsiveness
timeFrame: Baseline and post intervention (~9 months)
measure: Classroom/school food environment
timeFrame: Post intervention (~9 months)
measure: Waist Circumference
timeFrame: Baseline and post intervention (~9 months)
measure: Weight Status
timeFrame: Post intervention (~9 months)
Other outcomes:
Locations:
city: University Park
country: United States
facility: Pennsylvania State University
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Jennifer S Williams, PhD
role: PRINCIPAL_INVESTIGATOR
References: