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Clinical Trial 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 ~760 families across 64 classrooms serving largely low-income, rural populations. ONE PATH will capitalize on the existing infrastructure with the Supplemental Nutrition Assistance Program Education to engage trusted Extension educators making this model cost-effective, and increasing the potential for wide-scale dissemination and sustainability.


Clinical Trial Description

The ONE PATH: Optimizing Nutrition Education for Parents And Teachers for Healthy growth study will rigorously test the efficacy of adding responsive feeding (RF) and appetite regulation components to an existing evidence-based intervention, the Nutrition and Physical Activity Self-Assessment of Child Care (NAP SACC) program. NAP SACC intervenes on the childcare setting environment and has been shown to lower child body mass index (BMI) in childcare settings and positively impact food environment policies. NAP SACC lacks Responsive Feeding (RF) guidance and does not target parents or the home environment, which is the focus of this study. ONE PATH will intervene upon 3 unique targeted audiences, 1) Early Childhood Education providers (ECE), 2) preschool children, and 3) parents of the pre-school children, to address childhood obesity in rural, under-served areas. ECE providers will receive much-needed 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. 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03817021
Study type Interventional
Source Penn State University
Contact Jennifer S Williams, PhD
Phone 814-865-0514
Email jfs195@psu.edu
Status Recruiting
Phase N/A
Start date July 21, 2022
Completion date August 2025

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