Clinical Trials Directory

Trials / Completed

CompletedNCT03817021

ONE PATH: Optimizing Nutrition Education for Parents and Teachers for Healthy Growth

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
1,461 (actual)
Sponsor
Penn State University · Academic / Other
Sex
All
Age
2 Years – 6 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALECE ProviderProvide online training for Head Start educators
BEHAVIORALParent InterventionCoach parents remotely to educate them on responsive feeding and parenting
BEHAVIORALChild interventionThrough classrooms lessons cover 3 topics: 1) self-regulation, 2) hunger and fullness, and 3) mindfulness in eating and attention control practices

Timeline

Start date
2022-07-21
Primary completion
2025-07-07
Completion
2025-07-07
First posted
2019-01-25
Last updated
2025-10-15

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03817021. Inclusion in this directory is not an endorsement.