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

NCT ID: NCT03817021

Last Updated: 2025-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1461 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-21

Study Completion Date

2025-07-07

Brief Summary

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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

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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

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Childhood Obesity Self-regulation Appetite Regulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Parents, educators and children will not be informed of their treatment factor status, but it will not be hidden from them either.

Study Groups

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All Factors On

ECE Provider intervention will be turned on Parent intervention will be turned on Child intervention will be turned on

Group Type EXPERIMENTAL

ECE Provider

Intervention Type BEHAVIORAL

Provide online training for Head Start educators

Parent Intervention

Intervention Type BEHAVIORAL

Coach parents remotely to educate them on responsive feeding and parenting

Child intervention

Intervention Type BEHAVIORAL

Through classrooms lessons cover 3 topics: 1) self-regulation, 2) hunger and fullness, and 3) mindfulness in eating and attention control practices

ECE on/Parent on

ECE Provider intervention will be turned on Parent intervention will be turned on Child intervention will be turned off

Group Type EXPERIMENTAL

ECE Provider

Intervention Type BEHAVIORAL

Provide online training for Head Start educators

Parent Intervention

Intervention Type BEHAVIORAL

Coach parents remotely to educate them on responsive feeding and parenting

ECE on/Child on

ECE Provider intervention will be turned on Parent intervention will be turned off Child intervention will be turned on

Group Type EXPERIMENTAL

ECE Provider

Intervention Type BEHAVIORAL

Provide online training for Head Start educators

Child intervention

Intervention Type BEHAVIORAL

Through classrooms lessons cover 3 topics: 1) self-regulation, 2) hunger and fullness, and 3) mindfulness in eating and attention control practices

ECE on

ECE Provider intervention will be turned on Parent intervention will be turned off Child intervention will be turned off

Group Type EXPERIMENTAL

ECE Provider

Intervention Type BEHAVIORAL

Provide online training for Head Start educators

Parent on/Child on

ECE Provider intervention turned off Parent intervention turned on Child intervention turned on

Group Type EXPERIMENTAL

Parent Intervention

Intervention Type BEHAVIORAL

Coach parents remotely to educate them on responsive feeding and parenting

Child intervention

Intervention Type BEHAVIORAL

Through classrooms lessons cover 3 topics: 1) self-regulation, 2) hunger and fullness, and 3) mindfulness in eating and attention control practices

Parent on

ECE Provider intervention turned off Parent intervention turned on Child intervention turned off

Group Type EXPERIMENTAL

Parent Intervention

Intervention Type BEHAVIORAL

Coach parents remotely to educate them on responsive feeding and parenting

Child on

ECE Provider intervention turned off Parent intervention turned off Child intervention turned on

Group Type EXPERIMENTAL

Child intervention

Intervention Type BEHAVIORAL

Through classrooms lessons cover 3 topics: 1) self-regulation, 2) hunger and fullness, and 3) mindfulness in eating and attention control practices

All Factors Off

ECE Provider intervention turned off Parent intervention turned off Child intervention turned off

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ECE Provider

Provide online training for Head Start educators

Intervention Type BEHAVIORAL

Parent Intervention

Coach parents remotely to educate them on responsive feeding and parenting

Intervention Type BEHAVIORAL

Child intervention

Through classrooms lessons cover 3 topics: 1) self-regulation, 2) hunger and fullness, and 3) mindfulness in eating and attention control practices

Intervention Type BEHAVIORAL

Other Intervention Names

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Responsive feeding for early childhood educators ECE RF Parent Responsive Feeding Appetite regulation Child regulation

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Penn State University

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Savage Williams

Associate Professor of Nutritional Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jennifer S Williams, PhD

Role: PRINCIPAL_INVESTIGATOR

Penn State University

Locations

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Pennsylvania State University

University Park, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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1R01DK120754-01

Identifier Type: NIH

Identifier Source: org_study_id

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