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

The Pennsylvania State University (PENNSTATE) logo

The Pennsylvania State University (PENNSTATE)

Status

Completed

Conditions

Childhood Obesity
Appetite Regulation
Self-regulation

Treatments

Behavioral: ECE Provider
Behavioral: Child intervention
Behavioral: Parent Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT03817021
1R01DK120754-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,461 patients

Sex

All

Ages

2 to 6 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

1,461 participants in 8 patient groups

All Factors On
Experimental group
Description:
ECE Provider intervention will be turned on Parent intervention will be turned on Child intervention will be turned on
Treatment:
Behavioral: Parent Intervention
Behavioral: Child intervention
Behavioral: ECE Provider
ECE on/Parent on
Experimental group
Description:
ECE Provider intervention will be turned on Parent intervention will be turned on Child intervention will be turned off
Treatment:
Behavioral: Parent Intervention
Behavioral: ECE Provider
ECE on/Child on
Experimental group
Description:
ECE Provider intervention will be turned on Parent intervention will be turned off Child intervention will be turned on
Treatment:
Behavioral: Child intervention
Behavioral: ECE Provider
ECE on
Experimental group
Description:
ECE Provider intervention will be turned on Parent intervention will be turned off Child intervention will be turned off
Treatment:
Behavioral: ECE Provider
Parent on/Child on
Experimental group
Description:
ECE Provider intervention turned off Parent intervention turned on Child intervention turned on
Treatment:
Behavioral: Parent Intervention
Behavioral: Child intervention
Parent on
Experimental group
Description:
ECE Provider intervention turned off Parent intervention turned on Child intervention turned off
Treatment:
Behavioral: Parent Intervention
Child on
Experimental group
Description:
ECE Provider intervention turned off Parent intervention turned off Child intervention turned on
Treatment:
Behavioral: Child intervention
All Factors Off
No Intervention group
Description:
ECE Provider intervention turned off Parent intervention turned off Child intervention turned off

Trial contacts and locations

1

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Central trial contact

Lindsey B Hess, MPH; Jennifer S Williams, PhD

Data sourced from clinicaltrials.gov

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