| Registry | NCT03817021, acronym ONE PATH |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, factorial, masking: none, prevention |
| Enrollment | 1461 (Actual) |
| Sponsor | Penn State University (Other) |
| Conditions | Childhood Obesity, Self-regulation, Appetite Regulation |
| Interventions | ECE Provider, Parent Intervention, Child intervention (Behavioral) |
| Dates | start 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 in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Childhood Obesity All trials for Self-regulation All trials of ECE Provider All trials of Parent Intervention
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| All Factors On | Experimental | Behavioral: ECE Provider; Behavioral: Parent Intervention; Behavioral: Child intervention | ECE Provider intervention will be turned on Parent intervention will be turned on Child intervention will be turned on |
| ECE on/Parent on | Experimental | Behavioral: ECE Provider; Behavioral: Parent Intervention | ECE Provider intervention will be turned on Parent intervention will be turned on Child intervention will be turned off |
| ECE on/Child on | Experimental | Behavioral: ECE Provider; Behavioral: Child intervention | ECE Provider intervention will be turned on Parent intervention will be turned off Child intervention will be turned on |
| ECE on | Experimental | Behavioral: ECE Provider | ECE Provider intervention will be turned on Parent intervention will be turned off Child intervention will be turned off |
| Parent on/Child on | Experimental | Behavioral: Parent Intervention; Behavioral: Child intervention | ECE Provider intervention turned off Parent intervention turned on Child intervention turned on |
| Parent on | Experimental | Behavioral: Parent Intervention | ECE Provider intervention turned off Parent intervention turned on Child intervention turned off |
| Child on | Experimental | Behavioral: Child intervention | ECE Provider intervention turned off Parent intervention turned off Child intervention turned on |
| All Factors Off | No intervention | ECE Provider intervention turned off Parent intervention turned off Child intervention turned off |
Sex: All, ages: 2 Years to 6 Years, 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
| Facility | City | Country | Status |
|---|---|---|---|
| Pennsylvania State University | University Park, Pennsylvania | United States |