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

NCT03817021 | Completed

• 1 other identifier: 1R01DK120754-01
• Study Type: interventional
• Target: 1,461
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Childhood Obesity; Self-regulation; Appetite Regulation

Keywords

Responsive parenting; Early Childhood Education; Appetite Regulation

Outcome Measures

Primary Outcomes (5)

• Child Appetite Regulation

  Difference in mean COMPX score at post-intervention between intervention and control conditions: Child appetite regulation skills will be assessed using the gold standard caloric compensation score (COMPX). On 2 occasions, children will be served a smoothie \~20 minutes prior to lunch - on 1 occasion, they will receive a low-calorie smoothie, and on the other a high-calorie smoothie (order will be randomized by classroom). Children will then be served an ad-libitum lunch (same foods on both occasions), and intake will be determined by pre- and post-weighing of food. The difference in intake between the two conditions reflects the child's ability to compensate for the higher calorie preload, a measure of appetite regulation. Caloric compensation score (COMPX) will be calculated as a percentage score. A COMPX of 100% reflects perfect caloric compensation. A COMPX higher than 100% indicates overcompensation, whereas a COMPX lower than 100% indicates under-compensation.

  Post intervention (~9 months)

• Parent feeding practices

  Differences in baseline-post change in parent feeding practice scores between intervention and control conditions Parent feeding practices will be assessed using the Structure and Control in Parent Feeding (SCPF) questionnaire, a 34-item measure that assesses positive, structure based feeding practices (i.e., limit-setting, consistent routines) and controlling feeding practices (i.e., restriction, pressure to eat). Items are scored on a 5-point likert scale (0 = never- 4 = always), with higher scores indicating higher frequency of engagement in a specific feeding behavior.

  Baseline and post intervention (~9 months)

• Parent feeding practices

  Differences in baseline-post change in parent feeding practice scores between intervention and control conditions. Parent feeding practices will be assessed using the Feeding to Manage Child Behavior questionnaire (FMCBQ), a 9-item measure that assesses parents' use of food to soothe and food as reward. Items are scored on a 5-point Likert scale (0 = never- 4 = always), with higher scores indicating higher frequency of engagement in food to soothe or as reward.

  Baseline and post intervention (~9 months)

• Early childhood educator (ECE) feeding practices

  Difference in percentage of educators engaging in specific feeding practices between intervention and control conditions at post-study. Early childhood educators feeding practices will be assessed using the Mealtime Observation in Childcare Checklist (MOCC). This measure will capture whether educators engage in specific feeding styles and practices during meal time. Some of the behaviors observed will include: whether educators pressured children to eat their food, praised children for trying a certain food or finishing their food, or if they provided food- or non-food related rewards to children for eating food. Additionally, we will observe how educators handled food refusal and if they supported children's self-regulation. For each item on the check list, observers indicate if they did or did not observe the behavior.

  Post intervention (~9 months)

• Parent feeding practices

  Differences in baseline-post change in parent feeding practice scores between intervention and control conditions Parent feeding practices will be assessed using the Caregiver's Feeding Styles Questionnaire (CFSQ), a 19-item measure which classifies caregivers into 1 of 4 feeding styles (authoritarian, authoritative, indulgent and uninvolved). Items are scored on a 5-point scale (1=never-5=always), with higher scores indicating higher frequency of engagement in a specific feeding style.

  Baseline and post intervention (~9 months)

Secondary Outcomes (6)

• BMI z-scores

  Baseline and post intervention (~9 months)

• Child Appetite Regulation and Satiety Responsiveness

  Baseline and post intervention (~9 months)

• Child Appetite Regulation and Satiety Responsiveness

  Baseline and post intervention (~9 months)

• Classroom/school food environment

  Post intervention (~9 months)

• Waist Circumference

  Baseline and post intervention (~9 months)

Study Arms (8)

All Factors On

EXPERIMENTAL

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

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

ECE on/Parent on

EXPERIMENTAL

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

Behavioral: ECE Provider; Behavioral: Parent Intervention

ECE on/Child on

EXPERIMENTAL

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

Behavioral: ECE Provider; Behavioral: Child intervention

ECE on

EXPERIMENTAL

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

Behavioral: ECE Provider

Parent on/Child on

EXPERIMENTAL

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

Behavioral: Parent Intervention; Behavioral: Child intervention

Parent on

EXPERIMENTAL

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

Behavioral: Parent Intervention

Child on

EXPERIMENTAL

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

Behavioral: Child intervention

All Factors Off

NO INTERVENTION

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

Interventions

ECE Provider BEHAVIORAL

Provide online training for Head Start educators

Also known as: Responsive feeding for early childhood educators, ECE

All Factors On; ECE on; ECE on/Child on; ECE on/Parent on

Parent Intervention BEHAVIORAL

Coach parents remotely to educate them on responsive feeding and parenting

Also known as: RF, Parent Responsive Feeding

All Factors On; ECE on/Parent on; Parent on; Parent on/Child on

Child intervention BEHAVIORAL

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

Also known as: Appetite regulation, Child regulation

All Factors On; Child on; ECE on/Child on; Parent on/Child on

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Penn State University: lead

Study Sites (1)

Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

MeSH Terms

Conditions

Pediatric Obesity; Self-Control

Interventions

Appetite Regulation

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Appetite; Hunger; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Jennifer S Williams, PhD

  Penn State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Parents, educators and children will not be informed of their treatment factor status, but it will not be hidden from them either.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Nutritional Sciences

Model Details: 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.

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: January 25, 2019
• Study Start: July 21, 2022
• Primary Completion: July 7, 2025
• Study Completion: July 7, 2025
• Last Updated: October 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available one year following the conclusion of the study.
• Access Criteria: Researchers must submit a request with planned use to the PI, and complete a data sharing agreement with Penn State University.

Locations

US (1)