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

Primary Purpose

Childhood Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CORE NAP SACC
ECE Provider
Parent Intervention
Child intervention
Sponsored by
Penn State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity focused on measuring Responsive parenting, Children's Appetite Self-Regulation, Early Childhood Education

Eligibility Criteria

2 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • children must be enrolled in a participating Head Start 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 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

Sites / Locations

  • Pennsylvania State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

All Factors On

NAP SACC on/ECE on/Parent on

NAP SACC on/ECE on/Child on

NAP SACC on/ECE on

NAP SACC on/Parent on/Child on

NAP SACC on/Parent on

NAP SACC on/Child on

NAP SACC on

Arm Description

Nutrition and Physical Activity Self-Assessment of Childcare (Core NAP SACC) will be turned on ECE Provider intervention will be turned on Parent intervention will be turned on Child intervention will be turned on

Core NAP SACC will be turned on ECE Provider intervention will be turned on Parent intervention will be turned on Child intervention will be turned off

Core NAP SACC will be turned on ECE Provider intervention will be turned on Parent intervention will be turned off Child intervention will be turned on

Core NAP SACC will be turned on ECE Provider intervention will be turned on Parent intervention will be turned off Child intervention will be turned off

Core NAP SACC turned on ECE Provider intervention turned off Parent intervention turned on Child intervention turned on

Core NAP SACC turned on ECE Provider intervention turned off Parent intervention turned on Child intervention turned off

Core NAP SACC turned on ECE Provider intervention turned off Parent intervention turned off Child intervention turned on

Core NAP SACC turned on ECE Provider intervention turned off Parent intervention turned off Child intervention turned off

Outcomes

Primary Outcome Measures

Child appetite self-regulation
Difference in mean COMPX score at post-intervention between intervention and control conditions Child appetite self-regulation skills will be assessed using the gold standard caloric compensation score (COMPX). On two occasions, children will be served a snack ~20 minutes prior to lunch - on one occasion, they will receive a low-calorie snack, and on the other a high-calorie snack (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.
Parent responsive feeding practices
Differences in baseline-post change in parent feeding practice scores between intervention and control conditions Parent responsive 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.
Parent responsive feeding practices
Differences in baseline-post change in parent feeding practice scores between intervention and control conditions Parent responsive 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.
Early childhood educator (ECE) responsive feeding practices
Difference in percentage of educators engaging in specific feeding practices between intervention and control conditions at post-study. Early childhood educators responsive 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, response options range from: 0 = No; 1 = Yes, sometimes (1-2 times), 3 = Yes, regularly (3+ times).

Secondary Outcome Measures

BMI z-scores
Difference in change in BMI z-scores from baseline to post between intervention and control conditions Children's weights and heights will be obtained at baseline and the end of the study using standard procedures. BMI will be calculated and values will be standardized to z-scores and percentiles according to Centers for Disease Control (CDC) standards and adjusted for child's sex and age.
Child Appetite Regulation and Satiety Responsiveness
Differences in change from baseline-post intervention in calories consumed in the Eating in the Absence of Hunger (EAH) task between intervention and control conditions. The EAH procedure measures children's snack food consumption when not hungry. Children will be presented with a variety of snack foods shortly after being fed a full meal. The snacks will be weighed prior to and following the procedure to calculate intake. This will be evaluated at baseline and post intervention.
Child Appetite Regulation and Satiety Responsiveness
Differences in change in appetitive traits (parent-rated) from baseline-post, and mean appetitive traits at post-intervention (ECE provider-rated) between intervention and control conditions. Child appetitive traits will be assessed using the Children's Eating Behavior Questionnaire, which will be completed by parents at baseline and post intervention and by ECE providers post intervention only. This measure assesses children's eating style using a 5-point scale (1 = never - 5 = always).
Classroom/school food environment
Differences in percent of classrooms exhibiting specified characteristics of food environment at post-intervention between intervention and control conditions. The ECE environment, including food and beverages served, physical environment, teacher engagement, and regulations, planned trainings & formal education, and feeding practices will be assessed observationally at the conclusion of the project using the validated MOCC. We hope to observe more teacher engagement, positive environment and feeding practices, and visibility of more healthy foods in the classrooms post-intervention.

Full Information

First Posted
January 18, 2019
Last Updated
January 12, 2023
Sponsor
Penn State University
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1. Study Identification

Unique Protocol Identification Number
NCT03817021
Brief Title
ONE PATH: Optimizing Nutrition Education for Parents and Teachers for Healthy Growth
Acronym
ONE PATH
Official Title
ONE PATH: Optimizing Nutrition Education for Parents and Teachers for Healthy Growth
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 21, 2022 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Penn State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 ~760 families across 64 classrooms serving largely low-income, rural populations. ONE PATH will capitalize on the existing infrastructure with the Supplemental Nutrition Assistance Program Education to engage trusted Extension educators making this model cost-effective, and increasing the potential for wide-scale dissemination and sustainability.
Detailed Description
The ONE PATH: Optimizing Nutrition Education for Parents And Teachers for Healthy growth study will rigorously test the efficacy of adding responsive feeding (RF) and appetite regulation components to an existing evidence-based intervention, the Nutrition and Physical Activity Self-Assessment of Child Care (NAP SACC) program. NAP SACC intervenes on the childcare setting environment and has been shown to lower child body mass index (BMI) in childcare settings and positively impact food environment policies. NAP SACC lacks Responsive Feeding (RF) guidance and does not target parents or the home environment, which is the focus of this study. ONE PATH will intervene upon 3 unique targeted audiences, 1) Early Childhood Education providers (ECE), 2) preschool children, and 3) parents of the pre-school children, to address childhood obesity in rural, under-served areas. ECE providers will receive much-needed 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Responsive parenting, Children's Appetite Self-Regulation, Early Childhood Education

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
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.
Masking
None (Open Label)
Masking Description
Parents, educators and children will not be informed of their treatment factor status, but it will not be hidden from them either.
Allocation
Randomized
Enrollment
768 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
All Factors On
Arm Type
Experimental
Arm Description
Nutrition and Physical Activity Self-Assessment of Childcare (Core NAP SACC) will be turned on ECE Provider intervention will be turned on Parent intervention will be turned on Child intervention will be turned on
Arm Title
NAP SACC on/ECE on/Parent on
Arm Type
Experimental
Arm Description
Core NAP SACC will be turned on ECE Provider intervention will be turned on Parent intervention will be turned on Child intervention will be turned off
Arm Title
NAP SACC on/ECE on/Child on
Arm Type
Experimental
Arm Description
Core NAP SACC will be turned on ECE Provider intervention will be turned on Parent intervention will be turned off Child intervention will be turned on
Arm Title
NAP SACC on/ECE on
Arm Type
Experimental
Arm Description
Core NAP SACC will be turned on ECE Provider intervention will be turned on Parent intervention will be turned off Child intervention will be turned off
Arm Title
NAP SACC on/Parent on/Child on
Arm Type
Experimental
Arm Description
Core NAP SACC turned on ECE Provider intervention turned off Parent intervention turned on Child intervention turned on
Arm Title
NAP SACC on/Parent on
Arm Type
Experimental
Arm Description
Core NAP SACC turned on ECE Provider intervention turned off Parent intervention turned on Child intervention turned off
Arm Title
NAP SACC on/Child on
Arm Type
Experimental
Arm Description
Core NAP SACC turned on ECE Provider intervention turned off Parent intervention turned off Child intervention turned on
Arm Title
NAP SACC on
Arm Type
Experimental
Arm Description
Core NAP SACC turned on ECE Provider intervention turned off Parent intervention turned off Child intervention turned off
Intervention Type
Behavioral
Intervention Name(s)
CORE NAP SACC
Other Intervention Name(s)
NAP SACC
Intervention Description
Modify the food environment following a self-assessment of current food conditions
Intervention Type
Behavioral
Intervention Name(s)
ECE Provider
Other Intervention Name(s)
Responsive feeding for early childhood educators, ECE
Intervention Description
Provide online training for Head Start educators
Intervention Type
Behavioral
Intervention Name(s)
Parent Intervention
Other Intervention Name(s)
RF, Parent Responsive Feeding
Intervention Description
Coach parents remotely to educate them on responsive feeding and parenting
Intervention Type
Behavioral
Intervention Name(s)
Child intervention
Other Intervention Name(s)
Appetite regulation, Child regulation
Intervention Description
Through classrooms lessons cover 3 topics: 1) self-regulation, 2) hunger and fullness, and 3) mindfulness in eating and attention control practices
Primary Outcome Measure Information:
Title
Child appetite self-regulation
Description
Difference in mean COMPX score at post-intervention between intervention and control conditions Child appetite self-regulation skills will be assessed using the gold standard caloric compensation score (COMPX). On two occasions, children will be served a snack ~20 minutes prior to lunch - on one occasion, they will receive a low-calorie snack, and on the other a high-calorie snack (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.
Time Frame
Post intervention (~9 months)
Title
Parent responsive feeding practices
Description
Differences in baseline-post change in parent feeding practice scores between intervention and control conditions Parent responsive 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.
Time Frame
Baseline and post intervention (~9 months)
Title
Parent responsive feeding practices
Description
Differences in baseline-post change in parent feeding practice scores between intervention and control conditions Parent responsive 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.
Time Frame
Baseline and post intervention (~9 months)
Title
Early childhood educator (ECE) responsive feeding practices
Description
Difference in percentage of educators engaging in specific feeding practices between intervention and control conditions at post-study. Early childhood educators responsive 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, response options range from: 0 = No; 1 = Yes, sometimes (1-2 times), 3 = Yes, regularly (3+ times).
Time Frame
Post intervention (~9 months)
Secondary Outcome Measure Information:
Title
BMI z-scores
Description
Difference in change in BMI z-scores from baseline to post between intervention and control conditions Children's weights and heights will be obtained at baseline and the end of the study using standard procedures. BMI will be calculated and values will be standardized to z-scores and percentiles according to Centers for Disease Control (CDC) standards and adjusted for child's sex and age.
Time Frame
Baseline and post intervention (~9 months)
Title
Child Appetite Regulation and Satiety Responsiveness
Description
Differences in change from baseline-post intervention in calories consumed in the Eating in the Absence of Hunger (EAH) task between intervention and control conditions. The EAH procedure measures children's snack food consumption when not hungry. Children will be presented with a variety of snack foods shortly after being fed a full meal. The snacks will be weighed prior to and following the procedure to calculate intake. This will be evaluated at baseline and post intervention.
Time Frame
Baseline and post intervention (~9 months)
Title
Child Appetite Regulation and Satiety Responsiveness
Description
Differences in change in appetitive traits (parent-rated) from baseline-post, and mean appetitive traits at post-intervention (ECE provider-rated) between intervention and control conditions. Child appetitive traits will be assessed using the Children's Eating Behavior Questionnaire, which will be completed by parents at baseline and post intervention and by ECE providers post intervention only. This measure assesses children's eating style using a 5-point scale (1 = never - 5 = always).
Time Frame
Baseline and post intervention (~9 months)
Title
Classroom/school food environment
Description
Differences in percent of classrooms exhibiting specified characteristics of food environment at post-intervention between intervention and control conditions. The ECE environment, including food and beverages served, physical environment, teacher engagement, and regulations, planned trainings & formal education, and feeding practices will be assessed observationally at the conclusion of the project using the validated MOCC. We hope to observe more teacher engagement, positive environment and feeding practices, and visibility of more healthy foods in the classrooms post-intervention.
Time Frame
Post intervention (~9 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: children must be enrolled in a participating Head Start 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer S Williams, PhD
Phone
814-865-0514
Email
jfs195@psu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lindsey B Hess, MPH
Phone
814-865-2457
Email
lbb135@psu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer S Williams, PhD
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pennsylvania State University
City
University Park
State/Province
Pennsylvania
ZIP/Postal Code
16802
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Williams, PhD
Phone
814-865-5014
Email
jfs195@psu.edu
First Name & Middle Initial & Last Name & Degree
Lindsey Hess, MS
Phone
(814) 865-2457
Email
lbb13@psu.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified participant data will be available to researchers on request after the conclusion of the study.
IPD Sharing Time Frame
Data will be available one year following the conclusion of the study.
IPD Sharing Access Criteria
Researchers must submit a request with planned use to the PI, and complete a data sharing agreement with Penn State University.

Learn more about this trial

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

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