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

Childhood Obesity Clinical Trial

— ONE PATH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03817021
• Other study ID #: 1R01DK120754-01
• Status: Recruiting
• Phase: N/A
• Start date: July 21, 2022
• Est. completion date: August 2025

Study information

• Verified date: February 2024
• Source: Penn State University
• Contact: Jennifer S Williams, PhD
• Phone: 814-865-0514
• Email: jfs195[@]psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 768
• Est. completion date: August 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Childhood Obesity
• Pediatric Obesity

Intervention

Behavioral:
• CORE NAP SACC
Modify the food environment following a self-assessment of current food conditions
• ECE Provider
Provide online training for Head Start educators
• Parent Intervention
Coach parents remotely to educate them on responsive feeding and parenting
• Child intervention
Through classrooms lessons cover 3 topics: 1) self-regulation, 2) hunger and fullness, and 3) mindfulness in eating and attention control practices

Locations

Country	Name	City	State
United States	Pennsylvania State University	University Park	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Post intervention (~9 months)
Primary	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.	Baseline and post intervention (~9 months)
Primary	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.	Baseline and post intervention (~9 months)
Primary	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).	Post intervention (~9 months)
Secondary	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.	Baseline and post intervention (~9 months)
Secondary	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.	Baseline and post intervention (~9 months)
Secondary	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).	Baseline and post intervention (~9 months)
Secondary	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.	Post intervention (~9 months)