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

• ClinicalTrials.gov Identifier: NCT03817021
• Recruitment Status: Not yet recruiting
• First Posted: January 25, 2019
• Last Update Posted: June 21, 2021
• Sponsor: Penn State University
• Information provided by (Responsible Party): Jennifer Savage Williams, Penn State University

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 ~800 families across 48 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.

Condition or disease	Intervention/treatment	Phase
Childhood Obesity	Behavioral: CORE NAP SACC; Behavioral: Early Childhood Education; Behavioral: Parent Responsive Feeding; Behavioral: Child regulation	Not Applicable

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 guidance from Extension educators through home visitation.

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, 2) classroom curriculum that teaches regulation strategies to preschool children, and 3) responsive parenting (RP) curriculum and interactive activities for parents that provide opportunities to practice RF at home (delivered by Extension educators). 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 816 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Intervention 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.
• Primary Purpose: Prevention
• Official Title: ONE PATH: Optimizing Nutrition Education for Parents and Teachers for Healthy Growth
• Estimated Study Start Date: August 2022
• Estimated Primary Completion Date: July 2025
• Estimated Study Completion Date: August 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: All Factors On; Nutrition and Physical Activity Self-Assessment of Childcare (Core NAP SACC) will be turned on Early Childhood Education Training will be turned on Parent Responsive Feeding will be turned on Child regulation in the classroom will be turned on	Behavioral: CORE NAP SACC; Modify the food environment following a self-assessment of current food conditions; Other Name: NAP SACC; Behavioral: Early Childhood Education; Provide online training for Head Start educators; Other Names: Responsive feeding for early childhood educators; ECE; Behavioral: Parent Responsive Feeding; Visit parents in their homes to educate them on responsive feeding; Other Name: RF; Behavioral: Child regulation; Through classrooms lessons cover 3 topics: 1) self-regulation, 2) hunger and fullness, and 3) mindfulness in eating and attention control practices; Other Name: Appetite regulation
Experimental: NAP SACC on/ECE on/Parent RF on; Core NAP SACC will be turned on Early Childhood Education Training will be turned on Parent Responsive Feeding will be turned on Child regulation in the classroom will be turned off	Behavioral: CORE NAP SACC; Modify the food environment following a self-assessment of current food conditions; Other Name: NAP SACC; Behavioral: Early Childhood Education; Provide online training for Head Start educators; Other Names: Responsive feeding for early childhood educators; ECE; Behavioral: Parent Responsive Feeding; Visit parents in their homes to educate them on responsive feeding; Other Name: RF
Experimental: NAP SACC on/ECE on/Child Regulation on; Core NAP SACC will be turned on Early Childhood Education Training will be turned on Parent Responsive Feeding will be turned off Child regulation in the classroom will be turned on	Behavioral: CORE NAP SACC; Modify the food environment following a self-assessment of current food conditions; Other Name: NAP SACC; Behavioral: Early Childhood Education; Provide online training for Head Start educators; Other Names: Responsive feeding for early childhood educators; ECE; Behavioral: Child regulation; Through classrooms lessons cover 3 topics: 1) self-regulation, 2) hunger and fullness, and 3) mindfulness in eating and attention control practices; Other Name: Appetite regulation
Experimental: NAP SACC on/ECE on; Core NAP SACC will be turned on Early Childhood Education Training will be turned on Parent Responsive Feeding will be turned off Child regulation in the classroom will be turned off	Behavioral: CORE NAP SACC; Modify the food environment following a self-assessment of current food conditions; Other Name: NAP SACC; Behavioral: Early Childhood Education; Provide online training for Head Start educators; Other Names: Responsive feeding for early childhood educators; ECE
Experimental: NAP SACCon/Parent RF on/Child regulation on; Core NAP SACC turned on Early Childhood Education Training turned off Parent Responsive Feeding turned on Child regulation in the classroom turned on	Behavioral: CORE NAP SACC; Modify the food environment following a self-assessment of current food conditions; Other Name: NAP SACC; Behavioral: Parent Responsive Feeding; Visit parents in their homes to educate them on responsive feeding; Other Name: RF; Behavioral: Child regulation; Through classrooms lessons cover 3 topics: 1) self-regulation, 2) hunger and fullness, and 3) mindfulness in eating and attention control practices; Other Name: Appetite regulation
Experimental: NAP SACC on/Parent RF on; Core NAP SACC turned on Early Childhood Education Training turned off Parent Responsive Feeding turned on Child regulation in the classroom turned off	Behavioral: CORE NAP SACC; Modify the food environment following a self-assessment of current food conditions; Other Name: NAP SACC; Behavioral: Parent Responsive Feeding; Visit parents in their homes to educate them on responsive feeding; Other Name: RF
Experimental: NAP SACC on/Child regulation on; Core NAP SACC turned on Early Childhood Education Training turned off Parent Responsive Feeding turned off Child regulation in the classroom turned on	Behavioral: CORE NAP SACC; Modify the food environment following a self-assessment of current food conditions; Other Name: NAP SACC; Behavioral: Child regulation; Through classrooms lessons cover 3 topics: 1) self-regulation, 2) hunger and fullness, and 3) mindfulness in eating and attention control practices; Other Name: Appetite regulation
Experimental: NAP SACC on; Core NAP SACC turned on Early Childhood Education Training turned off Parent Responsive Feeding turned off Child regulation in the classroom turned off	Behavioral: CORE NAP SACC; Modify the food environment following a self-assessment of current food conditions; Other Name: NAP SACC

Outcome Measures

Primary Outcome Measures :

1. Child appetite self-regulation [ Time Frame: 9 months (at end of study) ]
   Influence child appetite self-regulation skills - using gold standard Compensation Index (COMPX). Children will consume a low-calorie snack and a high-calorie snack before each of 2 meals. Meals will be pre- and post-weighed to determine children's intake. Poorer COMPx is related to greater childhood adiposity.
2. Parent responsive feeding practices [ Time Frame: At the baseline and at 4.5 and 9 months ]
   Assess changes in parent feeding practices from beginning to end of study, using Caregiver's Feeding Styles Questionnaire, which classifies parents into 1 of 4 feeding styles (authoritarian, authoritative, indulgent and uninvolved). Indulgent feeding style has been associated with obesity risk. The Structure and Control in Feeding Questionnaire measures positive, structure based feeding practices (limit-setting, consistent routines) that promote self-regulation, as well as controlling feeding practices (restriction, pressure to eat).
3. Early childhood educator (ECE) responsive feeding practices [ Time Frame: At baseline and at 9 months (end of study) ]
   Assess changes in early childhood education feeding practices, as determined by the Feeding Behavior Coding System, which will identify feeding styles for ECE providers at beginning and end of study.

Secondary Outcome Measures :

1. BMI z-scores [ Time Frame: At baseline and at 9 months ]
   Evaluate change in BMI z-score. Children's weights, heights and waist circumference will be obtained at baseline and the end of the study, BMI will be calculated and values will be standardized to z-scores and percentiles according to Centers for Disease Control standards and adjusted for child's sex and age. For children of this age, who begin the study as obese, no change in BMI z-scores would be considered a positive outcome.
2. Child Appetite Regulation and Satiety Responsiveness [ Time Frame: At baseline and at 9 months ]
   Assess change in child food responsiveness using the Eating in the Absence of Hunger (EAH) protocol. This measure is related to obesity risk. This is a labor and cost intensive procedure, and will be collected for a sub-sample of classrooms. To collect this children are presented with several very palatable snack foods after having been fed a full meal (lunch), and quantity of snack foods eaten is measured (snack foods are pre- and post-weighed).
3. Classroom/school food environment [ Time Frame: At baseline and at 9 months ]
   To assess changes in Early Childhood Education (ECE) environment to determine if there are changes in foods served, physical environment and teacher engagement using validated Environment and Policy Assessment and Observation tool (EPAO).
4. Home food environment [ Time Frame: At baseline and at 9 months ]
   To assess changes in parents' daily nutrition and physical activity practices in the home using the validated Environment and Policy Assessment and Observation Self-Report instrument (EPAO-SR) which asks parents to report on daily nutrition and physical activity.

Eligibility Criteria

• Ages Eligible for Study: 3 Years to 6 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• children must be enrolled in a participating Head Start center
• children must be between 3 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:

• children with extreme food allergies or dietary restrictions
• parents who are illiterate

Contacts and Locations

Contacts

Contact: Jennifer F Williams, PhD; 814-865-0514; jfs195@psu.edu

Contact: Lindsey B Hess, MPH; 814-865-2457; lbb135@psu.edu

Sponsors and Collaborators

Penn State University

More Information

• Responsible Party: Jennifer Savage Williams, Assistant Professor of Nutritional Sciences, Penn State University
• ClinicalTrials.gov Identifier: NCT03817021
• Other Study ID Numbers: 1R01DK120754-01 ( U.S. NIH Grant/Contract )
• First Posted: January 25, 2019
• Last Update Posted: June 21, 2021
• Last Verified: June 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jennifer Savage Williams, Penn State University:

Responsive parenting; Children's Appetite Self-Regulation; Early Childhood Education

Additional relevant MeSH terms:

Pediatric Obesity; Obesity; Overnutrition; Nutrition Disorders; Overweight; Body Weight