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

Not Applicable
Recruiting
Conditions
Childhood Obesity
Self-regulation
Appetite Regulation
Interventions
Behavioral: CORE NAP SACC
Behavioral: ECE Provider
Behavioral: Parent Intervention
Behavioral: Child intervention
Registration Number
NCT03817021
Lead Sponsor
Penn State University
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.

Detailed Description

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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
768
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Arm && Interventions
GroupInterventionDescription
All Factors OnCORE NAP SACCNutrition 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
All Factors OnECE ProviderNutrition 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
NAP SACC on/ECE on/Parent onECE ProviderCore 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
All Factors OnParent InterventionNutrition 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
NAP SACC on/ECE on/Child onCORE NAP SACCCore 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
NAP SACC on/ECE on/Child onChild interventionCore 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
NAP SACC on/Child onChild interventionCore NAP SACC turned on ECE Provider intervention turned off Parent intervention turned off Child intervention turned on
All Factors OnChild interventionNutrition 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
NAP SACC on/ECE on/Parent onCORE NAP SACCCore 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
NAP SACC on/ECE on/Child onECE ProviderCore 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
NAP SACC on/ECE onCORE NAP SACCCore 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
NAP SACC on/Parent on/Child onChild interventionCore NAP SACC turned on ECE Provider intervention turned off Parent intervention turned on Child intervention turned on
NAP SACC on/Parent onParent InterventionCore NAP SACC turned on ECE Provider intervention turned off Parent intervention turned on Child intervention turned off
NAP SACC on/ECE on/Parent onParent InterventionCore 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
NAP SACC on/Parent on/Child onCORE NAP SACCCore NAP SACC turned on ECE Provider intervention turned off Parent intervention turned on Child intervention turned on
NAP SACC on/Parent on/Child onParent InterventionCore NAP SACC turned on ECE Provider intervention turned off Parent intervention turned on Child intervention turned on
NAP SACC on/Child onCORE NAP SACCCore NAP SACC turned on ECE Provider intervention turned off Parent intervention turned off Child intervention turned on
NAP SACC onCORE NAP SACCCore NAP SACC turned on ECE Provider intervention turned off Parent intervention turned off Child intervention turned off
NAP SACC on/ECE onECE ProviderCore 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
NAP SACC on/Parent onCORE NAP SACCCore NAP SACC turned on ECE Provider intervention turned off Parent intervention turned on Child intervention turned off
Primary Outcome Measures
NameTimeMethod
Parent feeding practicesBaseline and post intervention (~9 months)

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.

Child Appetite RegulationPost intervention (~9 months)

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.

Early childhood educator (ECE) feeding practicesPost intervention (~9 months)

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.

Secondary Outcome Measures
NameTimeMethod
BMI z-scoresBaseline and post intervention (~9 months)

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 ResponsivenessBaseline and post intervention (~9 months)

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 environmentPost intervention (~9 months)

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 feeding practices will be assessed observationally at baseline (subset) and the conclusion of the project (all classrooms) using the validated MOCC. We hope to observe more teacher engagement, positive environment, and feeding practices in the classrooms post-intervention.

Waist CircumferenceBaseline and post intervention (~9 months)

Differences in mean waist circumference at post-intervention between intervention and control conditions. Waist circumference values will be standardized to z-scores and percentiles according to sex- and age-specific guidelines. Waist circumference will be obtained using standardized procedures at baseline and post-intervention.

Weight StatusPost intervention (~9 months)

Differences in percentage of overweight and obesity status (compared to not having overweight or obesity) at post-intervention between intervention and control conditions.

BMI percentiles according to Centers for Disease Control (CDC) standards and adjusted for child's sex and age will be calculated and use to determine prevalence of overweight (≥ 85th percentile) and obesity (\< 95th percentile).

Trial Locations

Locations (1)

Pennsylvania State University

🇺🇸

University Park, Pennsylvania, United States

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