ONE PATH: Optimizing Nutrition Education for Parents and Teachers for Healthy Growth (ONE PATH)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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University Park, Pennsylvania, United States, 16802
- Pennsylvania State University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: All Factors On
ECE Provider intervention will be turned on Parent intervention will be turned on Child intervention will be turned on
|
Provide online training for Head Start educators
Other Names:
Coach parents remotely to educate them on responsive feeding and parenting
Other Names:
Through classrooms lessons cover 3 topics: 1) self-regulation, 2) hunger and fullness, and 3) mindfulness in eating and attention control practices
Other Names:
|
|
Experimental: ECE on/Parent on
ECE Provider intervention will be turned on Parent intervention will be turned on Child intervention will be turned off
|
Provide online training for Head Start educators
Other Names:
Coach parents remotely to educate them on responsive feeding and parenting
Other Names:
|
|
Experimental: ECE on/Child on
ECE Provider intervention will be turned on Parent intervention will be turned off Child intervention will be turned on
|
Provide online training for Head Start educators
Other Names:
Through classrooms lessons cover 3 topics: 1) self-regulation, 2) hunger and fullness, and 3) mindfulness in eating and attention control practices
Other Names:
|
|
Experimental: ECE on
ECE Provider intervention will be turned on Parent intervention will be turned off Child intervention will be turned off
|
Provide online training for Head Start educators
Other Names:
|
|
Experimental: Parent on/Child on
ECE Provider intervention turned off Parent intervention turned on Child intervention turned on
|
Coach parents remotely to educate them on responsive feeding and parenting
Other Names:
Through classrooms lessons cover 3 topics: 1) self-regulation, 2) hunger and fullness, and 3) mindfulness in eating and attention control practices
Other Names:
|
|
Experimental: Parent on
ECE Provider intervention turned off Parent intervention turned on Child intervention turned off
|
Coach parents remotely to educate them on responsive feeding and parenting
Other Names:
|
|
Experimental: Child on
ECE Provider intervention turned off Parent intervention turned off Child intervention turned on
|
Through classrooms lessons cover 3 topics: 1) self-regulation, 2) hunger and fullness, and 3) mindfulness in eating and attention control practices
Other Names:
|
|
No Intervention: All Factors Off
ECE Provider intervention turned off Parent intervention turned off Child intervention turned off
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child Appetite Regulation
Time Frame: Post 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. |
Post intervention (~9 months)
|
|
Parent feeding practices
Time Frame: Baseline 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 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
Time Frame: Baseline 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 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
Time Frame: Post 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. |
Post intervention (~9 months)
|
|
Parent feeding practices
Time Frame: Baseline 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. |
Baseline and post intervention (~9 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
BMI z-scores
Time Frame: Baseline 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. |
Baseline and post intervention (~9 months)
|
|
Child Appetite Regulation and Satiety Responsiveness
Time Frame: Baseline and post intervention (~9 months)
|
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)
|
|
Child Appetite Regulation and Satiety Responsiveness
Time Frame: Baseline 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). |
Baseline and post intervention (~9 months)
|
|
Classroom/school food environment
Time Frame: Post 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. |
Post intervention (~9 months)
|
|
Waist Circumference
Time Frame: Baseline 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.
|
Baseline and post intervention (~9 months)
|
|
Weight Status
Time Frame: Post 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). |
Post intervention (~9 months)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jennifer S Williams, PhD, Penn State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nutrition Disorders
- Overnutrition
- Body Weight
- Overweight
- Obesity
- Pathological Conditions, Signs and Symptoms
- Behavior
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Social Behavior
- Pediatric Obesity
- Self-Control
- Diet, Food, and Nutrition
- Physiological Phenomena
- Nutritional Physiological Phenomena
- Digestive System Physiological Phenomena
- Digestive System and Oral Physiological Phenomena
- Appetite
- Hunger
- Appetite Regulation
Other Study ID Numbers
- 1R01DK120754-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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