Healthy Bodies Project to Prevent Childhood Obesity

The Pennsylvania State University (PENNSTATE)

Status: Completed

Conditions: Obesity, Childhood

Treatments: Behavioral: Healthy Eating + Self-Regulation; Behavioral: Food Literacy + Parent Education; Behavioral: Active Play + Self-Regulation; Behavioral: Healthy Eating + Active Play; Behavioral: Self-Regulation Only; Behavioral: Healthy Eating, Active Play, Self-Regulation; Behavioral: Self-Regulation + Parent Education; Behavioral: Healthy Eating, Self-Regulation, Parent Education; Behavioral: Healthy Eating, Active Play, Parent Education; Behavioral: Active Play + Parent Education; Behavioral: Healthy Eating Only; Behavioral: Active Play Only; Behavioral: Active Play, Self-Regulation, Parent Education; Behavioral: Food Literacy Only; Behavioral: Healthy Eating, Active Play, Self-Regulation, Parent Education; Behavioral: Healthy Eating + Parent Education

Study type: Interventional

Funder types: Other

Identifiers

NCT04552678

2015-68001-23233

Details and patient eligibility

About

The goal of this study is to evaluate components of a preschool-based intervention designed to (1) increase children's nutrition knowledge, (2) increase physical activity in childcare settings, (3) increase emotional, behavioral and eating-related regulation, and (4) provide guidance to parents/caregivers about appropriate parenting and child-feeding strategies that promote healthy eating behaviors, dietary patterns and physical activity in preschool-aged children. The long-term goal is to help children develop healthy habits that reduce risk for obesity.

Full description

Findings from intervention studies designed to prevent obesity among preschool children are mixed. One approach to stemming the development of obesity in childhood is to alter children's choices and environments in ways that promote food literacy, acceptance of healthy foods, physical activity and self-regulation. Research on factors that influence the development of obesity in children has identified factors in children's environments that are potential targets for prevention programs. The goal of this study is to evaluate the efficacy of components designed for a preschool-based approach to preventing obesity in children. Using an innovative approach to optimizing behavioral interventions, the multiphase optimization strategy (MOST), we will examine the effects of a 28-week, randomized set of experiments designed to (1) increase children's nutrition knowledge, (2) increase physical activity in childcare settings, (3) increase emotional, behavioral and eating-related regulation, and (4) provide guidance to parents/caregivers about appropriate parenting and child-feeding strategies that promote healthy eating behaviors, dietary patterns and physical activity in preschool-aged children. Participants will include over 1300 predominantly low-income preschool children ages 3 to 5 years attending center-based childcare settings in Pennsylvania (~100 classrooms). The proposed study will provide information on the most efficacious components that produce measurable changes in children's nutrition knowledge and obesity-related behaviors. The results of this study will be used to inform the design of a randomized controlled trial to prevent obesity in children.

Enrollment: 2,480 patients

Sex: All

Ages: 3+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Children ages 3 to 5 years enrolled in full-day, center-based childcare programs
• Caregiver ≥ 18 years of age
• Caregiver responsible for providing meals for child at least half of the time
• Fluent in English (caregiver and child)

Exclusion criteria

• Developmental delays or disorders that affect learning, mobility and eating

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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2,480 participants in 16 patient groups

Healthy Eating, Active Play, Self-Regulation, Parent Education

Experimental group

Description:

Classrooms receive all curricula (Food Literacy, Healthy Eating, Active Play, Self-Regulation Curriculum) and Parent Education

Treatment:

Behavioral: Healthy Eating, Active Play, Self-Regulation, Parent Education

Healthy Eating, Active Play, Self-Regulation

Experimental group

Description:

Classrooms receive all curricula (Food Literacy, Healthy Eating, Active Play, Self-Regulation Curriculum), but no Parent Education

Treatment:

Behavioral: Healthy Eating, Active Play, Self-Regulation

Healthy Eating, Active Play, Parent Education

Experimental group

Description:

Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, the Active Play Curriculum, and Parent Education

Treatment:

Behavioral: Healthy Eating, Active Play, Parent Education

Healthy Eating + Active Play

Experimental group

Description:

Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, the Active Play Curriculum, but no Parent Education

Treatment:

Behavioral: Healthy Eating + Active Play

Healthy Eating, Self-Regulation, Parent Education

Experimental group

Description:

Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, the Self-Regulation Curriculum, and Parent Education

Treatment:

Behavioral: Healthy Eating, Self-Regulation, Parent Education

Healthy Eating + Self-Regulation

Experimental group

Description:

Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, the Self-Regulation Curriculum, but no Parent Education

Treatment:

Behavioral: Healthy Eating + Self-Regulation

Healthy Eating + Parent Education

Experimental group

Description:

Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, and Parent Education

Treatment:

Behavioral: Healthy Eating + Parent Education

Healthy Eating Only

Experimental group

Description:

Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, but no Parent Education

Treatment:

Behavioral: Healthy Eating Only

Active Play, Self-Regulation, Parent Education

Experimental group

Description:

Classrooms receive the core Food Literacy Curriculum, the Active Play Curriculum, the Self-Regulation Curriculum, and Parent Education

Treatment:

Behavioral: Active Play, Self-Regulation, Parent Education

Active Play + Self-Regulation

Experimental group

Description:

Classrooms receive the core Food Literacy Curriculum, the Active Play Curriculum, the Self-Regulation Curriculum, but no Parent Education

Treatment:

Behavioral: Active Play + Self-Regulation

Active Play + Parent Education

Experimental group

Description:

Classrooms receive the core Food Literacy Curriculum, the Active Play Curriculum, and Parent Education

Treatment:

Behavioral: Active Play + Parent Education

Active Play Only

Experimental group

Description:

Classrooms receive the core Food Literacy Curriculum, the Active Play Curriculum, but no Parent Education

Treatment:

Behavioral: Active Play Only

Self-Regulation + Parent Education

Experimental group

Description:

Classrooms receive the core Food Literacy Curriculum, the Self-Regulation Curriculum, and Parent Education

Treatment:

Behavioral: Self-Regulation + Parent Education

Self-Regulation Only

Experimental group

Description:

Classrooms receive the core Food Literacy Curriculum, the Self-Regulation Curriculum, but no Parent Education

Treatment:

Behavioral: Self-Regulation Only

Food Literacy + Parent Education

Experimental group

Description:

Classrooms receive the core Food Literacy Curriculum, and parents are invited to complete web-based education modules.

Treatment:

Behavioral: Food Literacy + Parent Education

Food Literacy Only

Experimental group

Description:

Classrooms only receive the core Food Literacy Curriculum, and no other intervention materials or parent education.

Treatment:

Behavioral: Food Literacy Only