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PROGRESS for the Primary Prevention of Early Overweight in Low-income, Rural Families
Sponsor: Penn State University
Summary
The Parent Responsiveness Optimized: Growth, Regulation, Eating, Sleep, and Soothing (PROGRESS) study is a randomized clinical trial designed to prevent early childhood overweight among rural, low-income families participating in the Pennsylvania Special Supplemental Nutrition Program for Women, Infants, and Children (PA WIC). The study will enroll 328 first-time mother-infant dyads, with infants having a birthweight at or above the 50th percentile, and follow families from infancy through age 2 years. All participants will receive responsive feeding education through WIC as part of standard care. In addition, the study will test three telehealth-delivered responsive parenting intervention components: (1) sleep-soothe-play guidance, (2) parent-child communication support using infant signing, and (3) parental mindfulness training. Using the Multiphase Optimization Strategy (MOST) framework (a 2 × 2 × 2 factorial design), participants will be randomly assigned to one of eight conditions representing different combinations of these intervention components. Participants not receiving a specific intervention component will receive a safety education curriculum. This approach allows investigators to evaluate the individual and combined effects of each intervention component and identify the most effective and efficient intervention package. The purpose of the study is to determine which responsive parenting components, alone or in combination, are most effective in reducing the risk of overweight and promoting healthy growth during early childhood. The primary outcome is overweight at age 24 months, defined as body mass index (BMI) at or above the 85th percentile for age and sex at 24 months. Secondary weight outcomes include BMI trajectory over 24 months, BMI z-score at 24 months, conditional weight gain from birth to 6 months, growth from 6-24 months, and obesity (BMI at or above 95th percentile for age and sex) at 24 months. Additional outcomes include responsive parenting practices, parent-child communication, parental mindfulness, and implementation outcomes such as intervention fidelity, adherence, acceptability, and participant satisfaction. Findings from this study may help identify scalable, evidence-based strategies for preventing early childhood overweight in rural, low-income populations and support future integration of optimized responsive parenting interventions within WIC and other community-based services.
Key Details
Gender
All
Age Range
0 Years - Any
Study Type
INTERVENTIONAL
Enrollment
328
Start Date
2027-01-01
Completion Date
2032-12
Last Updated
2026-09-16
Healthy Volunteers
Yes
Conditions
Interventions
Sleep-Soothe-Play Responsive Parenting
A telehealth-delivered responsive parenting intervention designed to promote healthy growth by supporting age-appropriate sleep, soothing, and play practices during infancy and toddlerhood. Parents receive guidance on establishing sleep routines, promoting self-soothing skills, reducing the use of feeding to soothe non-hunger distress, responding sensitively to child cues, supporting emotional regulation, and engaging in developmentally appropriate play activities that foster healthy development and parent-child interactions.
Parent-Child Communication
A telehealth-delivered intervention designed to enhance parent-child communication through infant signing and responsive communication strategies. Parents learn to recognize and respond to their child's communication cues and are taught age-appropriate signs related to feeding, sleep, play, emotions, and daily routines. The intervention aims to improve communication clarity, support responsive parenting, strengthen parent-child interactions, and help children express needs, interests, and emotions before the development of spoken language.
Parental Mindfulness
A telehealth-delivered intervention designed to increase mindfulness in parenting and improve parental self-regulation. Parents receive training in emotional awareness, non-reactivity, self-compassion, attention to child cues, stress management, and mindfulness-based coping strategies. The intervention aims to strengthen responsive parenting by helping parents recognize and regulate their own emotions while responding sensitively and appropriately to their child's needs and emotional signals.
Child Safety Curriculum
A telehealth-delivered, dose-matched child safety education program that serves as a control condition for intervention components not assigned in the factorial design. Content is based on American Academy of Pediatrics recommendations and includes safe sleep, injury prevention, food safety, home safety, car seat safety, water safety, and age-appropriate child safety guidance. The amount of safety education provided varies according to the number of intervention components not assigned, ensuring equivalent intervention intensity and participant contact across study conditions. Participants receiving no experimental intervention components will receive the full safety curriculum, while those receiving one or more intervention components will receive a proportionally reduced safety curriculum, with intermediate levels matched to intervention assignment. The curriculum provides equivalent participant contact without delivering experimental intervention content.
Responsive Feeding Education (Standard of Care via WIC)
All participants receive responsive feeding education from WIC nutritionists as part of routine WIC services. Education focuses on recognizing and responding appropriately to infant hunger and fullness cues, establishing healthy feeding routines, delaying introduction of complementary foods until developmentally appropriate, promoting healthy dietary patterns, and supporting responsive feeding practices that encourage self-regulation of food intake. This intervention is provided to all study participants and is not experimentally assigned.