PROGRESS for the Primary Prevention of Early Overweight in Low-income, Rural Families

NCT07823582 | Not Yet Recruiting DMC

• 1 other identifier: 1R01DK146257-01A1
• Study Type: interventional
• Target: 328
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Childhood Obesity

Keywords

Responsive Parenting; Obesity Prevention; Parent-Child Communication; Parental Mindfulness; Infant Sleep; Infant Soothing; WIC; Telehealth; Multiphase Optimization Strategy (MOST)

Outcome Measures

Primary Outcomes (1)

• Overweight at age 24 months

  Child overweight status defined as body mass index (BMI) at or above the 85th percentile for age and sex using Centers for Disease Control and Prevention (CDC) growth charts. BMI will be calculated from measured weight and height obtained through WIC and/or primary care provider anthropometric assessments.

  24 months of age

Secondary Outcomes (5)

• Body Mass Index (BMI) Trajectory

  Birth, 6, 12, 18, and 24 months

• BMI z-Score

  24 months

• Conditional Weight Gain

  Birth to 6 months

• Obesity at 24 months

  24 months

• Growth from 6-24 months

  Age 6 to 24 months

Other Outcomes (10)

• Parent Feeding Practices

  12 and 24 months

• Parent Responsiveness to Child Feeding Cues

  12 and 24 Months

• Child Communication Development

  12, 18, and 24 Months

Study Arms (8)

Interventions A + B + C

EXPERIMENTAL

A. Sleep-Soothe-Play Responsive Parenting B. Parent-Child Communication (Infant Signing) C. Parental Mindfulness

Behavioral: Sleep-Soothe-Play Responsive Parenting; Behavioral: Parent-Child Communication; Behavioral: Parental Mindfulness; Behavioral: Responsive Feeding Education (Standard of Care via WIC)

Interventions A + B

EXPERIMENTAL

A. Sleep-Soothe-Play Responsive Parenting B. Parent-Child Communication (Infant Signing)

Behavioral: Sleep-Soothe-Play Responsive Parenting; Behavioral: Parent-Child Communication; Behavioral: Child Safety Curriculum; Behavioral: Responsive Feeding Education (Standard of Care via WIC)

Interventions A + C

EXPERIMENTAL

A. Sleep-Soothe-Play Responsive Parenting C. Parental Mindfulness

Behavioral: Sleep-Soothe-Play Responsive Parenting; Behavioral: Parental Mindfulness; Behavioral: Child Safety Curriculum; Behavioral: Responsive Feeding Education (Standard of Care via WIC)

Intervention A

EXPERIMENTAL

A. Sleep-Soothe-Play Responsive Parenting

Behavioral: Sleep-Soothe-Play Responsive Parenting; Behavioral: Child Safety Curriculum; Behavioral: Responsive Feeding Education (Standard of Care via WIC)

Interventions B + C

EXPERIMENTAL

B. Parent-Child Communication (Infant Signing) C. Parental Mindfulness

Behavioral: Parent-Child Communication; Behavioral: Parental Mindfulness; Behavioral: Child Safety Curriculum; Behavioral: Responsive Feeding Education (Standard of Care via WIC)

Intervention B

EXPERIMENTAL

B. Parent-Child Communication (Infant Signing)

Behavioral: Parent-Child Communication; Behavioral: Child Safety Curriculum; Behavioral: Responsive Feeding Education (Standard of Care via WIC)

Intervention C

EXPERIMENTAL

C. Parental Mindfulness

Behavioral: Parental Mindfulness; Behavioral: Child Safety Curriculum; Behavioral: Responsive Feeding Education (Standard of Care via WIC)

No Intervention

ACTIVE COMPARATOR

Safety Curriculum Control

Behavioral: Child Safety Curriculum; Behavioral: Responsive Feeding Education (Standard of Care via WIC)

Interventions

Sleep-Soothe-Play Responsive Parenting BEHAVIORAL

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.

Intervention A; Interventions A + B; Interventions A + B + C; Interventions A + C

Parent-Child Communication BEHAVIORAL

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.

Intervention B; Interventions A + B; Interventions A + B + C; Interventions B + C

Parental Mindfulness BEHAVIORAL

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.

Intervention C; Interventions A + B + C; Interventions A + C; Interventions B + C

Child Safety Curriculum BEHAVIORAL

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.

Intervention A; Intervention B; Intervention C; Interventions A + B; Interventions A + C; Interventions B + C; No Intervention

Responsive Feeding Education (Standard of Care via WIC) BEHAVIORAL

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.

Intervention A; Intervention B; Intervention C; Interventions A + B; Interventions A + B + C; Interventions A + C; Interventions B + C; No Intervention

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Singleton
• Born at ≥37 weeks gestation.
• Birthweight at or above the 50th percentile for gestational age and sex.
• Age 18 years or older
• Pregnant in the third trimester (at recruitment)/≤1 month postpartum (at enrollment)
• Participating in the Pennsylvania Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) at a participating site
• First-time mother (primiparous)
• English-speaking
• Willing and able to provide informed consent and participate in study procedures through the child's age of 24 months.

You may not qualify if:

• Multiple gestation (e.g., twins, triplets)
• Born \<37 weeks gestation
• Birthweight below the 50th percentile for gestational age and sex
• Medical conditions, congenital anomalies, genetic disorders, or chronic health conditions that may substantially affect growth, feeding, development, or participation in study activities.
• Participation in another study that, in the opinion of the investigators, could interfere with study outcomes or participation.
• Age less than 18 years
• Unable to communicate in English
• Medical, psychiatric, cognitive, or developmental conditions that, in the opinion of the investigators, would interfere with participation in the intervention or completion of study procedures.
• Plans to relocate outside the service area of participating WIC clinics during the 24-month study period.
• Inability or unwillingness to provide informed consent.
• Participation in another study that, in the opinion of the investigators, could interfere with study outcomes or participation.

Sponsors & Collaborators

• Penn State University: lead

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jennifer Savage, PhD

  Penn State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lindsey Hess, MPH

CONTACT

814-865-2457; lbb135@psu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 2 × 2 × 2 factorial design using the Multiphase Optimization Strategy (MOST) framework

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 16, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2032
• Last Updated: September 16, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: All scientific data generated from this project will be made available as soon as possible, and no later than the time of publication or the end of the funding period, whichever comes first. The duration of preservation and sharing of the data will be a minimum of 10 years after the funding period
• Access Criteria: Data that can be shared will be deposited in the ScholarSphere institutional data repository with controlled access and will be made available upon request. Data will be shared with qualified investigators with an appropriate research question and approved Data Use Agreement, which limits subsequent use to the terms of the approved request and requires that users maintain data security, and refrain from any attempts to re-identify research participants or engage in any unauthorized uses of the data.