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NCT Number: NCT07823582

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

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.

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Key information

Conditions

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

Age range

0 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Infant inclusion criteria:

  • Singleton
  • Born at ≥37 weeks gestation.
  • Birthweight at or above the 50th percentile for gestational age and sex.

Mother inclusion criteria:

  • 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.

Infant exclusion criteria:

  • 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.

Mother exclusion criteria:

  • 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.

Treatment and study plan

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.

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.

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.

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.

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.

Primary outcomes

  1. Overweight at age 24 months

    Time frame: 24 months of age

    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.

Secondary outcomes

  1. Body Mass Index (BMI) Trajectory

    Time frame: Birth, 6, 12, 18, and 24 months

    Body mass index (BMI; kg/m²) calculated from measured weight and length/height collected at WIC visits and/or pediatric well child visits. Longitudinal BMI measurements will be used to evaluate growth trajectories from infancy through age 24 months.

  2. BMI z-Score

    Time frame: 24 months

    BMI-for-age z-score calculated using CDC growth references.

  3. Conditional Weight Gain

    Time frame: Birth to 6 months

    Conditional weight gain from birth to 6 months, calculated as standardized residuals from the regression of weight-for-age z-score at 6 months on weight-for-age z-score at birth, with length-for-age z-score at birth, gestational age at birth, length-for-age z-score at 6 months, and age at time of 6 month measurement as covariates

  4. Obesity at 24 months

    Time frame: 24 months

    Child obesity status defined as body mass index (BMI) at or above the 95th percentile for age and sex using Centers for Disease Control and Prevention (CDC) growth charts

  5. Growth from 6-24 months

    Time frame: Age 6 to 24 months

    BMI from 6 to 24 months will be analyzed using a multilevel model

Other outcomes

  1. Parent Feeding Practices

    Time frame: 12 and 24 months

    Parent feeding practices measured using the Structure and Control in Parent Feeding Questionnaire, including structure-based and control-based feeding behaviors.

  2. Parent Responsiveness to Child Feeding Cues

    Time frame: 12 and 24 Months

    Observed parent responsiveness during feeding interactions assessed using the Responsiveness to Child Feeding Cues Task.

  3. Child Communication Development

    Time frame: 12, 18, and 24 Months

    Child communication and language development assessed using the MacArthur Communicative Development Inventories.

  4. Parental Mindfulness

    Time frame: 6, 12, 18, and 24 Months

    Mindfulness in parenting assessed using the Interpersonal Mindfulness in Parenting Scale (IMP).

  5. Parenting Stress

    Time frame: 12 and 24 Months

    Parenting stress measured using the Parenting Stress Index.

  6. Infant and Child Sleep Behaviors

    Time frame: 6, 12, 18 and 24 Months

    Sleep duration, sleep routines, night waking, and related sleep behaviors measured using the Brief Infant Sleep Questionnaire.

  7. Sleep-Soothe-Play Parenting Practices

    Time frame: 6, 12, 18, and 24 Months

    Parent use of sleep, soothing, and behavioral regulation practices measured using the Babies Need Soothing Questionnaire.

  8. Intervention Adherence

    Time frame: Through 24 Months

    Proportion of scheduled intervention sessions completed by participants.

  9. Intervention Fidelity (PSU Educator and WIC Nutritionist)

    Time frame: Through 24 Months

    Fidelity of intervention components assessed using fidelity checklists and/or observation.

  10. Participant Satisfaction

    Time frame: Through 24 Months

    Participant-reported satisfaction with intervention content and delivery.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Penn State University

Other

Registry information

Acronym: PROGRESS

Important dates

Study start
2027
Primary completion
2031
Study completion
2032
First posted
Sep 16, 2026
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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