Childhood ObesityPROGRESSNCT07823582
PROGRESS for the Primary Prevention of Early Overweight in Low-income, Rural Families
A study testing Sleep-Soothe-Play Responsive Parenting, Parent-Child Communication and Parental Mindfulness in people with Childhood Obesity, run by Penn State University.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 years and olderHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Sleep-Soothe-Play Responsive Parenting, Parent-Child Communication and Parental Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to Dec 2032
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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
- Being tested
- Sleep-Soothe-Play Responsive Parenting, Parent-Child Communication, Parental Mindfulness, Child Safety Curriculum, Responsive Feeding Education (Standard of Care via WIC)
- Keywords
- Responsive Parenting, Obesity Prevention, Parent-Child Communication, Parental Mindfulness, Infant Sleep, Infant Soothing, WIC, Telehealth, Multiphase Optimization Strategy (MOST)
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep-Soothe-Play Responsive ParentingBehavioural
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 CommunicationBehavioural
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 MindfulnessBehavioural
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 CurriculumBehavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Interventions A + B + C | Experimental | A. Sleep-Soothe-Play Responsive Parenting B. Parent-Child Communication (Infant Signing) C. Parental Mindfulness Receives: 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) Receives: 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 Receives: 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 Receives: 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 Receives: 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) Receives: Behavioral: Parent-Child Communication; Behavioral: Child Safety Curriculum; Behavioral: Responsive Feeding Education (Standard of Care via WIC) |
| Intervention C | Experimental | C. Parental Mindfulness Receives: Behavioral: Parental Mindfulness; Behavioral: Child Safety Curriculum; Behavioral: Responsive Feeding Education (Standard of Care via WIC) |
| No Intervention | Active comparator | Safety Curriculum Control Receives: Behavioral: Child Safety Curriculum; Behavioral: Responsive Feeding Education (Standard of Care via WIC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months of age
Secondary outcomes (5)
Body Mass Index (BMI) Trajectory
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.
Measured: Birth, 6, 12, 18, and 24 months
BMI z-Score
BMI-for-age z-score calculated using CDC growth references.
Measured: 24 months
Conditional Weight Gain
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
Measured: Birth to 6 months
Obesity at 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
Measured: 24 months
Growth from 6-24 months
BMI from 6 to 24 months will be analyzed using a multilevel model
Measured: Age 6 to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start1 Jan 2027 (estimated)
- Primary completionDec 2031 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2 × 2 × 2 factorial design using the Multiphase Optimization Strategy (MOST) framework
- Masking
- None (open label)
- Enrolment
- 328 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Savage Williams, Penn State University
- Investigators
- Jennifer Savage, PhD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07823582
- Sponsor's protocol ID
- 1R01DK146257-01A1
- Acronym
- PROGRESS
- Status last verified
- May 2026
- First submitted
- 11 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified dataset will be deposited in a controlled repository and accessible by qualified researchers.