An interventional study of Sleep-Soothe-Play Responsive Parenting and Parent-Child Communication in Childhood Obesity, sponsored by Penn State University. Not yet recruiting. Open to participants aged 0 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Penn State University · Not applicable, Interventional, and Prevention
Among 22 studies in Pediatric Obesity by Penn State University — 3 open to participants now, 3 under way, none of them phase 3. Pediatric Obesity · Penn State University.
Among the 22 studies in Pediatric Obesity by Penn State University, this one is the 4th largest by planned enrollment of the 12 interventional ones that give a count, is the only one that started in 2027, is one of 11 with no phase, and was the 22nd registered.
1,129 studies on the registry are indexed under Pediatric Obesity; 187 are open to participants now.
Browse Pediatric Obesity studies →3 of the 22 studies in Pediatric Obesity by Penn State University are open now, in 1 country. Recruiting first, the newest first:
Penn State University · Sites in United States
Ages 6–9 · Healthy volunteers
Penn State University · Sites in United States
Ages 3–6 · Healthy volunteers
By country, each count listing its studies:
Of the 124 Pediatric Obesity studies recruiting now, 19 (15%) set no upper age limit and 103 (83%) stop at 75 or younger; 114 take children under 18; 69 take healthy volunteers.
This study: 0 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
22 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 1 started in 2027.
This study's planned enrollment of 328 is above the median of 100 across 870 interventional studies indexed under Pediatric Obesity.
Median enrollment 105 across the 12 interventional studies, 116 across the 10 observational. Of the 17 that completed or were terminated, 2 (12%) have results posted.
This tab as a report to print or save as PDF → With an account.
Penn State University is the lead sponsor of 270 studies on the registry; 53 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 11 (73%) have results posted.
1 of the studies in Pediatric Obesity by Penn State University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07095166Penn State UniversityMonitoring Eating Across Locations (MEAL) - Timing, Intake, and Mealtime Evaluation (TIME) | 2027-06-15 |
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Among the 22 studies in Pediatric Obesity by Penn State University, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Infant inclusion criteria:
Mother inclusion criteria:
Infant exclusion criteria:
Mother exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
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)
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)
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)
B. Parent-Child Communication (Infant Signing)
Behavioral: Parent-Child Communication · Behavioral: Child Safety Curriculum · Behavioral: Responsive Feeding Education (Standard of Care via WIC)
C. Parental Mindfulness
Behavioral: Parental Mindfulness · Behavioral: Child Safety Curriculum · Behavioral: Responsive Feeding Education (Standard of Care via WIC)
Safety Curriculum Control
Behavioral: Child Safety Curriculum · Behavioral: Responsive Feeding Education (Standard of Care via WIC)
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.
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.
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.
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.
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.
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.
Time frame: 24 months of age
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.
Time frame: Birth, 6, 12, 18, and 24 months
BMI z-Score
BMI-for-age z-score calculated using CDC growth references.
Time frame: 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
Time frame: 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
Time frame: 24 months
Growth from 6-24 months
BMI from 6 to 24 months will be analyzed using a multilevel model
Time frame: Age 6 to 24 months
Parent Feeding Practices
Parent feeding practices measured using the Structure and Control in Parent Feeding Questionnaire, including structure-based and control-based feeding behaviors.
Time frame: 12 and 24 months
Parent Responsiveness to Child Feeding Cues
Observed parent responsiveness during feeding interactions assessed using the Responsiveness to Child Feeding Cues Task.
Time frame: 12 and 24 Months
Child Communication Development
Child communication and language development assessed using the MacArthur Communicative Development Inventories.
Time frame: 12, 18, and 24 Months
Parental Mindfulness
Mindfulness in parenting assessed using the Interpersonal Mindfulness in Parenting Scale (IMP).
Time frame: 6, 12, 18, and 24 Months
Parenting Stress
Parenting stress measured using the Parenting Stress Index.
Time frame: 12 and 24 Months
Infant and Child Sleep Behaviors
Sleep duration, sleep routines, night waking, and related sleep behaviors measured using the Brief Infant Sleep Questionnaire.
Time frame: 6, 12, 18 and 24 Months
Sleep-Soothe-Play Parenting Practices
Parent use of sleep, soothing, and behavioral regulation practices measured using the Babies Need Soothing Questionnaire.
Time frame: 6, 12, 18, and 24 Months
Intervention Adherence
Proportion of scheduled intervention sessions completed by participants.
Time frame: Through 24 Months
Intervention Fidelity (PSU Educator and WIC Nutritionist)
Fidelity of intervention components assessed using fidelity checklists and/or observation.
Time frame: Through 24 Months
Participant Satisfaction
Participant-reported satisfaction with intervention content and delivery.
Time frame: Through 24 Months
No study locations are listed for this record.
Plan to share: Yes — De-identified dataset will be deposited in a controlled repository and accessible by qualified researchers.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, 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.
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Dec 2031, 59 months later.
Of 539 non-industry interventional studies with no phase under Pediatric Obesity, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's planned 59 months is above that.
Counting every sponsor, half of 541 studies reached it within 25 months; a quarter within 11 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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