NCT07823582Toborzás még nem indult
PROGRESS for the Primary Prevention of Early Overweight in Low-income, Rural Families
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 16.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 328 (tervezett)
- Első benyújtás
- 2026. szept. 11.
- Kezdés
- 2027. jan. 1.
- Elsődleges befejezés
- 2031. dec.
- Fő szponzor
- Penn State University
- Betegségek
- Elhízás
- NCT-szám
- NCT07823582
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 328
- 2027. jan. 1. és az elsődleges befejezés (2031. dec.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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A regiszterben nem jelölt feltételek
- 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.
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