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NCT04989738 · ClinicalTrials.gov registry record · NA
Teaching Healthy Responsive Parenting During Infancy to Promote Vital Growth and dEvelopment (THRIVE) Study
A NA study of Sleep and Parenting, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- NA
- Development phase
- 65
- Enrollment target
- 1
- Study location
NCT04989738 is a NA study of Sleep and Parenting that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 65 participants, below the 4,166-participant average among 151 other Sleep trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04989738, a NA study of Sleep and Parenting, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- NA
- Development phase
- 65 participants
- Enrollment target
- 1
- Study location
Study Summary
Background. Unprecedented rates of overweight and obesity are seen in childhood1 with evidence suggesting that infancy may be a critical period for the development of this high weight trajectory. This has led to a call for proposals for "understanding factors in infancy and early childhood (birth to 24 months) that influence obesity development (PA-18-032)." Objectives. The current study seeks to recruit a sample of mother-infant dyads to pilot a responsive parenting focused obesity prevention program delivered by behavior and development specialists in pediatric primary care. Methods. Approximately 80 mother-infant dyads will be recruited in pediatric primary care at their newborn visit and randomly assigned to one of two groups: a) Healthy Growth (new intervention) or b) Healthy Steps (as usual). We will obtain assessments of growth, feeding, and sleep throughout the study period for infants across five clinic visits and at-home measure completion. Research clinic visits will take place at their regularly scheduled well-child check visits at ages 1, 2, 4, and 6 mos and in-home measures will be completed monthly. The intervention program is hypothesized to show efficacy in both breast and formula fed infants as measured by the primary (i.e., BMI percentile and BMI z-score) and secondary outcomes (e.g., awareness of infant cues, use of alternative soothing strategies, when it is not time for a feeding).
Conditions Studied
Interventions
- BEHAVIORAL Active Control
- BEHAVIORAL THRIVE intervention
Study Locations (1)
Ohio
- Hopple Street Neighborhood Primary Care Clinic - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2020-08-05 |
| Est. Completion | 2021-11-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04989738
The ClinicalTrials.gov registry entry for NCT04989738 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,166-participant average among 151 other Sleep trials with a reported enrollment target (98% lower). The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Sleep appearing as the primary indexed condition, and to 2 interventions - of which Active Control is the first listed.
NCT04989738 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT04989738 about?
NCT04989738 is a clinical study titled "Teaching Healthy Responsive Parenting During Infancy to Promote Vital Growth and dEvelopment (THRIVE) Study". Background. Unprecedented rates of overweight and obesity are seen in childhood1 with evidence suggesting that infancy may be a critical period for the development of this high weight trajectory. This has led to a call for proposals for "understanding factors in infancy and early childhood (birth to...
What is the current status of trial NCT04989738?
This trial is currently completed. It is a NA study. The enrollment target is 65 participants. The study started on 2020-08-05. Estimated completion is 2021-11-30.
What conditions does trial NCT04989738 study?
This clinical trial studies the following conditions: Sleep, Parenting, Parent-Child Relations, Feeding Behavior.
What interventions are being tested in trial NCT04989738?
The interventions under investigation include: Active Control (BEHAVIORAL), THRIVE intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT04989738?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04989738 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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