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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: Completed NA study of Sleep and Parenting, sponsored by Children's Hospital Medical Center, Cincinnati.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Recruitment will be measured by number of participants able to be recruited in our time frame
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 |
What the finished NCT04989738 record still lists
NCT04989738 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 4,166-participant average among 151 other Sleep trials with a reported enrollment target (98% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04989738's enrollment target sits among peer trials
65 88th of 151 higher than 64 of 151 other Sleep trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sleep trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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