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NCT05020366 · ClinicalTrials.gov registry record · NA
Promoting Health Through Parent Empowerment and the Activation of Routines (PrO-PEAR)
A NA study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT05020366 is a NA study that has completed, run by University of Pittsburgh. The registered enrollment target is 40 participants.
The verdict
NCT05020366, a NA study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study Summary
This study will examine the feasibility of the Promoting Health through Parent Empowerment and the Activation of Routines (Pro-PEAR) intervention using a open case-series for intervention optimization followed by a pilot RCT in which participants are randomized to receive Pro-PEAR or enhanced usual care (EUC). Specific aims include: 1. Optimize the Pro-PEAR intervention manual using an open case series with iterative stakeholder feedback. 2. To determine the feasibility of the Pro-PEAR intervention in terms of recruitment, randomization, retention, adherence, and acceptability. 3. Estimate the effects of the Pro-PEAR intervention on parent reported child health behaviors in each Institute of Medicine obesity prevention area (nutrition, physical activity, sedentary behavior, sleep) over time as compared to a control group. The following benchmarks will be used to determine feasibility: Recruitment: \>3 parent/child dyads per month Retention: \>75% of consented dyads will complete \> 8 sessions Adherence: \>80% clinician protocol adherence during 100% of sampled sessions Data Collection: \>80% planned assessments collected among intervention completers. Acceptability: \>90% of parent intervention completers rate intervention as acceptable. Additionally, it is predicted that parents will report greater gains in the areas of nutrition, sleep, sedentary behavior and physical activity in the Pro-PEAR group than those in the control group.
Interventions
- BEHAVIORAL Enhanced Usual Care
- BEHAVIORAL Promoting Health through Parent Empowerment and the Activation of Routines
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2021-10-04 |
| Est. Completion | 2023-05-23 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05020366
The ClinicalTrials.gov registry entry for NCT05020366 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Enhanced Usual Care is the first listed.
NCT05020366 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05020366 about?
NCT05020366 is a clinical study titled "Promoting Health Through Parent Empowerment and the Activation of Routines (PrO-PEAR)". This study will examine the feasibility of the Promoting Health through Parent Empowerment and the Activation of Routines (Pro-PEAR) intervention using a open case-series for intervention optimization followed by a pilot RCT in which participants are randomized to receive Pro-PEAR or enhanced usual ...
What is the current status of trial NCT05020366?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2021-10-04. Estimated completion is 2023-05-23.
What interventions are being tested in trial NCT05020366?
The interventions under investigation include: Enhanced Usual Care (BEHAVIORAL), Promoting Health through Parent Empowerment and the Activation of Routines (BEHAVIORAL).
Who is sponsoring clinical trial NCT05020366?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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