Promoting Health Through Parent Empowerment and the Activation of Routines (PrO-PEAR)
Public ClinicalTrials.gov record NCT05020366. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Promoting Health Through Parent Empowerment and the Activation of Routines (Pro-PEAR) Optimization and Feasibility: A Pilot Randomized Controlled Trial (RCT)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05020366
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 40 participants
Conditions and interventions
Conditions
Interventions
- Promoting Health through Parent Empowerment and the Activation of Routines Behavioral
- Enhanced Usual Care Behavioral
Behavioral
Eligibility (public fields only)
- Age range
- 12 Months and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 3, 2021
- Primary completion
- May 22, 2023
- Completion
- May 22, 2023
- Last update posted
- Jul 14, 2024
2021 – 2023
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Down Syndrome Center of Western Pennsylvania | Pittsburgh | Pennsylvania | 15224 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05020366, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 14, 2024 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05020366 live on ClinicalTrials.gov.