Promoting Health Through Parent Empowerment and the Activation of Routines (PrO-PEAR)
Completed · Not applicable
Conditions studied: Down Syndrome
In brief
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.
Key facts
- Study ID
- NCT05020366
- Run by
- University of Pittsburgh
- People needed
- 40
- Starts
- 2021-10-04
- Expected to finish
- 2023-05-23
- Last updated by the study team
- 2024-07-15
Who can join
Age: 1 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Down Syndrome Center of Western Pennsylvania — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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