N/A
Completed N=20
Promoting Health Through Parent Empowerment and the Activation of Routines (PrO-PEAR)
Source: ClinicalTrials.gov NCT05020366 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcomePrimary: Number of Pro-PEAR Intervention Sessions Completed — 9.1 # of sessions completed
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Pro-PEAR Intervention Sessions Completed |
9.1 | — |
| PRIMARY Parent-reported Intervention Acceptability as Rated on a Likert Scale. |
38.8 | — |
| PRIMARY Percentage of Planned Data Collection Efforts Completed Successfully |
80; 94 | — |
| PRIMARY Number of Participant Families Recruited Per Month |
5.25 | — |
| SECONDARY Change in Healthy Eating From Baseline to 3 Months |
0.33; 0.2 | — |
| SECONDARY Change in Healthy Eating From Baseline to 6 Months |
0.11; -0.2 | — |
| SECONDARY Change in Physical Activity From Baseline to 3 Months |
0.45; 0.01 | — |
| SECONDARY Change in Physical Activity From Baseline to 6 Months |
0.32; 1.33 | — |
| SECONDARY Change in Sedentary Behavior From Baseline to 3 Months |
21.01; 11.66 | — |
| SECONDARY Change in Sedentary Behavior From Baseline to 6 Months |
-32.54; -54.45 | — |
| SECONDARY Change in Sleep Duration From Baseline to 3 Months |
13.50; 9.68 | — |
| SECONDARY Change in Sleep Duration From Baseline to 6 Months |
19.26; 21.12 | — |
| SECONDARY Change in Child Weight From Baseline to 6 Months |
4.40; 3.38 | — |
| SECONDARY Change in Child Height From Baseline to 6 Months |
3.78; 4.84 | — |
| SECONDARY Change in Child Weight From Baseline to 1 Year |
— | — |
| SECONDARY Change in Child Height From Baseline to 1 Year |
— | — |
Eligibility Criteria
Child Inclusion Criteria:
- between the ages of 12 and 36 months
- diagnosis of Down syndrome
- demonstrate independent mobility (e.g., walking, crawling)
Child Exclusion Criteria:
- mobility is significantly restricted because of a medical condition, or
- nutrition is received primarily by feeding tube.
Parent Inclusion Criteria
- aged > 18 years
Parent Exclusion Criteria
- N/A
Data sourced from ClinicalTrials.gov (NCT05020366). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.