Promoting Health Through Parent Empowerment and the Activation of Routines (Pro-PEAR) Optimization and Feasibility: A Pilot Randomized Controlled Trial (RCT)
Phase: NA
Conditions: Down Syndrome
Sponsor: University of Pittsburgh

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Study Protocol 
Official Title: Promoting Health through Parent Empowerment and 
the Activation of Routines (Pro-PEAR) 
ClinicalTrials.gov ID (NCT number): NCT05020366 
Protocol Date: 12/12/2022 

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Scientific Background 
Obesity disproportionately impacts children with Down syndrome. Despite serious comorbidities 
such as higher rates of type 2 diabetes and obstructive sleep apnea syndrome, obesity 
prevention efforts have been largely neglected within this population. As guided by the 6-SQuID 
framework, we: 1) defined the problem; 2) clarified causal/contextual factors; 3) identified 
mechanisms underlying change; and 4) identified how to most efficiently target the change 
mechanism. Our primary deliverable, a manualized intervention protocol for the PrO-PEAR 
intervention, will be optimized and tested for feasibility in this study. 
 
Preliminary Data: The Facilitators and Barriers to Health in Young Children with Down 
syndrome (FaB Health Ds) survey data can help to inform intervention design and drive 
prioritization of intervention components. According to data collected during our pilot phase 
(N=33), nutrition and sleep are emerging as priority areas to target for the PrO-PEAR 
intervention. The World Health Organization (WHO) recommends toddlers consume 5 or more 
servings of fruits and vegetables per day, however, only 34% of our sample meet this 
recommendation per parent report. When asked how much quality sleep their child gets over a 
24-hour period, less than half of all parents reported an estimate within the recommended range 
(11-14 hours). In contrast, most parents report that their children meet the recommendations for 
physical activity, in that they participate in at least 3 hours of activity each day. Most families 
reported meeting recommendations for sedentary behaviors, such as screen time and time 
spent restrained (e.g., in a device like a highchair) to 1 hour or less. 
 
Preliminary data also suggest that parents may not be aware of their child’s risk related to 
nutrition and sleep. Most parents are confident in their knowledge of nutrition recommendations 
(72%) and were “not at all concerned” with their child’s consumption of fruits (67%) or 
vegetables (53%). Similarly, most parents were also confident in their knowledge of sleep 
recommendations (89%), yet only 22% considered their child’s sleep to be problematic. These 
data signal a disconnect between parental confidence and/or knowledge of healthy behaviors 
and reports of their child’s behavior. We plan to measure child behavior change in each Institute 
of Medicine obesity prevention priority over time and identify associations with parental 
knowledge, readiness for change, empowerment, and activation.  
 
Study Objectives 
 
This proposed pilot RCT aims: 
1) 
To determine the feasibility of the Pro-PEAR intervention in terms of recruitment, 
randomization, retention, adherence, and acceptability.  
2) 
Estimate the effects of the Pro-PEAR intervention on parent reported child health 
behaviors in each IOM obesity prevention area (nutrition, physical activity, sedentary behavior, 
sleep) over time as compared to an enhanced usual care group. 
 
 
 
 
 
 

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Study Design & Methods 
 
We will recruit 24 parent/child dyads from the Down Syndrome Center of Western PA to 
participate in a pilot RCT.  Inclusion criteria for child participants are being between the ages of 
12-36 months and having a diagnosis of Down syndrome; parent participants must be >18 
years old and able to speak English fluently. We are recruiting children 12-36 months as most 
children are able to self-feed and sleep through the night at this time, yet it precedes the rapid 
weight gain observed among children with Down syndrome.7 
Sample size was determined based on prior recruitment 
efforts and data on number of children within this age range 
served at the clinic (~100). We will use a 2:1 randomization 
ratio for assignment to intervention versus control group 
status to gain more experience using the newly developed 
PrO-PEAR intervention (see Figure 3). Child health behavior 
in the areas of nutrition, physical activity, sedentary behavior, 
and sleep will be reported by parents, in addition to general 
health status and potential mechanisms of behavior change 
at baseline, 3-months (post-intervention) and 6-months 
(follow-up). We will track physical growth via chart review.  
 
B.2.1.3. Treatment. We will test the feasibility of delivering the PrO-PEAR intervention and our 
ability to randomize to an enhanced usual care group. Participants randomized to enhanced 
usual care will receive feedback on health behaviors after baseline assessments and continue 
to receive usual care therapies outside of the study. The PrO-PEAR group will complete four in-
person modules with an occupational therapist, each covering an IOM obesity prevention 
priority area: 1) Healthy Eating; 2) Sleep; 3) Sedentary Behavior; and 4) Physical Activity. 
Parents in the intervention group will also receive six telehealth visits of family-based coaching 
to help participants understand recommendations and adopt new, healthy routines.  
 
B.2.1.4. Measures. A priori benchmarks for recruitment, retention, adherence, data collection 
and acceptability have been established to test the feasibility of the PrO-PEAR intervention. 
Potential issues in each of these areas have been identified with possible solutions for each 
barrier (see Table 1). Protocol adherence will be evaluated via review of sessions using clinician 
documentation. Intervention acceptability will be rated using the Treatment Acceptability 
Questionnaire (TAQ),7 a valid and reliable assessment of parental intervention acceptance. 
Intervention completers are designated as those completing 80% of sessions (< 8 of 10). 
 
We willl assess parent-reported child health behaviors, parental mechanisms of behavior 
change, and child anthropometrics and demographics over time (see Table 2). The knowledge 
test will be created using the World Health Organization’s early childhood recommendations for 
obesity prevention. All other tools have been validated for use with parents of young children. 
For this study, we are specifically interested in parent factors that may influence behavior 
Table 1. Indicators of Feasibility and Acceptability 
Topic 
Benchmark 
Plan if Benchmark is Not Met 
Recruitment 
>3 parent/child dyads per month 
Partner with other Ds clinics 
Retention 
>80% of consented dyads will complete > 8 sessions 
Parent focus group to identify 
issues 
Adherence 
>80% clinician protocol adherence during 100% of sampled 
sessions 
Update protocol and increase 
training  
Data 
Collection 
>80% planned assessments collected among intervention 
completers 
Evaluate burden and reduce as 
needed 
Acceptability 
>90% of parent intervention completers rate intervention as 
acceptable (>28/48 on TAQ) 
Parent focus group to optimize 
protocol 
Figure 1. Randomization Plan 

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change, as parents provide the opportunities, environment, structure and feedback that will 
determine a child’s formation of healthy (or unhealthy) behaviors early in life. Data collected 
during this trial will inform intervention optimization to emphasize those mechanisms related to 
prioritized child behaviors.  
 
Table 2. Intervention Measures 
Assessment 
Brief Description 
Outcome 
Facilitators & Barriers to 
Health: Down syndrome (FaB 
Health Ds)8 
100-item parent survey designed to describe 
habits and facilitators/barriers to health in young 
children with Down syndrome (α=.91). 
Parent-reported child 
nutrition, physical activity, 
sedentary behavior and 
sleep behaviors  
Knowledge of 
Recommendations to Prevent 
Obesity in Young Children  
10-item test to determine knowledge of 
recommendations for nutrition, activity, sedentary 
behavior and sleep  
Parental knowledge of 
healthy behavior 
recommendations 
Readiness, Efficacy, 
Attributions, Defensiveness, & 
Importance Scale – Short 
Form (READI-SF)9 
15-item Likert-scale survey in which higher scores 
indicate greater parental readiness to engage in 
treatment and readiness for change (α=.94). 
Parental readiness for 
change 
Parent Empowerment and 
Efficacy Measure (PEEM)10 
20-item Brief Likert-scale and strength-based 
assessment of parental empowerment and 
efficacy (α=.92).  
Parental empowerment 
Child Anthropometrics 
Height, weight, body circumferences (waist, hip, 
arm, thigh)  
Health status (growth)  
Child Demographics 
Age, medical diagnoses, service utilization, 
surgical history, race, ethnicity, household income 
Health and socioeconomic 
status 
 
B.2.1.4. Data Analysis. Feasibility data will be assessed using descriptive statistics (e.g., 
frequencies, means, percentages) and compared to a priori benchmarks. We will calculate 
bivariate correlations between demographics, intervention adherence, and outcomes to identify 
potential confounders or factors that may influence response to treatment. We will estimate 
effect sizes (Cohen’s d) of child health behaviors and parental factors (knowledge, readiness, 
empowerment, activation) over time and between groups. Finally we will explore associations 
(bivariate correlations) between potential mechanisms of change (parental factors) and child 
behavior change scores. Parental factors significantly associated with child behavior change will 
be analyzed using multiple linear regression to identify significant predictors of child health 
behavior.  
 
Eligibility Criteria  
 
Inclusion criteria for child participants are being between the ages of 12-36 months and having a 
diagnosis of Down syndrome; parent participants must be >18 years old and able to speak 
English fluently. We are recruiting children 12-36 months as most children are able to self-feed 
and sleep through the night at this time, yet it precedes the rapid weight gain observed among 
children with Down syndrome. 
 
Statistical Considerations 
 
Feasibility data will be assessed using descriptive statistics (e.g., frequencies, means, 
percentages) and compared to a priori benchmarks. We will calculate bivariate correlations 
between demographics, intervention adherence, and outcomes to identify potential confounders 
or factors that may influence response to treatment. We will estimate effect sizes (Cohen’s d) of 
child health behaviors and parental factors (knowledge, readiness, empowerment) over time 

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and between groups. Finally we will explore associations (bivariate correlations) between 
potential mechanisms of change (parental factors) and child behavior change scores. Parental 
factors significantly associated with child behavior change will be analyzed using multiple linear 
regression to identify significant predictors of child health behavior.