Clinical trial NCT05020366: Promoting Health Through Parent Empowerment and the Activation of Routines (PrO-PEAR)
Official title: Promoting Health Through Parent Empowerment and the Activation of Routines (Pro-PEAR) Optimization and Feasibility: A Pilot Randomized Controlled Trial (RCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Down Syndrome
Keywords: Early Childhood
Health Promotion
Nutrition
Sleep
Physical Activity
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-08-25
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot RCT will follow a 2:1 randomization scheme with 2 participant families (parent + child) assigned to intervention (Pro-PEAR) for every 1 assigned to control (enhanced usual care) for a total of 24 participant families.
Primary purpose: PREVENTION

Brief 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.

Detailed description: Interested participants will contact the research team and screening to determine eligibility may be confirmed in person or over the phone. Interested parent participants will undergo the consent process with a trained research assistant and/or the principal investigator. Families will be sent the informed consent documents prior to informed consent process. Prior to data collection, a member of the research team will use a script to discuss the risks and activities involved in study participation and answer any questions the participant has about the study. Following signed informed consent, an appointment will be scheduled for baseline assessments.

Child participants will be provided with the wrist-worn actigraphy device and thigh-worn Physical Activities Logging (activPAL) device, and parents/caregivers educated on the wear schedule and periodic skin checks to ensure skin integrity. Parents will be instructed to complete skin checks daily to minimize risk of abrasions and to contact the study team immediately if any issues occur. The child will wear these devices to collect data on activity, sedentary behavior, and sleep for 7 full days. It is anticipated that each assessment appointment will last approximately 2 hours. If conducted remotely, devices and other materials will be mailed to the participant and completed with a member of the research team on the phone or video conference to answer any question. Equipment will be collected at the time of the first in- person intervention session or by placing in a pre-paid postage box (provided by research team) and placing in the mail.

After assessments, the first approximately ten families will receive the Pro-PEAR intervention from Caldwell (PI) over 12 sessions in their home. Every other week (weeks: 1, 3, 5, 7, 9, 11) parents will be coached on a new health promoting topic: family meals, healthy portions, bedtime routines, strategies for screens, moving and grooving, and health promoting play. Each of these sessions will last approximately 30 minutes and may be delivered in person or remotely (using Zoom). During the alternate weeks (2, 4, 6, 8, 10, 12) therapists will check in with families and address any issues or barriers (such as child behavior) that has impacted progress toward building healthy habits. Each of these sessions will last approximately 30 minutes and be delivered remotely via Zoom.

Data collected from these first \~10 families will inform intervention optimization and finalization of the manual of procedures for the pilot RCT. Once the manual is finalized, 24 additional families will be recruited and randomized (2:1) to receive either Pro-PEAR or a control (enhanced usual care). Families assigned to Pro-PEAR will receive intervention as described above with minor modification as informed by the first 10 participants. Pro-PEAR will be delivered by trained occupational therapy clinicians. Families assigned to control will receive enhanced usual care. Enhanced usual care will include information about child habits in the areas of healthy eating, physical activity, sedentary behavior and sleep based on parent questionnaires and actigraphy. For both the Pro-PEAR and the control group, usual care will be documented through questions about receipt of services and semi-structured interviews with parents.

Parent Experience:

All research activities will take place in the participants' homes. Parents will be expected to complete assessment and intervention activities in the comfort of their home with the research team joining in-person or virtually as needed/preferred. They may refuse to participate in any portion of the research study at any time and will be encouraged to be an active collaborator throughout all actives.

Child Experience:

Children will be expected to wear the Phillips Actiwatch on their wrist and the activPAL on their thigh for 1 week at each assessment timepoint. Children will be expected to participate in activities initiated by their parents and clinicians as appropriate throughout all phases of research.

Based on prior studies within the lab, it is anticipated that \>75% of participants will complete the 3-month program and 6 month follow-up (\>18/24). A sample size of 24 in the pilot RCT will provide us with the \>12 PrO-PEAR intervention completers needed to estimate average outcome values and variability to plan larger subsequent trials.

Descriptive statistics will be used to determine whether feasibility benchmarks have been met for each group. Between group differences and differences in primary outcomes over time will be analyzed using linear mixed models with fixed and random effects.

Eligibility criteria: Child Inclusion Criteria:

1. between the ages of 12 and 36 months
2. diagnosis of Down syndrome
3. demonstrate independent mobility (e.g., walking, crawling)

Child Exclusion Criteria:

1. mobility is significantly restricted because of a medical condition, or
2. nutrition is received primarily by feeding tube.

Parent Inclusion Criteria

1) aged \> 18 years

Parent Exclusion Criteria

* N/A

Primary outcomes:
measure: Number of Pro-PEAR Intervention Sessions Completed
timeFrame: 3 months
measure: Parent-reported Intervention Acceptability as Rated on a Likert Scale.
timeFrame: 3 months
measure: Percentage of Planned Data Collection Efforts Completed Successfully
timeFrame: 6 months
measure: Number of Participant Families Recruited Per Month
timeFrame: up to 1 year
Secondary outcomes:
measure: Change in Healthy Eating From Baseline to 3 Months
timeFrame: baseline to 3 months
measure: Change in Healthy Eating From Baseline to 6 Months
timeFrame: baseline to 6 months
measure: Change in Physical Activity From Baseline to 3 Months
timeFrame: baseline to 3 months
measure: Change in Physical Activity From Baseline to 6 Months
timeFrame: baseline to 6 months
measure: Change in Sedentary Behavior From Baseline to 3 Months
timeFrame: baseline to 3 months
measure: Change in Sedentary Behavior From Baseline to 6 Months
timeFrame: baseline to 6 months
measure: Change in Sleep Duration From Baseline to 3 Months
timeFrame: baseline to 3 months
measure: Change in Sleep Duration From Baseline to 6 Months
timeFrame: baseline to 6 months
measure: Change in Child Weight From Baseline to 6 Months
timeFrame: baseline to 6 months
measure: Change in Child Height From Baseline to 6 Months
timeFrame: baseline to 6 months
measure: Change in Child Weight From Baseline to 1 Year
timeFrame: 1 year
measure: Change in Child Height From Baseline to 1 Year
timeFrame: one year
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Down Syndrome Center of Western Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Angela Caldwell, PhD
role: PRINCIPAL_INVESTIGATOR
References: