Promoting Health Through Parent Empowerment and the Activation of Routines (Pro-PEAR) Optimization and Feasibility: A Pilot Randomized Controlled Trial (RCT)

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: