Promoting Health Through Parent Empowerment and the Activation of Routines (PrO-PEAR)

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.

Conditions

• Down Syndrome

Interventions

BEHAVIORAL

Promoting Health through Parent Empowerment and the Activation of Routines

Parents will receive a report of their child's current performance and adherence to World Health Organization recommendations in each intervention area. Parents will be coached to build consistent family mealtime routines, in which children are involved in meal preparation, food exploration, and play. They will receive education on appropriate serving sizes for young children and basic information nutrition recommendations. Predictable bedtime routines will be designed to incorporate calming sensory input to improve the transition to bed. Parents will be educated on screen time recommendations and help families brainstorm alternatives to screens, including family-based routines of movement and activity. Finally, parents will be coached to incorporate play into all newly adopted routines, as young children learn though play.

BEHAVIORAL

Enhanced Usual Care

For the control group, usual care will be enhanced by providing parents with a report of their child's performance and adherence to World Health Organization recommendations in the areas of healthy eating, physical activity, sedentary behavior and sleep. This report will consolidate data based on parent report, written logs, and actigraphy at baseline.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• University of Pittsburgh

  lead OTHER

Principal Investigators

• Angela Caldwell, PhD · University of Pittsburgh

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

12 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-10-04

Primary Completion

2023-05-23

Completion

2023-05-23

Countries

• United States

Study Locations