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

NCT05020366 | Completed Results

• 2 other identifiers: STUDY210401555K12HD055931-14
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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. 1.Optimize the Pro-PEAR intervention manual using an open case series with iterative stakeholder feedback.
2. 2.To determine the feasibility of the Pro-PEAR intervention in terms of recruitment, randomization, retention, adherence, and acceptability.
3. 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.

Conditions

Down Syndrome

Keywords

Early Childhood; Health Promotion; Nutrition; Sleep; Physical Activity

Outcome Measures

Primary Outcomes (4)

• Number of Pro-PEAR Intervention Sessions Completed

  As measured using interventionist documentation

  3 months

• Parent-reported Intervention Acceptability as Rated on a Likert Scale.

  Participant acceptability ratings of the PrO-PEAR intervention using the Treatment Acceptability Questionnaire. Scores range from 8 to 48 with higher scores indicating higher acceptability.

  3 months

• Percentage of Planned Data Collection Efforts Completed Successfully

  Measured by the number of outcomes collected divided by the number of planned outcomes

  6 months

• Number of Participant Families Recruited Per Month

  Quantified for each month of active recruitment and averaged

  up to 1 year

Secondary Outcomes (12)

• Change in Healthy Eating From Baseline to 3 Months

  baseline to 3 months

• Change in Healthy Eating From Baseline to 6 Months

  baseline to 6 months

• Change in Physical Activity From Baseline to 3 Months

  baseline to 3 months

• Change in Physical Activity From Baseline to 6 Months

  baseline to 6 months

• Change in Sedentary Behavior From Baseline to 3 Months

  baseline to 3 months

Study Arms (2)

Pro-PEAR

EXPERIMENTAL

This group will receive the optimized Pro-PEAR intervention (in addition to usual care).

Behavioral: Promoting Health through Parent Empowerment and the Activation of Routines

Enhanced Usual Care

ACTIVE COMPARATOR

This group will serve as the control group and only receive a report of their child's performance and adherence to World Health Organization recommendations based on baseline data.

Behavioral: Enhanced Usual Care

Interventions

Promoting Health through Parent Empowerment and the Activation of Routines BEHAVIORAL

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.

Also known as: Pro-PEAR

Pro-PEAR

Enhanced Usual Care BEHAVIORAL

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.

Also known as: EUC

Enhanced Usual Care

Eligibility Criteria

• Age: 12 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• mobility is significantly restricted because of a medical condition, or
• nutrition is received primarily by feeding tube.
• \) aged \> 18 years
• N/A

Sponsors & Collaborators

• University of Pittsburgh: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Down Syndrome Center of Western Pennsylvania

Pittsburgh, Pennsylvania, 15224, United States

Location

MeSH Terms

Conditions

Down Syndrome; Motor Activity

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Behavior

Limitations and Caveats

This trial's limitations include a small sample size and a 2:1 randomization scheme, which gives preference to the intervention group due to this being a feasibility study. Therefore, group comparisons would not be meaningful.

Results Point of Contact

• Title: Dr. Angela Caldwell
• Organization: University of Pittsburgh

arl78@pitt.edu

412-383-7231

Study Officials

• Angela Caldwell, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research assistants collecting outcome measures will be blinded to study assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: August 25, 2021
• Study Start: October 4, 2021
• Primary Completion: May 23, 2023
• Study Completion: May 23, 2023
• Last Updated: July 15, 2024
• Results First Posted: July 15, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)