← Back to Search

Preventing Obesity through Parent Empowerment and the Activation of Routines for Down Syndrome (PrO-PEAR Trial)

N/A

Waitlist Available

Led By Angela Caldwell, PhD

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

PrO-PEAR Trial Summary

This trial will study the feasibility of the PrO-PEAR intervention to help prevent obesity in children. The intervention will be tested with parents and children to see if it is acceptable and if it leads to improved health behaviors in the areas of nutrition, physical activity, sedentary behavior, and sleep.

PrO-PEAR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Interventionist fidelity to treatment protocol

Number of PrO-PEAR intervention sessions completed

Number of participant families recruited per month

+2 more

Secondary outcome measures

Change in Child Height from Baseline to 1 year

Change in Child Height from Baseline to 6 months

Change in Child Weight from Baseline to 1 year

+9 more

PrO-PEAR Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PrO-PEARExperimental Treatment1 Intervention

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

Group II: Enhanced Usual CareActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Preventing Obesity through Parent Empowerment and the Activation of Routines

2021

N/A

~30

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor

1,719 Previous Clinical Trials

16,342,316 Total Patients Enrolled

2 Trials studying Down Syndrome

123 Patients Enrolled for Down Syndrome

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

1,963 Previous Clinical Trials

2,674,716 Total Patients Enrolled

16 Trials studying Down Syndrome

145,399 Patients Enrolled for Down Syndrome

Angela Caldwell, PhDPrincipal InvestigatorUniversity of Pittsburgh

2 Previous Clinical Trials

153 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What ultimate outcome is being sought through this clinical study?

"This clinical trial will be conducted over a 3-month period and its primary outcome is the completion rate of collected data. Additionally, secondary outcomes include alterations in physical activity from baseline to 3 months, changes in child weight from baseline to 6 months, and shifts in sleep quality from baseline to 3 months as measured by activPALs and Phillips Actiwatchs respectively."

Answered by AI

Is it still feasible to join this experiment?

"Evidently, this medical experiment is recruiting participants. Clinicaltrials.gov has information that indicates the study was initiated on October 4th 2021 and updated as recently as September 8th 2022."

Answered by AI

How many participants are involved in this clinical exploration?

"Affirmative. On clinicaltrials.gov, there is evidence that this experiment commenced recruitment on October 4th 2021 and continues to do so today following an update September 8th 2022; it requires 48 volunteers from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Preventing Obesity Through Parent Empowerment and the Activation of Routines (PrO-PEAR)

Angela Caldwell 2021. "Preventing Obesity Through Parent Empowerment and the Activation of Routines (PrO-PEAR)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05020366.