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PODER Familiar Program for Families of Children with Developmental Disabilities (PODER Trial)

N/A

Recruiting

Research Sponsored by University of Texas at Austin

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 from baseline to 4 months

Awards & highlights

PODER Trial Summary

This trial tests a tailored health promotion program for parents of children with IDD and their families to promote health and well-being. 10 remote sessions + 3 family group workshops to improve health outcomes for families.

Who is the study for?

This trial is for Latino families in Chicago or Austin with children aged 6-17 who have intellectual and developmental disabilities (IDD) such as autism, Down syndrome, or intellectual disability. Parents must be the primary caregivers and over 18. Children who use mobility aids cannot participate.Check my eligibility

What is being tested?

The PODER Familiar program is being tested to see if it helps improve health behaviors in Latino families of children with IDD. It includes a pilot study followed by an RCT comparing outcomes from pre to post-test after receiving weekly remote sessions and attending workshops.See study design

What are the potential side effects?

Since this intervention involves educational sessions and workshops rather than medication, there are no direct medical side effects; however, participants may experience changes in family dynamics or stress levels due to lifestyle adjustments.

PODER Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to 4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 4 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change from baseline child body mass index percentile at 4 months

Change from baseline child health related quality of life at 4 months

Change from baseline parent Body Mass Index at 4 months

+2 more

Secondary outcome measures

Change from baseline child dietary Intake at 4 months

Change from baseline child physical activity at 4 months

Change from baseline parent dietary Intake at 4 months

+1 more

PODER Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention groupExperimental Treatment1 Intervention

Participants will receive 10 remote sessions with the curriculum with a promotora, and 3 in-person group workshops.

Group II: control groupActive Control1 Intervention

Participants will receive community services as usual

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Texas at AustinLead Sponsor

353 Previous Clinical Trials

81,154 Total Patients Enrolled

1 Trials studying Sedentary Lifestyle

12 Patients Enrolled for Sedentary Lifestyle

University of Illinois at ChicagoOTHER

609 Previous Clinical Trials

1,559,219 Total Patients Enrolled

Media Library

PODER Familiar Clinical Trial Eligibility Overview. Trial Name: NCT05713617 — N/A

Sedentary Lifestyle Research Study Groups: Intervention group, control group

Sedentary Lifestyle Clinical Trial 2023: PODER Familiar Highlights & Side Effects. Trial Name: NCT05713617 — N/A

PODER Familiar 2023 Treatment Timeline for Medical Study. Trial Name: NCT05713617 — N/A

Frequently Asked Questions

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

Does this research accommodate participants aged 75 or under?

"According to the enrollment parameters, participants must fall between 6 and 100 years of age. Additionally, there are 96 trials for underage individuals and 342 that cater to elderly people."

Answered by AI

Who meets the prerequisites for enrolling in this research endeavor?

"Prospective volunteers for this clinical trial must have psychological distress and be between 6 to 100 years old. The team is hoping to enlist around 90 individuals in total."

Answered by AI

Does this clinical research presently have any openings?

"Affirmative. Clinicaltrials.gov's data reveals that this medical trial, initially posted on January 17th 2023 is currently seeking participants. Approximately 90 people must be recruited from two different locations."

Answered by AI

What is the current participant enrollment for this research study?

"Affirmative. The clinical trial registry shows that this investigation is proactively searching for volunteers. Initially posted on the 17th of January 2023, and recently updated on 2nd February 2023, the study seeks 90 participants from two distinct sites."

Answered by AI

What is the purpose of this research endeavor?

"The primary endpoint of the clinical trial that will be monitored over a 4-month period is changes in parental health-related quality of life. Secondary outcomes include alterations to dietary intake as measured by DSQ, physical activity levels according to ActiGraph accelerometer readings and further modifications in food consumption based on DSQ metrics."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PODER Familiar: Health Promotion for Latino Families of Children With IDD

Sandy Magaña 2023. "PODER Familiar: Health Promotion for Latino Families of Children With IDD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05713617.