Recruiting

Health Promotion

Sponsor:

University of Texas at Austin

Code:

NCT05713617

Conditions

Health-Related Behavior

Quality of Life

Psychological Distress

Diet, Healthy

Physical Inactivity

Eligibility Criteria

Sex: All

Age: 6 - 70+

Healthy Volunteers: Accepted

Interventions

PODER Familiar

Study Details

Brief summary:

The goal of this clinical trial is to test a culturally tailored health promotion intervention for children with IDD and their families. First investigators will conduct a single group design pilot study of a health promotion intervention, followed by second, a small-scale randomized control trial (RCT). of the intervention with Latino parents of children with intellectual and developmental disabilities (IDD) in the Chicago, Illinois and Austin, Texas areas. The following research questions will be addressed:

Question 1: What is the appropriate content, dosage, and delivery method of the intervention?

Question 2: What is the feasibility and acceptability of the intervention?

Question 3: Do participants improve between pre and post-test on outcome measures both in the one group design and compared to the control group in the RCT?

Parents will receive 10 weekly remote sessions on health promotion content delivered by parent mentors called promotoras. Parents and children will attend 3 multi-family group workshops in-person that will provide demonstrations and interactive activities.

Conditions

Health-Related Behavior

Quality of Life

Psychological Distress

Diet, Healthy

Physical Inactivity

Study ID

NCT05713617

Start date

Jan 17, 2023

Status verified date

Jul, 2024

Completion date

Sep 30, 2024

Anticipated

Primary completion date

Sep 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

Parent/Caregiver

  • identify as parent or primary family caregiver
  • 18 years of age or older
  • Identify as Latino/a or of Latin American Descent
  • have a child with IDD between 6 and 17 years of age Child with IDD
  • between 6 and 17 years old
  • the child has a diagnosis of autism spectrum disorder, Down syndrome or intellectual disability

Exclusion Criteria:

  • Child uses mobility aid

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intervention group

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

no intervention: control group

Participants will receive community services as usual

Interventions

PODER Familiar

Educational intervention designed to improve healthy behaviors of families of children with intellectual and developmental disabilities.

Primary outcome measure

  • Change from baseline parent Body Mass Index at 4 months [ Time Frame: from baseline to 4 months ]
  • Change from baseline parent health-related quality of life at 4 months [ Time Frame: from baseline to 4 months ]
  • Change from baseline parent psychological distress at 4 months [ Time Frame: from baseline to 4 months ]
  • Change from baseline child body mass index percentile at 4 months [ Time Frame: from baseline to 4 months ]
  • Change from baseline child health related quality of life at 4 months [ Time Frame: from baseline to 4 months ]

Central Contacts and Locations

Locations

University of Illinois at Chicago

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Yolanda Suarez-Balcazar, PhD

312-413-0117ysuarez@uic.edu

Mansha Mirza, PhD

312-355-5427mmirza2@uic.edu

Steve Hicks School of Social Work, University of Texas at Austin

Recruiting

Austin, Texas, United States, 78712

Contacts

Desiree Pacheco

512-471-1937desiree.pacheco@austin.utexas.edu

Sandy Magana

512-232-9216smagana@austin.utexas.edu

Principal Investigator:

Sandy Magana, PhD

More Information

Sponsor

University of Texas at Austin

Last update posted

Jul 26, 2024

Last verified

Jul, 2024

Keywords

  • healthy lifestyle
  • Latino families
  • developmental disabilities

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Texas at Austin on 2024-07-26.