Open Actively Recruiting

A Two-Part Intervention to Target Cardiovascular Health

About

Brief Summary

Obesity is one of the most common health conditions among autistic young people and its prevalence rises at faster rates for autistic-relative to non-autistic-individuals. This places them at heightened risk for cardiovascular disease (CVD) and mortality before they enter adulthood. Studies have identified three key contributing factors to CVD outcomes in autistic individuals: unhealthy lifestyle behaviors, Adverse Childhood Experiences (ACEs), and chronic stress.

This study will explore the effectiveness of two CVD-focused primary care interventions for autistic individuals (ages 9-26): (1) lifestyle medicine consultations tailored towards supporting health-promoting behaviors; and (2) a Cognitive Behavioral Therapy (CBT) intervention tailored towards addressing chronic stress that contributes to excess weight and maladaptive eating behaviors and results in obesity and CVD. Participants and their caregivers will be randomly placed into either the Lifestyle Medicine Group, CBT Group, or combined Lifestyle Medicine with CBT Group. Participants will respond to questionnaires and surveys measuring lifestyle habits, stress, and psychological risk factors at their first visit, 6-month visit, and 3 months post-intervention visit. Over the course of 6 months, participants will attend virtual sessions (up to three times a month) in accordance with their intervention group.

Primary Purpose
The main objective of the intervention(s) being evaluated by the clinical trial. Learn more
Supportive care
Study Type
The nature of the investigation or investigational use for which clinical study information is being submitted. Learn more
Interventional
Phase
N/A

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
9 Years
Maximum Age
26 Years

Inclusion Criteria:

    • Have a diagnosis of autism or be told by a healthcare provider that you have autism
    • Be between the ages of 9 and 26
    • Have a BMI greater than the 84th percentile
    • English speaking

Exclusion Criteria:

    • Children younger than 9 years of age
    • Adults older than 26 years of age
    • Individuals without a diagnosis of autism
    • Individuals with a BMI less than the 84th percentile
Study Stats
Protocol No.
25-1848
Category
Brain/Neurological Diseases
Pediatric Disorders
Principal Investigator
Alice A. Kuo, MD
Alice A. Kuo, MD
Pediatrics, Internal Medicine
Alice A. Kuo, MD
Contact
  • Xinyu Hartshorn
Location
  • UCLA Westwood
For Providers
NCT No.
NCT07673172
For detailed technical eligibility, visit ClinicalTrials.gov.