What this study is
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.
What's being tested
- Lifestyle Medicine
Intervention · BEHAVIORAL
The intervention is a series of lifestyle medicine consultations.
- Cognitive Behavioral Therapy (CBT)
Intervention · BEHAVIORAL
The intervention is a series of CBT sessions.
- Lifestyle Medicine with CBT Group
Intervention · BEHAVIORAL
Receives both Lifestyle Medicine and CBT interventions
Study details
- Official title
- Autism Research Consortium on Physical Health: A Two-Part Intervention to Target Cardiovascular Health
- Sponsor
- University of California, Los Angeles
- Conditions
- Autism · Adverse Childhood Experience · Stress · Cardiovascular (CV) Risk
- Enrolling
- 130 people
- Starts
- 2026-08-05
- Est. completion
- 2028-08-31
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 9 Years – 26 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 open1100 Glendon Ave
Los Angeles, California, United States
Study team
Sponsor
University of California, Los Angeles
Study ID 25-1848
Principal investigator
Alice Kuo, MD, PhD
University of California, Los Angeles
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.