A Two-Part Intervention to Target Cardiovascular Health
NCT07673172 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130
Last updated 2026-06-29
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.
Conditions
- Autism
- Adverse Childhood Experience
- Stress
- Cardiovascular (CV) Risk
Interventions
- BEHAVIORAL
-
Lifestyle Medicine
The intervention is a series of lifestyle medicine consultations.
- BEHAVIORAL
-
Cognitive Behavioral Therapy (CBT)
The intervention is a series of CBT sessions.
- BEHAVIORAL
-
Lifestyle Medicine with CBT Group
Receives both Lifestyle Medicine and CBT interventions
Sponsors & Collaborators
-
Health Resources and Services Administration (HRSA)
collaborator FED -
University of California, Los Angeles
lead OTHER
Principal Investigators
-
Alice Kuo, MD, PhD · University of California, Los Angeles
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 9 Years
- Max Age
- 26 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-01
- Primary Completion
- 2028-07-30
- Completion
- 2028-08-31
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