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A Two-Part Intervention to Target Cardiovascular Health

Autism Research Consortium on Physical Health: A Two-Part Intervention to Target Cardiovascular Health

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07673172
Enrollment
130
Registered
2026-06-29
Start date
2026-08-05
Completion date
2028-08-31
Last updated
2026-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Childhood Experience, Autism, Cardiovascular (CV) Risk, Stress

Keywords

autism, adverse childhood experiences, stress, cardiovascular risk

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.

Detailed description

Autistic individuals experience almost three times the mortality rate relative to non-autistic populations, and are disproportionately likely to experience obesity-with increasing rates beginning in childhood and adolescence-relative to both the general population and those with other developmental conditions. 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. Taken together, this study addresses a critical gap in the field: lack of appropriate and effective healthcare/lifestyle interventions for autistic individuals with CVD and/or experiences of chronic stress that lead to obesity and poor cardiovascular health. These efforts require dedicated interventions selected for their impact on two key mechanisms underlying obesity and CVD: lifestyle and ACEs/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.

Interventions

The intervention is a series of lifestyle medicine consultations.

BEHAVIORALCognitive Behavioral Therapy (CBT)

The intervention is a series of CBT sessions.

BEHAVIORALLifestyle Medicine with CBT Group

Receives both Lifestyle Medicine and CBT interventions

Sponsors

University of California, Los Angeles
Lead SponsorOTHER
Health Resources and Services Administration (HRSA)
CollaboratorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

* Treatment: One or more interventions are being evaluated for treating a disease, syndrome, or condition. * Prevention: One or more interventions are being assessed for preventing the development of a specific disease or health condition.

Eligibility

Sex/Gender
ALL
Age
9 Years to 26 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Behavior Assessment System for Children: Third Edition (BASC-3)Administered at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.A series of instruments designed to help aid in the diagnosis and treatment of children, adolescents, and young adults between the ages of 2 and 25 - captures self- and/or caregiver reported psychological distress.
American College of Lifestyle Medicine (ACLM) Nutrition in Action Diet ScreenerAdministered at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.Self- and/or caregiver reported diet, physical activity, sleep, stress, and motivation to change.
Adverse Childhood Experiences Screener (PEARLS/ACEs)Administered at BaselineCaptures adverse childhood experiences.
General Nutrition Knowledge Questionnaire (GNKQ)Administered at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.Captures general knowledge of nutrition and food groups.
Project EAT-IV SurveyAdministered at BaselineSelf- and/or caregiver reported diet, physical activity, sleep, and stress.
Participant and Caregiver SurveyAdministered at final intervention visit (6-month mark).Addresses participant and caregiver experience in the study - captures acceptability and feasibility of intervention.
Childhood Autism Rating Scale: Second Edition (CARS-2)Administered at BaselineIdentifies autism spectrum disorder (ASD) in children and the severity of their symptoms.
ASD DSM-5 ChecklistAdministered at BaselineCaptures diagnostic criterion from clinicians when used to diagnose Autism Spectrum Disorder.
Vineland Adaptive Behavioral Scales: Third Edition (Vineland-III)Administered at BaselineUsed to measure adaptive behaviors and aid in the diagnosis of intellectual and developmental disabilities.

Secondary

MeasureTime frameDescription
Cardiovascular disease (CVD) indicatorsCollected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.Height (cm)

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAlice Kuo, MD, PhD

University of California, Los Angeles

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 12, 2026