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NCT Number: NCT07673172

A Two-Part Intervention to Target Cardiovascular Health

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.

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Key information

Conditions

Autism Adverse Childhood Experience Autism Spectrum Disorder Autistic Disorder Cardiovascular (CV) Risk Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders Stress

Age range

9 year–26 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Medicine

Behavioral

The intervention is a series of lifestyle medicine consultations.

Cognitive Behavioral Therapy (CBT)

Behavioral

The intervention is a series of CBT sessions.

Lifestyle Medicine with CBT Group

Behavioral

Receives both Lifestyle Medicine and CBT interventions

Primary outcomes

  1. Behavior Assessment System for Children: Third Edition (BASC-3)

    Time frame: 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.

  2. American College of Lifestyle Medicine (ACLM) Nutrition in Action Diet Screener

    Time frame: Administered 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.

  3. Adverse Childhood Experiences Screener (PEARLS/ACEs)

    Time frame: Administered at Baseline

    Captures adverse childhood experiences.

  4. General Nutrition Knowledge Questionnaire (GNKQ)

    Time frame: Administered at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.

    Captures general knowledge of nutrition and food groups.

  5. Project EAT-IV Survey

    Time frame: Administered at Baseline

    Self- and/or caregiver reported diet, physical activity, sleep, and stress.

  6. Participant and Caregiver Survey

    Time frame: Administered at final intervention visit (6-month mark).

    Addresses participant and caregiver experience in the study - captures acceptability and feasibility of intervention.

  7. Childhood Autism Rating Scale: Second Edition (CARS-2)

    Time frame: Administered at Baseline

    Identifies autism spectrum disorder (ASD) in children and the severity of their symptoms.

  8. ASD DSM-5 Checklist

    Time frame: Administered at Baseline

    Captures diagnostic criterion from clinicians when used to diagnose Autism Spectrum Disorder.

  9. Vineland Adaptive Behavioral Scales: Third Edition (Vineland-III)

    Time frame: Administered at Baseline

    Used to measure adaptive behaviors and aid in the diagnosis of intellectual and developmental disabilities.

Secondary outcomes

  1. Cardiovascular disease (CVD) indicators

    Time frame: Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.

    Height (cm)

  2. Cardiovascular disease (CVD) indicators

    Time frame: Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.

    Weight (kg)

  3. Cardiovascular disease (CVD) indicators

    Time frame: Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.

    Waist circumference (cm)

  4. Cardiovascular disease (CVD) indicators

    Time frame: Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.

    Blood pressure (mmHg)

Study contacts

Contact information is provided by the study sponsor or research team.

Alice Kuo, MD, PhD

CONTACT

[email protected]

3107942202

Marisol Macedo, MPH

CONTACT

[email protected]

3107942202

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Health Resources and Services Administration (HRSA)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 29, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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