A Two-Part Intervention to Target Cardiovascular Health

NCT07673172 — Not applicable, Enrolling by invitation, 130 participants, University of California, Los Angeles

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

RegistryNCT07673172
StatusEnrolling by invitation
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, supportive care
Enrollment130 (Estimated)
SponsorUniversity of California, Los Angeles (Other); collaborators: Health Resources and Services Administration (HRSA)
ConditionsAutism, Adverse Childhood Experience, Stress, Cardiovascular (CV) Risk
InterventionsLifestyle Medicine, Cognitive Behavioral Therapy (CBT), Lifestyle Medicine with CBT Group (Behavioral)
Datesstart 2026-08-05, primary completion 2028-07-30 (estimated), completion 2028-08-31 (estimated), first posted 2026-06-29, last updated 2026-09-11
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Autism All trials for Adverse Childhood Experience All trials of Lifestyle Medicine All trials of Cognitive Behavioral Therapy (CBT)

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
1) Lifestyle Medicine GroupActive comparatorBehavioral: Lifestyle MedicineThis group will receive the Lifestyle Medicine Intervention. This intervention is comprised of 6 monthly lifestyle medicine consultations with a health coach.
Cognitive Behavioral Therapy (CBT) GroupActive comparatorBehavioral: Cognitive Behavioral Therapy (CBT)This group will receive the CBT Intervention. This intervention is comprised of 12, twice-monthly CBT sessions over the span of 6 months.
Lifestyle Medicine with CBT GroupActive comparatorBehavioral: Lifestyle Medicine with CBT GroupThis group will receive both the Lifestyle Medicine and CBT Interventions.
  • 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

+Outcome measures

Primary outcomes

  • 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 Screener [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.
  • Adverse Childhood Experiences Screener (PEARLS/ACEs) [Administered at Baseline]: Captures 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 Survey [Administered at Baseline]: Self- and/or caregiver reported diet, physical activity, sleep, and stress.
  • Participant and Caregiver Survey [Administered 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 Baseline]: Identifies autism spectrum disorder (ASD) in children and the severity of their symptoms.
  • ASD DSM-5 Checklist [Administered at Baseline]: Captures diagnostic criterion from clinicians when used to diagnose Autism Spectrum Disorder.
  • Vineland Adaptive Behavioral Scales: Third Edition (Vineland-III) [Administered at Baseline]: Used to measure adaptive behaviors and aid in the diagnosis of intellectual and developmental disabilities.

Secondary outcomes

  • Cardiovascular disease (CVD) indicators [Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.]: Height (cm)
  • Cardiovascular disease (CVD) indicators [Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.]: Weight (kg)
  • Cardiovascular disease (CVD) indicators [Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.]: Waist circumference (cm)
  • Cardiovascular disease (CVD) indicators [Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.]: Blood pressure (mmHg)

+Eligibility

Sex: All, ages: 9 Years to 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

+Locations (1)

FacilityCityCountryStatus
1100 Glendon AveLos Angeles, CaliforniaUnited States

+Investigators