A Two-Part Intervention to Target Cardiovascular Health

NCT07673172 | Not Yet Recruiting

• 2 other identifiers: 25-18486 UM4MC54990-01-01
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

autism; adverse childhood experiences; stress; cardiovascular risk

Outcome Measures

Primary Outcomes (9)

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

  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.

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

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

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

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

• Adverse Childhood Experiences Screener (PEARLS/ACEs)

  Captures adverse childhood experiences.

  Administered at Baseline

• General Nutrition Knowledge Questionnaire (GNKQ)

  Captures general knowledge of nutrition and food groups.

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

• Project EAT-IV Survey

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

  Administered at Baseline

• Participant and Caregiver Survey

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

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

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

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

  Administered at Baseline

• ASD DSM-5 Checklist

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

  Administered at Baseline

• Vineland Adaptive Behavioral Scales: Third Edition (Vineland-III)

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

  Administered at Baseline

Secondary Outcomes (4)

• Cardiovascular disease (CVD) indicators

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

• Cardiovascular disease (CVD) indicators

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

• Cardiovascular disease (CVD) indicators

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

• Cardiovascular disease (CVD) indicators

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

Study Arms (3)

1) Lifestyle Medicine Group

ACTIVE COMPARATOR

This group will receive the Lifestyle Medicine Intervention. This intervention is comprised of 6 monthly lifestyle medicine consultations with a health coach.

Behavioral: Lifestyle Medicine

Cognitive Behavioral Therapy (CBT) Group

ACTIVE COMPARATOR

This group will receive the CBT Intervention. This intervention is comprised of 12, twice-monthly CBT sessions over the span of 6 months.

Behavioral: Cognitive Behavioral Therapy (CBT)

Lifestyle Medicine with CBT Group

ACTIVE COMPARATOR

This group will receive both the Lifestyle Medicine and CBT Interventions.

Behavioral: Lifestyle Medicine with CBT Group

Interventions

Lifestyle Medicine BEHAVIORAL

The intervention is a series of lifestyle medicine consultations.

1) Lifestyle Medicine Group

Cognitive Behavioral Therapy (CBT) BEHAVIORAL

The intervention is a series of CBT sessions.

Cognitive Behavioral Therapy (CBT) Group

Lifestyle Medicine with CBT Group BEHAVIORAL

Receives both Lifestyle Medicine and CBT interventions

Lifestyle Medicine with CBT Group

Eligibility Criteria

• Age: 9 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You 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 may not qualify 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Health Resources and Services Administration (HRSA): collaborator

MeSH Terms

Conditions

Autistic Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Alice Kuo, MD, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alice Kuo, MD, PhD

CONTACT

3107942202; akuo@mednet.ucla.edu

Marisol Macedo, MPH

CONTACT

3107942202; mmacedo@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief

Model Details: * 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.

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: June 29, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share