A Two-Part Intervention to Target Cardiovascular Health

NCT07673172 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2026-06-29

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07673172 on ClinicalTrials.gov