A Two-Part Intervention to Target Cardiovascular Health

Sponsor
University of California, Los Angeles
Study ID
NCT07673172
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

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

Eligibility Criteria

Sex
ALL
Age
9 Years - 26 Years
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

First listed
Jun 29, 2026
Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Jul 30, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
130 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

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

Primary Outcome Measure

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. ]

Central Contacts

Find similar trials

Nationwide
Autism spectrum disorder trialsPediatrics trials

Related Studies