Lifestyle Medicine + CBT for Cardiovascular Risk

AK
MM
Overseen ByMarisol Macedo, MPH
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: University of California, Los Angeles
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

AK

Alice Kuo, MD, PhD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

This trial is for English-speaking autistic individuals ages 9-26 who have a BMI above the 84th percentile (overweight or obese). Participants must have been diagnosed with autism or told by a healthcare provider that they have autism.

Inclusion Criteria

Have a BMI greater than the 84th percentile
English speaking
I am between 9 and 26 years old.
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Exclusion Criteria

Individuals with a BMI less than the 84th percentile
I am older than 26 years.
I do not have a diagnosis of autism.
See 1 more

What Are the Treatments Tested in This Trial?

Interventions

  • Cognitive Behavioral Therapy (CBT)
  • Lifestyle Medicine
  • Lifestyle Medicine with CBT

Trial Overview

The study compares three approaches: lifestyle medicine sessions to encourage healthy habits, cognitive behavioral therapy (CBT) to manage stress and eating behaviors, and a combination of both. Participants are randomly assigned to one group and attend virtual sessions over six months.

How Is the Trial Designed?

3

Treatment groups

Active Control

Group I: 1) Lifestyle Medicine GroupActive Control1 Intervention
Group II: Cognitive Behavioral Therapy (CBT) GroupActive Control1 Intervention
Group III: Lifestyle Medicine with CBT GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials
1,594
Recruited
10,430,000+

Health Resources and Services Administration (HRSA)

Collaborator

Trials
88
Recruited
152,000+