A Two-Part Intervention to Target Cardiovascular Health

University of California, Los Angeles (UCLA)

Status: Invitation-only

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

Treatments: Behavioral: Cognitive Behavioral Therapy (CBT); Behavioral: Lifestyle Medicine; Behavioral: Lifestyle Medicine with CBT Group

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT07673172

25-1848

6 UM4MC54990-01-01 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 estimated patients

Sex: All

Ages: 9 to 26 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 3 patient groups

1) Lifestyle Medicine Group

Active Comparator group

Description:

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

Treatment:

Behavioral: Lifestyle Medicine

Cognitive Behavioral Therapy (CBT) Group

Active Comparator group

Description:

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

Treatment:

Behavioral: Cognitive Behavioral Therapy (CBT)

Lifestyle Medicine with CBT Group

Active Comparator group

Description:

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

Treatment:

Behavioral: Lifestyle Medicine with CBT Group