Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 6 UM4MC54990-01-01 | Other Grant/Funding Number | HRSA |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Health Resources and Services Administration (HRSA) | FED |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Lifestyle Medicine with CBT Group | Active Comparator | This group will receive both the Lifestyle Medicine and CBT Interventions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle Medicine | Behavioral | The intervention is a series of lifestyle medicine consultations. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular disease (CVD) indicators | Height (cm) | Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention. |
| Cardiovascular disease (CVD) indicators |
Not provided
Inclusion Criteria:
• Have a diagnosis of autism or be told by a healthcare provider that you have autism
Exclusion Criteria:
• Children younger than 9 years of age
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alice Kuo, MD, PhD | Contact | 3107942202 | akuo@mednet.ucla.edu | |
| Marisol Macedo, MPH | Contact | 3107942202 | mmacedo@mednet.ucla.edu |
| Name | Affiliation | Role |
|---|---|---|
| Alice Kuo, MD, PhD | University of California, Los Angeles | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|
| 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 |
Weight (kg)
| Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention. |
| Cardiovascular disease (CVD) indicators | Waist circumference (cm) | Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention. |
| Cardiovascular disease (CVD) indicators | Blood pressure (mmHg) | Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention. |