AutismNCT07673172
A Two-Part Intervention to Target Cardiovascular Health
A study testing Lifestyle Medicine, Cognitive Behavioral Therapy (CBT) and Lifestyle Medicine with CBT Group in people with Autism and Adverse Childhood Experience, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 26 years
- Conditions the study is for
- Autism, Adverse Childhood Experience, Stress
- What is being tested?
- Lifestyle Medicine, Cognitive Behavioral Therapy (CBT) and Lifestyle Medicine with CBT Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2026to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- • 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
Who cannot join
- • 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Autism Research Consortium on Physical Health: A Two-Part Intervention to Target Cardiovascular Health
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.
Read the detailed 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.
- Conditions
- Autism, Adverse Childhood Experience, Stress, Cardiovascular (CV) Risk
- Being tested
- Lifestyle Medicine, Cognitive Behavioral Therapy (CBT), Lifestyle Medicine with CBT Group
- Keywords
- autism, adverse childhood experiences, stress, cardiovascular risk
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle MedicineBehavioural
The intervention is a series of lifestyle medicine consultations.
Cognitive Behavioral Therapy (CBT)Behavioural
The intervention is a series of CBT sessions.
Lifestyle Medicine with CBT GroupBehavioural
Receives both Lifestyle Medicine and CBT interventions
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Lifestyle Medicine |
| 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. Receives: Behavioral: Cognitive Behavioral Therapy (CBT) |
| Lifestyle Medicine with CBT Group | Active comparator | This group will receive both the Lifestyle Medicine and CBT Interventions. Receives: Behavioral: Lifestyle Medicine with CBT Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Administered at Baseline
General Nutrition Knowledge Questionnaire (GNKQ)
Captures general knowledge of nutrition and food groups.
Measured: 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.
Measured: Administered at Baseline
Participant and Caregiver Survey
Addresses participant and caregiver experience in the study - captures acceptability and feasibility of intervention.
Measured: Administered at final intervention visit (6-month mark).
Childhood Autism Rating Scale: Second Edition (CARS-2)
Identifies autism spectrum disorder (ASD) in children and the severity of their symptoms.
Measured: Administered at Baseline
ASD DSM-5 Checklist
Captures diagnostic criterion from clinicians when used to diagnose Autism Spectrum Disorder.
Measured: 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.
Measured: Administered at Baseline
Secondary outcomes (4)
Cardiovascular disease (CVD) indicators
Height (cm)
Measured: Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.
Cardiovascular disease (CVD) indicators
Weight (kg)
Measured: Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.
Cardiovascular disease (CVD) indicators
Waist circumference (cm)
Measured: Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.
Cardiovascular disease (CVD) indicators
Blood pressure (mmHg)
Measured: Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start5 Aug 2026
- Primary completion30 Jul 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Treatment: One or more interventions are being evaluated for treating a disease, syndrome, or condition. * Prevention: One or more interventions are being assessed for preventing the development of a specific disease or health condition.
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Responsible party
- Principal investigator, Alice Kuo, MD, PhD, MBA, University of California, Los Angeles
- Investigators
- Alice Kuo, MD, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07673172
- Sponsor's protocol ID
- 25-1848
- Other IDs
- 6 UM4MC54990-01-01
- Status last verified
- Sep 2026
- First submitted
- 13 Apr 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autism Research Consortium on Physical Health: A Two-Part Intervention to Target Cardiovascular Health
- ClinicalTrials.gov ID
- NCT07673172
- Acronym / sponsor ID
- 25-1848
- Conditions
- Autism, Adverse Childhood Experience, Stress, Cardiovascular (CV) Risk
- Keywords
- autism, adverse childhood experiences, stress, cardiovascular risk
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Study start
- 5 Aug 2026 (actual)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 29 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- * Treatment: One or more interventions are being evaluated for treating a disease, syndrome, or condition. * Prevention: One or more interventions are being assessed for preventing the development of a specific disease or health condition.
| Arm | Type | Receives |
|---|---|---|
| 1) Lifestyle Medicine Group | Active comparator | Behavioral: Lifestyle MedicineThis 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 | Behavioral: Cognitive Behavioral Therapy (CBT)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 | Behavioral: Lifestyle Medicine with CBT GroupThis group will receive both the Lifestyle Medicine and CBT Interventions. |
Who may qualify
- Ages
- 9 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- • Have a diagnosis of autism or be told by a healthcare provider that you have autism
Key exclusion criteria (4 listed)
- • Children younger than 9 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle MedicineThe intervention is a series of lifestyle medicine consultations. | Behavioural | 1) Lifestyle Medicine Group |
| Cognitive Behavioral Therapy (CBT)The intervention is a series of CBT sessions. | Behavioural | Cognitive Behavioral Therapy (CBT) Group |
| Lifestyle Medicine with CBT GroupReceives both Lifestyle Medicine and CBT interventions | Behavioural | Lifestyle Medicine with CBT Group |
Primary outcome
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.
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.
American College of Lifestyle Medicine (ACLM) Nutrition in Action Diet Screener
Time frame: Administered at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.
Self- and/or caregiver reported diet, physical activity, sleep, stress, and motivation to change.
Adverse Childhood Experiences Screener (PEARLS/ACEs)
Time frame: Administered at Baseline
Captures adverse childhood experiences.
General Nutrition Knowledge Questionnaire (GNKQ)
Time frame: Administered at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.
Captures general knowledge of nutrition and food groups.
Project EAT-IV Survey
Time frame: Administered at Baseline
Self- and/or caregiver reported diet, physical activity, sleep, and stress.
Participant and Caregiver Survey
Time frame: Administered at final intervention visit (6-month mark).
Addresses participant and caregiver experience in the study - captures acceptability and feasibility of intervention.
Childhood Autism Rating Scale: Second Edition (CARS-2)
Time frame: Administered at Baseline
Identifies autism spectrum disorder (ASD) in children and the severity of their symptoms.
ASD DSM-5 Checklist
Time frame: Administered at Baseline
Captures diagnostic criterion from clinicians when used to diagnose Autism Spectrum Disorder.
Vineland Adaptive Behavioral Scales: Third Edition (Vineland-III)
Time frame: Administered at Baseline
Used to measure adaptive behaviors and aid in the diagnosis of intellectual and developmental disabilities.
4 secondary outcomes
Cardiovascular disease (CVD) indicators
Time frame: Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.
Cardiovascular disease (CVD) indicators
Time frame: Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.
Cardiovascular disease (CVD) indicators
Time frame: Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.
Cardiovascular disease (CVD) indicators
Time frame: Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alice Kuo, MD, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Medicine, Cognitive Behavioral Therapy (CBT) and Lifestyle Medicine with CBT Group in people with Autism and Adverse Childhood Experience, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.