A Two-Part Intervention to Target Cardiovascular Health
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lifestyle Medicine, Cognitive Behavioral Therapy (CBT), Lifestyle Medicine with CBT Group.
- Who it may be relevant to
- Registry conditions: Autism, Adverse Childhood Experience, Stress, Cardiovascular (CV) Risk. Basic parameters: 9 years — 26 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Autism Research Consortium on Physical Health: A Two-Part Intervention to Target Cardiovascular Health
Overview
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.
Interventions
- Behavioral Lifestyle Medicine
The intervention is a series of lifestyle medicine consultations. - Behavioral Cognitive Behavioral Therapy (CBT)
The intervention is a series of CBT sessions. - Behavioral Lifestyle Medicine with CBT Group
Receives both Lifestyle Medicine and CBT interventions
Primary outcome measures
- 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.]
- 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.]
- Adverse Childhood Experiences Screener (PEARLS/ACEs) [Time frame: Administered at Baseline]
- General Nutrition Knowledge Questionnaire (GNKQ) [Time frame: Administered at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.]
- Project EAT-IV Survey [Time frame: Administered at Baseline]
- Participant and Caregiver Survey [Time frame: Administered at final intervention visit (6-month mark).]
- Childhood Autism Rating Scale: Second Edition (CARS-2) [Time frame: Administered at Baseline]
- ASD DSM-5 Checklist [Time frame: Administered at Baseline]
- Vineland Adaptive Behavioral Scales: Third Edition (Vineland-III) [Time frame: Administered at Baseline]
Secondary outcome measures (4)
- 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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07673172 · 25-1848 · 6 UM4MC54990-01-01