A Two-Part Intervention to Target Cardiovascular Health
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.
Обзор исследования
Статус
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
California
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Los Angeles, California, Соединенные Штаты, 90024
- 1100 Glendon Ave
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
Принимает здоровых добровольцев
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Активный компаратор: 1) Lifestyle Medicine Group
This group will receive the Lifestyle Medicine Intervention.
This intervention is comprised of 6 monthly lifestyle medicine consultations with a health coach.
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The intervention is a series of lifestyle medicine consultations.
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Активный компаратор: Cognitive Behavioral Therapy (CBT) Group
This group will receive the CBT Intervention.
This intervention is comprised of 12, twice-monthly CBT sessions over the span of 6 months.
|
The intervention is a series of CBT sessions.
|
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Активный компаратор: Lifestyle Medicine with CBT Group
This group will receive both the Lifestyle Medicine and CBT Interventions.
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Receives both Lifestyle Medicine and CBT interventions
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Behavior Assessment System for Children: Third Edition (BASC-3)
Временное ограничение: 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.
|
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
Временное ограничение: 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.
|
Administered at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.
|
|
Adverse Childhood Experiences Screener (PEARLS/ACEs)
Временное ограничение: Administered at Baseline
|
Captures adverse childhood experiences.
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Administered at Baseline
|
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General Nutrition Knowledge Questionnaire (GNKQ)
Временное ограничение: Administered at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.
|
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
Временное ограничение: Administered at Baseline
|
Self- and/or caregiver reported diet, physical activity, sleep, and stress.
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Administered at Baseline
|
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Participant and Caregiver Survey
Временное ограничение: Administered at final intervention visit (6-month mark).
|
Addresses participant and caregiver experience in the study - captures acceptability and feasibility of intervention.
|
Administered at final intervention visit (6-month mark).
|
|
Childhood Autism Rating Scale: Second Edition (CARS-2)
Временное ограничение: Administered at Baseline
|
Identifies autism spectrum disorder (ASD) in children and the severity of their symptoms.
|
Administered at Baseline
|
|
ASD DSM-5 Checklist
Временное ограничение: Administered at Baseline
|
Captures diagnostic criterion from clinicians when used to diagnose Autism Spectrum Disorder.
|
Administered at Baseline
|
|
Vineland Adaptive Behavioral Scales: Third Edition (Vineland-III)
Временное ограничение: Administered at Baseline
|
Used to measure adaptive behaviors and aid in the diagnosis of intellectual and developmental disabilities.
|
Administered at Baseline
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Cardiovascular disease (CVD) indicators
Временное ограничение: Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.
|
Height (cm)
|
Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.
|
|
Cardiovascular disease (CVD) indicators
Временное ограничение: Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.
|
Weight (kg)
|
Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.
|
|
Cardiovascular disease (CVD) indicators
Временное ограничение: Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.
|
Waist circumference (cm)
|
Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.
|
|
Cardiovascular disease (CVD) indicators
Временное ограничение: Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.
|
Blood pressure (mmHg)
|
Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.
|
Соавторы и исследователи
Следователи
- Главный следователь: Alice Kuo, MD, PhD, University of California, Los Angeles
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 25-1848
- 6 UM4MC54990-01-01 (Другой номер гранта/финансирования: HRSA)
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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