A Two-Part Intervention to Target Cardiovascular Health

Официальное название

Autism Research Consortium on Physical Health: A Two-Part Intervention to Target Cardiovascular Health

Обзор

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.

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.

Вмешательства

• Поведенческое Lifestyle Medicine
  The intervention is a series of lifestyle medicine consultations.
• Поведенческое Cognitive Behavioral Therapy (CBT)
  The intervention is a series of CBT sessions.
• Поведенческое Lifestyle Medicine with CBT Group
  Receives both Lifestyle Medicine and CBT interventions

Первичные конечные точки

• Behavior Assessment System for Children: Third Edition (BASC-3) [Срок оценки: 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 [Срок оценки: Administered at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.]
• Adverse Childhood Experiences Screener (PEARLS/ACEs) [Срок оценки: Administered at Baseline]
• General Nutrition Knowledge Questionnaire (GNKQ) [Срок оценки: Administered at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.]
• Project EAT-IV Survey [Срок оценки: Administered at Baseline]
• Participant and Caregiver Survey [Срок оценки: Administered at final intervention visit (6-month mark).]
• Childhood Autism Rating Scale: Second Edition (CARS-2) [Срок оценки: Administered at Baseline]
• ASD DSM-5 Checklist [Срок оценки: Administered at Baseline]
• Vineland Adaptive Behavioral Scales: Third Edition (Vineland-III) [Срок оценки: Administered at Baseline]

Вторичные конечные точки (4)

• Cardiovascular disease (CVD) indicators [Срок оценки: Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.]
• Cardiovascular disease (CVD) indicators [Срок оценки: Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.]
• Cardiovascular disease (CVD) indicators [Срок оценки: Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.]
• Cardiovascular disease (CVD) indicators [Срок оценки: Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.]

Критерии участия

Критерии включения

• • 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

Критерии исключения

• • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07673172 · 25-1848 · 6 UM4MC54990-01-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗