此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

A Two-Part Intervention to Target Cardiovascular Health

2026年9月9日 更新者：Alice Kuo, MD, PhD, MBA、University of California, Los Angeles

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.

研究概览

地位

邀请报名

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

130

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • California
      • Los Angeles、California、美国、90024
        • 1100 Glendon Ave

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：支持治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：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.
行为的：Lifestyle Medicine
The intervention is a series of lifestyle medicine consultations.
有源比较器：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.
行为的：Cognitive Behavioral Therapy (CBT)
The intervention is a series of CBT sessions.
有源比较器：Lifestyle Medicine with CBT Group
This group will receive both the Lifestyle Medicine and CBT Interventions.
行为的：Lifestyle Medicine with CBT Group
Receives both Lifestyle Medicine and CBT interventions

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Behavior Assessment System for Children: Third Edition (BASC-3)
大体时间：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
大体时间：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)
大体时间：Administered at Baseline
Captures adverse childhood experiences.
Administered at Baseline
General Nutrition Knowledge Questionnaire (GNKQ)
大体时间：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
大体时间：Administered at Baseline
Self- and/or caregiver reported diet, physical activity, sleep, and stress.
Administered at Baseline
Participant and Caregiver Survey
大体时间：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)
大体时间：Administered at Baseline
Identifies autism spectrum disorder (ASD) in children and the severity of their symptoms.
Administered at Baseline
ASD DSM-5 Checklist
大体时间：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)
大体时间：Administered at Baseline
Used to measure adaptive behaviors and aid in the diagnosis of intellectual and developmental disabilities.
Administered at Baseline

次要结果测量

结果测量
措施说明
大体时间
Cardiovascular disease (CVD) indicators
大体时间：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
大体时间：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
大体时间：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
大体时间：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.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of California, Los Angeles

合作者

Health Resources and Services Administration (HRSA)

调查人员

  • 首席研究员：Alice Kuo, MD, PhD、University of California, Los Angeles

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年8月5日

初级完成 (估计的)

2028年7月30日

研究完成 (估计的)

2028年8月31日

研究注册日期

首次提交

2026年4月13日

首先提交符合 QC 标准的

2026年6月22日

首次发布 (实际的)

2026年6月29日

研究记录更新

最后更新发布 (实际的)

2026年9月11日

上次提交的符合 QC 标准的更新

2026年9月9日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 25-1848
  • 6 UM4MC54990-01-01 (其他赠款/资助编号：HRSA)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅