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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Alice Kuo, MD, PhD
- 전화번호: 3107942202
- 이메일: akuo@mednet.ucla.edu
연구 연락처 백업
- 이름: Marisol Macedo, MPH
- 전화번호: 3107942202
- 이메일: mmacedo@mednet.ucla.edu
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: 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.
|
The intervention is a series of lifestyle medicine consultations.
|
|
활성 비교기: 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.
|
|
활성 비교기: Lifestyle Medicine with CBT Group
This group will receive both the Lifestyle Medicine and CBT Interventions.
|
Receives both Lifestyle Medicine and CBT interventions
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Behavior Assessment System for Children: Third Edition (BASC-3)
기간: 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
기간: 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)
기간: Administered at Baseline
|
Captures adverse childhood experiences.
|
Administered at Baseline
|
|
General Nutrition Knowledge Questionnaire (GNKQ)
기간: 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
기간: Administered at Baseline
|
Self- and/or caregiver reported diet, physical activity, sleep, and stress.
|
Administered at Baseline
|
|
Participant and Caregiver Survey
기간: 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)
기간: Administered at Baseline
|
Identifies autism spectrum disorder (ASD) in children and the severity of their symptoms.
|
Administered at Baseline
|
|
ASD DSM-5 Checklist
기간: 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)
기간: Administered at Baseline
|
Used to measure adaptive behaviors and aid in the diagnosis of intellectual and developmental disabilities.
|
Administered at Baseline
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Cardiovascular disease (CVD) indicators
기간: 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
기간: 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
기간: 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
기간: 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.
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Alice Kuo, MD, PhD, University of California, Los Angeles
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 25-1848
- 6 UM4MC54990-01-01 (기타 보조금/기금 번호: HRSA)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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