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.
A tanulmány áttekintése
Állapot
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
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California
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Los Angeles, California, Egyesült Államok, 90024
- 1100 Glendon Ave
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Gyermek
- Felnőtt
Egészséges önkénteseket fogad
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Támogató gondoskodás
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Aktív összehasonlító: 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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Aktív összehasonlító: 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.
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The intervention is a series of CBT sessions.
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Aktív összehasonlító: 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
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Behavior Assessment System for Children: Third Edition (BASC-3)
Időkeret: Administered at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.
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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.
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Administered at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.
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American College of Lifestyle Medicine (ACLM) Nutrition in Action Diet Screener
Időkeret: Administered at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.
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Self- and/or caregiver reported diet, physical activity, sleep, stress, and motivation to change.
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Administered at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.
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Adverse Childhood Experiences Screener (PEARLS/ACEs)
Időkeret: Administered at Baseline
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Captures adverse childhood experiences.
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Administered at Baseline
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General Nutrition Knowledge Questionnaire (GNKQ)
Időkeret: Administered at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.
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Captures general knowledge of nutrition and food groups.
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Administered at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.
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Project EAT-IV Survey
Időkeret: Administered at Baseline
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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
Időkeret: Administered at final intervention visit (6-month mark).
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Addresses participant and caregiver experience in the study - captures acceptability and feasibility of intervention.
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Administered at final intervention visit (6-month mark).
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Childhood Autism Rating Scale: Second Edition (CARS-2)
Időkeret: Administered at Baseline
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Identifies autism spectrum disorder (ASD) in children and the severity of their symptoms.
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Administered at Baseline
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ASD DSM-5 Checklist
Időkeret: Administered at Baseline
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Captures diagnostic criterion from clinicians when used to diagnose Autism Spectrum Disorder.
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Administered at Baseline
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Vineland Adaptive Behavioral Scales: Third Edition (Vineland-III)
Időkeret: Administered at Baseline
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Used to measure adaptive behaviors and aid in the diagnosis of intellectual and developmental disabilities.
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Administered at Baseline
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Cardiovascular disease (CVD) indicators
Időkeret: Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.
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Height (cm)
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Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.
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Cardiovascular disease (CVD) indicators
Időkeret: Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.
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Weight (kg)
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Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.
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Cardiovascular disease (CVD) indicators
Időkeret: Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.
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Waist circumference (cm)
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Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.
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Cardiovascular disease (CVD) indicators
Időkeret: Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.
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Blood pressure (mmHg)
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Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.
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Együttműködők és nyomozók
Együttműködők
Nyomozók
- Kutatásvezető: Alice Kuo, MD, PhD, University of California, Los Angeles
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 25-1848
- 6 UM4MC54990-01-01 (Egyéb támogatási/finanszírozási szám: HRSA)
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
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