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.
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Alice Kuo, MD, PhD
- Telefonní číslo: 3107942202
- E-mail: akuo@mednet.ucla.edu
Studijní záloha kontaktů
- Jméno: Marisol Macedo, MPH
- Telefonní číslo: 3107942202
- E-mail: mmacedo@mednet.ucla.edu
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Aktivní komparátor: 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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Aktivní komparátor: 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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Aktivní komparátor: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Behavior Assessment System for Children: Third Edition (BASC-3)
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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.
|
Administered at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.
|
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Project EAT-IV Survey
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: Administered at Baseline
|
Captures diagnostic criterion from clinicians when used to diagnose Autism Spectrum Disorder.
|
Administered at Baseline
|
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Vineland Adaptive Behavioral Scales: Third Edition (Vineland-III)
Časové okno: Administered at Baseline
|
Used to measure adaptive behaviors and aid in the diagnosis of intellectual and developmental disabilities.
|
Administered at Baseline
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Cardiovascular disease (CVD) indicators
Časové okno: Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.
|
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
Časové okno: 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.
|
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Cardiovascular disease (CVD) indicators
Časové okno: Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.
|
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
Časové okno: 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.
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Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Alice Kuo, MD, PhD, University of California, Los Angeles
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 25-1848
- 6 UM4MC54990-01-01 (Jiné číslo grantu/financování: HRSA)
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Klinické studie na Stres
-
VA Office of Research and DevelopmentVA St. Louis Health Care SystemUkončenoVeteráni podle St. Louis VAMC Stress TesSpojené státy
Klinické studie na Lifestyle Medicine
-
Aberystwyth UniversityHywel Dda Health BoardDokončenoChronická obstrukční plicní nemocSpojené království