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A Two-Part Intervention to Target Cardiovascular Health

22. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

130

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: 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.
Verhalten: Lifestyle Medicine
The intervention is a series of lifestyle medicine consultations.
Aktiver Komparator: 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.
Verhalten: Cognitive Behavioral Therapy (CBT)
The intervention is a series of CBT sessions.
Aktiver Komparator: Lifestyle Medicine with CBT Group
This group will receive both the Lifestyle Medicine and CBT Interventions.
Verhalten: Lifestyle Medicine with CBT Group
Receives both Lifestyle Medicine and CBT interventions

Was misst die Studie?

Primäre Ergebnismessungen

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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Cardiovascular disease (CVD) indicators
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of California, Los Angeles

Mitarbeiter

Health Resources and Services Administration (HRSA)

Ermittler

  • Hauptermittler: Alice Kuo, MD, PhD, University of California, Los Angeles

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juli 2026

Primärer Abschluss (Geschätzt)

30. Juli 2028

Studienabschluss (Geschätzt)

31. August 2028

Studienanmeldedaten

Zuerst eingereicht

13. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

22. Juni 2026

Zuerst gepostet (Tatsächlich)

29. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

29. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

22. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 25-1848
  • 6 UM4MC54990-01-01 (Andere Zuschuss-/Finanzierungsnummer: HRSA)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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