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A Two-Part Intervention to Target Cardiovascular Health

22. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

130

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv 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.
Adfærdsmæssigt: Lifestyle Medicine
The intervention is a series of lifestyle medicine consultations.
Aktiv 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.
Adfærdsmæssigt: Cognitive Behavioral Therapy (CBT)
The intervention is a series of CBT sessions.
Aktiv komparator: Lifestyle Medicine with CBT Group
This group will receive both the Lifestyle Medicine and CBT Interventions.
Adfærdsmæssigt: Lifestyle Medicine with CBT Group
Receives both Lifestyle Medicine and CBT interventions

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cardiovascular disease (CVD) indicators
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of California, Los Angeles

Samarbejdspartnere

Health Resources and Services Administration (HRSA)

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

30. juli 2028

Studieafslutning (Anslået)

31. august 2028

Datoer for studieregistrering

Først indsendt

13. april 2026

Først indsendt, der opfyldte QC-kriterier

22. juni 2026

Først opslået (Faktiske)

29. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 25-1848
  • 6 UM4MC54990-01-01 (Andet bevillings-/finansieringsnummer: HRSA)

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