A Two-Part Intervention to Target Cardiovascular Health
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age9-26
SponsorUniversity of California, Los Angeles
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• 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
Disqualifiers
• 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
Trial design
Design model
Parallel
Treatments tested in this trial
Lifestyle Medicine
BehavioralThe intervention is a series of lifestyle medicine consultations.
Cognitive Behavioral Therapy (CBT)
BehavioralThe intervention is a series of CBT sessions.
Lifestyle Medicine with CBT Group
BehavioralReceives both Lifestyle Medicine and CBT interventions
Treatment groups
130 Participants
are divided into 3 treatment groupsGroup A: 1) Lifestyle Medicine GroupActive comparator 1 intervention
Group B: Cognitive Behavioral Therapy (CBT) GroupActive comparator 1 intervention
Group C: Lifestyle Medicine with CBT GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Behavior Assessment System for Children: Third Edition (BASC-3)
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.
Time frame
Administered at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.2
American College of Lifestyle Medicine (ACLM) Nutrition in Action Diet Screener
Self- and/or caregiver reported diet, physical activity, sleep, stress, and motivation to change.
Time frame
Administered at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.3
Adverse Childhood Experiences Screener (PEARLS/ACEs)
Captures adverse childhood experiences.
Time frame
Administered at Baseline4
General Nutrition Knowledge Questionnaire (GNKQ)
Captures general knowledge of nutrition and food groups.
Time frame
Administered at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.Secondary outcomes
1
Cardiovascular disease (CVD) indicators
Height (cm)
Time frame
Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.2
Cardiovascular disease (CVD) indicators
Weight (kg)
Time frame
Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.3
Cardiovascular disease (CVD) indicators
Waist circumference (cm)
Time frame
Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.4
Cardiovascular disease (CVD) indicators
Blood pressure (mmHg)
Time frame
Collected at Baseline, at final intervention visit (6-month mark), and 3-Months post-intervention.Locations
Sponsors and contacts
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University of California, Los Angeles
Lead sponsor
Health Resources and Services Administration (HRSA)
Collaborator
Source ClinicalTrials.gov
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