Weight Management Intervention for Youth and Young Adults With Autism Spectrum Disorder

NCT03865719 | Completed DMC

• 1 other identifier: STUDY18120156
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Psychotropic medications are the first-line treatment across several diagnostic categories encompassing severe mood disturbances and behavioral problems. The use of Second Generation Antipsychotics (SGAs) has increased in children with Autism Spectrum Disorder (ASD) in the last decade. However, SGAs are associated with serious metabolic side effects in youth that include cardiovascular disease, hypertension, and diabetes mellitus. This makes the public health impact of treating medication-induced metabolic disturbances almost as important as treating the mental illness itself. Improving health and reducing premature mortality in people with severe mental illness, the investigators propose to provide early weight management prevention, delivered by clinicians, for youth starting SGAs in order to target common modifiable health risk factors in the developmental process. This study will provide an urgently needed practical model for integrating weight management into academic- and community-based autism care.

Conditions

Autism Spectrum Disorder

Keywords

Second Generation Antipsychotics; Weight Management

Outcome Measures

Primary Outcomes (2)

• Change in Body Mass Index (BMI) z-score

  BMI z-scores will be calculated from participant height(cm), weight(kg), sex and age

  Change from Baseline to intervention completion at 6 months

• Inflammation as indicated by change in circulating high sensitivity C-reactive protein (hs-CRP)

  hs-CRP level from blood work completed at local lab

  Change from Baseline to intervention completion at 6 months

Secondary Outcomes (12)

• Implementation effectiveness

  Month 6

• Change in Waist circumference

  Change from Baseline to intervention completion at 6 months

• Change in Blood pressure

  Change from Baseline to intervention completion at 6 months

• Change in Lipid Panel Lab Values

  Change from Baseline to intervention completion at 6 months

• Change in Glucose Serum

  Change from Baseline to intervention completion at 6 months

Study Arms (1)

Healthy Habits for Life Intervention

OTHER

Participants will receive the Healthy Habits for Life Intervention

Behavioral: Healthy Habits for Life

Interventions

Healthy Habits for Life BEHAVIORAL

Healthy Habits for Life: 11-session, 6 month, one-on-one, dietician-lead weight management manualized treatment.

Healthy Habits for Life Intervention

Eligibility Criteria

• Age: 8 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of Autism Spectrum Disorder based on Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) and The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
• Clinically stable on current SGA treatment regimen with olanzapine, quetiapine, risperidone, aripiprazole, ziprasidone, or clozapine.
• The patient meets one of the following criteria:
• If the participant is under 20 years old, the participant either:
• has a BMI greater than or equal to 85th percentile, corrected for age and sex, AND has a documented 3% increase or greater in BMI within the last 12 months, while on SGAs, or
• has persistent and unrelenting BMI percentile at or above 98%, corrected for age and sex (3% change in BMI is not necessary).
• If the participant is 20 years old or older, the participant either:
• has a BMI greater than or equal to 30 AND has a documented 3% increase or greater in BMI within the last 12 months, while on SGAs, or
• has persistent and unrelenting BMI at or above 40 (3% change in BMI is not necessary)4. Involvement of at least one parent or guardian if ≤ 18 years of age. If \> 18, an adult caregiver living with the participant must agree to complete the parent/guardian measures.
• Age between 8 and 26, inclusive.
• Prior to the study, minor participants must provide assent to participate in the study, and their parents (guardians) must provide written informed consent. Individuals \> 18 will provide written consent.

You may not qualify if:

• IQ \< 70.
• Recent suicide attempt (within 1 month of study entry) or illness severity requiring acute psychiatric hospitalization within 30 days of study entry.
• Current weight management treatment with CBT by an appropriately trained provider using a manual. If currently receiving treatment, willingness to suspend treatment for 12-week acute treatment phase of study.
• Pregnant.
• Diagnosis of diabetes.
• Participant and/or parent/caregiver/service provider/partner/friend of the participant unwilling or not able to commute for study visits
• Unwilling to have bloodwork.
• Taking medications that affect bodyweight, other than SGAs, for less than a month (e.g., Metformin, Prednisone, Topiramate, or any other medications, in the opinion of the Site Principal Investigator, would deem as a medication that would affect bodyweight).

Sponsors & Collaborators

• University of Pittsburgh: lead
• Massachusetts General Hospital: collaborator

Study Sites (1)

Autism Treatment Network Site at Merck Child and Adolescent Outpatient Clinic

Pittsburgh, Pennsylvania, 15203, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Dana L Rofey, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Benjamin L Handen, PhD, BCBA-D

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry and Pediatrics

Model Details: An 11 session, 6 month healthy lifestyle program comprised of 30 to 45 minute sessions run by a dietician. Session 1 Getting Started/ anthropometric measures (weight, height, blood pressure and waist circumference) Session 2 Healthy Eating Habits/ anthropometric measures Session 3 Healthy Snacking Habits/anthropometric measures Session 4 Healthy Portions \& Servings Habits/ anthropometric measures (BI-WEEKLY MEETINGS) Session 5 Healthy Shopping Habits/ anthropometric measures Session 6 Healthy Cooking \& Mealtime Habits/ anthropometric measures . Session 7 Healthy Dining Out Habits/ anthropometric measures Session 8 Healthy Physical Activity Habits/ anthropometric measures (MONTHLY MEETINGS) Session 9 Healthy Eating Behavior Habits/ anthropometric measures Session 10 Healthy Problem Solving Habits/anthropometric measures Session 11 Maintaining a Healthy Lifestyle/ anthropometric measures

Study Record Dates

• First Submitted: January 31, 2019
• First Posted: March 7, 2019
• Study Start: August 7, 2019
• Primary Completion: March 15, 2021
• Study Completion: December 1, 2021
• Last Updated: April 6, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)