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Weight Management Intervention for Youth and Young Adults With Autism Spectrum Disorder (ACORN-ASD)

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ClinicalTrials.gov Identifier: NCT03865719
Recruitment Status : Not yet recruiting
First Posted : March 7, 2019
Last Update Posted : July 11, 2019
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
Dana Rofey, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: Healthy Habits for Life Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Intervention Model Description:

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

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ameliorate Childhood Obesity Risks From Newer Antipsychotics for Autism Spectrum Disorder
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Healthy Habits for Life Intervention
Participants will receive the Healthy Habits for Life Intervention
Behavioral: Healthy Habits for Life
Healthy Habits for Life: 11-session, 6 month, one-on-one, dietician-lead weight management manualized treatment.




Primary Outcome Measures :
  1. Change in Body Mass Index (BMI) z-score [ Time Frame: Change from Baseline to intervention completion at 6 months ]
    BMI z-scores will be calculated from participant height(cm), weight(kg), sex and age

  2. Inflammation as indicated by change in Hemaglobin A1c (HbA1c) [ Time Frame: Change from Baseline to intervention completion at 6 months ]
    HbA1c percentage from blood work completed at local lab, percentage of total hemoglobin


Secondary Outcome Measures :
  1. Implementation effectiveness [ Time Frame: Month 6 ]
    Parent/Caregiver and Research team completed questionnaire regarding project implementation. There are 12 items to be rated on Likert scales as well as 3 open-ended questions. There are no scales associated with this survey. The results will help us draw a qualitative picture of the parent satisfaction with the program and research team appraisal of the effectiveness of the program across subjects.

  2. Change in Waist circumference [ Time Frame: Change from Baseline to intervention completion at 6 months ]
    Waist circumference measured in centimeters by dietician will be measured in duplicate, midway between the lowest rib and the superior border of the iliac crest, with a flexible tape.

  3. Change in Blood pressure [ Time Frame: Change from Baseline to intervention completion at 6 months ]
    Blood pressure measured in millimeters of mercury (mmHg) by dietician using a portable blood pressure cuff at intervention appointment

  4. Change in Lipid Panel Lab Values [ Time Frame: Change from Baseline to intervention completion at 6 months ]
    Fasting Lipids Panel from blood work completed at local lab (in mg/dL): Cholesterol, HDL, Cholesterol/HDL Ratio (calculated), LDL, Triglycerides

  5. Change in Glucose Serum [ Time Frame: Change from Baseline to intervention completion at 6 months ]
    Glucose serum level from blood work completed at local lab, mg/dL

  6. Change in Insulin [ Time Frame: change from Baseline to intervention completion at 6 months ]
    Insulin level from blood work completed at local lab, µIU/mL

  7. Change in HOMA-IR [ Time Frame: change from Baseline to intervention completion at 6 months ]
    HOMA-IR is a method used to quantify insulin resistance (fasting glucose X fasting insulin / 22.5).

  8. Change in aberrant behaviors [ Time Frame: change from Baseline to intervention completion at 6 months ]

    Change in aberrant behaviors as measured by the Aberrant Behavior Checklist (ABC). The ABC is comprised of 58 items aimed to capture specific behavioral symptom areas: Irritability (15 items), Lethargy (16 items), Sterotypy (7 items), Hyperactive/Noncompliace (16 items)/Inappropriate Speech (4 items).

    To score the ABC, the individual items for each subscale are simply summed to their respective subtotals with higher scores reflective of more pervasive symptoms on that subscale.


  9. Change in emotional dysregulation [ Time Frame: change from Baseline to intervention completion at 6 months ]

    Change in emotional dysregulation as measured by the Emotion Dysregulation Inventory with 30 items on two factors: (1) Reactivity, characterized by intense, rapidly escalating, sustained, and poorly modulated negative emotional reactions, and (2) Dysphoria, characterized by anhedonia, sadness, and nervousness. Items are rated on the following scale to reflect current behavior: and how much of a problem it has this been in the preceding 7 days?:

    Not at all (0, never happens) Mild (1, Present occasionally) and/or does not cause too much of a problem Moderate (2, Happens less than half the time and/or causes some problems Severe (3, Happens at least half of the time and/or substantially interferes Very Severe: 4, Almost always happens and/or causes a serious problems

    Scores for items on each factor are summed for a total scale score. Higher scores suggest more emotional dysregulation on that specific factor.


  10. Change in parenting stress [ Time Frame: change from Baseline to intervention completion at 6 months ]
    Change in participant's parent's/caregiver's stress as measured by the Parenting Stress Short Form (PSI-SF), a 36 items assessing Total Stress is calculated by summing the raw score from three scales: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. A higher score represents higher parent stress.

  11. Change in weight loss behaviors [ Time Frame: change from Baseline to intervention completion at 6 months ]
    Change in weight loss behaviors as measured by the Weight Loss Behavior Stage of Change Scale (WLB_SOC). The numerical values on the WLB-SOC questionnaire directly correspond to the five Stages of Change:1 = pre-contemplation; 2 = contemplation; 3 = preparation; 4 = action; 5 = maintenance The questionnaire has 5 sections: Potions, Dietary Fat, Fruits, Vegetables, Usual Physical Activity. For sections that have 9 or 10 questions (i.e., Portions, Fruits and Vegetables, Usual Physical Activity), the SOC is determined by using the third lowest stage for the behavioral items. For sections that have 11 questions (Dietary Fat), the SOC is determined by using the fourth lowest stage indicated for the behavioral items. Items answered "N/A" or left blank are scored as a "1".

  12. Change in physical activity habits [ Time Frame: change from Baseline to intervention completion at 6 months ]
    Change in physical activity habits as measured by the Modifiable Activity Questionnaire (MAQ). This measure is a self-reported questionnaire that records frequency and duration of different levels of physical activity. The MAQ assesses current physical activity during both work and leisure time, as well as some inactivity. The hours per week of all activities are summed to determine total hours per week.



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 26 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Clinically stable on current SGA treatment regimen with olanzapine, quetiapine, risperidone, aripiprazole, ziprasidone, or clozapine.
  3. Documented >7% increase in BMI since starting atypical antipsychotic therapy (within the last 12 months); or, if BMI is greater or equal to 85th percentile corrected for age and sex, then a greater than 5% body weight increase per year (prorated at greater than 5% body weight increase if medicated for longer than a year).
  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.
  5. Age between 8 and 26, inclusive.
  6. 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.

Exclusion Criteria:

  1. IQ < 70.
  2. Recent suicide attempt (within 1 month of study entry) or illness severity requiring acute psychiatric hospitalization within 30 days of study entry.
  3. 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.
  4. New mood stabilizer, selective serotonin reuptake inhibitor (SRRI) or stimulant medication. If patient has been stable on psychotropic medication for 30 days, inclusion is permitted.
  5. Pregnant.
  6. Diagnosis of diabetes.
  7. BMI > 40 (WHO) operationalized as morbid obesity regardless of age; referral for more intensive services are recommended.
  8. Participant and/or parent/caregiver/service provider/partner/friend of the participant unwilling or not able to commute for study visits
  9. Unwilling to have bloodwork.
  10. 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03865719


Contacts
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Contact: Dana L Rofey, PhD 412-383-8316 rofeydl@upmc.edu
Contact: Nermeen El Nokali, PhD 412-496-4677 elnokaline@upmc.edu

Locations
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United States, Pennsylvania
Autism Treatment Network Site at Merck Child and Adolescent Outpatient Clinic Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15203
Contact: Benjamin L Handen, Ph.D.    412-235-5447    handenbl@upmc.edu   
Contact: Sarah McAuliffe-Bellin, M.Ed.    412-235-5447    mcausj@upmc.edu   
Sponsors and Collaborators
University of Pittsburgh
Massachusetts General Hospital
Investigators
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Principal Investigator: Dana L Rofey, PhD University of Pittsburgh
Principal Investigator: Benjamin L Handen, PhD, BCBA-D University of Pittsburgh

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Responsible Party: Dana Rofey, Associate Professor of Psychiatry and Pediatrics, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03865719     History of Changes
Other Study ID Numbers: STUDY18120156
First Posted: March 7, 2019    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dana Rofey, University of Pittsburgh:
Second Generation Antipsychotics
Weight Management

Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Disease
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs