Weight Management Intervention for Youth and Young Adults With Autism Spectrum Disorder (ACORN-ASD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03865719|
Recruitment Status : Not yet recruiting
First Posted : March 7, 2019
Last Update Posted : July 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorder||Behavioral: Healthy Habits for Life||Not Applicable|
Show Detailed Description
|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
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
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)|
|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|
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.
- 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
- 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
- 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.
- 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.
- 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
- 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
- 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
- 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
- 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).
- 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.
- 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.
- 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.
- 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".
- 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.
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
|Contact: Dana L Rofey, PhDemail@example.com|
|Contact: Nermeen El Nokali, PhDfirstname.lastname@example.org|
|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 email@example.com|
|Contact: Sarah McAuliffe-Bellin, M.Ed. 412-235-5447 firstname.lastname@example.org|
|Principal Investigator:||Dana L Rofey, PhD||University of Pittsburgh|
|Principal Investigator:||Benjamin L Handen, PhD, BCBA-D||University of Pittsburgh|