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A Study Looking at How Well Children With Autism Spectrum Disorder on Medications Like Having More Protein

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ClinicalTrials.gov Identifier: NCT03708614
Recruitment Status : Recruiting
First Posted : October 17, 2018
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Lorry Chen, Holland Bloorview Kids Rehabilitation Hospital

Brief Summary:

Antipsychotic medications are commonly prescribed in children and adults with ASD (Curtin, Jojic & Bandini, 2014). But weight gain has been known to be one of the less desirable effects of these medications, increasing one's risk for overweight and obesity. Based on experience in Holland Bloorview's Nutrition Clinic, working with a dietitian to follow specific dietary advice, such as having more protein while keeping the amount of calories the same, may be a possible and useful way to limit weight gain.

This study's objective is to evaluate the feasibility (study designs, methods, processes) and acceptability (client/family satisfaction, perceived effectiveness) of a controlled energy diet with elevated protein intake in children and youth with ASD who are currently taking prescribed atypical antipsychotic medication.


Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Other: Controlled energy diet with elevated protein intake Not Applicable

Detailed Description:

The use of psychotropic medication in children and youth with Autism Spectrum Disorder (ASD) to treat symptoms of aggression, irritability and related behavioural problems has become increasingly common in recent years. Data obtained from clinical and nationally representative populations of children demonstrate that approximately 30%-60% of children with ASD are prescribed at least one psychotropic medication, and 10% are prescribed more than three medications at the same time (Curtin, Jojic & Bandini, 2014).

Weight gain, which is one of the harmful effects of psychotropic medication, is likely one of the most understood risk factors for obesity in children and adults with ASD. In a systematic review and meta-analysis of double-blinded, randomized, controlled trials studying the metabolic adverse effects of atypical antipsychotics in children and adolescents under 18 years of age, risperidone, olanzapine and aripiprazole were associated with statistically significant weight gain compared with placebo (Almandil et al., 2013). Similar findings were reported from a review of literature, using PubMed, on weight gain and increase of BMI among children and adolescents (0-18 years old) treated with antipsychotic medications (Martinez-Ortega et al., 2013).

Although clinical trials with different agents have been conducted in an attempt to address weight gain in individuals on psychotropic medications, no established treatments or preventative measures have been developed to combat psychotropic-induced weight gain (PIWG) to date (Curtin, Jojic & Bandini, 2014). A review of published literature using PubMed yielded limited and mixed results for using Metformin as the intervention for the treatment in combating PIWG (Anagostou et al., 2016; Handen et al., 2017). Based on clinical experience in Holland Bloorview's Nutrition Clinic, controlled energy intake combined with elevated protein intake (CEEP) may represent an effective and practical strategy for limiting weight gain.

Potential beneficial outcomes associated with protein ingestion include: a) increased satiety, which is being satisfactorily full - protein generally increases satiety to a greater extent than carbohydrate or fat and may facilitate a reduction in energy consumption; b) increased thermogenesis, which is the production of heat in the body - higher protein diets are associated with an increase in thermogenesis, which also influences satiety and increases energy expenditure; and c) maintenance or growth of fat-free mass (muscle) - an elevated protein diet may provide an increase effect on muscle protein synthesis in some individuals, favouring the retention of lean muscle mass while improving metabolic profile (Paddon-Jones et al., 2018).

This study's primary objective is to evaluate the feasibility (study designs, methods, processes) and acceptability (client/family satisfaction, perceived effectiveness) of a controlled energy diet with elevated protein intake in children and youth with ASD who are currently taking prescribed atypical antipsychotic medication.

Children and youth, ages 6-17 years old, with ASD (n=10) on atypical antipsychotic medication will be exposed to specific nutrition recommendations involving CEEP for ten consecutive weeks. Each participant and parent/guardian will work collaboratively with the RD/RA to formulate strategies to slowly increase protein intake in the range of 20-30% of total caloric intake and ensure consistent energy intake. Data will be collected through food records, anthropometric measurements and informal post-intervention interviews to measure the feasibility and acceptability of the study processes and elevated protein dietary changes.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Non-randomized pilot intervention study
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Feasibility and Acceptability Study of Elevated Protein Dietary Intake for Children Diagnosed With Autism Spectrum Disorder (ASD) While on Atypical Antipsychotic Medication
Actual Study Start Date : December 7, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Controlled energy intake with elevated protein intake
Dietary intervention - Participants will be counseled to elevate protein and control energy intake for ten consecutive weeks.
Other: Controlled energy diet with elevated protein intake
Participants will be counseled to elevate protein and control energy intake for ten consecutive weeks. Protein intake will be increased in the range of 20-30% of total daily caloric intake. Each participant's diet will also be modified to implement controlled energy intake. Controlled energy intake will be defined as being isocaloric with the participant's current dietary intake.




Primary Outcome Measures :
  1. Caloric and protein intake [ Time Frame: At the time of study enrolment (week 0) and during week 10 of intervention implementation (week 10) ]
    Average caloric (kcal) and protein (g) intake - comparison of three day food records measured at the time of enrolment and during week 10 of intervention implementation

  2. Pre- (at time of study enrolment) and post-intervention anthropometric measurements [ Time Frame: Measured at the time of study enrolment (week 0) and after ten weeks of intervention (week 11), assessed up to 11 weeks ]
    Weight in kilograms - to calculate weight changes and BMI

  3. Pre- (at time of study enrolment) and post-intervention anthropometric measurements [ Time Frame: Measured at the time of study enrolment (week 0) and after ten weeks of intervention (week 11), assessed up to 11 weeks ]
    Height in centimetres - to calculate BMI

  4. Pre- (at time of study enrolment) and post-intervention anthropometric measurements [ Time Frame: Measured at the time of study enrolment (week 0) and after ten weeks of following the intervention (week 11), assessed up to 11 weeks ]
    Skinfold (triceps and subscapular) measurements in millimetres

  5. Post-intervention interview with participants and family [ Time Frame: Interview (anticipated duration of 60 minutes) will be conducted after week ten of intervention implementation (week 11) ]
    Qualitative interview (guided using semi-structured format) to gain insight into successful strategies and potential barriers to consistently implement elevated protein dietary changes

  6. Study feasibility (designs, methods, processes) [ Time Frame: During the screening and recruitment process (anticipated duration of 1-1.5 months) ]
    Recruitment rates - comparisons between (i) number of patients screened; (ii) number of eligible patients identified from clinic; (iii) number of eligible patients approached; (iv) number of patients who agreed to further contact; and (v) number of participants consented and enrolled in the study.

  7. Study feasibility (designs, methods, processes) [ Time Frame: Measurements taken at the start of the study during enrolment and at study completion (anticipated duration of 5 months) ]
    Retention rate - comparison between (i) number of participants enrolled at the start of the study; and (ii) number of participants enrolled at the end of study.

  8. Study feasibility (designs, methods, processes) [ Time Frame: Measured at the time of study enrolment (week 0) and after ten weeks of intervention (week 11), assessed up to 11 weeks ]
    Completion rates - Number of participants who completed the three-day food records

  9. Study feasibility (designs, methods, processes) [ Time Frame: Interview (anticipated duration of 60 minutes) will be conducted after week ten of intervention implementation (week 11) ]
    Qualitative interview (guided using semi-structured format) to assess the participants' perspectives on the acceptability and feasibility of completing food records

  10. Study feasibility (designs, methods, processes) [ Time Frame: Interview (anticipated duration of 60 minutes) will be conducted after week ten of intervention implementation (week 11) ]
    Qualitative interview (guided using semi-structured format) to assess the participants' perspectives on the acceptability and feasibility of attending on-site visits for anthropometric measurements

  11. Study feasibility (designs, methods, processes) [ Time Frame: Interview (anticipated duration of 60 minutes) will be conducted after week ten of intervention implementation (week 11) ]
    Qualitative interview (guided using semi-structured format) to assess the participants' perspectives on the acceptability and feasibility of following-up with the RA via phone during intervention implementation

  12. Study feasibility (designs, methods, processes) [ Time Frame: Interview (anticipated duration of 60 minutes) will be conducted after week ten of intervention implementation (week 11) ]
    Qualitative interview (guided using semi-structured format) to assess the participants' perspectives on the acceptability and feasibility of participating in the on-site post-intervention interview



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Child Inclusion Criteria:

    • Diagnosis of ASD
    • Currently taking one or more atypical antipsychotic medication
    • Ages 6-17 years old
    • Enrolment as an active client in a Psychopharmacology Clinic at Holland Bloorview
    • Accepts all food, based on the SOS Feeding Approach: Defining Picky vs. Problem Eaters by Kay Toomey (2017) - has no significant food aversions; will accept new foods on plate, usually can touch or taste; and consumes one or more foods from all food groups, varying in textures
    • Can communicate in English
    • Has access to a telephone
  2. Parent/guardian inclusion criteria:

    • Provides care to study participant
    • Can communicate in English
    • Able to complete food records
    • Has access to a telephone

Exclusion Criteria:

a) Child exclusion criteria:

  • Medical condition that contradicts elevated protein intake
  • Has significant food aversions
  • Has any food allergies
  • Currently participating in another clinical study that would interfere with anticipated endpoints and outcome measurements

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): NCT03708614


Contacts
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Contact: Lorry Chen, Honors BSc. 416-425-6220 ext 6260 lchen@hollandbloorview.ca
Contact: Austina Mui, BASc., MHSc. amui@hollandbloorview.ca

Locations
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Canada, Ontario
Holland Bloorview Kids Rehabilitation Hospital Recruiting
Toronto, Ontario, Canada, M4G 1R8
Contact: Lorry Chen, Honors BSc.    416-425-6220 ext 6260    lchen@hollandbloorview.ca   
Contact: Austina Mui, BASc., MHSc.       amui@hollandbloorview.ca   
Principal Investigator: Lorry Chen, Honors BSc.         
Principal Investigator: Evdokia Anagnostou         
Sub-Investigator: Cathy Petta         
Sub-Investigator: Jessica Brian         
Sub-Investigator: Susan Cosgrove         
Sub-Investigator: Joseph Telch         
Sponsors and Collaborators
Holland Bloorview Kids Rehabilitation Hospital
Investigators
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Principal Investigator: Lorry Chen, Honors BSc. Holland Bloorview Kids Rehabilitation Hospital

Publications:

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Responsible Party: Lorry Chen, Clinical Dietitian, Holland Bloorview Kids Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT03708614     History of Changes
Other Study ID Numbers: REB 18-781
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared as all study data will be de-identified and coded after the recruitment process. Only members of the research team will have access to the research data and linking log. The key-code will be deleted at the end of the study. Results from the study will be disseminated through publication, written lay summary and knowledge translation communication products.

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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 Lorry Chen, Holland Bloorview Kids Rehabilitation Hospital:
Autism Spectrum Disorder
Atypical antipsychotic medication
Psychotropic medication
Psychotropic-induced weight gain
Controlled energy intake with elevated protein
Dietary intervention
Acceptability
Feasibility

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