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

NCT03708614 | Unknown DMC

• 1 other identifier: REB 18-781
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder; Atypical antipsychotic medication; Psychotropic medication; Psychotropic-induced weight gain; Controlled energy intake with elevated protein; Dietary intervention; Acceptability; Feasibility

Outcome Measures

Primary Outcomes (12)

• Caloric and protein intake

  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

  At the time of study enrolment (week 0) and during week 10 of intervention implementation (week 10)

• Pre- (at time of study enrolment) and post-intervention anthropometric measurements

  Weight in kilograms - to calculate weight changes and BMI

  Measured at the time of study enrolment (week 0) and after ten weeks of intervention (week 11), assessed up to 11 weeks

• Pre- (at time of study enrolment) and post-intervention anthropometric measurements

  Height in centimetres - to calculate BMI

  Measured at the time of study enrolment (week 0) and after ten weeks of intervention (week 11), assessed up to 11 weeks

• Pre- (at time of study enrolment) and post-intervention anthropometric measurements

  Skinfold (triceps and subscapular) measurements in millimetres

  Measured at the time of study enrolment (week 0) and after ten weeks of following the intervention (week 11), assessed up to 11 weeks

• Post-intervention interview with participants and family

  Qualitative interview (guided using semi-structured format) to gain insight into successful strategies and potential barriers to consistently implement elevated protein dietary changes

  Interview (anticipated duration of 60 minutes) will be conducted after week ten of intervention implementation (week 11)

• Study feasibility (designs, methods, processes)

  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.

  During the screening and recruitment process (anticipated duration of 1-1.5 months)

• Study feasibility (designs, methods, processes)

  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.

  Measurements taken at the start of the study during enrolment and at study completion (anticipated duration of 5 months)

• Study feasibility (designs, methods, processes)

  Completion rates - Number of participants who completed the three-day food records

  Measured at the time of study enrolment (week 0) and after ten weeks of intervention (week 11), assessed up to 11 weeks

• Study feasibility (designs, methods, processes)

  Qualitative interview (guided using semi-structured format) to assess the participants' perspectives on the acceptability and feasibility of completing food records

  Interview (anticipated duration of 60 minutes) will be conducted after week ten of intervention implementation (week 11)

• Study feasibility (designs, methods, processes)

  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

  Interview (anticipated duration of 60 minutes) will be conducted after week ten of intervention implementation (week 11)

• Study feasibility (designs, methods, processes)

  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

  Interview (anticipated duration of 60 minutes) will be conducted after week ten of intervention implementation (week 11)

• Study feasibility (designs, methods, processes)

  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

  Interview (anticipated duration of 60 minutes) will be conducted after week ten of intervention implementation (week 11)

Study Arms (1)

Controlled energy intake with elevated protein intake

OTHER

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

Interventions

Controlled energy diet with elevated protein intake OTHER

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.

Controlled energy intake with elevated protein intake

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Holland Bloorview Kids Rehabilitation Hospital: lead

Study Sites (1)

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, M4G 1R8, Canada

RECRUITING

Related Publications (6)

• Almandil NB, Liu Y, Murray ML, Besag FM, Aitchison KJ, Wong IC. Weight gain and other metabolic adverse effects associated with atypical antipsychotic treatment of children and adolescents: a systematic review and meta-analysis. Paediatr Drugs. 2013 Apr;15(2):139-50. doi: 10.1007/s40272-013-0016-6.

  PMID: 23519708 BACKGROUND

• Anagnostou E, Aman MG, Handen BL, Sanders KB, Shui A, Hollway JA, Brian J, Arnold LE, Capano L, Hellings JA, Butter E, Mankad D, Tumuluru R, Kettel J, Newsom CR, Hadjiyannakis S, Peleg N, Odrobina D, McAuliffe-Bellin S, Zakroysky P, Marler S, Wagner A, Wong T, Macklin EA, Veenstra-VanderWeele J. Metformin for Treatment of Overweight Induced by Atypical Antipsychotic Medication in Young People With Autism Spectrum Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2016 Sep 1;73(9):928-37. doi: 10.1001/jamapsychiatry.2016.1232.

  PMID: 27556593 BACKGROUND

• Curtin C, Jojic M, Bandini LG. Obesity in children with autism spectrum disorder. Harv Rev Psychiatry. 2014 Mar-Apr;22(2):93-103. doi: 10.1097/HRP.0000000000000031.

  PMID: 24614764 BACKGROUND

• Handen BL, Anagnostou E, Aman MG, Sanders KB, Chan J, Hollway JA, Brian J, Arnold LE, Capano L, Williams C, Hellings JA, Butter E, Mankad D, Tumuluru R, Kettel J, Newsom CR, Peleg N, Odrobina D, McAuliffe-Bellin S, Marler S, Wong T, Wagner A, Hadjiyannakis S, Macklin EA, Veenstra-VanderWeele J. A Randomized, Placebo-Controlled Trial of Metformin for the Treatment of Overweight Induced by Antipsychotic Medication in Young People With Autism Spectrum Disorder: Open-Label Extension. J Am Acad Child Adolesc Psychiatry. 2017 Oct;56(10):849-856.e6. doi: 10.1016/j.jaac.2017.07.790. Epub 2017 Aug 19.

  PMID: 28942807 BACKGROUND

• Martinez-Ortega JM, Funes-Godoy S, Diaz-Atienza F, Gutierrez-Rojas L, Perez-Costillas L, Gurpegui M. Weight gain and increase of body mass index among children and adolescents treated with antipsychotics: a critical review. Eur Child Adolesc Psychiatry. 2013 Aug;22(8):457-79. doi: 10.1007/s00787-013-0399-5. Epub 2013 Mar 17.

  PMID: 23503976 BACKGROUND

• Paddon-Jones D, Westman E, Mattes RD, Wolfe RR, Astrup A, Westerterp-Plantenga M. Protein, weight management, and satiety. Am J Clin Nutr. 2008 May;87(5):1558S-1561S. doi: 10.1093/ajcn/87.5.1558S.

  PMID: 18469287 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Lorry Chen, Honors BSc.

  Holland Bloorview Kids Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lorry Chen, Honors BSc.

CONTACT

416-425-6220; lchen@hollandbloorview.ca

Austina Mui, BASc., MHSc.

CONTACT

amui@hollandbloorview.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Dietitian

Model Details: Non-randomized pilot intervention study

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 17, 2018
• Study Start: December 7, 2018
• Primary Completion: April 1, 2020
• Study Completion: June 1, 2020
• Last Updated: August 26, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)