Recruiting

Autism & Protein

Sponsor:

Holland Bloorview Kids Rehabilitation Hospital

Code:

NCT03708614

Conditions

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Interventions

Controlled energy diet with elevated protein intake

Study Details

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

Study ID

NCT03708614

Start date

Dec 7, 2018

Status verified date

Aug, 2019

Completion date

Jun, 2020

Anticipated

Primary completion date

Apr, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

other: Controlled energy intake with elevated protein intake

Dietary intervention - Participants will be counseled to elevate protein and control energy intake for ten consecutive weeks.

Interventions

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 measure

  • Caloric and protein intake [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ 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 ]
  • 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) ]
  • Study feasibility (designs, methods, processes) [ Time Frame: During the screening and recruitment process (anticipated duration of 1-1.5 months) ]
  • 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) ]
  • 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 ]
  • Study feasibility (designs, methods, processes) [ Time Frame: Interview (anticipated duration of 60 minutes) will be conducted after week ten of intervention implementation (week 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) ]
  • Study feasibility (designs, methods, processes) [ Time Frame: Interview (anticipated duration of 60 minutes) will be conducted after week ten of intervention implementation (week 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) ]

Central Contacts and Locations

Central contacts

Lorry Chen, Honors BSc.

416-425-6220lchen@hollandbloorview.ca

Austina Mui, BASc., MHSc.

amui@hollandbloorview.ca

Locations

Holland Bloorview Kids Rehabilitation Hospital

Recruiting

Toronto, Ontario, Canada, M4G 1R8

Contacts

Lorry Chen, Honors BSc.

416-425-6220lchen@hollandbloorview.ca

Austina Mui, BASc., MHSc.

amui@hollandbloorview.ca

Principal Investigator:

Lorry Chen, Honors BSc.

More Information

Sponsor

Holland Bloorview Kids Rehabilitation Hospital

Last update posted

Aug 26, 2019

Last verified

Aug, 2019

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Holland Bloorview Kids Rehabilitation Hospital on 2019-08-26.