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

Sponsor

Holland Bloorview Kids Rehabilitation Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03708614

Collaborator

(none)

Enrollment

Location

Arm

17.8

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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;

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Non-randomized pilot intervention studyNon-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 :

Dec 7, 2018

Anticipated Primary Completion Date :

Apr 1, 2020

Anticipated Study Completion Date :

Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
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.	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.

Arm

Intervention/Treatment

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.

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.

Outcome Measures

Primary Outcome Measures

Caloric and protein intake [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
Pre- (at time of study enrolment) and post-intervention anthropometric measurements [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
Pre- (at time of study enrolment) and post-intervention anthropometric measurements [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
Pre- (at time of study enrolment) and post-intervention anthropometric measurements [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
Post-intervention interview with participants and family [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
Study feasibility (designs, methods, processes) [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.
Study feasibility (designs, methods, processes) [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.
Study feasibility (designs, methods, processes) [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
Study feasibility (designs, methods, processes) [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
Study feasibility (designs, methods, processes) [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
Study feasibility (designs, methods, processes) [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
Study feasibility (designs, methods, processes) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

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:

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