Autism Spectrum DisorderNCT03708614
A Study Looking at How Well Children With Autism Spectrum Disorder on Medications Like Having More Protein
A study of Autism Spectrum Disorder, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Autism Spectrum Disorder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 7 Dec 2018to Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austina Mui, BASc., MHSc. contact
Canada1 site, 1 recruiting
- Recruiting
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, M4G 1R8
Lorry Chen, Honors BSc., 416-425-6220 ext. 6260, lchen@hollandbloorview.ca
Austina Mui, BASc., MHSc., amui@hollandbloorview.ca
About this study
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
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Controlled energy diet with elevated protein intake
- Keywords
- Autism Spectrum Disorder, Atypical antipsychotic medication, Psychotropic medication, Psychotropic-induced weight gain, Controlled energy intake with elevated protein, Dietary intervention, Acceptability, Feasibility
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled energy diet with elevated protein intakeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Controlled energy diet with elevated protein intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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: 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: 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: 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
Measured: 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.
Measured: 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.
Measured: 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: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Interview (anticipated duration of 60 minutes) will be conducted after week ten of intervention implementation (week 11)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start7 Dec 2018
- Primary completionApr 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Non-randomized pilot intervention study
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Holland Bloorview Kids Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorry Chen, Holland Bloorview Kids Rehabilitation Hospital
- Investigators
- Lorry Chen, Honors BSc., Principal investigator, Holland Bloorview Kids Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03708614
- Sponsor's protocol ID
- REB 18-781
- Status last verified
- Aug 2019
- First submitted
- 2 Oct 2018
- Last updated
- 26 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 23519708Anagnostou 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.
PubMed 27556593Curtin 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.
PubMed 24614764Handen 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.
PubMed 28942807Martinez-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.
PubMed 23503976Paddon-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.
PubMed 18469287
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03708614
- Acronym / sponsor ID
- REB 18-781
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Holland Bloorview Kids Rehabilitation HospitalUniversity, hospital or other
- Study start
- 7 Dec 2018 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 17 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non-randomized pilot intervention study
| Arm | Type | Receives |
|---|---|---|
| Controlled energy intake with elevated protein intake | Other | Other: Controlled energy diet with elevated protein intakeDietary intervention - Participants will be counseled to elevate protein and control energy intake for ten consecutive weeks. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- Child Inclusion Criteria:
- Parent/guardian inclusion criteria:
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Controlled energy diet with elevated protein intakeParticipants 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. | Other | Controlled energy intake with elevated protein intake |
Primary outcome
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
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
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
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
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
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.
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.
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2019.
- Background: PubMed 23519708Almandil 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.
- Background: PubMed 27556593Anagnostou 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.
- Background: PubMed 24614764Curtin 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.
- Background: PubMed 28942807Handen 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.
- Background: PubMed 23503976Martinez-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.
- Background: PubMed 18469287Paddon-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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Austina Mui, BASc., MHSc. contact
Lorry Chen, Honors BSc. principal investigator
Holland Bloorview Kids Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Autism Spectrum Disorder, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lorry Chen, Honors BSc. (416-425-6220 ext. 6260, lchen@hollandbloorview.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03708614, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2019.