跳至主要内容
临床试验/NCT03708614
NCT03708614Unknown不适用

A Feasibility and Acceptability Study of Elevated Protein Dietary Intake for Children Diagnosed With Autism Spectrum Disorder (ASD) While on Atypical Antipsychotic Medication

Holland Bloorview Kids Rehabilitation Hospital2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年12月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
10
试验地点
2
主要终点
Pre- (at time of study enrolment) and post-intervention anthropometric measurements

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
6 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Controlled energy diet with elevated protein intake (Other)

结局指标

主要结局

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

时间窗: 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

时间窗: 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

Caloric and protein intake

时间窗: 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

Study feasibility (designs, methods, processes)

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lorry Chen

Clinical Dietitian

Holland Bloorview Kids Rehabilitation Hospital

研究点 (2)

Loading locations...

相似试验