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临床试验/NCT05112107
NCT05112107Unknown不适用

Evaluation Of Strategies For Improving Ketogenic Diet Compliance

University of Sao Paulo General Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年12月30日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
2
主要终点
Ketogenic diet compliance score

研究概览

简要总结

In order to increase adherence to ketogenic diet treatment, palatability of meals and diversify the foods offered to patients a ketogenic kitchen will be created. Intervention: Incorporation of culinary workshops and supply of recipes for patients undergoing ketogenic diet treatment at Instituto da Criança - HCFMUSP.

详细描述

Introduction

The ketogenic diet is a therapeutic option for the control of drug-resistant epileptic seizures. It is based on high fat consumption, protein control and carbohydrate restriction. As a result, the body uses fat as an energy substrate instead of glucose. Changing the patient's daily menu and eating routine is hard and requires dedication from the caregiver for the best therapeutic result. In clinical practice, the diet becomes monotonous and poorly accepted by the patient over time. Besides, there is a difficulty in understanding nutritional guidelines. It is necessary to develop strategies to increase adherence to treatment, palatability of meals and diversify the foods offered to patients. Objective: To evaluate the effectiveness of creating a ketogenic kitchen in improving compliance of patients with CD in the outpatient clinic of Instituto da Criança - HCFMUSP. Methods: this work will be carried out in 4 steps: (1st) Creation and validation of a questionnaire of ketogenic diet compliance, (2nd) Creation of ketogenic recipes of easy preparation and low cost, (3rd) Incorporation of culinary workshops and supply of recipes for patients undergoing treatment at Instituto da Criança - HCFMUSP and (4th) Application of the questionnaire of ketogenic diet compliance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Months 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients 0 to 18 years old;
  • Clinical indication of a classic ketogenic diet;
  • Predominantly oral feeding.

排除标准

  • Patients using exclusive gastrostomy;
  • Patients with other types of KD than Classical KD.

结局指标

主要结局

Ketogenic diet compliance score

时间窗: through study completion, an average of 2 years

Ketogenic diet compliance score will be obtained through a validated questionnaire.

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

Erasmo Barbante Casella

Clinical Professor

University of Sao Paulo General Hospital

研究点 (2)

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