Evaluation Of Strategies For Improving Ketogenic Diet Compliance

Epilepsy Clinical Trial

Official title:

Evaluation Of Strategies For Improving Ketogenic Diet Compliance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05112107
• Other study ID #: CAAE19812919.2.0000.0068
• Status: Recruiting
• Phase: N/A
• Start date: December 30, 2021
• Est. completion date: May 5, 2024

Study information

• Verified date: October 2021
• Source: University of Sao Paulo General Hospital
• Contact: LENYCIA NERI, MsC RD
• Phone: +5511983662866
• Email: lenycia[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 5, 2024
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 18 Years

Eligibility

Inclusion Criteria:

• Patients 0 to 18 years old;

• Clinical indication of a classic ketogenic diet;

• Predominantly oral feeding.

Exclusion Criteria:

• Patients using exclusive gastrostomy;

• Patients with other types of KD than Classical KD.

Related Conditions & MeSH terms

• Compliance, Treatment
• Epilepsy
• Ketogenic Dieting

Intervention

Behavioral:
• Culinary workshops
Approved ketogenic recipes will be applied in educational cooking workshops at the ketogenic diet clinic at Instituto da Criança HCFMUSP.

Locations

Country	Name	City	State
Brazil	Instituto da Criança Hospital das Clinicas da Universidade de São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ketogenic diet compliance score	Ketogenic diet compliance score will be obtained through a validated questionnaire.	through study completion, an average of 2 years