Evaluation Of Strategies For Improving Ketogenic Diet Compliance

Not Applicable

• Conditions: Epilepsy; Ketogenic Dieting; Compliance, Treatment
• Interventions: Behavioral: Culinary workshops

• Registration Number: NCT05112107
• Lead Sponsor: University of Sao Paulo General Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-08-15
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-27
• Last Update Submitted: 2021-10-27
• Study First Posted: 2021-11-08
• Last Update Posted: 2021-11-08
• Study Start: 2021-12-30
• Primary Completion: 2022-06-30
• Study Completion: 2024-05-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Intervention	Culinary workshops	-

Primary Outcome Measures

Name	Time	Method
Ketogenic diet compliance score	through study completion, an average of 2 years	Ketogenic diet compliance score will be obtained through a validated questionnaire.

Trial Locations

Locations (1)

Instituto da Criança Hospital das Clinicas da Universidade de São Paulo; 🇧🇷 São Paulo, Brazil