Evaluation Of Strategies For Improving Ketogenic Diet Compliance

Sponsor

University of Sao Paulo General Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05112107

Collaborator

(none)

Enrollment

Location

Arms

28.2

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Epilepsy Ketogenic Dieting Compliance, Treatment	Behavioral: Culinary workshops	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Evaluation Of Strategies For Improving Ketogenic Diet Compliance

Anticipated Study Start Date :

Dec 30, 2021

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

May 5, 2024

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control
Experimental: Intervention	Behavioral: Culinary workshops Approved ketogenic recipes will be applied in educational cooking workshops at the ketogenic diet clinic at Instituto da Criança HCFMUSP.

Arm

Intervention/Treatment

No Intervention: Control

Experimental: Intervention

Behavioral: Culinary workshops

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto da Criança Hospital das Clinicas da Universidade de São Paulo	São Paulo		Brazil	05403-000

Sponsors and Collaborators

University of Sao Paulo General Hospital

Investigators

Principal Investigator: Erasmo Casella, PhD, University of Sao Paulo General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Erasmo Barbante Casella, Clinical Professor, University of Sao Paulo General Hospital

ClinicalTrials.gov Identifier:

NCT05112107

Other Study ID Numbers:

CAAE19812919.2.0000.0068

First Posted:

Nov 8, 2021

Last Update Posted:

Nov 8, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Epilepsy

Study Results

No Results Posted as of Nov 8, 2021