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Evaluation Of Strategies For Improving Ketogenic Diet Compliance

NCT ID: NCT05112107

Last Updated: 2021-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-30

Study Completion Date

2024-05-05

Brief Summary

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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

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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.

Conditions

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Epilepsy Ketogenic Dieting Compliance, Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

Group Type EXPERIMENTAL

Culinary workshops

Intervention Type BEHAVIORAL

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

Interventions

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Culinary workshops

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

6 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Erasmo Barbante Casella

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erasmo Casella, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo General Hospital

Locations

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Instituto da Criança Hospital das Clinicas da Universidade de São Paulo

São Paulo, , Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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LENYCIA NERI, MsC RD

Role: CONTACT

Phone: +5511983662866

Email: [email protected]

Letícia Sampaio, PhD

Role: CONTACT

Facility Contacts

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LENYCIA NERI, MsC

Role: primary

Other Identifiers

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CAAE19812919.2.0000.0068

Identifier Type: -

Identifier Source: org_study_id