ClinicalTrials.Veeva

Menu

Evaluation Of Strategies For Improving Ketogenic Diet Compliance

U

University of Sao Paulo General Hospital

Status

Unknown

Conditions

Compliance, Treatment
Epilepsy
Ketogenic Dieting

Treatments

Behavioral: Culinary workshops

Study type

Interventional

Funder types

Other

Identifiers

NCT05112107
CAAE19812919.2.0000.0068

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

6 months to 18 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

20 participants in 2 patient groups

Control
No Intervention group
Intervention
Experimental group
Treatment:
Behavioral: Culinary workshops

Trial contacts and locations

1

Loading...

Central trial contact

Letícia Sampaio, PhD; LENYCIA NERI, MsC RD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems