NCT05112107

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 8, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

December 30, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2024

Completed
Last Updated

November 8, 2021

Status Verified

October 1, 2021

Enrollment Period

6 months

First QC Date

August 15, 2021

Last Update Submit

October 27, 2021

Conditions

EpilepsyKetogenic DietingCompliance, Treatment

Outcome Measures

Primary Outcomes (1)

  • Ketogenic diet compliance score

    Ketogenic diet compliance score will be obtained through a validated questionnaire.

    through study completion, an average of 2 years

Study Arms (2)

Control

NO INTERVENTION

Intervention

EXPERIMENTAL
Behavioral: Culinary workshops

Interventions

Culinary workshopsBEHAVIORAL

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

Intervention

Eligibility Criteria

Age6 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients 0 to 18 years old;
  • Clinical indication of a classic ketogenic diet;
  • Predominantly oral feeding.

You may not qualify if:

  • Patients using exclusive gastrostomy;
  • Patients with other types of KD than Classical KD.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto da Criança Hospital das Clinicas da Universidade de São Paulo

São Paulo, 05403-000, Brazil

RECRUITING

MeSH Terms

Conditions

EpilepsyPatient Compliance

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Erasmo Casella, PhD

    University of Sao Paulo General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

LENYCIA NERI, MsC RD

CONTACT

+5511983662866lenycia@gmail.com

Letícia Sampaio, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

August 15, 2021

First Posted

November 8, 2021

Study Start

December 30, 2021

Primary Completion

June 30, 2022

Study Completion

May 5, 2024

Last Updated

November 8, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)