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Evaluation Of Strategies For Improving Ketogenic Diet Compliance

Evaluation Of Strategies For Improving Ketogenic Diet Compliance

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05112107
Enrollment
20
Registered
2021-11-08
Start date
2021-12-30
Completion date
2024-05-05
Last updated
2021-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Compliance, Treatment, Epilepsy, Ketogenic Dieting

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.

Interventions

BEHAVIORALCulinary workshops

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

Sponsors

University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Months to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Ketogenic diet compliance scorethrough study completion, an average of 2 yearsKetogenic diet compliance score will be obtained through a validated questionnaire.

Countries

Brazil

Contacts

Primary ContactLENYCIA NERI, MsC RD
lenycia@gmail.com+5511983662866
Backup ContactLetícia Sampaio, PhD

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026