Validation of an Italian Questionnaire of Adherence to the Ketogenic Diet

NCT05377762 | Unknown

• 1 other identifier: iKETOCHECK
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 2

Brief Summary

The ketogenic diet (KD) represents an effective and safe non-drug treatment for drug-resistant epilepsy in pediatric and adult age based on normocaloric, hyperlipidic (80-90% of the daily energy), normoproteic and hypoglucidic dietary regimen. Adherence to treatment with KD is often difficult in the long term, for the patient and for caregivers, especially in adolescence. There are no tools in the literature other than monitoring ketonemia to measure adherence to the diet. A quality tool, validated by experts, on a large population, would allow for a more solid assessment of adherence to treatment, facilitating clinicians in the interpretation of efficacy results and in implementing an early intervention to adjust the therapy.

Conditions

Epilepsy

Keywords

ketogenic diet; adherence; questonnaire

Outcome Measures

Primary Outcomes (1)

• Adherence score

  The answer of questionnaire will generate a score. Minimum value will be 10 points and maximum 50 points. Higher scores mean a better outcome.

  Through study completion, an average of 6 months

Eligibility Criteria

• Age: Up to 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All patients treated with a ketogenic diet for more than three months belonging to the Center for Childhood and Adolescent Epileptology of the Mondino Foundation of Pavia will be enrolled, who will accept to participate in the study and will have signed the relative informed consent. For patients under the age of 18, the answers to the questionnaire and the related informed consent must be provided by the parents or legal guardian.

You may qualify if:

• Age \<60 years
• Gender: both sexes
• Route of administration of the diet: totally or partially oral
• Diagnosis: drug-resistant epilepsy or GLUT1 deficiency
• Duration of treatment with the ketogenic diet: at least 3 months
• Informed consent of the patient and / or an authorized caregiver / legal representative•

You may not qualify if:

• Age \> 60 years
• Route of administration of the exclusively enteral or parenteral diet
• Duration of treatment with KD less than 3 months

Sponsors & Collaborators

• University of Pavia: lead
• University of Sao Paulo: collaborator

Study Sites (2)

University of Pavia

Pavia, 27100, Italy

Location

Center for Childhood and Adolescent Epileptology of the Mondino Foundation

Pavia, Italy

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Valentina De Giorgis

  University of Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 17, 2022
• Study Start: March 16, 2022
• Primary Completion: July 1, 2022
• Study Completion: September 1, 2022
• Last Updated: June 22, 2022

Record last verified: 2022-05

Locations

IT (2)