Back to resultsEvaluation Of Strategies For Improving Ketogenic Diet Compliance
Primary Purpose
Epilepsy, Ketogenic Dieting, Compliance, Treatment
Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Culinary workshops
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy
Eligibility Criteria
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.
Sites / Locations
- Instituto da Criança Hospital das Clinicas da Universidade de São PauloRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention
Arm Description
Outcomes
Primary Outcome Measures
Ketogenic diet compliance score
Ketogenic diet compliance score will be obtained through a validated questionnaire.
Secondary Outcome Measures
Full Information
NCT ID
NCT05112107
First Posted
August 15, 2021
Last Updated
October 27, 2021
Sponsor
University of Sao Paulo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05112107
Brief Title
Evaluation Of Strategies For Improving Ketogenic Diet Compliance
Official Title
Evaluation Of Strategies For Improving Ketogenic Diet Compliance
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 30, 2021 (Anticipated)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
May 5, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Ketogenic Dieting, Compliance, Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Title
Intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Culinary workshops
Intervention Description
Approved ketogenic recipes will be applied in educational cooking workshops at the ketogenic diet clinic at Instituto da Criança HCFMUSP.
Primary Outcome Measure Information:
Title
Ketogenic diet compliance score
Description
Ketogenic diet compliance score will be obtained through a validated questionnaire.
Time Frame
through study completion, an average of 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
LENYCIA NERI, MsC RD
Phone
+5511983662866
Email
lenycia@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Letícia Sampaio, PhD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erasmo Casella, PhD
Organizational Affiliation
University of Sao Paulo General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto da Criança Hospital das Clinicas da Universidade de São Paulo
City
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LENYCIA NERI, MsC
Phone
+5511983662866
Email
lenycia@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluation Of Strategies For Improving Ketogenic Diet Compliance
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