The Keto-eCoach program: supporting dietary treatment for epilepsy.
- Conditions
- EpilepsyNeurological - Epilepsy
- Registration Number
- ACTRN12624000486527
- Lead Sponsor
- Alfred Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 136
1. Male or female, aged 18 years and over, and less than 60 years.
2.Diagnosis of drug-resistant epilepsy according to ILAE definition, failure of adequate trials of two tolerated and appropriately chosen and used anti-seizure medication schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom”.
3.Must be under the care of a neurologist for their epilepsy treatment.
4.Experiencing 2 or more seizures per 28-days during the 4-week baseline screening phase.
5.Not currently on ketogenic diet therapy.
6.No changes made to concomitant anti-seizure medications, or neuromodulation settings in the prior four weeks to enrolment.
7.Access to a smartphone, tablet and/or computer and internet access.
8.Has a Medicare card.
9.Is living in Australia.
10.Proficient in speaking and reading English.
1. Contraindications to the modified ketogenic diet for epilepsy, including fatty acid and/or amino acid oxidation or transport disorders.
2. Current or previous diagnosis of an eating disorder
3. Pregnancy or breast-feeding
4. Diagnosis of diabetes mellitus, serious hepatic or renal disease, or cancer.
5. Current substance abuse disorder that may affect treatment adherence or response
6. Psychogenic non-epileptic (functional) seizures within the past 12 months.
7. Elevated fasting serum total cholesterol, LDL cholesterol and/or triglyceride levels at baseline, defined as >10% above the reference range. Participants will be excluded if baseline serum total cholesterol is >6.1mmol/L, LDL cholesterol is >2.2mmol/L and/or triglycerides is >2.2mmol/L.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method