None listed
Conditions
Brief summary
Problem: One-third of people with epilepsy continue to experience seizures despite treatment with anti-seizure medications. Dietary therapy, such as the ketogenic diet, is an effective treatment, however, high discontinuation rate remains a significant issue limiting its effectiveness in practice. Our Solution: To utilise digital health interventions to enhance the delivery of dietary therapy for epilepsy, thereby improving treatment adherence and seizure control. Three components will be used: (1) at-home saliva ketone testing, (2) digital seizure and food diaries, underpinned by (3) dynamic dietitian support via telemedicine. Aim: To evaluate the effectiveness of incorporating multi-modality technologies in the delivery of dietary therapy for epilepsy. Study Design and Methods: A randomised controlled trial, enrolling 136 adults newly commencing on dietary therapy for epilepsy. Participants will be randomised to the enhanced technology (ET) or standard care (SC) group and followed up for 12 weeks. The treatment benefit will be measured by a novel consumer co-designed Desirability of Outcome Ranking (DOOR) measure combining seizure frequency, adverse events and quality of life. Secondary outcomes include changes in seizure frequency, quality of life scores and healthcare utilization; retention on dietary treatment; participant and clinician acceptance of the intervention and cost-effectiveness evaluation. Significance: Our enhanced model of providing dietary therapy with medical technologies to support patients and families, has potential to improve adherence to treatment, thereby reducing seizure frequency. Reducing seizures, reduces the risk of hospitalisation, injuries and death, and improved quality of life for people with epilepsy and their families. The virtual delivery and monitoring of dietary therapy will increase access to specialist care in regional areas and could be utilised for other conditions requiring dietary therapy.
Interventions
Participants in the intervention arm will commence on the modified ketogenic diet with the addition of enhanced technology modalities for 12 weeks.
The modified ketogenic diet (MKD) is a low carbohydrate, high fat diet based on a macronutrient distribution of 75% of calories from fat, 20% from protein and 5% from carbohydrate. The MKD will be based on the participant’s weight, age and activity levels. Participants will receive individualised dietary advice from a qualified Dietitian at the ran
Participants in the intervention arm will commence on the modified ketogenic diet with the addition of enhanced technology modalities for 12 weeks. The modified ketogenic diet (MKD) is a low carbohydrate, high fat diet based on a macronutrient distribution of 75% of calories from fat, 20% from protein and 5% from carbohydrate. The MKD will be based on the participant’s weight, age and activity levels. Participants will receive individualised dietary advice from a qualified Dietitian at the randomisation visit at Week 0 (Visit 2). Participants will begin to implement the MKD over a period of two week (run-in phase) and then continue of the MKD for a 12-week treatment phase. Participants will have appointments with the dietitian lasting approximately 30-45 minutes, either in-person or by telemedicine at the beginning of the treatment period at Week 2 (Visit 3), Week 4 (Visit 4), Week 6 (Visit 5), Week 10 (Visit 6) and Week 14 (Visit 7), Participants in the intervention arm will receive all of the following enhanced technology modalities include (1) daily home-based saliva ketone testing using the MX3 Lab device; (2) daily digital seizure and food diaries, underpinned by (3) dynamic dietitian follow-up, this means the dietitian will have access to the participant's digital diaries and will be able to provide tailored nutrition advice during the study visits. During the 12-week intervention period, participants will be asked test their saliva using the MX3 Lab device. This takes less than 60 seconds daily to complete. Participants will be asked to complete daily electronic food and seizure diaries. The food diaries are summary of daily energy, carbohydrate, protein, fat and fibre intake. Each seizure event will recorded indicating the time and type of event, e.g. focal aware seizure or generalized tonic-clonic seizure, and documentation any anti-seizure rescue medication used. It is estimated these diaries will take between 5-10 minutes per day to complete. Following the completion of the 12-week treatment period, participants will be followed up every 12 weeks until week 50.
Sponsors
Alfred Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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.
Outcome results
None listed