The Keto eCoach trial will randomize 136 adults starting a modified ketogenic diet for drug‑resistant epilepsy to either standard clinical care or standard care plus a digital health package (diary, at‑home saliva ketone meter, and dynamic dietitian support) for 12 weeks. The primary endpoint is the epilepsy desirability of outcome rank (e‑DOOR), a composite measure co‑designed with patients, with secondary outcomes covering seizures, retention, safety, quality of life and cost‑effectiveness.
Study and findings
This two‑arm, parallel‑group, randomized controlled trial enrolls adults with drug‑resistant epilepsy who are commencing the modified ketogenic diet (75 % fat, 20 % protein, 5 % carbohydrate). Participants are allocated 1:1 to receive either standard dietitian‑led care or the same care supplemented by a multimodality digital health intervention for 12 weeks. The intervention comprises (1) a mobile app for daily food and symptom diaries, (2) a novel at‑home saliva‑based beta‑hydroxybutyrate testing device, and (3) dietitian support that adapts in real time to diary and ketone data. The primary outcome is the epilepsy desirability of outcome rank (e‑DOOR), an ordinal composite that integrates seizure frequency, adverse effects and quality‑of‑life ratings, and was developed with input from people living with drug‑resistant epilepsy. Secondary outcomes include seizure count, treatment retention, adverse events, psychiatric symptom scales, health‑related quality of life, anti‑seizure medication changes, direct and indirect healthcare costs, and participant acceptability of the digital platform.
Clinical interpretation
If the e‑DOOR score improves with the digital package, the trial would provide evidence that technology‑enhanced monitoring and feedback can augment adherence and clinical benefit in adults using the modified ketogenic diet. The inclusion of a non‑invasive saliva ketone meter addresses a known barrier—discomfort and cost of finger‑prick blood testing—potentially increasing the frequency of ketone monitoring, which is linked to seizure control. Real‑time dietitian interaction, driven by diary and ketone data, may allow more timely dietary adjustments and side‑effect management, factors previously identified as influencing early discontinuation rates. However, because the study is limited to a 12‑week horizon, any observed effect on e‑DOOR will reflect short‑term outcomes; longer‑term sustainability of adherence and seizure control will remain uncertain.
Limitations and open questions
The protocol does not specify blinding, which could introduce performance bias, especially for patient‑reported components of e‑DOOR. The composite primary outcome, while patient‑centered, combines several domains; improvement in one domain (e.g., quality of life) could mask lack of effect on seizure frequency. The sample size (136) may be insufficient to detect modest differences in secondary seizure counts, and the trial is not powered for subgroup analyses (e.g., age, baseline seizure burden). Finally, the study evaluates only the modified ketogenic diet; findings may not extrapolate to other ketogenic regimens or to pediatric populations.
Source
Kaul N, Vivash L, Chen S, King L, Johns H, Churilov L, et al. A randomized controlled trial of a multimodality digital health intervention to aid the delivery of the modified ketogenic diet therapy for epilepsy: The Keto eCoach trial protocol. Epilepsia Open. 2026. doi: 10.1002/epi4.70345. PMID: 42704249.