OptiCALS Randomised Controlled Trial
Research type
Research Study
Full title
OptiCALS: A Randomised Controlled Trial with parallel Process Evaluation and Health Economic analysis to evaluate a nutritional management intervention, OptiCALS, for patients with Amyotrophic Lateral Sclerosis
IRAS ID
275949
Contact name
Christopher McDermott
Contact email
Sponsor organisation
Sheffield Teaching Hospitals, NHS Foundation Trust
ISRCTN Number
ISRCTN30588041
Duration of Study in the UK
3 years, 4 months, 1 days
Research summary
The purpose of this study is to test a support package (the ‘OptiCALS’ intervention) designed to improve nutritional management for people living with amyotrophic lateral sclerosis (ALS), also known as motor neurone disease.
Little is currently known regarding how food intake affects ALS and there is a lack of guidance for patients and healthcare professionals on weight and nutrition in ALS. Evidence from small studies suggests better nutrition helps people with ALS live for longer. In light of this, we have designed a web portal called OptiCALS that people with ALS can use. The OptiCALS intervention has been designed to help people with ALS receive the best diet at the most appropriate time, in the most cost-effective manner. The package will include a range of materials including videos, information, advice and interactive tools designed to assist people with ALS to optimise their nutrition. This will be provided alongside support from a healthcare professional. We will test if using OptiCALS helps people with ALS live for longer than those who do not use OptiCALS.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
20/NW/0334
Date of REC Opinion
7 Sep 2020
REC opinion
Further Information Favourable Opinion