LP App for PKU
Research type
Research Study
Full title
A low protein diet application for Phenylketonuria (PKU)
IRAS ID
260370
Contact name
Sharon Evans
Contact email
Sponsor organisation
Birmingham Women's & Children's NHS Foundation Trust
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Research Summary
Severe dietary phenylalanine restriction is an essential treatment strategy in children with phenylketonuria (PKU). Phenylalanine is found in protein containing foods and protein intake is commonly reduced to <10g/day. All sources of protein intake must be calculated each day. The diet is complicated by factors including: all foods do not contain the same amount of phenylalanine for each gram of protein they contain, there is no phenylalanine labelling on regular foods, European legislation allows manufacturers to declare foods as protein free if they contain below a specified threshold. Therefore, in PKU, it is not easy to assess the suitability of a food by examining food labels. Furthermore, uncertainty exists within families and between dietitians regarding appropriateness of inclusion of some foods and interpretation of protein values on food labels, particularly manufactured foods. Use of mobile-media to access dietary information is rising, but current applications (APPs) in PKU are often biased, commercially developed, under researched, and inattentive to food suitability. For patients/caregivers with PKU, we aim to create and study the effectiveness of a UK mobile ‘dietary’ APP,’ providing information on low protein food suitability and protein labelling interpretation, in improving accuracy of their daily food protein calculation. The APP will contain dietary information based on professional consensus dietary statements (developed by UK IMD dietitians utilising Delphi methodology). Containing a databank of specialist and regular low protein foods/ingredients, the APP will guide food labelling interpretation and calculate food protein exchanges. Pilot testing in 10 patients/caregivers will collect user feedback on APP ease-of-use to direct design improvements. In a randomised, parallel, controlled, intervention study, 80 patients/caregivers will either use the APP or traditional written instructions to guide food choices and food protein calculation. Outcome measures will include patient/caregiver accuracy of calculating protein intake, changes in dietary knowledge, self-care and blood phenylalanine control.
Summary of Results
Patients with phenylketonuria (PKU) require a phenylalanine/protein-restricted diet, with limited food choice. Interpreting food labels, calculating protein intake, and determining food suitability are complex and confusing tasks. A mobile multi-media low-protein diet app was developed to guide food choice, label interpretation, and protein calculation. ‘PKU Bite’® includes >1100 specialist and regular low-protein foods, is colour-coded for suitability, and features a protein calculator. A 12-week randomised controlled trial assessed app efficacy, compared with written/pictorial material, in 60 parents/caregivers of children with PKU, aged 1–16 years, and 21 adolescents with PKU. Questionnaires examined self-efficacy and label reading knowledge; food records evaluated natural protein intake, compared with prescriptions. There was no difference between groups in label-reading knowledge or self-efficacy, but there was a trend for improved accuracy of dietary protein calculation, when using the app (baseline/12-weeks: app 35%/48%; control 39%/35%). Parents of children <10 years of age (median 5.5 years), were most likely to use the app to check the phenylalanine/protein content of a food or to verify suitability of foods. Whilst the app was popular (43%), so too was contacting the dietitian (43%), using written/pictorial information (24%), or using social media (18%). This is the first dietary app for PKU to be studied in a systematic way as well as validated by healthcare professionals. It is a useful adjunct to existing resources and will be a valuable tool for educating parents of younger children.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
20/WM/0010
Date of REC Opinion
20 Feb 2020
REC opinion
Further Information Favourable Opinion