VITAmin and Micronutrient Testing: Acceptability and SCOPE of Point-of-care Device

NCT06882421 | Completed

• 2 other identifiers: Version 1.2 03/06/2062431
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Childhood obesity is a global health crisis with 1.2 million children in England severely obese, predisposing them to multiple health risks which decrease lifespan and compromise health. Children suffering from obesity experience a state of paradoxical malnutrition; despite excessive calorie intake they have high rates of micronutrient deficiencies rates due to consumption of energy dense, nutrient poor diets. Around 70-80% of obese children are Vitamin D deficient, 10% have low B12 concentrations and 50% have folic acid deficiency. Currently screening for micronutrient deficiencies does not form a routine part of clinical care at all medical centres because they require a large volume of blood and are expensive to perform. A prototype point-of-care in-vitro diagnostic test has been developed which allows at-home/primary care testing of micronutrient levels, using an integrated finger-prick and minimal amount of blood. This device should be simple to use, with just one push of a button. The results are analysed using a phone app for clear decision-making, with data uploaded to healthcare providers automatically. This study aims to ask service users (young people and their families) for their views on the usability and acceptability of the device prior to developing the product further.

Conditions

Micronutrient Levels

Keywords

micronutrient testing acceptability; Point-of-care device

Outcome Measures

Primary Outcomes (1)

• Number of participants and their parents who prefer using a finger prick test for micronutrient measurement.

  1. What are the preferences of young people and their families regarding the new technology? 2. To identify the problems and any benefits of the new technology from patients/parents/guardians/ medical staff

  12 months

Secondary Outcomes (1)

• Demographics of study participants

  12 months

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

30 children and their parents/carers, attending the Complications of Excess weight (CEW)/ Health Futures Clinic at the Jenny Lind Children's Hospital, NNUH. Parents can participate in the study independently of their children.

You may qualify if:

• Patient aged\>10 years or parents of a patient being seen in a NNUH CEW clinic.
• Parents/Participants must have capacity to consent/assent and provide a signed and dated informed consent
• Able to participate in an interview regarding the acceptability/usability of the device.

You may not qualify if:

• \- Potential participants will not be eligible if they lack capacity to provide informed consent (or in the case of young people under the age of 16, informed assent and informed parental consent)

Sponsors & Collaborators

• Norfolk and Norwich University Hospitals NHS Foundation Trust: lead
• University of East Anglia: collaborator

Study Sites (1)

Norfolk and Norwich University Hospitals NHS Foundation Trust

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

Study Officials

• Emma Webb, PhD

  Consultant at NNUH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 18, 2025
• Study Start: June 25, 2024
• Primary Completion: July 31, 2024
• Study Completion: September 27, 2024
• Last Updated: April 2, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)