Juvenile Idiopathic ArthritisJIANCT04903067
An Investigation Into the Relationship Between Dietary Intake and Health-related Quality of Life in Children and Young People With Juvenile Idiopathic Arthritis
An observational study of Juvenile Idiopathic Arthritis, run by Oxford Brookes University at 1 site in United Kingdom.
Trial summary
"Physical activity and diet in children and young people with arthritis" A qualitative study of exploring stake holder's experiences. Juvenile Idiopathic Arthritis (JIA) is the most common type of arthritis in children under the age of 16. Read more about this study
- Who is it for?
- Ages 9 to 18 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis
- How many people
- 99 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2021to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Nuffield Orthopaedic Centre Oxford, Usual referral clinic.
Who may be able to join
- A) Patients
- Male or female, age range 9 to 18 years old.
- Diagnosed with JIA.
- Speaking and understanding English.
- Willing and able to provide consent if 16-18 years old, or have a parent/carer to provide consent and able to provide assent if the participant is <16.
- Having the access to telephone/video call for those who wish to have distance interview.
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- Parent/Carer
- parent or caregiver of a child with JIA.
- Willing and able to give informed consent for their own and their child's participation (if the child is under 16 years of age).
- Having the access to telephone/video call for those who wish to have distance interview.
- Speaking and understanding English. C) Healthcare professionals
- Willing and able to give informed consent.
- Clinical HCP with at least 2-year experience in treating children and young people with JIA.
- Academic in the field of clinical research in the treatment of JIA.
- Having the access to telephone/video call for those who wish to have distance interview.
- Speaking and understanding English.
Who cannot join
- Individuals will be excluded from the study if ANY of the following apply:
- Patient
- They have been diagnosed JIA but older than 18 years old.
- Unable to speak and understand English. B) Healthcare professionals
- HCP with insufficient experience in JIA management.
- They have less than two years of managing/treating JIA patients.
- They have worked in this field but have stopped for two years or more.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Najmeh Zare
Oxford, Oxfordshire, ox3obp
Sarah Quinton, Dr, +44 (0) 1865 485694, sequinton@brookes.ac.uk
About this study
"Physical activity and diet in children and young people with arthritis" A qualitative study of exploring stake holder's experiences.
Juvenile Idiopathic Arthritis (JIA) is the most common type of arthritis in children under the age of 16. The disease and its therapeutic management can cause serious long-term complications, which affect general activities and quality of life. The lack of specific guidelines for safe physical activity and appropriate management of any nutritional deficit aiming our study to find out your views and opinions about the needs of children and young people with juvenile idiopathic arthritis. We want to improve our knowledge about the impact of physical activity and eating habit on juvenile idiopathic arthritis and we want to develop a tool to help evaluate care. Few studies targeting quality of life and wellbeing in children adolescent populations have adopted the diet and physical activity perspective or approaches, consequently, this research project will help to address this gap through:
- Interview: to look at young people's current experiences with JIA as well as their parents/caregivers and health care professionals. Study findings will provide a snapshot of the current experiences of participants, helping to improve our knowledge about JIA, physical activity, and diet. Qualitative studies exploring people perspectives on their experiences, when collected systematically, adds valuable depth, insight and understanding into the issues related to JIA not possible through quantitative methodologies. This study uses a qualitative approach known as framework methodology to understand stakeholder's experience of what helps and what hinders improving the quality of life in children and young adult with JIA. 21-30 stakeholders will be recruited in Oxford UK, to take part in individual semi-structured guided interviews lasting approximately one hour. Participant responses will be transcribed by the chief investigator and analysed to extract themes that will answer the research question.
- Delphi study: which aims to develop a diet and physical activity intervention for children and young adult with JIA.
Read the detailed description
"Physical activity and diet in children and young people with arthritis" A qualitative study of exploring stake holder's experiences.
Juvenile Idiopathic Arthritis (JIA) is the most common type of arthritis in children under the age of 16. The disease and its therapeutic management can cause serious long-term complications, which affect general activities and quality of life. The lack of specific guidelines for safe physical activity and appropriate management of any nutritional deficit aiming our study to find out your views and opinions about the needs of children and young people with juvenile idiopathic arthritis. We want to improve our knowledge about the impact of physical activity and eating habit on juvenile idiopathic arthritis and we want to develop a tool to help evaluate care. Few studies targeting quality of life and wellbeing in children adolescent populations have adopted diet and physical activity perspective or approaches, consequently this research project will help to address this gap through:
- Systematic review: to evaluate current evidence about diet, health and health related quality of life in children and young adult with JIA.
- Interview: to look at young people's current experiences with JIA as well as their parents/caregivers and health care professionals. Study findings will provide a snapshot of current experiences of participants, helping to improve our knowledge about JIA, physical activity, and diet. Qualitative studies exploring people perspectives on their experiences, when collected systematically, adds valuable depth, insight and understanding into the issues related to JIA not possible through quantitative methodologies. This study uses a qualitative approach known as framework methodology to understand stakeholder's experience of what helps and what hinders improving the quality of life in children and young adult with JIA. 21-30 stakeholders will be recruited in Oxford UK, to take part in individual semi-structured guided interviews lasting approximately one hour. Participant responses will be transcribed by the chief investigator (PhD student) and analysed to extract themes that will answer the research question.
- Delphi study: which aims to develop diet and physical activity intervention for children and young adult with JIA.
This protocol covers the second and third approaches only (interview and Delphi).
- Conditions
- Juvenile Idiopathic Arthritis
- Keywords
- Juvenile idiopathic arthritis, children, young people, health-related quality of life, diet, physical activity
- Medical subject headings
- Arthritis, Juvenile, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
study one interviews
views and opinions of participants
Measured: one hour
Secondary outcomes (1)
study two Delphi
consensus of views and opinions
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start1 May 2021
- Primary completion1 May 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oxford Brookes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Najmeh Zare, Oxford Brookes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04903067
- Sponsor's protocol ID
- 110611
- Acronym
- JIA
- Status last verified
- May 2021
- First submitted
- 21 May 2021
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation Into the Relationship Between Dietary Intake and Health-related Quality of Life in Children and Young People With Juvenile Idiopathic Arthritis
- ClinicalTrials.gov ID
- NCT04903067
- Acronym / sponsor ID
- JIA / 110611
- Conditions
- Juvenile Idiopathic Arthritis
- Keywords
- Juvenile idiopathic arthritis, children, young people, health-related quality of life, diet, physical activity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Oxford Brookes UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 26 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"Physical activity and diet in children and young people with arthritis" A qualitative study of exploring stake holder's experiences.
Juvenile Idiopathic Arthritis (JIA) is the most common type of arthritis in children under the age of 16. The disease and its therapeutic management can cause serious long-term complications, which affect general activities and quality of life. The lack of specific guidelines for safe physical activity and appropriate management of any nutritional deficit aiming our study to find out your views and opinions about the needs of children and young people with juvenile idiopathic arthritis. We want to improve our knowledge about the impact of physical activity and eating habit on juvenile idiopathic arthritis and we want to develop a tool to help evaluate care. Few studies targeting quality of life and wellbeing in children adolescent populations have adopted the diet and physical activity perspective or approaches, consequently, this research project will help to address this gap through:
- Interview: to look at young people's current experiences with JIA as well as their parents/caregivers and health care professionals. Study findings will provide a snapshot of the current experiences of participants, helping to improve our knowledge about JIA, physical activity, and diet. Qualitative studies exploring people perspectives on their experiences, when collected systematically, adds valuable depth, insight and understanding into the issues related to JIA not possible through quantitative methodologies. This study uses a qualitative approach known as framework methodology to understand stakeholder's experience of what helps and what hinders improving the quality of life in children and young adult with JIA. 21-30 stakeholders will be recruited in Oxford UK, to take part in individual semi-structured guided interviews lasting approximately one hour. Participant responses will be transcribed by the chief investigator and analysed to extract themes that will answer the research question.
- Delphi study: which aims to develop a diet and physical activity intervention for children and young adult with JIA.
Detailed description
"Physical activity and diet in children and young people with arthritis" A qualitative study of exploring stake holder's experiences.
Juvenile Idiopathic Arthritis (JIA) is the most common type of arthritis in children under the age of 16. The disease and its therapeutic management can cause serious long-term complications, which affect general activities and quality of life. The lack of specific guidelines for safe physical activity and appropriate management of any nutritional deficit aiming our study to find out your views and opinions about the needs of children and young people with juvenile idiopathic arthritis. We want to improve our knowledge about the impact of physical activity and eating habit on juvenile idiopathic arthritis and we want to develop a tool to help evaluate care. Few studies targeting quality of life and wellbeing in children adolescent populations have adopted diet and physical activity perspective or approaches, consequently this research project will help to address this gap through:
- Systematic review: to evaluate current evidence about diet, health and health related quality of life in children and young adult with JIA.
- Interview: to look at young people's current experiences with JIA as well as their parents/caregivers and health care professionals. Study findings will provide a snapshot of current experiences of participants, helping to improve our knowledge about JIA, physical activity, and diet. Qualitative studies exploring people perspectives on their experiences, when collected systematically, adds valuable depth, insight and understanding into the issues related to JIA not possible through quantitative methodologies. This study uses a qualitative approach known as framework methodology to understand stakeholder's experience of what helps and what hinders improving the quality of life in children and young adult with JIA. 21-30 stakeholders will be recruited in Oxford UK, to take part in individual semi-structured guided interviews lasting approximately one hour. Participant responses will be transcribed by the chief investigator (PhD student) and analysed to extract themes that will answer the research question.
- Delphi study: which aims to develop diet and physical activity intervention for children and young adult with JIA.
This protocol covers the second and third approaches only (interview and Delphi).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Nuffield Orthopaedic Centre Oxford, Usual referral clinic.
Key inclusion criteria (16 listed)
- A) Patients
- Parent/Carer
- parent or caregiver of a child with JIA.
- Willing and able to give informed consent for their own and their child's participation (if the child is under 16 years of age).
- Having the access to telephone/video call for those who wish to have distance interview.
Key exclusion criteria (7 listed)
- Patient
- They have been diagnosed JIA but older than 18 years old.
- Unable to speak and understand English. B) Healthcare professionals
- HCP with insufficient experience in JIA management.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
study one interviews
Time frame: one hour
views and opinions of participants
1 secondary outcome
study two Delphi
Time frame: one hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Juvenile Idiopathic Arthritis, run by Oxford Brookes University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Najmeh Zare, phd student (+4401865483293, 18106168@brookes.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
study one interviews (time frame: one hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2021.