Lifestyle Weight Management Program: Interviews and Stakeholder Meetings.

NCT05070286 | Unknown

• 1 other identifier: F.02.2019.13
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Background: An assessment by paediatric neurologists specializing in demyelinating conditions brought attention to the rapid weight change seen among patients recently diagnosed with, and receiving therapy for, neuromyelitis optica spectrum disorder (NMOSD) and multiple sclerosis (MS). An overview of the current literature pinpointed weight change as a concern, and identified fatigue and fear as limiting factors for participation in physical activity, with BMI trajectories in this population significantly higher compared to healthy peers. A look at current patient data highlighted extreme NMOSD cases where some patients' weight doubled in two years. There is currently no available research that addresses weight change and management in paediatric MS or NMOSD patients, but there is research to highlight the importance of maintaining health behaviours. The aim of this research is to co-develop a comprehensive lifestyle weight management program for this cohort. Methods: Unpinned by the Medical Research Council guidance for developing complex interventions, this research will involve a fourfold approach. It will build on a previously completed systematic review, and a secondary data analysis of current clinical data regarding weight changes in these populations. Semi-structured interviews will be conducted with patients, parents and clinicians in order to obtain qualitative data regarding the collective perspectives of nutrition, weight change and overall health. A list of factors will be identified and presented in a logic model. A program will then be designed, informed by previously gathered information and will be reviewed by a group of stakeholders via stakeholder meetings. This will output a program design, implementation and evaluation plan which will then be evaluated for feasibility. Recruitment, participation, implementation and adherence to the program will be tested. A patient, public involvement (PPI) approach will be taken, with a PPI panel of experts overseeing and guiding the project for its duration. Results: The results of this research will output a primary version of the lifestyle weight management program for paediatric patients with demyelinating conditions, ready for a feasibility trial.

Conditions

Multiple Sclerosis; Neuromyelitis Optica

Keywords

Paediatric

Outcome Measures

Primary Outcomes (1)

• Lifestyle interviews: Themes and factors.

  The interview phase of this research will output a list of factors reported by patients, parents and clinicians with regards to lifestyle change following their diagnosis. The investigators will measure the factors and themes most frequently identified by the interviewees and will assess themes through thematic analysis. Recruitment will also be assessed as well as overall participant experience.

  6 months from start

Study Arms (3)

Young people with MS and NMOSD

Young people aged 10-25 years, who were diagnosed with MS or NMOSD prior to the age of 18. Semi-structured interviews.

Behavioral: Observational Study.

Parents of young people with MS and NMOSD

Parents of young people aged 10-25 who were diagnosed with MS or NMOSD prior to the age of 18. Semi-Structured Interviews

Behavioral: Observational Study.

Clinicians

Health care practitioners from medical, nursing and AHP backgrounds with at least two years' experience in NMOSD and MS.

Behavioral: Observational Study.

Interventions

Observational Study. BEHAVIORAL

Semi-structured interviews.

Clinicians; Parents of young people with MS and NMOSD; Young people with MS and NMOSD

Eligibility Criteria

• Age: 10 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This study will see a total of 57 participants (some repeated) over the course of phase 1 and phase 3. Phase 1 will include a sample size of n=45: 15 young people, 15 parents and 15 clinicians. Phase 3 will include 4 parent, 4 patient, and 4 clinicians for a total of n=12. As these are rare conditions, with complicated diagnostic criteria, it is difficult to obtain exact national figures; however it is estimated that 200 young people across the UK have relapsing demyelinating syndromes (RDS). This figure includes MS and NMOSD cases, but also includes other such as CID, but only accounts for patients aged 18 and under. It is very difficult to provide an accurate number of patients aged 10-25 with MS or NMOSD who have been diagnosed prior to the age of 18. The three PIC sites associated with this study are part of the national MS and NMOSD services, and there is currently a combined total of 64 MS patients aged 10-18, and 73 NMOSD cases aged 10-18; for a total of n=137.

You may qualify if:

• Patients:
• Age 10-25 years
• Diagnosis of MS or NMOSD (including MOG) prior to 18 years
• Living in England or Wales
• Currently monitored by the JR in Oxford, or GOSH or Evelina in London
• With the capacity to assent/ consent Parents
• Parent of a young person with MS or NMOSD (including MOG)
• Child must have been diagnosed prior to the age of 18
• Living in England or Wales
• With the capacity to consent Clinicians
• Health care practitioner from medical, nursing and AHP backgrounds
• With at least two years' experience working in MS and NMSOD clinics (adult or paediatric).

You may not qualify if:

• Unable to give informed consent
• Unable to communicate or participate safely (as determined by themselves or their parents/carers)

Sponsors & Collaborators

• Oxford Brookes University: lead
• Great Ormond Street Hospital for Children NHS Foundation Trust: collaborator
• Guy's and St Thomas' NHS Foundation Trust: collaborator
• Oxford University Hospitals NHS Trust: collaborator

Study Sites (1)

John Radcliffe Hospital

Oxford, Oxfordshire, OX3 9DU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Neuromyelitis Optica

Interventions

Observation

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Myelitis, Transverse; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Helen Dawes

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: October 7, 2021
• Study Start: January 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 21, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)