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NCT05070286
Lifestyle Weight Management Program: Interviews and Stakeholder Meetings.
trial testing Observational Study. in Multiple Sclerosis in 45 participants. Status unknown.
31 December 2022
Quick facts
| Lead sponsor | Oxford Brookes University |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 45 |
| Start date | 1 January 2022 |
| Primary completion | 31 December 2022 |
| Estimated completion | 31 December 2022 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Observational Study.
Conditions studied
- Multiple Sclerosis — all drugs for Multiple Sclerosis →
- Neuromyelitis Optica — all drugs for Neuromyelitis Optica →
Sponsor
Oxford Brookes University
Who can join
Adults 10 to 25, any sex, with Multiple Sclerosis or Neuromyelitis Optica. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05070286
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05070286 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Oxford Brookes University
- Last refreshed: 21 January 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05070286.
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