Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06305936
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-02-27
Brief Title:
Feasibility Study Plant Based Diet to Patients With Rheumatoid Arthritis
Sponsor:
Bispebjerg Hospital
Organization:
Bispebjerg Hospital
Study Overview
Official Title:
The Feasibility and Acceptability of a Plant-Based Diet in People With Rheumatoid Arthritis - A Randomized Feasibility Study
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PLATE
Brief Summary:
In this feasibility study our primary goal is to assess the practicality of implementing a plant-based food diet intervention for individuals with rheumatoid arthritis RA The intervention consists of three key components 1 Educational materials videos 2 Participation in a cooking workshop introducing plant-based meals complete with recipes and 3 Daily delivery of plant-based dinner meals over a four-week period This comprehensive investigation covers the testing of recruitment procedures randomization intervention elements outcome assessments and participant retention
Adopting a daily plant-based diet involves introducing several new plant-based foods and making adjustments to the existing diets of patients with RA Consequently the feasibility study will also aim to explore the acceptability of the intervention and whether a full-scale RCT is practically possible
Adopting a daily plant-based diet involves introducing several new plant-based foods and making adjustments to the existing diets of patients with RA Consequently the feasibility study will also aim to explore the acceptability of the intervention and whether a full-scale RCT is practically possible
Detailed Description:
Rheumatoid arthritis RA is a common chronic autoimmune disease requiring lifelong pharmacological treatment and causing significant burden to the patient and society Evidence has suggested that it is important that patients take an active role in their self-management to improve their overall health and quality of life Effective self-management strategies often involve changes in lifestyle We have previously conducted a lifestyle intervention study to reduce sedentary behavior and increase physical activity in 150 patients with RA An individually tailored intervention motivating patients to self-manage their arthritis by reducing sedentary behavior and replacing it with light-intensity physical activity reduced disease activity eg levels of pain and fatigue Nutrition may be another important part of self-management strategies in patients with RA Emerging evidence suggests that an anti-inflammatory diet may reduce disease activity and improve quality of life among patients with RA3 Compared to a diet including animal foods a Plant-Based Diet PBD is believed to include less of the pro-inflammatory and more of the anti-inflammatory ingredients and thus may have the potential to reduce disease activity in patients with RA
Our overall and long-term aim is to test and evaluate the effect of a PBD intervention on disease activity in patients with RA in a later randomized controlled trial RCT As a first step towards this we wish to investigate strengths and limitations of the planned intervention which introduces a PBD to patients with RA
Thus in a feasibility study we aim to investigate the feasibility of the intervention including recruitment procedures randomization intervention elements outcome assessments and retention Following a daily PBD will involve inclusion of several new plant-based foods and changes in earlier diets for patients with RA As such the feasibility study will also aim to investigate acceptability of the intervention including how people with RA respond to the intervention elements and how a PBD affect their daily lives eg how easy is it to prepare plant-based foods how desirable is it to eat and how does it affect digestion Ultimately the findings from this feasibility study will provide crucial insights into whether a full-scale randomized controlled trial RCT designed to evaluate the effects of a 100 plant-based diet on patients with RA is a feasible and realistic undertaking
Our overall and long-term aim is to test and evaluate the effect of a PBD intervention on disease activity in patients with RA in a later randomized controlled trial RCT As a first step towards this we wish to investigate strengths and limitations of the planned intervention which introduces a PBD to patients with RA
Thus in a feasibility study we aim to investigate the feasibility of the intervention including recruitment procedures randomization intervention elements outcome assessments and retention Following a daily PBD will involve inclusion of several new plant-based foods and changes in earlier diets for patients with RA As such the feasibility study will also aim to investigate acceptability of the intervention including how people with RA respond to the intervention elements and how a PBD affect their daily lives eg how easy is it to prepare plant-based foods how desirable is it to eat and how does it affect digestion Ultimately the findings from this feasibility study will provide crucial insights into whether a full-scale randomized controlled trial RCT designed to evaluate the effects of a 100 plant-based diet on patients with RA is a feasible and realistic undertaking
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None