Feasibility Study: Plant Based Diet to Patients With Rheumatoid Arthritis

NCT06305936 | Recruiting

• 1 other identifier: PLATE H-23042292
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Rheumatoid Arthritis

Keywords

feasibility study; rheumatoid arthritis; plant-based food diet intervention

Outcome Measures

Primary Outcomes (5)

• Evaluation of Feasibility and Intervention Fidelity in Implementing a Plant-Based Food Diet Intervention - Evaluating the feasibilty of included objectively measured outcomes and self-administered questionnaires

  This study aims to evaluate the feasibility of implementing a plant-based food diet (PBD) intervention by assessing participant acceptability and feasibility in achieving desired outcomes. Feasibility testing will involve specific objective outcome assessments, including both objectively measured outcomes and self-administered questionnaires outlined below as secondary outcomes.

  3 months

• Evaluation of Study Acceptance

  This study assesses the acceptability of the study protocol from qualitative methods through focus group interviews, exploring topics such as the effectiveness of food delivery methods and participants' perceptions of the plant-based diet intervention.

  3 months

• Recruitment

  Recruitment rates will be calculated as the proportion of patients randomised/proportion of patients eligible

  3 months

• Retention

  Retention rates will be calculated as the proportion of patients providing the outcomes of interest/proportion of patients randomised

  3 months

• Intervention adherence

  Adherence of intervention protocol will be calculated as the number of received optional elements of the intervention out of the total number of optional intervention elements available

  3 months

Secondary Outcomes (24)

• Disease Activity Score (DAS28)

  3 months

• Fatigue: Bristol Rheumatoid Arthritis Fatigue (BRAF MDQ)

  3 months

• Pain (VAS)

  3 months

• Sleep

  3 months

• Anxiety/depression

  3 months

Study Arms (2)

Intervention group

EXPERIMENTAL

As part of the 4-week intervention in the feasibility study, the intervention group will receive 1) Educational materials (videos) 2) Participation in a cooking workshop with introduction to PBD meals, including recipes, and 3) Daily delivered PBD dinner meal during the four weeks.

Other: Intervention with 100% plant-based diet

Control group

NO INTERVENTION

The control group will be asked to maintain habitual diet and lifestyle. In addition, they will follow the same outcome assessments as the intervention group.

Interventions

Intervention with 100% plant-based diet OTHER

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. The remaining meals during the period are modified by the participant to also adhere to a 100% plant-based composition.

Also known as: Diet intervention

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Disease Activity Score with 28 Joint Counts (DAS28) between 2.0-3.2
• A rheumatoid arthritis diagnosis of minimum 1 year
• Under stable pharmaceutical treatment for at least 4 months and with no planned change in treatment within 8 weeks

You may not qualify if:

• Daily smokers
• Diabetes Mellitus
• Pregnancy / planned pregnancy
• Lactation
• Prednisolone treatment
• DAS28 below 2.0 and above 3.2
• Current dietary habits resembling intervention diet (e.g., 100% plant based diets)
• Participation in other intervention studies or clinical trials via the rheumatology outpatient clinic that will affect their adherence to plant based diets
• Not able to eat ad libitum meals because of e.g., allergy
• Unable to understand the informed consent and study procedures
• Alcohol and/or drug abuse

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• Glostrup University Hospital, Copenhagen: collaborator

Study Sites (2)

Center for Clinical Research and Prevention, BispebjergH

Frederiksberg, DK 2000, Denmark

ACTIVE NOT RECRUITING

The Department of Rheumatology and Spine Diseases, Copenhagen Center for Arthritis Research (COPECARE), Rigshospitalet, Glostrup

Glostrup Municipality, 2600, Denmark

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Methods; Diet, Plant-Based

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Allan Linneberg, Ph.D.

  Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kirsten Schroll Bjørnsbo, Ph.D.

CONTACT

+4520169134; Kirsten.bjoernsbo@regionh.dk

Tanja Thomsen, Ph.D.

CONTACT

+4538163107; Tanja.thomsen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Not possible to blind participants and study staff delivering the intervention to allocation status, whereas all outcome data is planned to be collected by blinded outcome assessors.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Professor, MD, PhD

Model Details: Randomised feasibility study of an intervention group, receiving 100% plant-based diet and a control group

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 12, 2024
• Study Start: February 15, 2024
• Primary Completion: July 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)