NCT06339957

Brief Summary

This study aims to collect information on rheumatology patients' dietary habits, autoimmune disease activity, dietary changes, disease symptom improvements, and perceptions on their dietary habits and how it affects their autoimmune disease. The main objective is to see if rheumatology patients change their dietary habits after their diagnosis of an autoimmune disease and if it subjectively improved their disease symptoms. It will also look at rheumatology patients' expectations for their rheumatologist when it comes to dietary advice and what resources they used to choose their new dietary habits. The study also seeks to measure the interest that rheumatology patients have in pursuing dietary changes as a means of controlling the symptoms of their autoimmune disease. It is expected that patients who changed their eating habits to healthier diets such as a Mediterranean diet would report less severe autoimmune disease symptoms. There are limited dietary recommendations for the management of many rheumatological diseases, so this study seeks to assess rheumatology patients' willingness to try dietary modifications, what improvements they had, and why they decide to make these changes in light of limited information.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 1, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

December 6, 2024

Status Verified

December 1, 2024

Enrollment Period

1.3 years

First QC Date

March 25, 2024

Last Update Submit

December 3, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • To determine how diet habits and activity affects autoimmune diseases using the proper statistical tests for the data set such as t-test and ANOVA.

    4 months

Secondary Outcomes (1)

  • To identify if rheumatology patients change their dietary habits after their diagnosis of an autoimmune disease and if it subjectively improved their disease symptoms.

    4 months

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The participants are expected to come from the established rheumatology patient census at the UCF Health Clinics. The research team will identify potential participants via pre-screening the electronic medical records for the inclusion criteria.

You may qualify if:

  • Adults (over 18 years old) patients
  • established UCF Health patients
  • diagnosed with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, dermatomyositis/polymyositis, Sjogren's Syndrome, systemic lupus erythematous, scleroderma, osteoarthritis, or fibromyalgia.

You may not qualify if:

  • UCF Students, Faculty or Staff
  • Children or Young Adults Under the age of 18
  • Adults over 65
  • Pregnant Women
  • Prisoners
  • Adults to Unable to Consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCF Health Clinics

Orlando, Florida, 32827, United States

RECRUITING

MeSH Terms

Conditions

Feeding BehaviorCollagen DiseasesAutoimmune DiseasesArthritis, RheumatoidArthritis, PsoriaticSpondylitis, AnkylosingDermatomyositisSjogren's SyndromeScleroderma, DiffuseFibromyalgia

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorConnective Tissue DiseasesSkin and Connective Tissue DiseasesImmune System DiseasesArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesAxial SpondyloarthritisAnkylosisPolymyositisMyositisMuscular DiseasesNeuromuscular DiseasesNervous System DiseasesXerostomiaSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesDry Eye SyndromesLacrimal Apparatus DiseasesEye DiseasesScleroderma, Systemic

Study Officials

  • Neha Bhanusali, MD

    University of Central Florida

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amoy Fraser, PhD, CCRP, PMP

CONTACT

Erica Martin, B.S.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2024

First Posted

April 1, 2024

Study Start

March 1, 2024

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

December 6, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations