Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jun 30, 2025
Date Accepted: Dec 4, 2025
Biopsychosocial Determinants, Diet Quality, Gastrointestinal Health, and Disease Activity in Adults with Rheumatoid Arthritis: Method/ Study Design.
ABSTRACT
Background:
Rheumatoid arthritis (RA) causes pain, fatigue, joint deformity, disability, and an increased risk for serious sequela, often despite of treatment in 1.3 million Americans. RA is affected by numerous biopsychosocial determinants, which greatly complicates treatment, including altered efficacy.
Objective:
The purpose of this study is to examine associations between individual biopsychosocial determinants, diet quality, gastrointestinal (GI) health, and disease activity in adults with RA.
Methods:
This cross-sectional, descriptive study will include 96 adults with RA. Individual biopsychosocial factors will be measured with a demographic survey and direct measures. The Arizona Food Frequency Questionnaire will measure dietary intake for the past 6 months, and Healthy Eating Index-2020 scores will be calculated with this data. The Automated Self-Administered 24-hour diet recall will measure recent dietary intake. Fecal analyses for gut microbiome diversity/composition and fecal calprotectin, an inflammatory biomarker, will measure current GI health. Disease activity will be measured via the Health Assessment Questionnaire-Disability Index and pain scale, Disease Activity Score of 28 Joints, and hematology results (C-reactive protein and erythrocyte sedimentation rate). In addition to descriptive statistics, hierarchical linear regression will be used to examine hypothesized associations between diet quality, GI health, and disease activity. We believe that individual biopsychosocial determinants will be associated with diet quality, which will be indirectly associated with disease activity via gut microbiome diversity and level of GI inflammation in adults with RA.
Results:
Recruitment and study participation are expected to begin in September 2025 and will be completed by May 31, 2026. As of May 31, 2025, recruitment sites have been identified, study materials have been prepared, and student assistants have been trained.
Conclusions:
Our findings will have broad implications for understanding consequences of diet for individuals with RA. More specifically, our results will also inform future interventional research and be an important step towards understand these complicated relationships to improve the health-related quality of life for those with RA. Details of our research plan can provide methodological resources for other RA researchers. Research results have the potential to improve communication between rheumatology providers and patients, and we will use the results to inform the development of an R21 National Institute of Health grant: a pilot study to include a dietary intervention (via meal kit to address disparities) to support a healthy GI tract and decrease RA inflammation.
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