Rheumatoid Arthritis (RA)
Conditions
Keywords
Indian patients, RA India, Protein Intake in Punjab, Household work limitiations
Brief summary
The goal of this clinical trial is to learn if optimised protein intake improves household work capacity and overall functional status in women with rheumatoid arthritis. It will also assess the safety and tolerability of dietary protein supplementation. The main questions it aims to answer are: Does optimised protein intake reduce household work limitations measured by the Household Work Limitations Questionnaire (HOWL-Q)? Does optimised protein intake improve overall functional disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI)? What side effects or tolerability issues do participants experience with dietary protein modification and supplementation? Researchers compared participants receiving structured dietary counselling and protein supplementation (targeting 1.0 g/kg/day) to their baseline protein intake to determine if the intervention improves functional outcomes in women with stable rheumatoid arthritis on disease-modifying antirheumatic drugs.
Interventions
DIETARY_SUPPLEMENTProtein Optimisation through Dietary Counselling and Supplementation
Dietary Protein Optimisation Intervention targeting 1.0 g/kg/day. Two components: (1) Individualised dietary counselling promoting increased protein-rich foods including legumes, soybean, nuts, seeds, eggs, milk, yogurt, paneer, and fish, tailored to cultural dietary preferences and delivered in Hindi, Punjabi, or English; (2) Commercial protein supplementation (whey protein isolate 20-25g/serving or fortified nutritional beverages ≥15g protein/serving) for participants with dietary modification resistance. Administered over 12 weeks. All participants maintained stable disease-modifying antirheumatic drug regimens throughout. Dietary assessment via 3-day recall at baseline and 7-day recall at 12 weeks.
Sponsors
Satguru Partap Singh Hospitals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
This is an open-label, unmasked study. Participants were aware they were receiving dietary counselling and protein supplementation. Care providers administered the intervention openly. Investigators and outcomes assessors were not blinded to group assignment. No blinding was possible due to the nature of the dietary intervention.
Intervention model description
Single-arm prospective intervention study. All 120 women with rheumatoid arthritis received 12-week dietary counselling and protein supplementation targeting 1.0 g/kg/day. Assessments performed at baseline and 12 weeks. Primary outcomes measured using Health Assessment Questionnaire-Disability Index (HAQ-DI) and Household Work Limitations Questionnaire (HOWL-Q). No control group. All participants maintained stable disease-modifying antirheumatic drug regimens throughout.
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
Women aged equal to or more than 18 years with rheumatoid arthritis diagnosed according to American College of Rheumatology/European League Against Rheumatism 2010 criteria
Exclusion criteria
Males Unstable disease requiring DMARD modification during the study period Overlap connective tissue disease Chronic kidney disease stage 3 or above
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Household Work Limitations measured by Household Work Limitations Questionnaire (HOWL-Q) | 12 weeks | Household Work Limitations measured using Household Work Limitations Questionnaire (HOWL-Q). A 41-item instrument assessing functional limitations across five domains: housekeeping, object interaction, care for others, personal motion and transportation, and manual dexterity. Each item scored 0-3; domain scores calculated as highest item score per domain; global HOWL-Q score transformed to 0-10 scale (0=best, 10=worst). Primary outcome: change from baseline to 12 weeks. HOWL-Q captures household-specific functional limitations not measured by generic disability scales (HAQ-DI), directly relevant to women's household responsibilities and quality of life. |
| Change in Overall Functional Disability measured by Health Assessment Questionnaire-Disability Index (HAQ-DI) | 12 weeks | Overall Functional Disability measured using Health Assessment Questionnaire-Disability Index (HAQ-DI). An 8-domain self-report instrument measuring disability across dressing, arising, eating, walking, hygiene, reach, grip, and activities of daily living. Each domain scored 0-3; final score calculated as mean of eight domains (range 0-3), with lower scores indicating better function. Minimally clinically important difference 0.22 points. Primary outcome: change from baseline to 12 weeks. HAQ-DI demonstrates excellent test-retest reliability (intraclass correlation \>0.95) and internal consistency (Cronbach's alpha \>0.90), established as standard functional disability measure in rheumatoid arthritis research. |
Countries
India
Contacts
PRINCIPAL_INVESTIGATORManmeet Singh, MBBS
Satguru Partal Singh Hospitals
Outcome results
None listed