Comparing the effectiveness of an online interactive lifestyle intervention with general nutrition recommendations in rheumatoid arthritis and psoriatic arthritis patients with a low disease activity from a clinical, patient's as well as a societal point of view

HEalthy Living in Inflammatory Arthritis (HELIA): a randomized controlled trial comparing efficacy between an interactive, online lifestyle intervention program and general nutrition recommendations

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN21290281

Enrollment

200

Registered

2023-06-13

Start date

2023-03-21

Completion date

Unknown

Last updated

2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis or psoriatic arthritis according to respectively 2010 criteria or CASPAR criteria (Symmetrical) joint inflammation with or without auto-antibodies (i.e. rheumatoid factor and/or anti-citrullinated protein antibodies) or psoriasis Musculoskeletal Diseases

Interventions

Patients have a personal responsibility for the implementation of the interactive online lifestyle program or general nutrition recommendations into their own lives. All food products are available at

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diagnosed with rheumatoid arthritis (RA) or psoriatic arthritis (PsA), according to respectively the American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) 2010 criteria for RA and ClASsification for Psoriatic ARthritis (CASPAR) criteria 2. Low disease activity, defined as Disease Activity Score (DAS28)2.6 or Disease Activity in PSoriatic Arthritis (DAPSA) 5 3. Stable disease-modifying antirheumatic drug (DMARD) dosage in the past 6 months 4. Age =18 years

Exclusion criteria

Exclusion criteria: 1. Unable to understand, speak and write in Dutch 2. Vegan diet/lifestyle or following a specific (medical) diet 3. Pregnant or nursing (lactating) women 4. History of bariatric surgery 5. Underlying metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions which in the opinion of the Investigator places the patient at unacceptable risk for participation in a lifestyle intervention program

Design outcomes

Primary

Measure	Time frame
1. The proportional difference in DAS28/DAPSA remission and/or those who were able to taper their medication without having a disease flare after 12 months of follow-up between inflammatory arthritis patients who followed the lifestyle intervention program and those who received general nutrition recommendations. Disease activity in rheumatoid arthritis (RA) and psoriatic arthritis (PsA) patients is respectively measured with the DAS28 and DAPSA. 2. The incremental cost-effectiveness ratio (ICER), which is the ratio of the difference in costs to incremental benefits between the lifestyle intervention program and general nutrition recommendations. For the cost-effectiveness analysis the researchers will calculate the Quality Adjusted Life Years (QALYs) and total costs. Direct costs are the costs of treatment and medical consumption, whereas indirect costs are costs due to loss of productivity (i.e. presenteeism and absenteeism). Medication costs are calculated from doses reported in the patients’ case records, valued according to the Dutch College of Health Insurance. Medical consumption, including duration of hospitalizations and admission diagnosis are recorded with the iMTA medical consumption questionnaire at baseline, 3 months, 6 months, 12 months and 24 months. The researchers will use the Dutch average length of stay by diagnosis if the duration of hospitalization is unknown. Indirect costs include not fully functioning, sick leave and reduction in work time. Worker productivity is measured with the Work Productivity and Activity Impairment (WPAI) questionnaire, which includes presentism and absenteeism at baseline, 3 months, 6 months, 12 months and 24 months.	—

Measure

Time frame

1. The proportional difference in DAS28/DAPSA remission and/or those who were able to taper their medication without having a disease flare after 12 months of follow-up between inflammatory arthritis patients who followed the lifestyle intervention program and those who received general nutrition recommendations. Disease activity in rheumatoid arthritis (RA) and psoriatic arthritis (PsA) patients is respectively measured with the DAS28 and DAPSA. 2. The incremental cost-effectiveness ratio (ICER), which is the ratio of the difference in costs to incremental benefits between the lifestyle intervention program and general nutrition recommendations. For the cost-effectiveness analysis the researchers will calculate the Quality Adjusted Life Years (QALYs) and total costs. Direct costs are the costs of treatment and medical consumption, whereas indirect costs are costs due to loss of productivity (i.e. presenteeism and absenteeism). Medication costs are calculated from doses reported in the patients’ case records, valued according to the Dutch College of Health Insurance. Medical consumption, including duration of hospitalizations and admission diagnosis are recorded with the iMTA medical consumption questionnaire at baseline, 3 months, 6 months, 12 months and 24 months. The researchers will use the Dutch average length of stay by diagnosis if the duration of hospitalization is unknown. Indirect costs include not fully functioning, sick leave and reduction in work time. Worker productivity is measured with the Work Productivity and Activity Impairment (WPAI) questionnaire, which includes presentism and absenteeism at baseline, 3 months, 6 months, 12 months and 24 months.

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Secondary

Measure	Time frame
1. Self-reported disease activity is measured with the RAPID-3 at baseline, 3 months, 6 months, 12 months and 24 months 2. General health is measured with a visual analogue scale at baseline, 3 months, 6 months, 12 months and 24 months 3. Pain is measured with a visual analogue scale at baseline, 3 months, 6 months, 12 months and 24 months 4. Morning stiffness is measured with a 10-point Likert scale at baseline, 3 months, 6 months, 12 months and 24 months 5. Fatigue is measured with a visual analogue scale at baseline, 3 months, 6 months, 12 months and 24 months 6. Functional ability is measured with the health assessment questionnaire (HAQ) at baseline, 3 months, 6 months, 12 months and 24 months 7. Quality of life is measured with the EQ-5D-5L at baseline, 3 months, 6 months, 12 months and 24 months 8. Quality of sleep is measured with the Medical Outcomes Study sleep scale (MOS-ss) at baseline, 3 months, 6 months, 12 months and 24 months 9. Perceived stress is measured with the Perceived Stress Scale at baseline, 3 months, 6 months, 12 months and 24 months 10. Physical activity is measured with the Dutch Standard for Healthy Exercise questionnaire at baseline, 3 months, 6 months, 12 months and 24 months 11. Diet compliance is measured with a self-developed questionnaire consisting of 17 questions at baseline, 3 months, 6 months, 12 months and 24 months	—

Measure

Time frame

1. Self-reported disease activity is measured with the RAPID-3 at baseline, 3 months, 6 months, 12 months and 24 months 2. General health is measured with a visual analogue scale at baseline, 3 months, 6 months, 12 months and 24 months 3. Pain is measured with a visual analogue scale at baseline, 3 months, 6 months, 12 months and 24 months 4. Morning stiffness is measured with a 10-point Likert scale at baseline, 3 months, 6 months, 12 months and 24 months 5. Fatigue is measured with a visual analogue scale at baseline, 3 months, 6 months, 12 months and 24 months 6. Functional ability is measured with the health assessment questionnaire (HAQ) at baseline, 3 months, 6 months, 12 months and 24 months 7. Quality of life is measured with the EQ-5D-5L at baseline, 3 months, 6 months, 12 months and 24 months 8. Quality of sleep is measured with the Medical Outcomes Study sleep scale (MOS-ss) at baseline, 3 months, 6 months, 12 months and 24 months 9. Perceived stress is measured with the Perceived Stress Scale at baseline, 3 months, 6 months, 12 months and 24 months 10. Physical activity is measured with the Dutch Standard for Healthy Exercise questionnaire at baseline, 3 months, 6 months, 12 months and 24 months 11. Diet compliance is measured with a self-developed questionnaire consisting of 17 questions at baseline, 3 months, 6 months, 12 months and 24 months

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Countries

Netherlands

Contacts

Public ContactPascal, H.P. De Jong

p.h.p.dejong@erasmusmc.nl+31 (0)6 28224368

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 11, 2026