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Research project

Lifestyle Intervention Trial in Early knee osteoarthritis (LITE)

Status: Ongoing (April 2021 - December 2024)

The (cost-)effectiveness of a combined lifestyle intervention in overweight and obese patients with knee osteoarthritis in primary care.

What we do

About our project

Obesity is an important risk factor for knee osteoarthritis (OA). Hence, weight loss is recommended in many international guidelines for the treatment of overweight or obese patients with knee OA. Especially in the early stage of the disease, weight loss is important to prevent further clinical and structural progression. Since 2019, general practitioners (GP) can refer eligible patients to a combined lifestyle intervention (GLI) focused on exercise, nutrition, and behavioral change. However, GPs scarcely refer patients with knee OA because of the unfamiliarity with the intervention, unawareness of the target group with OA, and lack of scientific evidence on the (cost-)effectiveness. The aim of this study is to determine the (cost-)effectiveness of a combined lifestyle intervention in early knee OA patients in primary care.

Multidisciplinary lifestyle interventions with a focus on diet and exercise show large potential for the treatment of knee OA. However, there is still uncertainty on the cost-effectiveness and effectiveness of the combined lifestyle intervention (GLI) in overweight or obese patients with early stage of knee OA in comparison with usual care. Also, for successful implementation of the lifestyle program insight into perceived facilitating factors and barriers, as in individual and environmental determinants are required.

We hypothesize that a combined lifestyle intervention added to usual care is more effective in weight reduction resulting in greater improvements of knee complaints and prevent structural progression compared to usual care only.

A total of 234 patients aged between 45 and 70 years, a BMI of 25 kg/m2 or higher, diagnosis of clinical knee OA (according to NICE guidelines), and a first presentation at their general practitioner with knee complaints within the previous 12 months will be included. Participants will be randomly allocated to either the combined lifestyle intervention program in combination with usual care or usual care only. All participants will be sent 3-monthly questionnaires and invited for a physical examination, blood sampling, and MRI assessment at baseline and after 24-month follow-up. The analysis will be performed using an intention-to-treat approach.

Our research focus

Primary outcomes
The primary outcomes include a 5 kg or 5% weight reduction at 24 months follow-up, clinical progression (decrease in monthly mean pain intensity during the last month using 11-point NRS), and structural progression on MRI at 24 months follow-up (MOAKS). For the cost-effectiveness analysis, societal costs over 24 months using the medical consumption and productivity cost questionnaire (iMCQ and iPCQ) will be evaluated.

Secondary outcomes
Secondary outcome measures include physical function and health outcomes including HbA1c levels, cholesterol, inflammatory markers, and proteomic biomarkers. Patients’ reported severity of knee pain and activity limitations will be evaluated with the Knee injury and Osteoarthritis Outcome Score (KOOS), the severity of intermittent and constant osteoarthritis pain (ICOAP), the global rating of change (GRoC), Patient Acceptable Symptom State (PASS), and health-related quality of life measured with the EQ-5D-5L. Lifestyle and nutrition will be assessed using the Short Questionnaire to Assess Health-enhancing physical activity (SQUASH), physical activity during work and leisure (FORSS), and nutrient intake with a 3-day dietary record. General health status, co-morbidities, and psychosocial factors are measured.

Funds & Grants

ZonMw (5550003207) and ReumaNederland (ZNW 20-501).


Internal collaborations

  • Department of Internal Medicine
  • Department of Rheumatology

External collaborations

  • Department of Health Sciences, Vrije Universiteit Amsterdam
  • Bewegen naar Gezondheid, Hogeschool Rotterdam
  • Diëtistenpraktijk HRC, https://dietistenpraktijkhrc.nl/

Our team

Dr. M. van Middelkoop (co-promotor), m.vanmiddelkoop@erasmusmc.nl
MSc. N.E.J. Jansen, n.jansen@erasmusmc.nl
Dr. A. Feleus, a.feleus@hr.nl
Dr. D. Schiphof, d.schiphof@erasmusmc.nl
Dr. E.H.G. Oei, e.oei@erasmusmc.nl
Dr. E.S. de Kiewit - van Eijk, e.vaneijk@erasmusmc.nl
G. van der Hoek, gerrit.fysioplus@gmail.com
J. van Teeffelen, jolande.vanteeffelen@dietistenpraktijkhrc.nl
Dr. J.B.J. van Meurs, j.vanmeurs@erasmusmc.nl
Prof. dr. J.E. Bosmans, j.e.bosmans@vu.nl
Dr. J. Runhaar, j.runhaar@erasmusmc.nl
Prof. dr. S.M.A. Bierma-Zeinstra (promotor), s.bierma-zeinstra@erasmusmc.nl

Contact address for the project: litestudie@erasmusmc.nl.