NCT05811624Recruiting
Lifestyle Intervention in Overweight/Obese Chronic Low Back Pain (CLBP) Patients: an International Multi-center RCT
Lifestyle Intervention in Overweight/Obese People Suffering From Chronic Low Back Pain: an International Multi-center Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 20 Aug 2026
Brief summary (registry, in English)
Chronic low back pain (CLBP) is the most expensive cause of workrelated disability: it causes the highest number of years lived with disability. The most severe and debilitated CLBP patients often have comorbidities such as overweight and obesity. Despite the growing body of scientific literature pointing towards the close interaction between overweight/obesity and CLBP, few treatment programs for people with CLBP nowadays take overweight into account. Therefore this study will examine the added value of a behavioral weight reduction program (changes in diet, behavior and physical exercise) to current best evidence rehabilitation (pain neuroscience education plus cognition-targeted exercise therapy) for overweight or obese people with CLBP. An international, multicenter randomized controlled trial comparing a behavioral weight reduction program combined with pain neuroscience education and cognition-targeted exercise therapy versus pain neuroscience education and cognition-targeted exercise therapy alone, will be conducted. The primary outcome is pain and the primary endpoint was chosen at 12 months follow-up; secondary outcomes include health care use and daily functioning (see detailed description of outcomes for an overview of all secondary outcomes). If the promising results of the proof of concept study are corroborated, the new intervention will have a high socio-economic impact, including an annual health care cost reduction of €66 million in Switzerland, and €60 million in Flanders, and is expected to increase life expectancy in the long term.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 252 (estimated)
- First submitted
- 14 Mar 2023
- Start date
- 13 Apr 2023
- Primary completion date
- Apr 2028
- Lead sponsor
- Vrije Universiteit Brussel
- Diseases
- Obesity
- NCT number
- NCT05811624
What you commit to
- Study type: Interventional
- Planned participants: 252
- From 13 Apr 2023 to the primary completion date, Apr 2028
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently receiving dietary or exercise interventions or received in the past 6 weeks.
Other illness
- Show evidence of specific spinal pathology based on self-report (e.g., hernia, spi-nal stenosis, spondylolisthesis, infection, spinal fracture or malignancy), or a se-vere underlying comorbidity specific diagnoses that interfere with treatment (e.g., diagnosed diabetes, cardiovascular problems, metabolic diseases)
- Other severe diseases based on current medication intake or being currently treated by a medical doctor for a specific diagnosis, (e.g. diagnosed eating disorders).
Age
- Patients with BMI ≥ 40 kg/m² will be excluded as people being morbid obese are eligible to undergo abdominal surgery. Because BMI may not always correspond to the same body fat percentage in different individuals (e.g., athletic types with higher muscle mass may also have BMIs ≥ 25 km/kg²), each participant's body fat percentage will be measured using the TANITA and compared to the body fat percentage reference values. Participants with exceeding BMI but falling into the healthy fat percentage range (which is sex-, age- and ethnicity dependent will be excluded.
Other
- Pregnant, currently breastfeeding or given birth in preceding year.
- Ongoing problems or cases with insurance companies regarding their back.
Who the study is looking for
- Adults (18 - 65 years)
- Overweight (BMI ≥ 25 kg/m2) or obese (BMI ≥ 30 kg/m2) women and men.
- CLBP (n=252), which is defined as nonspecific low back pain for at least 3 months duration, currently seeking care for low back pain and leg pain not ≥ 7 (on a maximum of 10) on a numeric rating scale.
- Continue usual care 6 weeks prior to (to obtain a steady stat) and during study participation.
- Depending on the country of inclusion: Native Dutch speaker (for Belgium) or Native German speaker (for Switzerland).
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vrije Universiteit Brussel Coordinator of this site? Confirm its status | Brussels | Belgium | Recruiting |
| Berner Fachhochschule Coordinator of this site? Confirm its status | Bern | Switzerland | Recruiting |
Related publications
- Cost of illness analysis in individuals with overweight or obesity and chronic low back pain in the Bern metropolitan area (the BO2WL trial).Front Public Health · 2025 · PMID 41607914
This page is information, not medical advice. Discuss any trial with your doctor.