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Lifestyle Intervention in Overweight/Obese Chronic Low Back Pain (CLBP) Patients: an International Multi-center RCT

Study acronym: BO2WL
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 11 months later Apr 2026 → Apr 2028
See other at-risk trials from Vrije Universiteit Brussel

Record History

  1. Notable Primary completion pushed from Apr 2026 to Apr 2028
    • Study completion pushed from Nov 2026 to Nov 2028
    • Site contacts updated at 2 of 2 sites
    v6
  2. Minor Re-verified, no change to tracked fieldsv5
  3. Notable Primary completion date: Apr 2025 to Apr 2026
    • Study completion date: Nov 2025 to Nov 2026
    v4
  4. Minor Site contacts updated at 2 of 2 sitesv3
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 2023 to Apr 13, 2023
    • Site details revised at 2 of 2 sites
    v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05811624
Lead Sponsor Vrije Universiteit Brussel
Collaborators: Bern University of Applied Sciences, University of Applied Sciences and Arts of Southern Switzerland
Conditions
(from sponsor)
Overweight or Obesity, Chronic Low-back Pain
Related terms Obesity, Overweight
Enrollment 252 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov