Lifestyle Intervention in Overweight/Obese Chronic Low Back Pain (CLBP) Patients: an International Multi-center RCT
- NCT ID
- NCT05811624
- Registry status
- Recruiting
- Study type
- Not specified in the registry data
- Phase
- Not applicable
- Sponsor
- Vrije Universiteit Brussel
Overview
ClinicalTrials.gov lists this study as Recruiting.
Enrollment: 252 participants (Estimated).
What is being studied
No interventions are listed in the registry data.
Who may be eligible
- Ages
- Not specified in the registry data
- Sex
- Not specified in the registry data
- Healthy volunteers accepted
- No
ClinicalTrials.gov lists the following eligibility criteria.
Inclusion Criteria:
* 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).
Exclusion Criteria:
* 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.
* Pregnant, currently breastfeeding or given birth in preceding year.
* Currently receiving dietary or exercise interventions or received in the past 6 weeks.
* 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).
* Ongoing problems or cases with insurance companies regarding their back.
Study locations
2 study locations are listed.
Site recruitment status is not specified in the registry data for these locations.
Countries: Belgium, Switzerland
Sample of listed locations
- Vrije Universiteit Brussel — Brussels, 1090, Belgium — Site recruitment status not specified in the registry data
- Berner Fachhochschule — Bern, 3012, Switzerland — Site recruitment status not specified in the registry data
Study details
- Start date
- April 13, 2023
- Primary completion date
- April 1, 2028
- First posted
- April 13, 2023
Source and update information
- Source
- ClinicalTrials.gov
- NCT ID
- NCT05811624
- Registry last updated
- August 20, 2026
- QualifiedStudies registry data refreshed
- September 21, 2026
View NCT05811624 on ClinicalTrials.gov
Trial information can change. Confirm current study details with the study team or the registry.
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