Weight loss and brain training could be the key to beating back pain
NCT ID NCT05811624
First seen Jun 25, 2026 · Last updated Aug 21, 2026 · Updated 3 times
Summary
This study tests whether adding a behavioral weight reduction program (diet, exercise, and behavior changes) to standard pain education and exercise therapy can reduce chronic low back pain in overweight or obese adults. Researchers will compare the combined approach against pain education and exercise alone in 252 participants across multiple countries. The main goal is to see if pain intensity decreases after 12 months, with secondary measures including daily functioning and healthcare use.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- behavioral weight reduction program combined with pain neuroscience education and cognition-targeted exercise therapy
- What this could lead to
- If it works, this could offer a new, non-drug treatment option for chronic low back pain in people who are overweight or obese, potentially reducing pain and healthcare costs.
- What could go wrong
- This is a mid-sized trial (252 people) testing a behavioral intervention, not a drug. Results may vary, and the effect on pain might be modest or not last long-term.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 252 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2023
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Berner Fachhochschule
RECRUITINGBern, 3012, Switzerland
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Vrije Universiteit Brussel
RECRUITINGBrussels, 1090, Belgium
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can an experimental injection help people with obesity shed pounds?