Weight loss and brain training could be the key to beating back pain

NCT ID NCT05811624

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 252 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 65 years

Sex

Anyone

Healthy volunteers

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

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.

Obesity obesity disorder Overweight

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.

  1. The places running it

    2 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Berner Fachhochschule

    RECRUITING

    Bern, 3012, Switzerland

  • Vrije Universiteit Brussel

    RECRUITING

    Brussels, 1090, Belgium

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