Weight Reduction in CLBP

August 18, 2026 updated by: Malfliet Anneleen, Vrije Universiteit Brussel

The Added Value of a Behavioral Weight Reduction Program to Blended Rehabilitation in Patients With Chronic Low Back Pain: A Randomized Clinical Trial

We will recruit overweight/ obese participants between the age of 18 and 65 with chronic nonspecific low back pain . The participants will be randomly assigned to one of two interventions (each lasting 10 weeks). All interventions will be delivered in a blended format and will be a combination of online education material and face-to-face sessions with a physical therapist. The first group (experimental intervention) will receive a behavioral weight reduction program combined with pain neuroscience education plus cognition-targeted exercise therapy. Participants in the second group (control intervention) will receive pain neuroscience education and cognition-targeted exercise therapy alone. Allocation to the groups will be at random. Participants and assessors will be blinded for group allocation. The primary outcomes is pain intensity. Secondary outcomes include other pain related outcomes, body composition, physical activity, sedentary behavior, dietary intake and function.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
      • Brussels, Belgium
  • Netherlands
      • Rotterdam, Netherlands
        • Recruiting
        • Rotterdam University of Applied Sciences
        • Contact:
          • Lennard Voogt, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Overweight (BMI ≥ 25 kg/m2) or obese (BMI ≥ 30 kg/m2) with chronic low back pain
  • Non-specific low back pain for at least 3 months' duration
  • Currently seeking care for low back pain
  • Native Dutch speaker
  • Access to internet and computer/tablet/smartphone

Exclusion Criteria:

  • Leg pain of 7 or higher (on a maximum of 10) on a numeric rating scale
  • Evidence of specific spinal pathology (e.g., hernia, spinal stenosis, spondylolisthesis, infection, spinal fracture or malignancy)
  • Evidence of a severe underlying comorbidity (e.g. diabetes, cardiovascular problems, metabolic diseases)
  • BMI ≥ 40 kg/m2
  • Being pregnant or given birth in the preceding year
  • Currently receiving dietary or exercise interventions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental intervention
10 weeks blended therapy delivered using a blended approach. The blended (online and on site) therapy consists of instructive video's, challenges to complete, 1-on-1 sessions with the therapist, online quizzes, online booklets, and online diaries/workbooks. . The experimental group will receive a behavioral weight reduction program combined with pain neuroscience education plus cognition-targeted exercise therapy. The combined therapy will adhere to guidelines for patient-centered care
Behavioral: Pain Neuroscience Education
Increase pain coping skills and educating the patients that pain is in the brain, and that hypersensitivity of the central nervous system rather than local tissue damage contributes to their symptoms.
Other Names:
  • Pain Education
Behavioral: Cognition-targeted exercise therapy
Daily (physical) activity and exercise therapy. To confront the patient with movements and activities that are feared, avoided and/or painful using a gradual and cognition-targeted approach.
Behavioral: Behavioral weight reduction program
Changes in diet, behavior and a physical exercise to reach weight loss. It will include a lifestyle approach, incorporating behavioral theories and constructs to assist and facilitate healthy energy balance related behavior.
Active Comparator: Control intervention
Identically to the experimental intervention, the therapy is provided in a blended format within 10 weeks. Also identical to the experimental intervention, the control intervention will adhere to guidelines for patient-centered care. The control group will receive pain neuroscience education in combination with cognition-targeted exercise therapy alone.
Behavioral: Pain Neuroscience Education
Increase pain coping skills and educating the patients that pain is in the brain, and that hypersensitivity of the central nervous system rather than local tissue damage contributes to their symptoms.
Other Names:
  • Pain Education
Behavioral: Cognition-targeted exercise therapy
Daily (physical) activity and exercise therapy. To confront the patient with movements and activities that are feared, avoided and/or painful using a gradual and cognition-targeted approach.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Brief Pain inventory (BPI)
Time Frame: Change from baseline to 6 months (T3) after therapy completion
Questionnaire for assessing clinical pain
Change from baseline to 6 months (T3) after therapy completion
Brief Pain inventory (BPI)
Time Frame: Difference between groups at 6 months (T3) after therapy completion
Questionnaire for assessing clinical pain
Difference between groups at 6 months (T3) after therapy completion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Brief Pain inventory (BPI)
Time Frame: Baseline assessment (T0)
Questionnaire for assessing clinical pain
Baseline assessment (T0)
Brief Pain inventory (BPI)
Time Frame: T1 assessment directly post treatment (i.e. 10 weeks after baseline)
Questionnaire for assessing clinical pain
T1 assessment directly post treatment (i.e. 10 weeks after baseline)
Brief Pain inventory (BPI)
Time Frame: T2-assessment 3 months after therapy completion
Questionnaire for assessing clinical pain
T2-assessment 3 months after therapy completion
Brief Pain inventory (BPI)
Time Frame: T3-assessment 6 months after therapy completion
Questionnaire for assessing clinical pain
T3-assessment 6 months after therapy completion
Central sensitization inventory (CSI)
Time Frame: Baseline Assessment (T0)
Questionnaire to asses self-reported signs of central sensitization and its overlapping symptoms.
Baseline Assessment (T0)
Central sensitization inventory (CSI)
Time Frame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
Questionnaire to asses self-reported signs of central sensitization and its overlapping symptoms.
T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
Central sensitization inventory (CSI)
Time Frame: T2-assessment 3 months after therapy completion
Questionnaire to asses self-reported signs of central sensitization and its overlapping symptoms.
T2-assessment 3 months after therapy completion
Central sensitization inventory (CSI)
Time Frame: T3-assessment 6 months after therapy completion
Questionnaire to asses self-reported signs of central sensitization and its overlapping symptoms.
T3-assessment 6 months after therapy completion
TANITA Bio-electrical Impedance Analyzer
Time Frame: Baseline assessment (T0)
Body weight measurement used to calculate BMI (= weight[kg] / height[m]²)
Baseline assessment (T0)
TANITA Bio-electrical Impedance Analyzer
Time Frame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
Body weight measurement used to calculate BMI (= weight[kg] / height[m]²)
T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
TANITA Bio-electrical Impedance Analyzer
Time Frame: T3-assessment 6 months after therapy completion
Body weight measurement used to calculate BMI (= weight[kg] / height[m]²)
T3-assessment 6 months after therapy completion
SECA wall-fixed SECA wall-fixed stadiometer
Time Frame: Baseline measurement
Body height measurement used to calculate BMI (= weight[kg] / height[m]²)
Baseline measurement
SECA wall-fixed SECA wall-fixed stadiometer
Time Frame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
Body height measurement used to calculate BMI (= weight[kg] / height[m]²)
T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
SECA wall-fixed SECA wall-fixed stadiometer
Time Frame: T3-assessment 6 months after therapy completion
Body height measurement used to calculate BMI (= weight[kg] / height[m]²)
T3-assessment 6 months after therapy completion
TANITA MC-780SMA Bio-electrical Impedance Analyzer - body fat
Time Frame: Baseline
Body composition measurement - body fat
Baseline
TANITA MC-780SMA Bio-electrical Impedance Analyzer - body fat
Time Frame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
Body composition measurement - body fat
T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
TANITA MC-780SMA Bio-electrical Impedance Analyzer - body fat
Time Frame: T3-assessment 6 months after therapy completion
Body composition measurement - body fat
T3-assessment 6 months after therapy completion
TANITA MC-780SMA Bio-electrical Impedance Analyzer - fat free mass
Time Frame: Baseline
Body composition measurement - fat free mass
Baseline
TANITA MC-780SMA Bio-electrical Impedance Analyzer - fat free mass
Time Frame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
Body composition measurement - fat free mass
T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
TANITA MC-780SMA Bio-electrical Impedance Analyzer - fat free mass
Time Frame: T3-assessment 6 months after therapy completion
Body composition measurement - fat free mass
T3-assessment 6 months after therapy completion
TANITA MC-780SMA Bio-electrical Impedance Analyzer - hydration status
Time Frame: Baseline
Body composition measurement - hydration status
Baseline
TANITA MC-780SMA Bio-electrical Impedance Analyzer - hydration status
Time Frame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
Body composition measurement - hydration status
T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
TANITA MC-780SMA Bio-electrical Impedance Analyzer - hydration status
Time Frame: T3-assessment 6 months after therapy completion
Body composition measurement - hydration status
T3-assessment 6 months after therapy completion
Food Frequency Questionnaire
Time Frame: Baseline
Self report questionnaire to asses dietary intake
Baseline
Food Frequency Questionnaire
Time Frame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
Self report questionnaire to asses dietary intake
T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
Food Frequency Questionnaire
Time Frame: T2-assessment 3 months after therapy completion
Self report questionnaire to asses dietary intake
T2-assessment 3 months after therapy completion
Food Frequency Questionnaire
Time Frame: T3-assessment 6 months after therapy completion
Self report questionnaire to asses dietary intake
T3-assessment 6 months after therapy completion
International Physical Activity Questionnaire (IPAQ)
Time Frame: Baseline
Self report questionnaire to asses physical activity
Baseline
International Physical Activity Questionnaire (IPAQ)
Time Frame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
Self report questionnaire to asses physical activity
T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
International Physical Activity Questionnaire (IPAQ)
Time Frame: T2-assessment 3 months after therapy completion
Self report questionnaire to asses physical activity
T2-assessment 3 months after therapy completion
International Physical Activity Questionnaire (IPAQ)
Time Frame: T3-assessment 6 months after therapy completion
Self report questionnaire to asses physical activity
T3-assessment 6 months after therapy completion
Sedentary Behavior Questionnaire of Busschaert et a
Time Frame: Baseline
Self report questionnaire to asses sedentary behavior
Baseline
Sedentary Behavior Questionnaire of Busschaert et a
Time Frame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
Self report questionnaire to asses sedentary behavior
T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
Sedentary Behavior Questionnaire of Busschaert et a
Time Frame: T2-assessment 3 months after therapy completion
Self report questionnaire to asses sedentary behavior
T2-assessment 3 months after therapy completion
Sedentary Behavior Questionnaire of Busschaert et a
Time Frame: T3-assessment 6 months after therapy completion
Self report questionnaire to asses sedentary behavior
T3-assessment 6 months after therapy completion
The Short Form Health Survey-36 items (SF-36)
Time Frame: Baseline
Self report questionnaire to evaluate functional status and well-being or quality of life
Baseline
The Short Form Health Survey-36 items (SF-36)
Time Frame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
Self report questionnaire to evaluate functional status and well-being or quality of life
T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
The Short Form Health Survey-36 items (SF-36)
Time Frame: T2-assessment 3 months after therapy completion
Self report questionnaire to evaluate functional status and well-being or quality of life
T2-assessment 3 months after therapy completion
The Short Form Health Survey-36 items (SF-36)
Time Frame: T3-assessment 6 months after therapy completion
Self report questionnaire to evaluate functional status and well-being or quality of life
T3-assessment 6 months after therapy completion
Fear avoidance Beliefs Questionnaire
Time Frame: Baseline
Self report questionnaire to evaluate fear avoidance beliefs. Total score: 0 - 96 (min-max) Work Subscore: 0 - 66 (min-max) Physical Activity Subscore: 0 - 30 (min-max) Higher scores indicate more fear, pain and disability.
Baseline
Fear avoidance Beliefs Questionnaire
Time Frame: T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
Self report questionnaire to evaluate fear avoidance beliefs. Total score: 0 - 96 (min-max) Work Subscore: 0 - 66 (min-max) Physical Activity Subscore: 0 - 30 (min-max) Higher scores indicate more fear, pain and disability.
T1-assessment directly post-treatment (i.e. 10 weeks after baseline)
Fear avoidance Beliefs Questionnaire
Time Frame: T2-assessment 3 months after therapy completion
Self report questionnaire to evaluate fear avoidance beliefs. Total score: 0 - 96 (min-max) Work Subscore: 0 - 66 (min-max) Physical Activity Subscore: 0 - 30 (min-max) Higher scores indicate more fear, pain and disability.
T2-assessment 3 months after therapy completion
Fear avoidance Beliefs Questionnaire
Time Frame: T3-assessment 6 months after therapy completion
Self report questionnaire to evaluate fear avoidance beliefs. Total score: 0 - 96 (min-max) Work Subscore: 0 - 66 (min-max) Physical Activity Subscore: 0 - 30 (min-max) Higher scores indicate more fear, pain and disability.
T3-assessment 6 months after therapy completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vrije Universiteit Brussel

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Rotterdam University of Applied Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B.U.N. 1432021000411

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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