Inflammatory Bowel DiseasesGLI-IBDNCT05725369
The Effects of Combined Lifestyle Intervention (CLI) in Patients With Inflammatory Bowel Disease (IBD)
An observational study of Inflammatory Bowel Diseases, run by Radboud University Medical Center.
Trial summary
A single-center observational study to investigate the effects of combined lifestyle intervention (CLI, in Dutch: gecombineerde leefstijlinterventie, GLI) in patients with Inflammatory Bowel Disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Combined Lifestyle Intervention (CLI)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2023to 1 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients ≥ 18 years old with a BMI ≥ 30 mg/kg2 or a BMI between 25 and 30 mg/kg2 and an increased risk of diabetes or cardiovascular disease, who are eligible to be referred to the CLI or have already been referred to the CLI.
Who may be able to join
- Age ≥ 18 years old;
- Diagnosis of IBD (Ulcerative Colitis, Crohn's Disease or IBD-Unclassified) confirmed by clinical, endoscopic, and histological evidence prior to screening as per standard criteria;
- BMI ≥ 30 mg/kg2 or a BMI between 25 and 30 mg/kg2 and an increased risk of diabetes or cardiovascular disease;
- Patients that are or have been referred to the CLI;
- Oral informed consent must be obtained and documented in EPIC.
Who cannot join
- Serious underlying disease other than IBD that in the opinion of the investigator may interfere with the subject's ability to participate fully in the study or would compromise subject safety (such as major neurological disorders, certain orthopedic impairments or any unstable, uncontrolled or severe systemic medical disorder);
- If female, the subject is pregnant or lactating;
- Illiteracy (disability to read and understand Dutch).
Trial locations and contacts
No sites are listed yet.
About this study
A single-center observational study to investigate the effects of combined lifestyle intervention (CLI, in Dutch: gecombineerde leefstijlinterventie, GLI) in patients with Inflammatory Bowel Disease.
Read the detailed description
This is an exploratory observational study of IBD patients ≥ 18 years old with a BMI ≥ 30 mg/kg2 or a BMI between 25 and 30 and an increased risk of diabetes or cardiovascular disease, who are or have been referred to the CLI.
During the 2-year CLI program, fitness measurements take place according to CLI protocol and by the CLI provider: bodyweight, BMI, waist circumference, fat percentage and the EQ-5D-5L are recorded at baseline and 1-year and 2-year timepoints. Whilst patients are offered a CLI referral, willingness to partake will be recorded.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Combined Lifestyle Intervention (CLI)
- Keywords
- lifestyle, diet, combined lifestyle intervention, exercise
- Medical subject headings
- Inflammatory Bowel Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Lifestyle Intervention (CLI)Behavioural
In the Netherlands, the combined lifestyle intervention (CLI, in Dutch: gecombineerde leefstijlinterventie (GLI)) is available for all Dutch citizens with a BMI ≥ 30 mg/kg2 or a BMI between 25 and 30 mg/kg2 and an increased risk of diabetes or cardiovascular disease. The CLI aims to realize health benefits for people with a moderate weight-related health risk and consists of a two-year program with advice and counseling to improve health-related behavior such as physical activity and diet.
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in bodyweight
Measured in kilograms
Measured: 2 years
Decrease in BMI
Measures in mg/kg2
Measured: 2 years
Decrease in waist circumference
Measured in centimeters
Measured: 2 years
Decrease in fat percentage
Measured in percentages
Measured: 2 years
Quality of life
EQ-5D-5L score
Measured: 2 years
Secondary outcomes (3)
Adherence
Adherence to the CLI (i.e. amount of patients to stop the CLI prematurely)
Measured: 2 years
Willingness
Willingness to partake in the CLI (and to be referred to the CLI)
Measured: 2 years
IBD related adverse events
Incidence of IBD related adverse events during the study period
Measured: 2 yera
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start1 Feb 2023 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marjolijn Duijvestein, MD PhD, Principal investigator, Radboud University Medical Center (Radboudumc)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725369
- Sponsor's protocol ID
- 2022-16137
- Acronym
- GLI-IBD
- Status last verified
- Jan 2023
- First submitted
- 10 Jan 2023
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Combined Lifestyle Intervention (CLI) in Patients With Inflammatory Bowel Disease (IBD)
- ClinicalTrials.gov ID
- NCT05725369
- Acronym / sponsor ID
- GLI-IBD / 2022-16137
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- lifestyle, diet, combined lifestyle intervention, exercise
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A single-center observational study to investigate the effects of combined lifestyle intervention (CLI, in Dutch: gecombineerde leefstijlinterventie, GLI) in patients with Inflammatory Bowel Disease.
Detailed description
This is an exploratory observational study of IBD patients ≥ 18 years old with a BMI ≥ 30 mg/kg2 or a BMI between 25 and 30 and an increased risk of diabetes or cardiovascular disease, who are or have been referred to the CLI.
During the 2-year CLI program, fitness measurements take place according to CLI protocol and by the CLI provider: bodyweight, BMI, waist circumference, fat percentage and the EQ-5D-5L are recorded at baseline and 1-year and 2-year timepoints. Whilst patients are offered a CLI referral, willingness to partake will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients ≥ 18 years old with a BMI ≥ 30 mg/kg2 or a BMI between 25 and 30 mg/kg2 and an increased risk of diabetes or cardiovascular disease, who are eligible to be referred to the CLI or have already been referred to the CLI.
Key inclusion criteria (5 listed)
- Age ≥ 18 years old;
- Diagnosis of IBD (Ulcerative Colitis, Crohn's Disease or IBD-Unclassified) confirmed by clinical, endoscopic, and histological evidence prior to screening as per standard criteria;
- BMI ≥ 30 mg/kg2 or a BMI between 25 and 30 mg/kg2 and an increased risk of diabetes or cardiovascular disease;
- Patients that are or have been referred to the CLI;
- Oral informed consent must be obtained and documented in EPIC.
Key exclusion criteria (3 listed)
- Serious underlying disease other than IBD that in the opinion of the investigator may interfere with the subject's ability to participate fully in the study or would compromise subject safety (such as major neurological disorders, certain orthopedic impairments or any unstable, uncontrolled or severe systemic medical disorder);
- If female, the subject is pregnant or lactating;
- Illiteracy (disability to read and understand Dutch).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined Lifestyle Intervention (CLI)In the Netherlands, the combined lifestyle intervention (CLI, in Dutch: gecombineerde leefstijlinterventie (GLI)) is available for all Dutch citizens with a BMI ≥ 30 mg/kg2 or a BMI between 25 and 30 mg/kg2 and an increased risk of diabetes or cardiovascular disease. The CLI aims to realize health benefits for people with a moderate weight-related health risk and consists of a two-year program with advice and counseling to improve health-related behavior such as physical activity and diet. | Behavioural | – |
Primary outcome
Decrease in bodyweight
Time frame: 2 years
Measured in kilograms
Decrease in BMI
Time frame: 2 years
Measures in mg/kg2
Decrease in waist circumference
Time frame: 2 years
Measured in centimeters
Decrease in fat percentage
Time frame: 2 years
Measured in percentages
Quality of life
Time frame: 2 years
EQ-5D-5L score
3 secondary outcomes
Adherence
Time frame: 2 years
Willingness
Time frame: 2 years
IBD related adverse events
Time frame: 2 yera
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marjolijn Duijvestein, MD PhD principal investigator
Radboud University Medical Center (Radboudumc)
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by Radboud University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dorien Oomkens, MD (+31650084590, dorien.oomkens@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in bodyweight (time frame: 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.