Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-02-27 @ 4:31 PM
Study NCT ID:
NCT05725369
Status:
UNKNOWN
Last Update Posted:
2023-02-13
First Post:
2023-01-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Combined Lifestyle Intervention (CLI) in Patients With Inflammatory Bowel Disease (IBD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-09', 'studyFirstSubmitDate': '2023-01-10', 'studyFirstSubmitQcDate': '2023-02-09', 'lastUpdatePostDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decrease in bodyweight', 'timeFrame': '2 years', 'description': 'Measured in kilograms'}, {'measure': 'Decrease in BMI', 'timeFrame': '2 years', 'description': 'Measures in mg/kg2'}, {'measure': 'Decrease in waist circumference', 'timeFrame': '2 years', 'description': 'Measured in centimeters'}, {'measure': 'Decrease in fat percentage', 'timeFrame': '2 years', 'description': 'Measured in percentages'}, {'measure': 'Quality of life', 'timeFrame': '2 years', 'description': 'EQ-5D-5L score'}], 'secondaryOutcomes': [{'measure': 'Adherence', 'timeFrame': '2 years', 'description': 'Adherence to the CLI (i.e. amount of patients to stop the CLI prematurely)'}, {'measure': 'Willingness', 'timeFrame': '2 years', 'description': 'Willingness to partake in the CLI (and to be referred to the CLI)'}, {'measure': 'IBD related adverse events', 'timeFrame': '2 yera', 'description': 'Incidence of IBD related adverse events during the study period'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lifestyle', 'diet', 'combined lifestyle intervention', 'exercise'], 'conditions': ['Inflammatory Bowel Diseases']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nDuring 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years old;\n* 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;\n* BMI ≥ 30 mg/kg2 or a BMI between 25 and 30 mg/kg2 and an increased risk of diabetes or cardiovascular disease;\n* Patients that are or have been referred to the CLI;\n* Oral informed consent must be obtained and documented in EPIC.\n\nExclusion Criteria:\n\n* 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);\n* If female, the subject is pregnant or lactating;\n* Illiteracy (disability to read and understand Dutch)."}, 'identificationModule': {'nctId': 'NCT05725369', 'acronym': 'GLI-IBD', 'briefTitle': 'The Effects of Combined Lifestyle Intervention (CLI) in Patients With Inflammatory Bowel Disease (IBD)', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'The Effects of Combined Lifestyle Intervention (CLI) in Patients With Inflammatory Bowel Disease (IBD)', 'orgStudyIdInfo': {'id': '2022-16137'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Combined Lifestyle Intervention (CLI)', 'type': 'BEHAVIORAL', 'description': '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.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Dorien Oomkens, MD', 'role': 'CONTACT', 'email': 'dorien.oomkens@radboudumc.nl', 'phone': '+31650084590'}], 'overallOfficials': [{'name': 'Marjolijn Duijvestein, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud University Medical Center (Radboudumc)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}