The Effects of Combined Lifestyle Intervention (CLI) in Patients With Inflammatory Bowel Disease (IBD)

NCT05725369 | Unknown

• 1 other identifier: 2022-16137
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Inflammatory Bowel Diseases

Keywords

lifestyle; diet; combined lifestyle intervention; exercise

Outcome Measures

Primary Outcomes (5)

• Decrease in bodyweight

  Measured in kilograms

  2 years

• Decrease in BMI

  Measures in mg/kg2

  2 years

• Decrease in waist circumference

  Measured in centimeters

  2 years

• Decrease in fat percentage

  Measured in percentages

  2 years

• Quality of life

  EQ-5D-5L score

  2 years

Secondary Outcomes (3)

• Adherence

  2 years

• Willingness

  2 years

• IBD related adverse events

  2 yera

Interventions

Combined Lifestyle Intervention (CLI) BEHAVIORAL

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Radboud University Medical Center: lead

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Motor Activity

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Behavior

Study Officials

• Marjolijn Duijvestein, MD PhD

  Radboud University Medical Center (Radboudumc)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dorien Oomkens, MD

CONTACT

+31650084590; dorien.oomkens@radboudumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: February 13, 2023
• Study Start: February 1, 2023
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: February 13, 2023

Record last verified: 2023-01