Cognitive-Behavioral Therapy for Weight Management in Chronic Kidney Disease
Cognitive-Behavioral Therapy for Managing Obesity in People With Chronic Kidney Disease
This study tests if Cognitive-Behavioral Therapy can help people with obesity and chronic kidney disease lose weight and improve their health better than regular diet and exercise advice.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Centre Ljubljana Academic / other |
| Locations | 1 site (Ljubljana) |
| Trial ID | NCT05927337 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Cognitive-Behavioral Therapy (CBT) in promoting weight loss and maintaining weight in patients with obesity and chronic kidney disease. Participants will be randomly assigned to either receive CBT or standard dietary and physical activity counseling. The study aims to determine if those receiving CBT achieve greater weight loss and reduced proteinuria compared to those in the control group. The intervention focuses on changing dysfunctional eating patterns through a collaborative therapeutic relationship.
Who should consider this trial
Good fit: Ideal candidates include adults with chronic kidney disease (stages 2 to 4) and obesity, characterized by a BMI over 30 kg/m2 or specific waist circumference measurements.
Not a fit: Patients with acute psychiatric illnesses, dementia, or other serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to significant weight loss and improved kidney function for patients with chronic kidney disease.
How similar studies have performed: Previous studies have shown that cognitive-behavioral approaches can be effective in managing obesity, suggesting potential success for this intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients with chronic kidney disease (proteinuric form) from stage 2 to stage 4 (oGF 60 to 15 ml/min/1.73m2); * with or without associated type 2 diabetes mellitus; * with a body mass index greater than 30 kg/m2 or waist circumference greater than 94 cm (men) or 80 cm (women); * who have an estimated daily proteinuria exceeding 200 mg protein per g urinary creatinine. Exclusion Criteria: * acute psychiatric illness or chronic, poorly managed psychiatric illness; * dementia; * bioimpedance findings of low lean body mass index below that expected for age and sex (or presence of any other sarcopenic obesity criteria); * active chronic inflammatory disease (e.g. active vasculitis, SLE, rheumatoid arthritis) or active cancer; * active nephrotic syndrome; * NYHA grade 3 or 4 heart failure; * spontaneous weight loss of 5% or more in the last 6-month period; * receiving induction immunosuppression therapy for autoimmune renal disease (receiving maintenance immunosuppression therapy for no retention); * any other clinical factor that puts the patient at risk with regard to metabolic stability and daily energy expenditure.
Where this trial is running
Ljubljana
- University Medical Centre Ljubljana — Ljubljana, Slovenia (Recruiting)
Study contacts
- Study coordinator: Katja Kurnik Mesarič
- Email: katja.mesaric21@gmail.com
- Phone: +38640722080
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.