Clinical trial NCT05927337: Cognitive-Behavioral Therapy for Managing Obesity in People With Chronic Kidney Disease
Official title: Cognitive-Behavioral Therapy for Managing Obesity in People With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Kidney Diseases
Obesity
Overweight
Keywords: Obesity
Chronic KIdney Disease
Overweight
Cognitive Behavioral Therapy
Weight loss
Weight maintenance
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
Collaborators: name: Slovenian Research Agency
First posted: 2023-07-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the study Cognitive-Behavioral Therapy (CBT) for Managing Obesity in People with Chronic Kidney Disease (CKD) the investigators will test whether CBT programme is effective for weight loss and weight maintenance after the treatment programme in patients with obesity, chronic kidney disease and proteinuria. The investigators will test whether subjects randomised to the intervention group and receiving cognitive behavioural therapy can achieve greater weight loss and proteinuria reduction in chronic kidney disease than subjects randomised to the control group and not receiving cognitive behavioural therapy. Both groups of subjects will be counselled by a dietician to improve their diet and reduce excess weight and to kinesiologist for advice on physical activity.

Detailed description: The inclusion of clinical psychological and psychotherapeutic interventions in the management of overweight and obese patients can contribute significantly to the success of lifestyle changes and higher motivation for weight loss. Indeed, cognitive processes play an important role in the maintenance of dysfunctional eating patterns. Cognitive-behavioural therapy and behavioural therapies are widely used in the weight loss process. The starting point of behavioural and cognitive-behavioural therapies is that behaviours are learned and therefore can be unlearned, changed or replaced through a therapeutic process involving a variety of behavioural and cognitive techniques.

Individualised cognitive-behavioural therapy for obesity management has three central goals, namely i) losing and maintaining an appropriate weight, ii) adopting and maintaining a lifestyle that allows for appropriate weight control, and iii) developing a stable mindset about weight control. In the therapeutic process, the therapist develops a collaborative relationship with the patient, in which the patient plays an active role in abandoning unhealthy lifestyle habits and developing more appropriate ones that facilitate the achievement and maintenance of a healthy weight. The approach has been designed for different levels of obesity, is delivered in an individual or group format and includes a preparatory phase (one to two sessions) in which the level of obesity, associated medical and psychological problems are assessed and the patient is engaged in the treatment, followed by a first phase, focused on weight loss, and a second phase, focused on weight maintenance.

The content of the programme includes behavioural strategies to help weight loss and environmental modification, cognitive techniques and techniques to prevent weight regain. The treatment programme will consist of 12 sessions spread over four months. The initial sessions will focus on weight loss, while the later sessions will focus on consolidation or learning strategies for weight maintenance.

Obesity is one of the common health problems encountered by patients with chronic kidney disease. By making lifestyle changes and reducing weight, individuals can achieve a slower disease progression and a better quality of life. Knowledge in this area would be useful for the planning of clinical psychological and medical management of patients with chronic kidney disease and would also shed light on the role of the psychologist in the management of this patient population.

The specific objectives of the study are:

* To investigate the effectiveness of an individualised cognitive behavioural therapy programme for the management of obesity in patients with chronic kidney disease.
* To analyse the association of psychological variables with the effectiveness of a cognitive-behavioural intervention.
* Analysis of the impact of a cognitive behavioural intervention for obesity management on quality of life, depression and anxiety.

Eligibility 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.

Primary outcomes:
measure: Change in Body Mass Index (BMI)
timeFrame: baseline, 4 months, 7 months, 12 months
measure: Change in Proteinuria
timeFrame: baseline, 4 months, 7 months, 12 months
Secondary outcomes:
measure: Change in Waist circumference
timeFrame: baseline, 4 months, 7 months, 12 months
measure: Change in Body Fat Percentage
timeFrame: baseline, 4 months, 7 months, 12 months
measure: Change in Cholesterol
timeFrame: baseline, 4 months, 7 months, 12 months
measure: Change in Systolic and Diastolic Blood Pressure
timeFrame: baseline, 4 months, 7 months, 12 months
measure: Change in Blood Sugar
timeFrame: baseline, 4 months, 7 months, 12 months
measure: Chanhe in Glycated Haemoglobin
timeFrame: baseline, 4 months, 7 months, 12 months
measure: Change in Depression
timeFrame: baseline, 4 months, 7 months, 12 months
measure: Change in Anxiety
timeFrame: baseline, 4 months, 7 months, 12 months
measure: Change in Quality of Life measure
timeFrame: baseline, 4 months, 7 months, 12 months
measure: Risk Factors for Eating Disorders
timeFrame: baseline, 4 months, 7 months, 12 months
measure: Personality Traits
timeFrame: baseline
measure: General Self-Efficacy
timeFrame: baseline
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
Study officials:
affiliation: Department of Nephrology, University Medical Centre Ljubljana, Ljubljana, Slovenia.
name: Jernej Pajek, PhD
role: STUDY_DIRECTOR
affiliation: Department of Nephrology, University Medical Centre Ljubljana, Ljubljana, Slovenia.
name: Jadranka Buturovič Ponikvar, PhD
role: STUDY_CHAIR
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