Cognitive-Behavioral Therapy for Managing Obesity in People With Chronic Kidney Disease

Sponsor

University Medical Centre Ljubljana (Other)

Overall Status

Recruiting

CT.gov ID

NCT05927337

Collaborator

Slovenian Research Agency (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Diseases Obesity Overweight	Behavioral: Cognitive Behavioral Therapy (CBT) for managing Obesity	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Masking Description:

The nature of the intervention (Cognitive Behavioral Therapy) makes it impossible to mask interventions assigned.

Primary Purpose:

Treatment

Official Title:

Cognitive-Behavioral Therapy for Managing Obesity in People With Chronic Kidney Disease

Actual Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Aug 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cognitive Behavioral Therapy for managing Obesity Participants will be enrolled in a 4-month programme of cognitive behavioural therapy for obesity management. The programme is described in more detail in the annex. The programme will consist of 12 individual sessions, with weekly sessions for the first eight weeks and bi-monthly sessions for the following eight weeks. Treatment as usual: participants will receive three sessions with a dietician to receive basic information on appropriate diet, energy deficit and nutrition plan and three sessions with a kinesiologist to receive advice on physical activity.	Behavioral: Cognitive Behavioral Therapy (CBT) for managing Obesity Patients included in the intervention group will be treated with a tailored cognitive behavioural therapy programme for obesity management. The programme is designed and adapted from the Individualised Cognitive Behavioural Therapy for Obesity Management programme (Dalle Grave et al., 2018), which is divided into six content modules aimed at weight loss and weight maintenance. For the purpose of the research, an abbreviated programme will be designed and used, and the content modules will remain the same as in the original version of the programme.
No Intervention: Control group Treatment as usual: participants will receive three sessions with a dietician to receive basic information on appropriate diet, energy deficit and nutrition plan and three sessions with a kinesiologist to receive advice on physical activity.

Arm

Intervention/Treatment

Experimental: Cognitive Behavioral Therapy for managing Obesity

Participants will be enrolled in a 4-month programme of cognitive behavioural therapy for obesity management. The programme is described in more detail in the annex. The programme will consist of 12 individual sessions, with weekly sessions for the first eight weeks and bi-monthly sessions for the following eight weeks. Treatment as usual: participants will receive three sessions with a dietician to receive basic information on appropriate diet, energy deficit and nutrition plan and three sessions with a kinesiologist to receive advice on physical activity.

Behavioral: Cognitive Behavioral Therapy (CBT) for managing Obesity

Patients included in the intervention group will be treated with a tailored cognitive behavioural therapy programme for obesity management. The programme is designed and adapted from the Individualised Cognitive Behavioural Therapy for Obesity Management programme (Dalle Grave et al., 2018), which is divided into six content modules aimed at weight loss and weight maintenance. For the purpose of the research, an abbreviated programme will be designed and used, and the content modules will remain the same as in the original version of the programme.

No Intervention: Control group

Treatment as usual: participants will receive three sessions with a dietician to receive basic information on appropriate diet, energy deficit and nutrition plan and three sessions with a kinesiologist to receive advice on physical activity.

Outcome Measures

Primary Outcome Measures

Change in Body Mass Index (BMI) [baseline, 4 months, 7 months, 12 months]
derived from the mass and height of a person
Change in Proteinuria [baseline, 4 months, 7 months, 12 months]
daily proteinuria exceeding 200 mg protein per g creatinine in urine

Secondary Outcome Measures

Change in Waist circumference [baseline, 4 months, 7 months, 12 months]
in centimeters
Change in Body Fat Percentage [baseline, 4 months, 7 months, 12 months]
measured with bioelectrical impedance analysis
Change in Cholesterol [baseline, 4 months, 7 months, 12 months]
LDL Cholesterol level
Change in Systolic and Diastolic Blood Pressure [baseline, 4 months, 7 months, 12 months]
pressure of circulating blood against the walls of blood vessels
Change in Blood Sugar [baseline, 4 months, 7 months, 12 months]
blood sugar concentration - measure of glucose concentrated in the blood
Chanhe in Glycated Haemoglobin [baseline, 4 months, 7 months, 12 months]
est shows an average of the blood sugar level over the past 90 days and represents a percentage.
Change in Depression [baseline, 4 months, 7 months, 12 months]
Measured with Beck Depression Inventory; scores 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression.
Change in Anxiety [baseline, 4 months, 7 months, 12 months]
Measured with The State-Trait Anxiety Inventory. The total score ranges from 0-63. The following guidelines are recommended for the interpretation of scores: 0-9, normal or no anxiety; 10-18, mild to moderate anxiety; 19-29, moderate to severe anxiety; and 30-63, severe anxiety.
Change in Quality of Life measure [baseline, 4 months, 7 months, 12 months]
Measured with SF-36v2®. The SF-36v2® Health Survey measures functional health and well-being from the patient's perspective with questions that span eight health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health. To score the SF-36, scales are standardized with a scoring algorithm or by the SF-36v2 scoring software to obtain a score ranging from 0 to 100. Higher scores indicate better health status, and a mean score of 50 has been articulated as a normative value for all scales.
Risk Factors for Eating Disorders [baseline, 4 months, 7 months, 12 months]
Measured with Eating disorder Examination Questionnaire (EDEQ-6). EDE-Q is a 28-item self-report questionnaire. The EDE-Q is scored using a 7-point, forced-choice rating scale (0-6) with scores of 4 or higher indicative of clinical range. The subscale and global scores reflect the severity of eating disorder psychopathology.
Personality Traits [baseline]
Measured with Big Five Questionnaire BFQ. The BFQ was designed to assess the constellation of traits defined by the Five Factor Theory of Personality. It consist of 132 items using 5-point ratings (1 = very false for me to 5 = very true for me). It has 5 sub-scales (neuroticism, extraversion, openness, agreeableness, and conscientiousness). Higher score means a more pronounced trait.
General Self-Efficacy [baseline]
Measured with General Self-Efficacy Scale GSE. GSE scores range from 10 to 40, where the higher the score, the greater the individual's generalised self-efficacy belief.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Medical Centre Ljubljana	Ljubljana		Slovenia	1231

Sponsors and Collaborators

University Medical Centre Ljubljana
Slovenian Research Agency

Investigators

Study Director: Jernej Pajek, PhD, Department of Nephrology, University Medical Centre Ljubljana, Ljubljana, Slovenia.
Study Chair: Jadranka Buturovič Ponikvar, PhD, Department of Nephrology, University Medical Centre Ljubljana, Ljubljana, Slovenia.