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

Primary Purpose

Chronic Kidney Diseases, Obesity, Overweight

Status
Recruiting
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy (CBT) for managing Obesity
Sponsored by
University Medical Centre Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring Obesity, Chronic KIdney Disease, Overweight, Cognitive Behavioral Therapy, Weight loss, Weight maintenance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University Medical Centre LjubljanaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cognitive Behavioral Therapy for managing Obesity

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Body Mass Index (BMI)
derived from the mass and height of a person
Change in Proteinuria
daily proteinuria exceeding 200 mg protein per g creatinine in urine

Secondary Outcome Measures

Change in Waist circumference
in centimeters
Change in Body Fat Percentage
measured with bioelectrical impedance analysis
Change in Cholesterol
LDL Cholesterol level
Change in Systolic and Diastolic Blood Pressure
pressure of circulating blood against the walls of blood vessels
Change in Blood Sugar
blood sugar concentration - measure of glucose concentrated in the blood
Chanhe in Glycated Haemoglobin
est shows an average of the blood sugar level over the past 90 days and represents a percentage.
Change in Depression
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
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
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
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
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
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.

Full Information

First Posted
May 30, 2023
Last Updated
June 21, 2023
Sponsor
University Medical Centre Ljubljana
Collaborators
Slovenian Research Agency
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1. Study Identification

Unique Protocol Identification Number
NCT05927337
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Medical Centre Ljubljana
Collaborators
Slovenian Research Agency

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases, Obesity, Overweight
Keywords
Obesity, Chronic KIdney Disease, Overweight, Cognitive Behavioral Therapy, Weight loss, Weight maintenance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
The nature of the intervention (Cognitive Behavioral Therapy) makes it impossible to mask interventions assigned.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Therapy for managing Obesity
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy (CBT) for managing Obesity
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Body Mass Index (BMI)
Description
derived from the mass and height of a person
Time Frame
baseline, 4 months, 7 months, 12 months
Title
Change in Proteinuria
Description
daily proteinuria exceeding 200 mg protein per g creatinine in urine
Time Frame
baseline, 4 months, 7 months, 12 months
Secondary Outcome Measure Information:
Title
Change in Waist circumference
Description
in centimeters
Time Frame
baseline, 4 months, 7 months, 12 months
Title
Change in Body Fat Percentage
Description
measured with bioelectrical impedance analysis
Time Frame
baseline, 4 months, 7 months, 12 months
Title
Change in Cholesterol
Description
LDL Cholesterol level
Time Frame
baseline, 4 months, 7 months, 12 months
Title
Change in Systolic and Diastolic Blood Pressure
Description
pressure of circulating blood against the walls of blood vessels
Time Frame
baseline, 4 months, 7 months, 12 months
Title
Change in Blood Sugar
Description
blood sugar concentration - measure of glucose concentrated in the blood
Time Frame
baseline, 4 months, 7 months, 12 months
Title
Chanhe in Glycated Haemoglobin
Description
est shows an average of the blood sugar level over the past 90 days and represents a percentage.
Time Frame
baseline, 4 months, 7 months, 12 months
Title
Change in Depression
Description
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.
Time Frame
baseline, 4 months, 7 months, 12 months
Title
Change in Anxiety
Description
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.
Time Frame
baseline, 4 months, 7 months, 12 months
Title
Change in Quality of Life measure
Description
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.
Time Frame
baseline, 4 months, 7 months, 12 months
Title
Risk Factors for Eating Disorders
Description
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.
Time Frame
baseline, 4 months, 7 months, 12 months
Title
Personality Traits
Description
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.
Time Frame
baseline
Title
General Self-Efficacy
Description
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.
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katja Kurnik Mesarič
Phone
+38640722080
Email
katja.mesaric21@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jernej Pajek, PhD
Organizational Affiliation
Department of Nephrology, University Medical Centre Ljubljana, Ljubljana, Slovenia.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jadranka Buturovič Ponikvar, PhD
Organizational Affiliation
Department of Nephrology, University Medical Centre Ljubljana, Ljubljana, Slovenia.
Official's Role
Study Chair
Facility Information:
Facility Name
University Medical Centre Ljubljana
City
Ljubljana
ZIP/Postal Code
1231
Country
Slovenia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katja Kurnik Mesarič
Phone
+38640722080
Email
katja.kurnik.mesaric@kclj.si
First Name & Middle Initial & Last Name & Degree
Jernej Pajek, PhD
First Name & Middle Initial & Last Name & Degree
Jana Kodrič, PhD
First Name & Middle Initial & Last Name & Degree
Bernarda Logar Zakrajšek, PhD
First Name & Middle Initial & Last Name & Degree
Špela Bogataj, PhD
First Name & Middle Initial & Last Name & Degree
Andreja Marn, PhD
First Name & Middle Initial & Last Name & Degree
Katja Kurnik Mesarič

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
It is planned to publish it on the repository of University of Ljubljana. Personal data will not be provided, participants will be encrypted and unrecognizable.
IPD Sharing Time Frame
After the study will be finished
IPD Sharing Access Criteria
Not fully decided yet
Citations:
PubMed Identifier
11684524
Citation
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Results Reference
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32683134
Citation
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Results Reference
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33782940
Citation
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Results Reference
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Citation
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PubMed Identifier
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Cognitive-Behavioral Therapy for Managing Obesity in People With Chronic Kidney Disease

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