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

June 21, 2023 updated by: University Medical Centre Ljubljana
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1231
        • Recruiting
        • University Medical Centre Ljubljana
        • Contact:
        • Sub-Investigator:
          • Jernej Pajek, PhD
        • Sub-Investigator:
          • Jana Kodrič, PhD
        • Sub-Investigator:
          • Bernarda Logar Zakrajšek, PhD
        • Sub-Investigator:
          • Špela Bogataj, PhD
        • Sub-Investigator:
          • Andreja Marn, PhD
        • Principal Investigator:
          • Katja Kurnik Mesarič

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Body Mass Index (BMI)
Time Frame: baseline, 4 months, 7 months, 12 months
derived from the mass and height of a person
baseline, 4 months, 7 months, 12 months
Change in Proteinuria
Time Frame: baseline, 4 months, 7 months, 12 months
daily proteinuria exceeding 200 mg protein per g creatinine in urine
baseline, 4 months, 7 months, 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Waist circumference
Time Frame: baseline, 4 months, 7 months, 12 months
in centimeters
baseline, 4 months, 7 months, 12 months
Change in Body Fat Percentage
Time Frame: baseline, 4 months, 7 months, 12 months
measured with bioelectrical impedance analysis
baseline, 4 months, 7 months, 12 months
Change in Cholesterol
Time Frame: baseline, 4 months, 7 months, 12 months
LDL Cholesterol level
baseline, 4 months, 7 months, 12 months
Change in Systolic and Diastolic Blood Pressure
Time Frame: baseline, 4 months, 7 months, 12 months
pressure of circulating blood against the walls of blood vessels
baseline, 4 months, 7 months, 12 months
Change in Blood Sugar
Time Frame: baseline, 4 months, 7 months, 12 months
blood sugar concentration - measure of glucose concentrated in the blood
baseline, 4 months, 7 months, 12 months
Chanhe in Glycated Haemoglobin
Time Frame: 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.
baseline, 4 months, 7 months, 12 months
Change in Depression
Time Frame: 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.
baseline, 4 months, 7 months, 12 months
Change in Anxiety
Time Frame: 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.
baseline, 4 months, 7 months, 12 months
Change in Quality of Life measure
Time Frame: 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.
baseline, 4 months, 7 months, 12 months
Risk Factors for Eating Disorders
Time Frame: 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.
baseline, 4 months, 7 months, 12 months
Personality Traits
Time Frame: 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.
baseline
General Self-Efficacy
Time Frame: 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.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Medical Centre Ljubljana

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Slovenian Research Agency

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • L3-KKM-MR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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