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Chronic Kidney DiseasesNCT05927337

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

A study testing Cognitive Behavioral Therapy (CBT) for managing Obesity in people with Chronic Kidney Diseases and Obesity, run by University Medical Centre Ljubljana at 1 site in Slovenia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Kidney Diseases, Obesity, Overweight
What is being tested?
Cognitive Behavioral Therapy (CBT) for managing Obesity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteSlovenia
Study dates
1 May 2023to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country.

Katja Kurnik Mesarič contact

+38640722080

katja.mesaric21@gmail.com

Slovenia1 site, 1 recruiting

  • University Medical Centre Ljubljana

    Ljubljana, 1231

    Katja Kurnik Mesarič, +38640722080, katja.kurnik.mesaric@kclj.si

    Jernej Pajek, PhD

    Recruiting

Other trials in Slovenia

About this study

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.

Read the 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.
Being tested
Cognitive Behavioral Therapy (CBT) for managing Obesity
Keywords
Obesity, Chronic KIdney Disease, Overweight, Cognitive Behavioral Therapy, Weight loss, Weight maintenance
Medical subject headings
Renal Insufficiency, Chronic, Obesity, Overweight, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Behavioral Therapy (CBT) for managing ObesityBehavioural

    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.

Study groups in NCT05927337
Study groupRoleWhat they receive
Cognitive Behavioral Therapy for managing ObesityExperimentalParticipants 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.
Receives: Behavioral: Cognitive Behavioral Therapy (CBT) for managing Obesity
Control groupNo interventionTreatment 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Body Mass Index (BMI)

    derived from the mass and height of a person

    Measured: baseline, 4 months, 7 months, 12 months

  2. Change in Proteinuria

    daily proteinuria exceeding 200 mg protein per g creatinine in urine

    Measured: baseline, 4 months, 7 months, 12 months

Secondary outcomes (12)

  1. Change in Waist circumference

    in centimeters

    Measured: baseline, 4 months, 7 months, 12 months

  2. Change in Body Fat Percentage

    measured with bioelectrical impedance analysis

    Measured: baseline, 4 months, 7 months, 12 months

  3. Change in Cholesterol

    LDL Cholesterol level

    Measured: baseline, 4 months, 7 months, 12 months

  4. Change in Systolic and Diastolic Blood Pressure

    pressure of circulating blood against the walls of blood vessels

    Measured: baseline, 4 months, 7 months, 12 months

  5. Change in Blood Sugar

    blood sugar concentration - measure of glucose concentrated in the blood

    Measured: baseline, 4 months, 7 months, 12 months

  6. Chanhe in Glycated Haemoglobin

    est shows an average of the blood sugar level over the past 90 days and represents a percentage.

    Measured: baseline, 4 months, 7 months, 12 months

  7. 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.

    Measured: baseline, 4 months, 7 months, 12 months

  8. 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.

    Measured: baseline, 4 months, 7 months, 12 months

  9. 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.

    Measured: baseline, 4 months, 7 months, 12 months

  10. 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.

    Measured: baseline, 4 months, 7 months, 12 months

  11. 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.

    Measured: baseline

  12. 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.

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2023
  2. Study start1 May 2023
  3. Primary completion31 Aug 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05927337
Sponsor's protocol ID
L3-KKM-MR
Status last verified
May 2023
First submitted
30 May 2023
Last updated
3 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Anderson JW, Konz EC, Frederich RC, Wood CL. Long-term weight-loss maintenance: a meta-analysis of US studies. Am J Clin Nutr. 2001 Nov;74(5):579-84. doi: 10.1093/ajcn/74.5.579.

    PubMed 11684524

  • Comsa L, David O, David D. Outcomes and mechanisms of change in cognitive-behavioral interventions for weight loss: A meta-analysis of randomized clinical trials. Behav Res Ther. 2020 Sep;132:103654. doi: 10.1016/j.brat.2020.103654. Epub 2020 Jun 2.

    PubMed 32683134

  • Conley MM, McFarlane CM, Johnson DW, Kelly JT, Campbell KL, MacLaughlin HL. Interventions for weight loss in people with chronic kidney disease who are overweight or obese. Cochrane Database Syst Rev. 2021 Mar 30;3(3):CD013119. doi: 10.1002/14651858.CD013119.pub2.

    PubMed 33782940

  • Dalle Grave R, Calugi S, Bosco G, Valerio L, Valenti C, El Ghoch M, Zini D. Personalized group cognitive behavioural therapy for obesity: a longitudinal study in a real-world clinical setting. Eat Weight Disord. 2020 Apr;25(2):337-346. doi: 10.1007/s40519-018-0593-z. Epub 2018 Oct 10.

    PubMed 30306498

  • Dalle Grave R, Sartirana M, Calugi S. Personalized cognitive-behavioural therapy for obesity (CBT-OB): theory, strategies and procedures. Biopsychosoc Med. 2020 Mar 9;14:5. doi: 10.1186/s13030-020-00177-9. eCollection 2020.

    PubMed 32175002

  • Dalle Grave R, Sartirana M, El Ghoch M, Calugi S. Personalized multistep cognitive behavioral therapy for obesity. Diabetes Metab Syndr Obes. 2017 Jun 1;10:195-206. doi: 10.2147/DMSO.S139496. eCollection 2017.

    PubMed 28615960

  • Dombrowski SU, Knittle K, Avenell A, Araujo-Soares V, Sniehotta FF. Long term maintenance of weight loss with non-surgical interventions in obese adults: systematic review and meta-analyses of randomised controlled trials. BMJ. 2014 May 14;348:g2646. doi: 10.1136/bmj.g2646.

    PubMed 25134100

  • Greaves CJ, Sheppard KE, Abraham C, Hardeman W, Roden M, Evans PH, Schwarz P; IMAGE Study Group. Systematic review of reviews of intervention components associated with increased effectiveness in dietary and physical activity interventions. BMC Public Health. 2011 Feb 18;11:119. doi: 10.1186/1471-2458-11-119.

    PubMed 21333011

  • Jacob A, Moullec G, Lavoie KL, Laurin C, Cowan T, Tisshaw C, Kazazian C, Raddatz C, Bacon SL. Impact of cognitive-behavioral interventions on weight loss and psychological outcomes: A meta-analysis. Health Psychol. 2018 May;37(5):417-432. doi: 10.1037/hea0000576.

    PubMed 29698017

  • Jansen A, Houben K, Roefs A. A Cognitive Profile of Obesity and Its Translation into New Interventions. Front Psychol. 2015 Nov 27;6:1807. doi: 10.3389/fpsyg.2015.01807. eCollection 2015.

    PubMed 26640451

  • Loveman E, Frampton GK, Shepherd J, Picot J, Cooper K, Bryant J, Welch K, Clegg A. The clinical effectiveness and cost-effectiveness of long-term weight management schemes for adults: a systematic review. Health Technol Assess. 2011 Jan;15(2):1-182. doi: 10.3310/hta15020.

    PubMed 21247515

  • Navaneethan SD, Yehnert H, Moustarah F, Schreiber MJ, Schauer PR, Beddhu S. Weight loss interventions in chronic kidney disease: a systematic review and meta-analysis. Clin J Am Soc Nephrol. 2009 Oct;4(10):1565-74. doi: 10.2215/CJN.02250409. Epub 2009 Sep 17.

    PubMed 19808241

  • Wang Y, Chen X, Song Y, Caballero B, Cheskin LJ. Association between obesity and kidney disease: a systematic review and meta-analysis. Kidney Int. 2008 Jan;73(1):19-33. doi: 10.1038/sj.ki.5002586. Epub 2007 Oct 10.

    PubMed 17928825

  • Kurnik Mesaric K, Kodric J, Logar Zakrajsek B, Pernat AM, Bogataj S, Pajek J. Cognitive behavioral therapy for managing obesity in patients with chronic kidney disease: Study protocol for a randomized controlled trial. Contemp Clin Trials Commun. 2023 Nov 21;36:101236. doi: 10.1016/j.conctc.2023.101236. eCollection 2023 Dec.

    PubMed 38074489

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Behavioral Therapy (CBT) for managing Obesity in people with Chronic Kidney Diseases and Obesity, run by University Medical Centre Ljubljana at 1 site in Slovenia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Katja Kurnik Mesarič (+38640722080, katja.mesaric21@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Body Mass Index (BMI) (time frame: baseline, 4 months, 7 months, 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05927337, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.

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