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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05927337
• Other study ID #: L3-KKM-MR
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2023
• Source: University Medical Centre Ljubljana
• Contact: Katja Kurnik Mesaric
• Phone: +38640722080
• Email: katja.mesaric21[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Obesity
• Overweight
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
Slovenia	University Medical Centre Ljubljana	Ljubljana

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana	Slovenian Research Agency

Country where clinical trial is conducted

Slovenia, 

References & Publications (13)

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. — View Citation

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 Jun 2;132:103654. doi: 10.1016/j.brat.2020.103654. Online ahead of print. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Body Mass Index (BMI)	derived from the mass and height of a person	baseline, 4 months, 7 months, 12 months
Primary	Change in Proteinuria	daily proteinuria exceeding 200 mg protein per g creatinine in urine	baseline, 4 months, 7 months, 12 months
Secondary	Change in Waist circumference	in centimeters	baseline, 4 months, 7 months, 12 months
Secondary	Change in Body Fat Percentage	measured with bioelectrical impedance analysis	baseline, 4 months, 7 months, 12 months
Secondary	Change in Cholesterol	LDL Cholesterol level	baseline, 4 months, 7 months, 12 months
Secondary	Change in Systolic and Diastolic Blood Pressure	pressure of circulating blood against the walls of blood vessels	baseline, 4 months, 7 months, 12 months
Secondary	Change in Blood Sugar	blood sugar concentration - measure of glucose concentrated in the blood	baseline, 4 months, 7 months, 12 months
Secondary	Chanhe in Glycated Haemoglobin	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
Secondary	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.	baseline, 4 months, 7 months, 12 months
Secondary	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.	baseline, 4 months, 7 months, 12 months
Secondary	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.	baseline, 4 months, 7 months, 12 months
Secondary	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.	baseline, 4 months, 7 months, 12 months
Secondary	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.	baseline
Secondary	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.	baseline