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

NCT05927337 | Unknown

• 1 other identifier: L3-KKM-MR
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases; Obesity; Overweight

Keywords

Obesity; Chronic KIdney Disease; Overweight; Cognitive Behavioral Therapy; Weight loss; Weight maintenance

Outcome Measures

Primary Outcomes (2)

• Change in Body Mass Index (BMI)

  derived from the mass and height of a person

  baseline, 4 months, 7 months, 12 months

• Change in Proteinuria

  daily proteinuria exceeding 200 mg protein per g creatinine in urine

  baseline, 4 months, 7 months, 12 months

Secondary Outcomes (12)

• Change in Waist circumference

  baseline, 4 months, 7 months, 12 months

• Change in Body Fat Percentage

  baseline, 4 months, 7 months, 12 months

• Change in Cholesterol

  baseline, 4 months, 7 months, 12 months

• Change in Systolic and Diastolic Blood Pressure

  baseline, 4 months, 7 months, 12 months

• Change in Blood Sugar

  baseline, 4 months, 7 months, 12 months

Study Arms (2)

Cognitive Behavioral Therapy for managing Obesity

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Cognitive Behavioral Therapy (CBT) for managing Obesity BEHAVIORAL

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.

Cognitive Behavioral Therapy for managing Obesity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead
• Slovenian Research Agency: collaborator

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1231, Slovenia

RECRUITING

Related Publications (14)

• 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.

  PMID: 11684524 BACKGROUND

• 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.

  PMID: 32683134 BACKGROUND

• 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.

  PMID: 33782940 BACKGROUND

• 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.

  PMID: 30306498 BACKGROUND

• 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.

  PMID: 32175002 BACKGROUND

• 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.

  PMID: 28615960 BACKGROUND

• 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.

  PMID: 25134100 BACKGROUND

• 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.

  PMID: 21333011 BACKGROUND

• 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.

  PMID: 29698017 BACKGROUND

• 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.

  PMID: 26640451 BACKGROUND

• 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.

  PMID: 21247515 BACKGROUND

• 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.

  PMID: 19808241 BACKGROUND

• 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.

  PMID: 17928825 BACKGROUND

• 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.

  PMID: 38074489 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Obesity; Overweight; Weight Loss

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jernej Pajek, PhD

  Department of Nephrology, University Medical Centre Ljubljana, Ljubljana, Slovenia.

  STUDY DIRECTOR

• Jadranka Buturovič Ponikvar, PhD

  Department of Nephrology, University Medical Centre Ljubljana, Ljubljana, Slovenia.

  STUDY CHAIR

Central Study Contacts

Katja Kurnik Mesarič

CONTACT

+38640722080; katja.mesaric21@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The nature of the intervention (Cognitive Behavioral Therapy) makes it impossible to mask interventions assigned.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: July 3, 2023
• Study Start: May 1, 2023
• Primary Completion: August 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 3, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the study will be finished
• Access Criteria: Not fully decided yet

Locations

SL (1)