Quality of Life, Nutritional Status and Functional Capacity in People With Advanced Chronic Kidney Disease

NCT05072574 | Completed

• 1 other identifier: ACKD
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the clinical response (quality of life, nutritional status, functional capacity, and disease knowledge) of advanced CKD patients who undergo an individualized dietary intervention and a nutritional education program (group workshops) using motivation coaching techniques, compared to controls who receive general hygiene-nutritional education at every visit.

Conditions

Chronic Kidney Diseases

Keywords

Advanced CKD; diet; nutritional education; coaching; quality of life (QoL); nutritional status; functional capacity

Outcome Measures

Primary Outcomes (1)

• Assess the clinical response after the quality of life intervention

  Kidney Disease and Quality of Life test (KDQOL-36). The generic component of the KDQOL-36 (items 1-12) is the SF-12, which allows obtaining 2 general scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The specific component of the KDQOL-36 (items 13-36), allows obtaining the scores of the specific subscales for the disease.

  From baseline to week 12

Secondary Outcomes (37)

• Assess the clinical response after intervention in the management of CKD

  From baseline to week 12

• Assess the clinical response after the intervention in knowledge about the disease

  From baseline to week 12

• BMI (body mass index) changes

  From baseline to week 12

• Change in weight

  From baseline to week 12

• Change in fat free body mass

  From baseline to week 12

Study Arms (2)

Experimental: nutritional education program

EXPERIMENTAL

Specific dietary treatment and follow-up using coaching techniques, supported by new technologies, and will attend a nutritional education program

Other: Specific dietary treatment and follow-up using coaching techniques

Control Group

NO INTERVENTION

Dietary and general lifestyle recommendations

Interventions

Specific dietary treatment and follow-up using coaching techniques OTHER

Intervention group will receive specific dietary treatment and follow-up using coaching techniques, supported by new technologies, and will attend a nutritional education program

Experimental: nutritional education program

Eligibility Criteria

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

You may qualify if:

• \- Patients \>18 years old with advanced CKD (GFR \<30ml/min) starting follow-up in the advanced CKD consulting room of the Malaga University Regional Hospital and who clearly understand the study and give their informed consent.

You may not qualify if:

• Patients presenting any of these conditions:
• Active cancer
• Being already participants of another study that may affect the results
• Pregnancy or possible pregnancy
• Informed consent refusal
• Hospital admission during one month previous to the study
• Severe mental disorders (SMD), prolonged mental disorders involving a high level of disability and social dysfunction, which requires attendance by the mental health and social care network
• Alcohol or any other substance abuse that, in the researcher's opinion, may interfere with the study

Sponsors & Collaborators

• Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud: lead

Study Sites (1)

Hospital Regional Universitario de Málaga

Málaga, 29009, Spain

Location

Related Publications (1)

• Padial M, Rebollo A, Jimenez-Salcedo T, Lopez V, Avesani CM, Lindholm B, Qureshi AR, Olveira G. A Pilot Clinical Trial of a Nutrition Education Program on Quality of Life in CKD. Clin J Am Soc Nephrol. 2025 Oct 1;20(10):1352-1364. doi: 10.2215/CJN.0000000790. Epub 2025 Aug 19.

  PMID: 40828609 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

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

Study Officials

• Gabriel Olveira, MD, PhD

  Hospital Regional Universitario de Málaga - FIMABIS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized in a 1:1 ratio

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: October 11, 2021
• Study Start: April 23, 2021
• Primary Completion: September 30, 2022
• Study Completion: December 31, 2022
• Last Updated: July 20, 2023

Record last verified: 2022-02

Locations

ES (1)