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

NCT ID: NCT05072574

Last Updated: 2023-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-23
• Study Completion Date: 2022-12-31

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.

Detailed Description

Randomized study including two parallel groups: patients from the advanced chronic kidney disease (CKD) consulting room of the Malaga University Regional Hospital and controls. The main objective is to assess 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.

Both groups will be composed of 54 participants. The control group will be provided general dietary and lifestyle recommendations (standard procedure in the nephrology consulting room), whereas the intervention group will receive treatment and individualized dietary follow-up using coaching techniques, supported by information and communication technologies, and will participate in a nutritional education program composed of four on-line sessions.

Two visits (basal and three months after) will be scheduled during the study to obtain and analyse the data. Moreover, in these visits researchers will collect a blood sample in order to perform an assessment of the metabolism, inflammation, and oxidation, and a stool sample in order to evaluate the gut microbiota.

Conditions

Chronic Kidney Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: nutritional education program

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

Group Type: EXPERIMENTAL

Specific dietary treatment and follow-up using coaching techniques

Intervention Type: 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

Control Group

Dietary and general lifestyle recommendations

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Specific dietary treatment and follow-up using coaching techniques

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gabriel Olveira, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Regional Universitario de Málaga - FIMABIS

Locations

Hospital Regional Universitario de Málaga

Málaga, , Spain

Countries

Spain

References

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. No abstract available.

Reference Type: DERIVED

PMID: 40828609 (View on PubMed)

Other Identifiers

ACKD

Identifier Type: -

Identifier Source: org_study_id