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

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

Status

Completed

Conditions

Chronic Kidney Diseases

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05072574

ACKD

Details and patient eligibility

About

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.

Full 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.

Enrollment

54 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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