Clinical trial NCT05072574: Quality of Life, Nutritional Status and Functional Capacity in People With Advanced Chronic Kidney Disease
Official title: Assessment of Quality of Life, Nutritional Status and Functional Capacity in People With Advanced Chronic Kidney Disease (CKD) After the Implementation of a Nutritional Education Plan and Individualized Dietary Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Diseases
Keywords: Advanced CKD
diet
nutritional education
coaching
quality of life (QoL)
nutritional status
functional capacity
Lead sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Sponsor class: OTHER
First posted: 2021-10-11
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized in a 1:1 ratio
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Assess the clinical response after the quality of life intervention
timeFrame: From baseline to week 12
Secondary outcomes:
measure: Assess the clinical response after intervention in the management of CKD
timeFrame: From baseline to week 12
measure: Assess the clinical response after the intervention in knowledge about the disease
timeFrame: From baseline to week 12
measure: BMI (body mass index) changes
timeFrame: From baseline to week 12
measure: Change in weight
timeFrame: From baseline to week 12
measure: Change in fat free body mass
timeFrame: From baseline to week 12
measure: Change in upper arm circumference
timeFrame: From baseline to week 12
measure: Change in arm muscle circumference
timeFrame: From baseline to week 12
measure: waist circumference
timeFrame: From baseline to week 12
measure: Change in serum potassium concentration (assess kidney function)
timeFrame: From baseline to week 12
measure: Change in serum phosphorus concentration (assess kidney function)
timeFrame: From baseline to week 12
measure: Change in glomerular filtration (assess kidney function)
timeFrame: From baseline to week 12
measure: Change in serum albumin concentration
timeFrame: From baseline to week 12
measure: Change in serum prealbumin concentration
timeFrame: From baseline to week 12
measure: Change in cholesterol concentration
timeFrame: From baseline to week 12
measure: Change in HDL concentration
timeFrame: From baseline to week 12
measure: Change in LDL concentration
timeFrame: From baseline to week 12
measure: Change in TG concentration
timeFrame: From baseline to week 12
measure: Changes in plasma levels of high sensitivity C reactive protein (hs-CRP)
timeFrame: From baseline to week 12
measure: Changes in blood cells
timeFrame: From baseline to week 12
measure: Change in iron concentration
timeFrame: From baseline to week 12
measure: Change in ferritin concentration
timeFrame: From baseline to week 12
measure: Change in uric acid concentration
timeFrame: From baseline to week 12
measure: Change in urea concentration
timeFrame: From baseline to week 12
measure: Change in magnesium concentration
timeFrame: From baseline to week 12
measure: Change in calcium concentration
timeFrame: From baseline to week 12
measure: Change in intact parathyroid hormone (PTHi) concentration
timeFrame: From baseline to week 12
measure: Changes in vitamin D
timeFrame: From baseline to week 12
measure: Changes in metabolic control
timeFrame: From baseline to week 12
measure: Assess changes in the degree of depression and / or anxiety
timeFrame: From baseline to week 12
measure: Assess the clinical response after the intervention on functional capacity
timeFrame: From baseline to week 12
measure: Assess on functional capacity
timeFrame: From baseline to week 12
measure: Changes on functional capacity: International Physical Activity Questionnaire (IPAQ)
timeFrame: From baseline to week 12
measure: Change from Handgrip Strength
timeFrame: From baseline to week 12
measure: Characterize exercise participant behavior
timeFrame: From baseline to week 12
measure: Change in handgrip strength
timeFrame: From baseline to week 12
measure: Changes the clinical response after the intervention in blood pressure figures (mmHg).
timeFrame: From baseline to week 12
measure: Diet composition: PREDIMED test (Prevention with Mediterranean Diet)
timeFrame: From baseline to week 12
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga
Study officials:
affiliation: Hospital Regional Universitario de Málaga - FIMABIS
name: Gabriel Olveira, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: