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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Intervention group will receive specific dietary treatment and follow-up using coaching techniques, supported by new technologies, and will attend a nutritional education program
Hospital Regional Universitario de Málaga
Málaga, Spain
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.
Time frame: From baseline to week 12
Assess the clinical response after intervention in the management of CKD
Self-Efficacy for Managing Chronic Disease test. The Self-Efficacy Scale for the Management of Chronic Diseases (SEMCD) is made up of 6 items on an analog scale, ranging from 1 (not at all sure) to 10 (totally safe). The Spanish version (SEMCD-S) consists of 4 items. A higher number means greater self-efficacy. The scale score is the mean of the items.
Time frame: From baseline to week 12
Assess the clinical response after the intervention in knowledge about the disease
Kidney Disease Knowledge Survey test. The Kidney Disease Knowledge Survey (KiKS) instrument consists of 28 items and aims to assess specific knowledge about chronic kidney disease in non-dialysis patients. One point is considered for each correct answer and zero for the incorrect one. The total score is calculated by adding all the correct points and divided by 28, obtaining a value from 0 to 1, with 1 being the highest level of knowledge.
Time frame: From baseline to week 12
BMI (body mass index) changes
Measured by body composition analysis
Time frame: From baseline to week 12
Change in weight
Weight in kg
Time frame: From baseline to week 12
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Change in fat free body mass
Fat free body mass in kg assessed by bioelectrical impedance analysis
Time frame: From baseline to week 12
Change in upper arm circumference
circumference in cm
Time frame: From baseline to week 12
Change in arm muscle circumference
circumference in cm
Time frame: From baseline to week 12
waist circumference
circumference in cm
Time frame: From baseline to week 12
Change in serum potassium concentration (assess kidney function)
serum potassium in mEq/l
Time frame: From baseline to week 12
Change in serum phosphorus concentration (assess kidney function)
serum phosphorus mg/dl
Time frame: From baseline to week 12
Change in glomerular filtration (assess kidney function)
Calculated with the formula of CKD-EPI and MDRD and measured in ml/ min/ 1.73 m2
Time frame: From baseline to week 12
Change in serum albumin concentration
Serum albumin in g/dl
Time frame: From baseline to week 12
Change in serum prealbumin concentration
Serum prealbumin in mg/dl
Time frame: From baseline to week 12
Change in cholesterol concentration
Serum cholesterol in mg/dl
Time frame: From baseline to week 12
Change in HDL concentration
Serum HDL in mg/dl
Time frame: From baseline to week 12
Change in LDL concentration
Serum LDL in mg/dl
Time frame: From baseline to week 12
Change in TG concentration
Serum TG in mg/dl
Time frame: From baseline to week 12
Changes in plasma levels of high sensitivity C reactive protein (hs-CRP)
Plasma levels of high sensitivity C reactive protein (hs-CRP) in mg/dl
Time frame: From baseline to week 12
Changes in blood cells
Blood count
Time frame: From baseline to week 12
Change in iron concentration
Serum iron in μg/dl
Time frame: From baseline to week 12
Change in ferritin concentration
Serum ferritin in ng/ml
Time frame: From baseline to week 12
Change in uric acid concentration
Serum uric acid in mg/dl
Time frame: From baseline to week 12
Change in urea concentration
Serum uric acid in mg/dl
Time frame: From baseline to week 12
Change in magnesium concentration
Serum magnesium in mg/dl
Time frame: From baseline to week 12
Change in calcium concentration
Serum calcium in mg/dl
Time frame: From baseline to week 12
Change in intact parathyroid hormone (PTHi) concentration
Serum intact parathyroid hormone (PTHi) in pg/ml
Time frame: From baseline to week 12
Changes in vitamin D
Serum vitamin D in ng/ml
Time frame: From baseline to week 12
Changes in metabolic control
Measured as HbA1c (glycated hemoglobin)
Time frame: From baseline to week 12
Assess changes in the degree of depression and / or anxiety
HADS depression and anxiety symptoms screening test. It is a self-administered scale with 14 items divided into 2 subscales (anxiety and depression) whose maximum score is 21 points for each of them. Based on the score obtained, the patients can be classified as normal (\<7), doubtful (between 8 and 10) and potential clinical case (≥ 11). The score is referred to the last week.
Time frame: From baseline to week 12
Assess the clinical response after the intervention on functional capacity
Scale of autonomy for activities of daily life "Barthel test". This test measures the capacity of the person to carry out ten basic activities of daily life, obtaining a quantitative estimate of the degree of dependence of the subject. The range of possible IB values is between 0 and 100, with 5-point intervals for the original version. The closer a subject's score is to 0, the more dependency they have; the closer to 100 the more independence.
Time frame: From baseline to week 12
Assess on functional capacity
Physical activity test "Short Physical Performance Battery" SPPB. This in turn includes 3 tests: balance, gait speed and getting up and sitting in a chair 5 times. Each test is scored from 0 (worst performance) to 4 (best performance): for the balance test according to a hierarchical combination of performance in the 3 component subtests and for the other 2 tests a score of 0 is assigned to those who do not complete or they attempt the task and scores from 1 to 4 based on the time spent. In addition, a total score for the entire battery is obtained, which is the sum of the 3 tests and ranges from 0 to 12.
Time frame: From baseline to week 12
Changes on functional capacity: International Physical Activity Questionnaire (IPAQ)
The International Physical Activity Questionnaire (IPAQ) will be used to evaluate the current physical activity level of the participants. The survey consists of 27 questions and 5 parts.
Time frame: From baseline to week 12
Change from Handgrip Strength
Strength will be recorded by Jamar Hydraulic Hand Dynamometer (Kg)
Time frame: From baseline to week 12
Characterize exercise participant behavior
International Physical Activity Questionnaire (IPAQ). The IPAQ consists of 7 questions about the frequency, duration and intensity of activity (moderate and intense) carried out in the last seven days, as well as walking and sitting time in a work day. It evaluates three characteristics of physics (PA): intensity (mild, moderate or vigorous), frequency (days per week) and duration (time per day). Weekly activity is recorded in Mets (Metabolic Equivalent of Task or Metabolic Index Units) per minute and week.
Time frame: From baseline to week 12
Change in handgrip strength
Handgrip strength in kg, measured by the jamar hydraulic hand dynamometer.
Time frame: From baseline to week 12
Changes the clinical response after the intervention in blood pressure figures (mmHg).
Assess if syastolic and diastolic pressure improves after training and at 6 months of follow-up.
Time frame: From baseline to week 12
Diet composition: PREDIMED test (Prevention with Mediterranean Diet)
Adherence to the Predimed Plus diet pattern 17 (0 - minimum adherence, 17 - maximum adherence)
Time frame: From baseline to week 12