Hospital Regional Universitario de Málaga
Málaga, 29009, Spain
NCT Number: NCT05072574
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Málaga, 29009, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intervention group will receive specific dietary treatment and follow-up using coaching techniques, supported by new technologies, and will attend a nutritional education program
Time frame: From baseline to week 12
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
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
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
Measured by body composition analysis
Time frame: From baseline to week 12
Weight in kg
Time frame: From baseline to week 12
Fat free body mass in kg assessed by bioelectrical impedance analysis
Time frame: From baseline to week 12
circumference in cm
Time frame: From baseline to week 12
circumference in cm
Time frame: From baseline to week 12
circumference in cm
Time frame: From baseline to week 12
serum potassium in mEq/l
Time frame: From baseline to week 12
serum phosphorus mg/dl
Time frame: From baseline to week 12
Calculated with the formula of CKD-EPI and MDRD and measured in ml/ min/ 1.73 m2
Time frame: From baseline to week 12
Serum albumin in g/dl
Time frame: From baseline to week 12
Serum prealbumin in mg/dl
Time frame: From baseline to week 12
Serum cholesterol in mg/dl
Time frame: From baseline to week 12
Serum HDL in mg/dl
Time frame: From baseline to week 12
Serum LDL in mg/dl
Time frame: From baseline to week 12
Serum TG in mg/dl
Time frame: From baseline to week 12
Plasma levels of high sensitivity C reactive protein (hs-CRP) in mg/dl
Time frame: From baseline to week 12
Blood count
Time frame: From baseline to week 12
Serum iron in μg/dl
Time frame: From baseline to week 12
Serum ferritin in ng/ml
Time frame: From baseline to week 12
Serum uric acid in mg/dl
Time frame: From baseline to week 12
Serum uric acid in mg/dl
Time frame: From baseline to week 12
Serum magnesium in mg/dl
Time frame: From baseline to week 12
Serum calcium in mg/dl
Time frame: From baseline to week 12
Serum intact parathyroid hormone (PTHi) in pg/ml
Time frame: From baseline to week 12
Serum vitamin D in ng/ml
Time frame: From baseline to week 12
Measured as HbA1c (glycated hemoglobin)
Time frame: From baseline to week 12
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
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
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
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
Strength will be recorded by Jamar Hydraulic Hand Dynamometer (Kg)
Time frame: From baseline to week 12
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
Handgrip strength in kg, measured by the jamar hydraulic hand dynamometer.
Time frame: From baseline to week 12
Assess if syastolic and diastolic pressure improves after training and at 6 months of follow-up.
Time frame: From baseline to week 12
Adherence to the Predimed Plus diet pattern 17 (0 - minimum adherence, 17 - maximum adherence)
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Other
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
Acronym: ERCANUT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03386539
Behavior, Cardiac Allograft Vasculopathy
Birmingham, Alabama, United States
View Trial DetailsNCT03938324
Anemia, Anemia, Hemolytic
Durham, North Carolina, United States
View Trial DetailsNCT06071143
Chronic Disease, Chronic Kidney Diseases
Daejeon, Chungcheongnam-do, South Korea
View Trial DetailsNCT05033652
Acute Kidney Injury, Chronic Disease
Alès, France
View Trial Details