Chronic Kidney DiseasesERCANUTNCT05072574
Quality of Life, Nutritional Status and Functional Capacity in People With Advanced Chronic Kidney Disease
A study testing Specific dietary treatment and follow-up using coaching techniques in people with Chronic Kidney Diseases, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Specific dietary treatment and follow-up using coaching techniques
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSpain
- Study dates
- 23 Apr 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Specific dietary treatment and follow-up using coaching techniques
- Keywords
- Advanced CKD, diet, nutritional education, coaching, quality of life (QoL), nutritional status, functional capacity
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific dietary treatment and follow-up using coaching techniquesOther
Intervention group will receive specific dietary treatment and follow-up using coaching techniques, supported by new technologies, and will attend a nutritional education program
| Study group | Role | What they receive |
|---|---|---|
| Experimental: nutritional education program | Experimental | Specific dietary treatment and follow-up using coaching techniques, supported by new technologies, and will attend a nutritional education program Receives: Other: Specific dietary treatment and follow-up using coaching techniques |
| Control Group | No intervention | Dietary and general lifestyle recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to week 12
Secondary outcomes (37)
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.
Measured: 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.
Measured: From baseline to week 12
BMI (body mass index) changes
Measured by body composition analysis
Measured: From baseline to week 12
Change in weight
Weight in kg
Measured: From baseline to week 12
Change in fat free body mass
Fat free body mass in kg assessed by bioelectrical impedance analysis
Measured: From baseline to week 12
Change in upper arm circumference
circumference in cm
Measured: From baseline to week 12
Change in arm muscle circumference
circumference in cm
Measured: From baseline to week 12
waist circumference
circumference in cm
Measured: From baseline to week 12
Change in serum potassium concentration (assess kidney function)
serum potassium in mEq/l
Measured: From baseline to week 12
Change in serum phosphorus concentration (assess kidney function)
serum phosphorus mg/dl
Measured: 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
Measured: From baseline to week 12
Change in serum albumin concentration
Serum albumin in g/dl
Measured: From baseline to week 12
Change in serum prealbumin concentration
Serum prealbumin in mg/dl
Measured: From baseline to week 12
Change in cholesterol concentration
Serum cholesterol in mg/dl
Measured: From baseline to week 12
Change in HDL concentration
Serum HDL in mg/dl
Measured: From baseline to week 12
Change in LDL concentration
Serum LDL in mg/dl
Measured: From baseline to week 12
Change in TG concentration
Serum TG in mg/dl
Measured: 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
Measured: From baseline to week 12
Changes in blood cells
Blood count
Measured: From baseline to week 12
Change in iron concentration
Serum iron in μg/dl
Measured: From baseline to week 12
Change in ferritin concentration
Serum ferritin in ng/ml
Measured: From baseline to week 12
Change in uric acid concentration
Serum uric acid in mg/dl
Measured: From baseline to week 12
Change in urea concentration
Serum uric acid in mg/dl
Measured: From baseline to week 12
Change in magnesium concentration
Serum magnesium in mg/dl
Measured: From baseline to week 12
Change in calcium concentration
Serum calcium in mg/dl
Measured: From baseline to week 12
Change in intact parathyroid hormone (PTHi) concentration
Serum intact parathyroid hormone (PTHi) in pg/ml
Measured: From baseline to week 12
Changes in vitamin D
Serum vitamin D in ng/ml
Measured: From baseline to week 12
Changes in metabolic control
Measured as HbA1c (glycated hemoglobin)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to week 12
Change from Handgrip Strength
Strength will be recorded by Jamar Hydraulic Hand Dynamometer (Kg)
Measured: 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.
Measured: From baseline to week 12
Change in handgrip strength
Handgrip strength in kg, measured by the jamar hydraulic hand dynamometer.
Measured: 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.
Measured: 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)
Measured: From baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start23 Apr 2021
- Primary completion30 Sep 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized in a 1:1 ratio
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriel Olveira, MD, PhD, Principal investigator, Hospital Regional Universitario de Málaga - FIMABIS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072574
- Sponsor's protocol ID
- ACKD
- Acronym
- ERCANUT
- Status last verified
- Feb 2022
- First submitted
- 8 Apr 2021
- Last updated
- 20 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40828609
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05072574
- Acronym / sponsor ID
- ERCANUT / ACKD
- Conditions
- Chronic Kidney Diseases
- Keywords
- Advanced CKD, diet, nutritional education, coaching, quality of life (QoL), nutritional status, functional capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludUniversity, hospital or other
- Study start
- 23 Apr 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 11 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized in a 1:1 ratio
| Arm | Type | Receives |
|---|---|---|
| Experimental: nutritional education program | Experimental | Other: Specific dietary treatment and follow-up using coaching techniquesSpecific dietary treatment and follow-up using coaching techniques, supported by new technologies, and will attend a nutritional education program |
| Control Group | No intervention | –Dietary and general lifestyle recommendations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- Patients presenting any of these conditions:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specific dietary treatment and follow-up using coaching techniquesIntervention group will receive specific dietary treatment and follow-up using coaching techniques, supported by new technologies, and will attend a nutritional education program | Other | Experimental: nutritional education program |
Primary outcome
Assess the clinical response after the quality of life intervention
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.
37 secondary outcomes
Assess the clinical response after intervention in the management of CKD
Time frame: From baseline to week 12
Assess the clinical response after the intervention in knowledge about the disease
Time frame: From baseline to week 12
BMI (body mass index) changes
Time frame: From baseline to week 12
Change in weight
Time frame: From baseline to week 12
Change in fat free body mass
Time frame: From baseline to week 12
Change in upper arm circumference
Time frame: From baseline to week 12
Change in arm muscle circumference
Time frame: From baseline to week 12
waist circumference
Time frame: From baseline to week 12
Change in serum potassium concentration (assess kidney function)
Time frame: From baseline to week 12
Change in serum phosphorus concentration (assess kidney function)
Time frame: From baseline to week 12
Change in glomerular filtration (assess kidney function)
Time frame: From baseline to week 12
Change in serum albumin concentration
Time frame: From baseline to week 12
Change in serum prealbumin concentration
Time frame: From baseline to week 12
Change in cholesterol concentration
Time frame: From baseline to week 12
Change in HDL concentration
Time frame: From baseline to week 12
Change in LDL concentration
Time frame: From baseline to week 12
Change in TG concentration
Time frame: From baseline to week 12
Changes in plasma levels of high sensitivity C reactive protein (hs-CRP)
Time frame: From baseline to week 12
Changes in blood cells
Time frame: From baseline to week 12
Change in iron concentration
Time frame: From baseline to week 12
Change in ferritin concentration
Time frame: From baseline to week 12
Change in uric acid concentration
Time frame: From baseline to week 12
Change in urea concentration
Time frame: From baseline to week 12
Change in magnesium concentration
Time frame: From baseline to week 12
Change in calcium concentration
Time frame: From baseline to week 12
Change in intact parathyroid hormone (PTHi) concentration
Time frame: From baseline to week 12
Changes in vitamin D
Time frame: From baseline to week 12
Changes in metabolic control
Time frame: From baseline to week 12
Assess changes in the degree of depression and / or anxiety
Time frame: From baseline to week 12
Assess the clinical response after the intervention on functional capacity
Time frame: From baseline to week 12
Assess on functional capacity
Time frame: From baseline to week 12
Changes on functional capacity: International Physical Activity Questionnaire (IPAQ)
Time frame: From baseline to week 12
Change from Handgrip Strength
Time frame: From baseline to week 12
Characterize exercise participant behavior
Time frame: From baseline to week 12
Change in handgrip strength
Time frame: From baseline to week 12
Changes the clinical response after the intervention in blood pressure figures (mmHg).
Time frame: From baseline to week 12
Diet composition: PREDIMED test (Prevention with Mediterranean Diet)
Time frame: From baseline to week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Derived from this study: PubMed 40828609Padial 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriel Olveira, MD, PhD principal investigator
Hospital Regional Universitario de Málaga - FIMABIS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specific dietary treatment and follow-up using coaching techniques in people with Chronic Kidney Diseases, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the clinical response after the quality of life intervention (time frame: From baseline to week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05072574, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.