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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Kidney Diseases
- Sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Assess the clinical response after the quality of life intervention
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Change in LDL concentration(From baseline to week 12)
- Assess the clinical response after intervention in the management of CKD(From baseline to week 12)
- Assess the clinical response after the intervention in knowledge about the disease(From baseline to week 12)
- Change in intact parathyroid hormone (PTHi) concentration(From baseline to week 12)
- Change in weight(From baseline to week 12)
- Change in fat free body mass(From baseline to week 12)
- waist circumference(From baseline to week 12)
- Change in serum albumin concentration(From baseline to week 12)
- Change in serum prealbumin concentration(From baseline to week 12)
- Change in HDL concentration(From baseline to week 12)
- BMI (body mass index) changes(From baseline to week 12)
- Change in serum potassium concentration (assess kidney function)(From baseline to week 12)
- Change in iron concentration(From baseline to week 12)
- Change in upper arm circumference(From baseline to week 12)
- Change in arm muscle circumference(From baseline to week 12)
- Change in serum phosphorus concentration (assess kidney function)(From baseline to week 12)
- Change in glomerular filtration (assess kidney function)(From baseline to week 12)
- Change in cholesterol concentration(From baseline to week 12)
- Change in TG concentration(From baseline to week 12)
- Change in ferritin concentration(From baseline to week 12)
- Change in calcium concentration(From baseline to week 12)
- Changes in vitamin D(From baseline to week 12)
- Changes the clinical response after the intervention in blood pressure figures (mmHg).(From baseline to week 12)
- Changes in plasma levels of high sensitivity C reactive protein (hs-CRP)(From baseline to week 12)
- Changes in blood cells(From baseline to week 12)
- Change in uric acid concentration(From baseline to week 12)
- Change in urea concentration(From baseline to week 12)
- Change in magnesium concentration(From baseline to week 12)
- Assess changes in the degree of depression and / or anxiety(From baseline to week 12)
- Change from Handgrip Strength(From baseline to week 12)
- Changes in metabolic control(From baseline to week 12)
- Characterize exercise participant behavior(From baseline to week 12)
- Diet composition: PREDIMED test (Prevention with Mediterranean Diet)(From baseline to week 12)
- Assess the clinical response after the intervention on functional capacity(From baseline to week 12)
- Assess on functional capacity(From baseline to week 12)
- Changes on functional capacity: International Physical Activity Questionnaire (IPAQ)(From baseline to week 12)
- Change in handgrip strength(From baseline to week 12)