Educational Program on Dietary Adherence and Nutritional Knowledge in Chronic Kidney Disease Pati… (NCT06351007) | Clinical Trial Compass
UnknownNot Applicable
Educational Program on Dietary Adherence and Nutritional Knowledge in Chronic Kidney Disease Patients (EPAK)
Mexico63 participantsStarted 2023-09-19
Plain-language summary
A fundamental strategy to improve adherence to nutritional treatment in patients with chronic kidney disease is the implementation of educational programs. The aim of this study is to evaluate the effect of a multidisciplinary educational program on dietary adherence, nutritional knowledge, nutritional status, metabolic control and quality of life in patients with chronic kidney disease, predialysis, peritoneal dialysis and hemodialysis.
A randomized clinical trial will be carried out, in which patients who meet the inclusion criteria will be randomly assigned to three possible groups: predialysis educational intervention, dialysis educational intervention and control group. At the initial visit, the nutritional status will be evaluated by means of anthropometric parameters, screening and dynamometry, the biochemical parameters of interest will be extracted from the clinical record, nutritional knowledge and quality of life will be evaluated, and the diet will be explained. In the second visit, adherence to the diet will be evaluated and the food registry will be carried out. In the intervention groups, the educational program will begin with a duration of five months. Patients will come twice a month to the hospital to participate in the educational sessions and attend group psychology sessions. After completion of the educational program, the same measurements as at the beginning of the study will be carried out in the three groups.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Men and women over 18 years old
* Residence in Mexico City, (in order to make it easier for them to attend the educational workshops that will be held within the hospital facilities).
* Patients who are active in the nephrology office of National Institute of Medical Science and Nutrition
* With more than 3 months of diagnosis of chronic kidney disease in pre-dialysis phase (glomerular filtration rate \< 60 ml/min/1.73m2) at National Institute of Medical Science and Nutrition
* With more than 3 months with peritoneal dialysis treatment in the National Institute of Medical Science and Nutrition
* With more than 3 months with hemodialysis treatment in the National Institute of Medical Science and Nutrition
* Signed informed consent form
Exclusion Criteria:
* Patients with uncorrected cognitive problems:
* Patients with post-dialytic syndrome (uremia).
* Patients with neurological alterations induced by renal failure.
* Patients with mental or psychiatric illness that prevents them from learning and following directions:
* Patients with persistent delirium
* Patients with schizophrenia
* Patients with manic episode
* Patients with confusional syndrome
* Patients with minor or major neurocognitive deficits
* Patients with dissociative amnesia
* Patients with neurodevelopmental disorder
* Patients who meet Diagnostic and Statistical Manual of Mental Disorders (DSM IV- TR) diagnostic criteria for substance abuse and dependence.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patients´ dietary attitude
Timeframe: From enrollment to the end of the intervention at 5 months
2
Dietary adherence
Timeframe: From enrollment to the end of the intervention at 5 months
3
Nutritional knowledge
Timeframe: From enrollment to the end of the intervention at 5 months
Trial details
NCT IDNCT06351007
SponsorInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran