Educational Program on Dietary Adherence and Nutritional Knowledge in Chronic Kidney Disease Patients (EPAK)

NCT06351007 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2024-04-08

No results posted yet for this study

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.

Conditions

  • Chronic Kidney Disease
  • Predialysis
  • Peritoneal Dialysis
  • Hemodialysis
  • Educational Activities
  • Adherence
  • Nutritional Status

Interventions

OTHER

Nutritional education and psychological intervention

In the two intervention groups, after the delivery of the meal plan, the educational and psychological intervention will begin, with a duration of 5 months. The main objective of the educational program in pre-dialysis patients is to delay the progression of renal damage and in dialysis patients is control of complications. The content of monthly educational sessions will be: Month 1: proteins (predialysis group), potassium (dialysis group) Month 2: Sodium and fluids (predialysis group), phosphorus (dialysis group) Month 3: Phosphorus (predialysis group), sodium and fluids (dialysis group) Month 4: Potassium (predialysis group), proteins (dialysis group) Month 5: Myths and facts about food (both groups) Simultaneously, group psychological sessions will be carried out, aimed at modifying patient behaviors to increase adherence to diet plan through understanding the patient´s situation, promoting the development of healthy behaviors, barrier identification and goal setting

OTHER

Standard care

The control group (predialysis and dialysis patients) will receive standard nutritional care consisting of dietary prescription with follow-up for questions and adjustment of the meal plan every 2 months. Based on the nutritional status, biochemical parameters and stage of renal disease, the meal plan will be calculated. The characteristics of the diet will be as follows: Calories - 30 kcal/Kg ideal body weight/day Protein - 0.8 g/kg ideal body weight/day (predialysis group) 1.2 kg ideal body weight/day (dialysis group) Carbohydrates - 50-60% of total calorie content Lipids - 30% of total calorie content Sodium \< 2300 mg/day Potassium \< 2000 mg/day Phosphorus \< 1000 mg/day Fluids - Urine output + 500 ml

Sponsors & Collaborators

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    lead OTHER

Principal Investigators

  • Ximena Atilano Carsi, PhD · Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiránn

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-19
Primary Completion
2024-07-31
Completion
2024-07-31

Countries

  • Mexico

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06351007 on ClinicalTrials.gov