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

NCT06351007 | Unknown

• 1 other identifier: NMM-4650-23-24-1
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Education program; Adherence; Nutritional knowledge; Nutritional status; Quality of Life; Chronic kidney disease

Outcome Measures

Primary Outcomes (3)

• Patients´ dietary attitude

  Measurement of patients' attitude toward fluid restriction and dietary modifications and their impact on daily life. Adherence to the diet will be measured by the renal adherence attitude questionnaire (RAAQ), at the beginning of the study and after the end of the intervention. RAAQ questionnaire will be filled out by the patient with the purpose of evaluating the patients' attitudes and behaviors in relation to diet adherence. The questionnaire consists of 26 items with a 5-point Likert scale indicating total agreement (5 points) or total disagreement (1 point). The lowest score on the scale is 26 points and the highest is 130 points. Higher scores on this scale are associated with a more positive patient attitude to dietary restrictions and to a higher dietary adherence.

  From enrollment to the end of the intervention at 5 months

• Dietary adherence

  Extent to which a patient's eating behavior corresponds to the recommendations agreed upon with the nutritionist. Adherence to the diet will be measured by a three-day food record at the beginning of the study and after the end of the intervention. The evaluation of the diet will be carried out by a trained nutritionist, describing the amount and type of food consumed by the patients in a three-day period. The three-day average consumption of calories (kcal), protein (g), sodium, potassium and phosphorus (mg) will be estimated. Good adherence will be considered when the actual intake of these nutrients is between 90 and 110% of the recommended intake for each patient.

  From enrollment to the end of the intervention at 5 months

• Nutritional knowledge

  Assessment of the level of knowledge about food groups and nutrients that are important in chronic kidney disease. Knowledge will be assessed by the CONURE self-administered questionnaire consisting of 35 multiple-choice questions related to sodium, potassium, phosphorus, protein and the use of beverages and nutritional supplements, at the beginning and end of the intervention. The level of knowledge will be classified into three categories according to the number of correct answers obtained: low knowledge with less than 60% correct answers, regular knowledge with 60-80% correct answers and good knowledge with more than 80% correct answers.

  From enrollment to the end of the intervention at 5 months

Secondary Outcomes (5)

• Muscle status

  From enrollment to the end of the intervention at 5 months

• Muscle functionality

  From enrollment to the end of the intervention at 5 months

• Nutritional status of predialysis patients

  From enrollment to the end of the intervention at 5 months

• Nutritional status of dialysis patients

  From enrollment to the end of the intervention at 5 months

• Patients´ quality of life

  From enrollment to the end of the intervention at 5 months

Study Arms (3)

Control

ACTIVE COMPARATOR

The control group will consist of both pre-dialysis and dialysis patients.They will receive standard nutritional care consisting of dietary prescription with follow-up for questions and adjustment of the meal plan every 2 months.

Other: Standard care

Intervention predialysis

EXPERIMENTAL

This group will consist of pre-dialysis patients in Kidney Disease Improving Global Outcomes (KDIGO) stages 3 to 5 who will receive, in addition to the meal plan, a nutritional education program with psychological support.The meal plan will have the same characteristics as in the control group. The educational program will have a duration of 5 monthly sessions . Simultaneously, monthly sessions will be held in groups of 5 patients, with a group of clinical psychologists.

Other: Nutritional education and psychological intervention

Intervention dialysis

EXPERIMENTAL

This group will consist of peritoneal dialysis and hemodialysis patients who will receive, in addition to the meal plan, a nutritional education program with psychological support.The meal plan will have the same characteristics as in the control group. The educational program will have a duration of 5 monthly sessions . Simultaneously, monthly sessions will be held in groups of 5 patients, with a group of clinical psychologists.

Other: Nutritional education and psychological intervention

Interventions

Nutritional education and psychological intervention OTHER

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

Intervention dialysis; Intervention predialysis

Standard care OTHER

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead

Study Sites (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, 14080, Mexico

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Psychosocial Intervention; Standard of Care

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Ximena Atilano Carsi, PhD

  Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiránn

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ximena Atilano Carsi, PhD

CONTACT

00 52 55 54 87 09 00; ximena.atilanoc@incmnsz.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: April 8, 2024
• Study Start: September 19, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: April 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)