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| ID | Type | Description | Link |
|---|---|---|---|
| ID-RCB | Other Identifier | 2023-A00510-45 |
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In France, 10% of the population suffers from chronic kidney disease (CKD). CKD is classified into five stages, described from the least severe (stage 1) to the most severe (stage 5). Every year, in the PACA region, around 1,000 new patients present with end-stage CKD (5D), necessitating the introduction of suppletive therapy, whether hemodialysis, peritoneal dialysis or kidney transplantation. In CKD stages 4 and 5, a hypo-protein diet can be proposed to delay dialysis initiation (Garneata et al. 2016).
To introduce a low-protein diet, the dietician first assesses protein intake. This can be done by :
MS-Nutrition is a start-up that has developed a web application that can be used by patients themselves to assess nutritional intakes, incorporating a food frequency questionnaire (known as the FFQ questionnaire) used to obtain information on the frequency of foods and drinks consumed over a period of time (1 week, 1 month...).
For the general population (without CKD), there is good agreement between the FFQ questionnaire and a conventional ingesta assessment (3-day dietary record as currently practiced or 24h recall, another collection based on the previous day's consumption) (Affret et al., 2018; Deschamps et al., 2009). These studies on healthy adults do not take into account the reference method (urinary urea) for assessing protein intake.
Only one study in the CKD population evaluates the concordance of the assessment of protein intakes (as well as calcium, phosphorus, potassium and sodium intakes) between an FFQ questionnaire and a dietary record (24-hour recall) (Affret et al. 2017). This study shows an acceptable correlation between the FFQ and the dietary record (correlation coefficient between 0.05 and 0.79, with a median of 0.40), yet this study was carried out without dietary intervention and using a different type of dietary record. As in studies on a population of healthy adults, protein intakes assessed by any type of dietary questionnaire are not compared with a more reliable assessment of these same intakes (24-hour urine urea).
The proposed study will compare the concordance of dietary intake assessment between each of the 2 types of dietary collection (FFQ and a 3-day dietary collection) and 24-hour urine urea, which limits the biases inherent in dietary collection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with chronic kidney disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3-day dietary record | Other | This is the conventional ingesta assessment. It will be performed twice during the study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Estimation of the concordance between the reference method (24-hour urinary urea) and : (1) protein intake estimated by the 3-day dietary record ; (2) protein intakes estimated by FFQ via web application at the initial dietary consultation. | Between 15 days and 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of concordance between protein intake estimated by the 3-day dietary record and 24-hour urine urea measurement 6 months after the initial dietary consultation | Between 6 and 7 months | |
| Assessment of concordance between protein intakes estimated by FFQ via web application and 24-hour urine urea measurement 6 months after the initial dietary consultation |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with chronic kidney disease at stage 4 ou 5
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Valérie PRUDHOMME, Dietician | Contact | 0491483092 | 33 | valerie.prudhomme@ap-hm.fr |
| Lysa HAZAN, Dietician | Contact | 0491483092 | 33 | lysa.hazan@ap-hm.fr |
| Name | Affiliation | Role |
|---|---|---|
| François CREMIEUX | AP-HM | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de néphrologie et de transplantation rénale | Recruiting | Marseille | France | 13005 | France |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D015930 | Diet Records |
| ID | Term |
|---|---|
| D011996 | Records |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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| Food Frequency Questionnaire (FFQ) | Other | This questionnaire is used to obtain information on the frequency of foods and drinks consumed over a period of time (1 week, 1 month...). It will be performed twice during the study. |
|
| Between 6 and 7 months |
| Evaluation and comparison of the time taken by the dietician to collect the data required to assess protein intake with the 2 types of dietary record at the initial dietary consultation | Between 15 days and 1 month |
| Evaluation and comparison of the time taken by the dietician to collect the data required to assess protein intake with the 2 types of dietary record 6 months after the initial dietary consultation | Between 6 and 7 months |
| Assessment of the concordance between nutritional intakes obtained by the 2 food collection methods at the initial dietary consultation | Between 15 days and 1 month |
| Assessment of the concordance between nutritional intakes obtained by the 2 food collection methods 6 months after the initial dietary consultation | Between 6 and 7 months |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |