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Validation of the STAMP Screening Tool For Pediatric Nutritional Risk (STAMP2)

Primary Purpose

Malnutrition

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
questionnaire STAMP
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Malnutrition focused on measuring Nutritional assessment, children, malnutrition

Eligibility Criteria

1 Year - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. children between 1 and 6 years old
  2. children treated at the clinics participating in the study

Exclusion Criteria:

  1. Lack of consent or lack of Hebrew proficiency
  2. children that not receiving treatment in day hospitalization at any hospital

Sites / Locations

  • Netka child healthcare services

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

STAMP using

No STAMP using

Arm Description

100 boys and girls aged 1 to 6, attending Clalit Health Care Services Pediatric Centers, will undergo an assessment using the STAMP Tool; a questionnaire including 3 questions with a summary score, according to which the nutritional risk level shall be determined. These children shall also undergo a complete dietician assessment in order to examine the validity of the STAMP Tool.

150 files shall be reviewed in the beginning of the research and after 6 months in order to estimate the change in medical staff's attention to nutritional status, by way of noting relevant diagnoses, reference to nutritional status- related tests and recording of anthropometric measurements.

Outcomes

Primary Outcome Measures

Validity and reliability will be determined by comparing questionnaire scores with the complete nutritional assessment scores.
The STAMP questionnaire scores will be compared to a complete nutritional assessment conducted by a dietitian in Clalit Health Care Service clinics.
A change in frequency of recording of nutritional diagnoses for malnutrition; abnormal growth curves, FTT (Failure To Thrive), underweight, overweight, and obesity.
The following will be evaluated before and after conducting the study: % of children < percentile 5, % of children > percentile 85, % of children > percentile 95, frequency of referrals to a dietician, frequency of blood counts, frequency of tests: hemoglobin, transferrin and TLC, frequency of anemia, differences in infection diagnosis (pneumonia, UTI, etc.), frequency of referrals to the ER.

Secondary Outcome Measures

To evaluate the frequency of malnutrition among children in the community in the study clinics.
The following will be measured: Height, weight and BMI recording,% of children > percentile 95 in the weight-height curve, frequency of referrals to a dietician, frequency of blood counts, frequency of tests: albumin, hemoglobin, transferrin and TLC, frequency of anemia, differences in infection diagnosis (pneumonia, UTI, etc.), frequency of referrals to the ER, exposure to professional material on the subject of nutrition (leaflets, videos) before and after intervention, change in the number of children under growth follow up by a multi-professional team.
To evaluate the ratio of children with acute or chronic malnutrition out of all malnourished children
The following will be measured: Height, weight and BMI recording,% of children > percentile 95 in the weight-height curve, frequency of referrals to a dietician, frequency of blood counts, frequency of tests: albumin, hemoglobin, transferrin and TLC, frequency of anemia, differences in infection diagnosis (pneumonia, UTI, etc.), frequency of referrals to the ER, exposure to professional material on the subject of nutrition (leaflets, videos) before and after intervention, change in the number of children under growth follow up by a multi-professional team.

Full Information

First Posted
March 20, 2012
Last Updated
April 26, 2016
Sponsor
Meir Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01718769
Brief Title
Validation of the STAMP Screening Tool For Pediatric Nutritional Risk
Acronym
STAMP2
Official Title
Validation of the STAMP Screening Tool For Pediatric Nutritional Risk To Be Used in the Ambulatory Setting.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Background: Insufficient nutritional intake, with or without concomitant morbidity, leads to weight loss or insufficient weight gain, is related to an increase in morbidity and mortality and exposes the child to medical complications. In addition, obesity is also related to complications during hospitalization and complications in general, and therefore early identification of these children is extremely important. Studies show that malnutrition is frequent among children upon hospitalization, where the risk of pediatric nutritional deterioration increases, even in the presence of mild stress factors. This risk is frequent mainly among children that arrive at the hospital with an initial poor nutritional status. Improving the nutritional status as part of the standard of care already at the ambulatory setting might improve the prognosis of children when ill. In Israel, nutritional screening in not conducted among children since there is no proper validated screening tool. Study objectives: To test the accuracy of the STAMP Screening Tool for pediatric nutritional risk which is designed to be used by nurses, and to compare it to a complete nutritional assessment conducted by a dietician in Clalit Health Care Services clinics. In addition, the investigators wish to examine the effects of using a screening tool for nutritional risk on the medical staff's attention to the nutritional status; this is measured by the collection of nutritional status-related data and their recording in the patient file. Methods: 100 boys and girls aged 1 to 6, attending Clalit Health Care Services Pediatric Centers, will undergo an assessment using the STAMP Tool; a questionnaire including 3 questions with a summary score, according to which the nutritional risk level shall be determined. These children shall also undergo a complete dietician assessment in order to examine the validity of the STAMP Tool. In addition, 150 files shall be reviewed in the beginning of the research and after 6 months in order to estimate the change in medical staff's attention to nutritional status, by way of noting relevant diagnoses, reference to nutritional status- related tests and recording of anthropometric measurements. A statistical analysis to examine the validity of the STAMP Tool shall be carried out using the kappa test (K) (30). The effect of the STAMP Tool use shall be calculated using the chi square test.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
Nutritional assessment, children, malnutrition

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
STAMP using
Arm Type
Active Comparator
Arm Description
100 boys and girls aged 1 to 6, attending Clalit Health Care Services Pediatric Centers, will undergo an assessment using the STAMP Tool; a questionnaire including 3 questions with a summary score, according to which the nutritional risk level shall be determined. These children shall also undergo a complete dietician assessment in order to examine the validity of the STAMP Tool.
Arm Title
No STAMP using
Arm Type
Placebo Comparator
Arm Description
150 files shall be reviewed in the beginning of the research and after 6 months in order to estimate the change in medical staff's attention to nutritional status, by way of noting relevant diagnoses, reference to nutritional status- related tests and recording of anthropometric measurements.
Intervention Type
Other
Intervention Name(s)
questionnaire STAMP
Intervention Description
Children will undergo an assessment using the STAMP Tool; a questionnaire including 3 questions with a summary score, according to which the nutritional risk level shall be determined. These children shall also undergo a complete dietician assessment in order to examine the validity of the STAMP Tool.
Primary Outcome Measure Information:
Title
Validity and reliability will be determined by comparing questionnaire scores with the complete nutritional assessment scores.
Description
The STAMP questionnaire scores will be compared to a complete nutritional assessment conducted by a dietitian in Clalit Health Care Service clinics.
Time Frame
one year
Title
A change in frequency of recording of nutritional diagnoses for malnutrition; abnormal growth curves, FTT (Failure To Thrive), underweight, overweight, and obesity.
Description
The following will be evaluated before and after conducting the study: % of children < percentile 5, % of children > percentile 85, % of children > percentile 95, frequency of referrals to a dietician, frequency of blood counts, frequency of tests: hemoglobin, transferrin and TLC, frequency of anemia, differences in infection diagnosis (pneumonia, UTI, etc.), frequency of referrals to the ER.
Time Frame
Baseline and after 1 year
Secondary Outcome Measure Information:
Title
To evaluate the frequency of malnutrition among children in the community in the study clinics.
Description
The following will be measured: Height, weight and BMI recording,% of children > percentile 95 in the weight-height curve, frequency of referrals to a dietician, frequency of blood counts, frequency of tests: albumin, hemoglobin, transferrin and TLC, frequency of anemia, differences in infection diagnosis (pneumonia, UTI, etc.), frequency of referrals to the ER, exposure to professional material on the subject of nutrition (leaflets, videos) before and after intervention, change in the number of children under growth follow up by a multi-professional team.
Time Frame
one year
Title
To evaluate the ratio of children with acute or chronic malnutrition out of all malnourished children
Description
The following will be measured: Height, weight and BMI recording,% of children > percentile 95 in the weight-height curve, frequency of referrals to a dietician, frequency of blood counts, frequency of tests: albumin, hemoglobin, transferrin and TLC, frequency of anemia, differences in infection diagnosis (pneumonia, UTI, etc.), frequency of referrals to the ER, exposure to professional material on the subject of nutrition (leaflets, videos) before and after intervention, change in the number of children under growth follow up by a multi-professional team.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: children between 1 and 6 years old children treated at the clinics participating in the study Exclusion Criteria: Lack of consent or lack of Hebrew proficiency children that not receiving treatment in day hospitalization at any hospital
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raanan Shamir, Professor
Organizational Affiliation
Institute of Gastroenterology, Nutrition and Liver Diseases, Schneider Children's Medical Center of Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Netka child healthcare services
City
Tel Aviv
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
26628448
Citation
Rub G, Marderfeld L, Poraz I, Hartman C, Amsel S, Rosenbaum I, Pergamentzev-Karpol S, Monsonego-Ornan E, Shamir R. Validation of a Nutritional Screening Tool for Ambulatory Use in Pediatrics. J Pediatr Gastroenterol Nutr. 2016 May;62(5):771-5. doi: 10.1097/MPG.0000000000001046.
Results Reference
derived

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Validation of the STAMP Screening Tool For Pediatric Nutritional Risk

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