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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Meir Medical Center
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01718769
First received: March 20, 2012
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Malnutrition
Other: questionnaire STAMP

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Validation of the STAMP Screening Tool For Pediatric Nutritional Risk To Be Used in the Ambulatory Setting.

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Validity and reliability will be determined by comparing questionnaire scores with the complete nutritional assessment scores. [ Time Frame: one year ] [ Designated as safety issue: No ]
    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. [ Time Frame: Baseline and after 1 year ] [ Designated as safety issue: No ]
    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. [ Time Frame: one year ] [ Designated as safety issue: No ]
    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 [ Time Frame: one year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 250
Study Start Date: October 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: STAMP using
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.
Other: questionnaire STAMP
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.
Placebo Comparator: No STAMP using
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.

  Eligibility

Ages Eligible for Study:   1 Year to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01718769

Contacts
Contact: Gal Rub, Mrs. +972-507-862426 galarub@gmail.com
Contact: Reut Klein, M. Sc, Mrs. +972-528024685 reutkl@clalit.org.il

Locations
Israel
Netka child healthcare services Recruiting
Tel Aviv, Israel
Contact: Shlomo Amsel, Dr.       shlomoam@clalit.org.il   
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Raanan Shamir, Professor Institute of Gastroenterology, Nutrition and Liver Diseases, Schneider Children's Medical Center of Israel
  More Information

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01718769     History of Changes
Other Study ID Numbers: MMC206-2011KCTIL
Study First Received: March 20, 2012
Last Updated: February 24, 2014
Health Authority: Israel: Clalit Health Services

Keywords provided by Meir Medical Center:
Nutritional assessment
children
malnutrition

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on September 16, 2014