<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01718769</url>
  </required_header>
  <id_info>
    <org_study_id>MMC206-2011KCTIL</org_study_id>
    <nct_id>NCT01718769</nct_id>
  </id_info>
  <brief_title>Validation of the STAMP Screening Tool For Pediatric Nutritional Risk</brief_title>
  <acronym>STAMP2</acronym>
  <official_title>Validation of the STAMP Screening Tool For Pediatric Nutritional Risk To Be Used in the Ambulatory Setting.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meir Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Meir Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Insufficient nutritional intake, with or without concomitant morbidity, leads to&#xD;
      weight loss or insufficient weight gain, is related to an increase in morbidity and mortality&#xD;
      and exposes the child to medical complications. In addition, obesity is also related to&#xD;
      complications during hospitalization and complications in general, and therefore early&#xD;
      identification of these children is extremely important. Studies show that malnutrition is&#xD;
      frequent among children upon hospitalization, where the risk of pediatric nutritional&#xD;
      deterioration increases, even in the presence of mild stress factors. This risk is frequent&#xD;
      mainly among children that arrive at the hospital with an initial poor nutritional status.&#xD;
      Improving the nutritional status as part of the standard of care already at the ambulatory&#xD;
      setting might improve the prognosis of children when ill. In Israel, nutritional screening in&#xD;
      not conducted among children since there is no proper validated screening tool. Study&#xD;
      objectives: To test the accuracy of the STAMP Screening Tool for pediatric nutritional risk&#xD;
      which is designed to be used by nurses, and to compare it to a complete nutritional&#xD;
      assessment conducted by a dietician in Clalit Health Care Services clinics. In addition, the&#xD;
      investigators wish to examine the effects of using a screening tool for nutritional risk on&#xD;
      the medical staff's attention to the nutritional status; this is measured by the collection&#xD;
      of nutritional status-related data and their recording in the patient file.&#xD;
&#xD;
      Methods: 100 boys and girls aged 1 to 6, attending Clalit Health Care Services Pediatric&#xD;
      Centers, will undergo an assessment using the STAMP Tool; a questionnaire including 3&#xD;
      questions with a summary score, according to which the nutritional risk level shall be&#xD;
      determined. These children shall also undergo a complete dietician assessment in order to&#xD;
      examine the validity of the STAMP Tool. In addition, 150 files shall be reviewed in the&#xD;
      beginning of the research and after 6 months in order to estimate the change in medical&#xD;
      staff's attention to nutritional status, by way of noting relevant diagnoses, reference to&#xD;
      nutritional status- related tests and recording of anthropometric measurements.&#xD;
&#xD;
      A statistical analysis to examine the validity of the STAMP Tool shall be carried out using&#xD;
      the kappa test (K) (30). The effect of the STAMP Tool use shall be calculated using the chi&#xD;
      square test.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Validity and reliability will be determined by comparing questionnaire scores with the complete nutritional assessment scores.</measure>
    <time_frame>one year</time_frame>
    <description>The STAMP questionnaire scores will be compared to a complete nutritional assessment conducted by a dietitian in Clalit Health Care Service clinics.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>A change in frequency of recording of nutritional diagnoses for malnutrition; abnormal growth curves, FTT (Failure To Thrive), underweight, overweight, and obesity.</measure>
    <time_frame>Baseline and after 1 year</time_frame>
    <description>The following will be evaluated before and after conducting the study: % of children &lt; percentile 5, % of children &gt; percentile 85, % of children &gt; 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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To evaluate the frequency of malnutrition among children in the community in the study clinics.</measure>
    <time_frame>one year</time_frame>
    <description>The following will be measured: Height, weight and BMI recording,% of children &gt; 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate the ratio of children with acute or chronic malnutrition out of all malnourished children</measure>
    <time_frame>one year</time_frame>
    <description>The following will be measured: Height, weight and BMI recording,% of children &gt; 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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Malnutrition</condition>
  <arm_group>
    <arm_group_label>STAMP using</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No STAMP using</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>questionnaire STAMP</intervention_name>
    <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.</description>
    <arm_group_label>No STAMP using</arm_group_label>
    <arm_group_label>STAMP using</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. children between 1 and 6 years old&#xD;
&#xD;
          2. children treated at the clinics participating in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Lack of consent or lack of Hebrew proficiency&#xD;
&#xD;
          2. children that not receiving treatment in day hospitalization at any hospital&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Raanan Shamir, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Gastroenterology, Nutrition and Liver Diseases, Schneider Children's Medical Center of Israel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Netka child healthcare services</name>
      <address>
        <city>Tel Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>March 20, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>April 26, 2016</last_update_submitted>
  <last_update_submitted_qc>April 26, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 27, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nutritional assessment</keyword>
  <keyword>children</keyword>
  <keyword>malnutrition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01718769
org study id: MMC206-2011KCTIL
nct id: NCT01718769
lead sponsor: 
has dmc: No
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Validity and reliability will be determined by comparing questionnaire scores with the complete nutritional assessment scores.
time frame: one year
description: The STAMP questionnaire scores will be compared to a complete nutritional assessment conducted by a dietitian in Clalit Health Care Service clinics.
measure: 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
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.
measure: To evaluate the frequency of malnutrition among children in the community in the study clinics.
time frame: one year
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.
measure: To evaluate the ratio of children with acute or chronic malnutrition out of all malnourished children
time frame: one year
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.
arm group label: STAMP using
arm group type: Active Comparator
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 group label: No STAMP using
arm group type: Placebo Comparator
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: questionnaire STAMP
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.
arm group label: No STAMP using
arm group label: STAMP using
criteria: 
gender: All
minimum age: 1 Year
maximum age: 6 Years
healthy volunteers: No
last name: Raanan Shamir, Professor
role: Principal Investigator
affiliation: Institute of Gastroenterology, Nutrition and Liver Diseases, Schneider Children's Medical Center of Israel
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Malnutrition