MalnutritionSTAMP2NCT01718769
Validation of the STAMP Screening Tool For Pediatric Nutritional Risk
A study testing questionnaire STAMP in people with Malnutrition, run by Meir Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Malnutrition
- What is being tested?
- questionnaire STAMP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2012to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children between 1 and 6 years old
- children treated at the clinics participating in the study
Who cannot join
- Lack of consent or lack of Hebrew proficiency
- children that not receiving treatment in day hospitalization at any hospital
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of the STAMP Screening Tool For Pediatric Nutritional Risk To Be Used in the Ambulatory Setting.
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.
- Conditions
- Malnutrition
- Being tested
- questionnaire STAMP
- Keywords
- Nutritional assessment, children, malnutrition
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire STAMPOther
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.
| Study group | Role | What they receive |
|---|---|---|
| STAMP using | Active comparator | 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. Receives: Other: questionnaire STAMP |
| No STAMP using | Placebo comparator | 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. Receives: Other: questionnaire STAMP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
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.
Measured: Baseline and after 1 year
Secondary outcomes (2)
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.
Measured: one year
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionJul 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raanan Shamir, Professor, Principal investigator, Institute of Gastroenterology, Nutrition and Liver Diseases, Schneider Children's Medical Center of Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01718769
- Sponsor's protocol ID
- MMC206-2011KCTIL
- Acronym
- STAMP2
- Status last verified
- Apr 2015
- First submitted
- 20 Mar 2012
- Last updated
- 27 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26628448
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the STAMP Screening Tool For Pediatric Nutritional Risk To Be Used in the Ambulatory Setting.
- ClinicalTrials.gov ID
- NCT01718769
- Acronym / sponsor ID
- STAMP2 / MMC206-2011KCTIL
- Conditions
- Malnutrition
- Keywords
- Nutritional assessment, children, malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 31 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STAMP using | Active comparator | Other: questionnaire STAMP100 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. |
| No STAMP using | Placebo comparator | Other: questionnaire STAMP150 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. |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children between 1 and 6 years old
- children treated at the clinics participating in the study
Key exclusion criteria (2 listed)
- Lack of consent or lack of Hebrew proficiency
- children that not receiving treatment in day hospitalization at any hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaire STAMPChildren 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 | No STAMP using, STAMP using |
Primary outcome
Validity and reliability will be determined by comparing questionnaire scores with the complete nutritional assessment scores.
Time frame: one year
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
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.
2 secondary outcomes
To evaluate the frequency of malnutrition among children in the community in the study clinics.
Time frame: one year
To evaluate the ratio of children with acute or chronic malnutrition out of all malnourished children
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2016.
- Derived from this study: PubMed 26628448Rub 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raanan Shamir, Professor principal investigator
Institute of Gastroenterology, Nutrition and Liver Diseases, Schneider Children's Medical Center of Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing questionnaire STAMP in people with Malnutrition, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity and reliability will be determined by comparing questionnaire scores with the complete nutritional assessment scores. (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01718769, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2016.