Weight LossLIMITNCT02476578
Low Indexes of Metabolism - Information to Teams (LIMIT)
A study testing Email in people with Weight Loss and Thinness, run by Clalit Health Services.
Trial summary
The purpose of this study is to determine whether alerting primary care providers by email about low values of BMI, HbA1c% or cholesterol will affect treatment and improve overall survival and other health indexes of people older than 75 years. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Weight Loss, Thinness, Malnutrition
- What is being tested?
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,584 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- All found by computerized search in the data base of Clalit Health Services North and South districts:
- 1. A drop in BMI of 2 Kg/m^2 or more during previous two years AND
- BMI less than 23 Kg/m^2 AND
- No dietitian counseling during previous year
- OR
- 2. Last HbA1c% level of 6.5% or less AND
Show all 10Show fewer
- dispensing anti-diabetic medicines during previous 2 months
- OR
- 3. Last total cholesterol less than 160 mg/dL AND
- dispensing cholesterol-lowering medicines during previous 2 months
Who cannot join
- Patients whose their primary doctor and nurse email address is unobtainable
- For criterion 3: Patients diagnosed to have had a myocardial infarction, an ischemic heart disease, a transient ischemic attack or an ischemic stroke.
About this study
Official title: Sending Advisory Electronic Mail to Primary Care Staff, Addressing Low Metabolic Measures: Assessing the Health Outcomes for Patients Above Age 75
The purpose of this study is to determine whether alerting primary care providers by email about low values of BMI, HbA1c% or cholesterol will affect treatment and improve overall survival and other health indexes of people older than 75 years.
Read the detailed description
Scientific background
Interventions aimed to ameliorate malnutrition are important for elderly health and include dietary counseling and discontinuing unnecessary medicines.
Emailing an alert regarding low BMI was found to improve dietary counseling numbers.
Correlation between death and HbA1c% is U-shaped, with increased mortality under a 6.5% level in patients taking two anti-diabetic medicines. Sending an email alert regarding an over-tight control of diabetes was followed by a reduction in mortality.
Death and cholesterol correlation is also U-shaped, with increased mortality and morbidity under 160 mg%. The investigator found no interventional study for this situation.
Objectives
To check whether alerting the primary care providers by email, about low values of BMI, HbA1c% or cholesterol will affect treatment and improve health indexes of people older than 75 years.
Working hypotheses
During a year, and relative to the control group, intervention emails may result in the following:
- A decrease in mortality.
- An increase in dietary counseling percentage and a decrease in prescribing anti-diabetic and cholesterol-lowering medicines.
- A decrease in medical expenses and in other morbidity indexes.
Type of research and methods of data collection
This randomized controlled trial will be conducted entirely through the existing computer system. The participants (patients) will be assigned to the two Arms/Groups "Intervention Email" and "Control". It has three separate interventions: a. Alerting about a significant drop in BMI. b. Alerting about a low HbA1c% level in patients taking anti-diabetics. c. Alerting about a low cholesterol level in patients taking cholesterol-lowering medicines. The alerts will be sent to the primary clinicians.
Method(s) of data analysis
Differences between intervention groups and control groups will be analyzed using Chi-square test (or Fishers' exact test) for categorical variables and using T-test (or Two-sample Wilcoxon test) for continuous variables.
Uniqueness and relevance
Health service policy regarding signs of malnutrition and excessive medicinal treatment needs a relevant scientific knowledge base. Nutritional counseling and revision of medicinal treatment may dramatically affect health. This research deals with questions that have no commercial interest, but are important to the public.
- Conditions
- Weight Loss, Thinness, Malnutrition
- Being tested
- Keywords
- Hypocholesterolemia, Frail Elderly, Aged, Aged, 80 and over, Cholesterol, Clinical Laboratory Information Systems, Hemoglobin A, Glycosylated, diet therapy, Anticholesteremic Agents, Health Services for the Aged, Hypoglycemic Agents, Hypoglycemia
- Medical subject headings
- Weight Loss, Thinness, Malnutrition, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmailOther
Also called "Dry Counseling"
Automated Email to the primary doctor and nurse, with the details of the patient, the condition found and the relevant measures to consider.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Email | Experimental | An email is sent, alerting the primary care providers about low values of BMI, HbA1c% or cholesterol and advising to consider appropriate dietary and medical revision. Receives: Other: Email |
| Control | No intervention | No email is sent. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death From Any Cause
Impact on overall-survival
Measured: 1 year
Secondary outcomes (3)
Impact on Evaluation Rate
Percentage of patients evaluated by a nurse and counseled by a dietitian
Measured: 1 year
Impact on Medical Costs
Medical expenses to the medical insurer, including hospitalizations, consultations, examinations, devices and medicines.
Measured: 1 year
Impact on a Composite Measure of Medical Treatment
A composite measure of doses of prescribed anti-diabetic and cholesterol-lowering medicines - According to relevant alert by email.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study startOct 2015
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8,584 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clalit Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Nir Tsabar, Clalit Health Services
- Investigators
- Nir Tsabar, MD/PhD, Principal investigator, ClalitHS North District Principal Geriatrist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02476578
- Sponsor's protocol ID
- 0023-15-COM
- Other IDs
- ר/2015/49, METABOL_EMAIL, 0023-15-COM
- Acronym
- LIMIT
- Status last verified
- Mar 2020
- First submitted
- 11 Jun 2015
- Last updated
- 9 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request to email nir.tsabar@clalit.org.il. Shared data will not include exact dates, exact lab results or any data that might expose the identity of patients. Also, commercial data such as drug brands or costs may not be shared.
Publications
Flegal KM, Kit BK, Orpana H, Graubard BI. Association of all-cause mortality with overweight and obesity using standard body mass index categories: a systematic review and meta-analysis. JAMA. 2013 Jan 2;309(1):71-82. doi: 10.1001/jama.2012.113905.
PubMed 23280227Giovannelli J, Coevoet V, Vasseur C, Gheysens A, Basse B, Houyengah F. How can screening for malnutrition among hospitalized patients be improved? An automatic e-mail alert system when admitting previously malnourished patients. Clin Nutr. 2015 Oct;34(5):868-73. doi: 10.1016/j.clnu.2014.09.008. Epub 2014 Sep 18.
PubMed 25277380Iribarren C, Reed DM, Chen R, Yano K, Dwyer JH. Low serum cholesterol and mortality. Which is the cause and which is the effect? Circulation. 1995 Nov 1;92(9):2396-403. doi: 10.1161/01.cir.92.9.2396.
PubMed 7586337Currie CJ, Peters JR, Tynan A, Evans M, Heine RJ, Bracco OL, Zagar T, Poole CD. Survival as a function of HbA(1c) in people with type 2 diabetes: a retrospective cohort study. Lancet. 2010 Feb 6;375(9713):481-9. doi: 10.1016/S0140-6736(09)61969-3. Epub 2010 Jan 26.
PubMed 20110121Tsabar N, Press Y, Rotman J, Klein B, Grossman Y, Vainshtein-Tal M, Eilat-Tsanani S. A Randomized Trial of Alerting to Low Glycated Hemoglobin Level in Older Adults: Results of the Low Indexes of Metabolism Intervention Trial B (LIMIT-B). J Am Med Dir Assoc. 2020 Feb;21(2):277-280.e3. doi: 10.1016/j.jamda.2019.08.004. Epub 2019 Oct 3.
PubMed 31588026Tsabar N, Press Y, Rotman J, Klein B, Grossman Y, Vainshtein-Tal M, Eilat-Tsanani S. A Randomized Trial of Alerting to Hypocholesterolemia Results of the Low Indexes of Metabolism Intervention Trial-C (LIMIT-C). J Am Med Dir Assoc. 2020 Mar;21(3):410-414. doi: 10.1016/j.jamda.2019.08.018. Epub 2019 Oct 12.
PubMed 31610995Tsabar N, Press Y, Rotman J, Klein B, Grossman Y, Vainshtein-Tal M, Eilat-Tsanani S. Randomized trial results of alerting primary clinicians to severe weight loss among older adults in the Low Indexes of Metabolism Intervention Trial part A. Geriatr Gerontol Int. 2020 Apr;20(4):329-335. doi: 10.1111/ggi.13888. Epub 2020 Feb 16.
PubMed 32064727Tsabar N, Press Y, Rotman J, Klein B, Grossman Y, Vainshtein-Tal M, Eilat-Tsanani S. The low indexes of metabolism intervention trial (LIMIT): design and baseline data of a randomized controlled clinical trial to evaluate how alerting primary care teams to low metabolic values, could affect the health of patients aged 75 or older. BMC Health Serv Res. 2018 Jan 5;18(1):4. doi: 10.1186/s12913-017-2812-0.
PubMed 29301522
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sending Advisory Electronic Mail to Primary Care Staff, Addressing Low Metabolic Measures: Assessing the Health Outcomes for Patients Above Age 75
- ClinicalTrials.gov ID
- NCT02476578
- Acronym / sponsor ID
- LIMIT / 0023-15-COM
- Conditions
- Weight Loss, Thinness, Malnutrition
- Keywords
- Hypocholesterolemia, Frail Elderly, Aged, Aged, 80 and over, Cholesterol, Clinical Laboratory Information Systems, Hemoglobin A, Glycosylated, diet therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,584 participants (actual)
- Lead sponsor
- Clalit Health ServicesUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 19 Jun 2015 (estimated)
- Results
- Posted 29 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether alerting primary care providers by email about low values of BMI, HbA1c% or cholesterol will affect treatment and improve overall survival and other health indexes of people older than 75 years.
Detailed description
Scientific background
Interventions aimed to ameliorate malnutrition are important for elderly health and include dietary counseling and discontinuing unnecessary medicines.
Emailing an alert regarding low BMI was found to improve dietary counseling numbers.
Correlation between death and HbA1c% is U-shaped, with increased mortality under a 6.5% level in patients taking two anti-diabetic medicines. Sending an email alert regarding an over-tight control of diabetes was followed by a reduction in mortality.
Death and cholesterol correlation is also U-shaped, with increased mortality and morbidity under 160 mg%. The investigator found no interventional study for this situation.
Objectives
To check whether alerting the primary care providers by email, about low values of BMI, HbA1c% or cholesterol will affect treatment and improve health indexes of people older than 75 years.
Working hypotheses
During a year, and relative to the control group, intervention emails may result in the following:
- A decrease in mortality.
- An increase in dietary counseling percentage and a decrease in prescribing anti-diabetic and cholesterol-lowering medicines.
- A decrease in medical expenses and in other morbidity indexes.
Type of research and methods of data collection
This randomized controlled trial will be conducted entirely through the existing computer system. The participants (patients) will be assigned to the two Arms/Groups "Intervention Email" and "Control". It has three separate interventions: a. Alerting about a significant drop in BMI. b. Alerting about a low HbA1c% level in patients taking anti-diabetics. c. Alerting about a low cholesterol level in patients taking cholesterol-lowering medicines. The alerts will be sent to the primary clinicians.
Method(s) of data analysis
Differences between intervention groups and control groups will be analyzed using Chi-square test (or Fishers' exact test) for categorical variables and using T-test (or Two-sample Wilcoxon test) for continuous variables.
Uniqueness and relevance
Health service policy regarding signs of malnutrition and excessive medicinal treatment needs a relevant scientific knowledge base. Nutritional counseling and revision of medicinal treatment may dramatically affect health. This research deals with questions that have no commercial interest, but are important to the public.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Email | Experimental | Other: EmailAn email is sent, alerting the primary care providers about low values of BMI, HbA1c% or cholesterol and advising to consider appropriate dietary and medical revision. |
| Control | No intervention | –No email is sent. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- All found by computerized search in the data base of Clalit Health Services North and South districts:
- 1. A drop in BMI of 2 Kg/m^2 or more during previous two years AND
- BMI less than 23 Kg/m^2 AND
- No dietitian counseling during previous year
- OR
Key exclusion criteria (2 listed)
- Patients whose their primary doctor and nurse email address is unobtainable
- For criterion 3: Patients diagnosed to have had a myocardial infarction, an ischemic heart disease, a transient ischemic attack or an ischemic stroke.
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 |
|---|---|---|
| EmailAlso: "Dry Counseling"Automated Email to the primary doctor and nurse, with the details of the patient, the condition found and the relevant measures to consider. | Other | Intervention Email |
Primary outcome
Death From Any Cause
Time frame: 1 year
Impact on overall-survival
3 secondary outcomes
Impact on Evaluation Rate
Time frame: 1 year
Impact on Medical Costs
Time frame: 1 year
Impact on a Composite Measure of Medical Treatment
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23280227Flegal KM, Kit BK, Orpana H, Graubard BI. Association of all-cause mortality with overweight and obesity using standard body mass index categories: a systematic review and meta-analysis. JAMA. 2013 Jan 2;309(1):71-82. doi: 10.1001/jama.2012.113905.
- Background: PubMed 25277380Giovannelli J, Coevoet V, Vasseur C, Gheysens A, Basse B, Houyengah F. How can screening for malnutrition among hospitalized patients be improved? An automatic e-mail alert system when admitting previously malnourished patients. Clin Nutr. 2015 Oct;34(5):868-73. doi: 10.1016/j.clnu.2014.09.008. Epub 2014 Sep 18.
- Background: PubMed 7586337Iribarren C, Reed DM, Chen R, Yano K, Dwyer JH. Low serum cholesterol and mortality. Which is the cause and which is the effect? Circulation. 1995 Nov 1;92(9):2396-403. doi: 10.1161/01.cir.92.9.2396.
- Background: PubMed 20110121Currie CJ, Peters JR, Tynan A, Evans M, Heine RJ, Bracco OL, Zagar T, Poole CD. Survival as a function of HbA(1c) in people with type 2 diabetes: a retrospective cohort study. Lancet. 2010 Feb 6;375(9713):481-9. doi: 10.1016/S0140-6736(09)61969-3. Epub 2010 Jan 26.
- Results publication: PubMed 31588026Tsabar N, Press Y, Rotman J, Klein B, Grossman Y, Vainshtein-Tal M, Eilat-Tsanani S. A Randomized Trial of Alerting to Low Glycated Hemoglobin Level in Older Adults: Results of the Low Indexes of Metabolism Intervention Trial B (LIMIT-B). J Am Med Dir Assoc. 2020 Feb;21(2):277-280.e3. doi: 10.1016/j.jamda.2019.08.004. Epub 2019 Oct 3.
- Results publication: PubMed 31610995Tsabar N, Press Y, Rotman J, Klein B, Grossman Y, Vainshtein-Tal M, Eilat-Tsanani S. A Randomized Trial of Alerting to Hypocholesterolemia Results of the Low Indexes of Metabolism Intervention Trial-C (LIMIT-C). J Am Med Dir Assoc. 2020 Mar;21(3):410-414. doi: 10.1016/j.jamda.2019.08.018. Epub 2019 Oct 12.
- Results publication: PubMed 32064727Tsabar N, Press Y, Rotman J, Klein B, Grossman Y, Vainshtein-Tal M, Eilat-Tsanani S. Randomized trial results of alerting primary clinicians to severe weight loss among older adults in the Low Indexes of Metabolism Intervention Trial part A. Geriatr Gerontol Int. 2020 Apr;20(4):329-335. doi: 10.1111/ggi.13888. Epub 2020 Feb 16.
- Derived from this study: PubMed 29301522Tsabar N, Press Y, Rotman J, Klein B, Grossman Y, Vainshtein-Tal M, Eilat-Tsanani S. The low indexes of metabolism intervention trial (LIMIT): design and baseline data of a randomized controlled clinical trial to evaluate how alerting primary care teams to low metabolic values, could affect the health of patients aged 75 or older. BMC Health Serv Res. 2018 Jan 5;18(1):4. doi: 10.1186/s12913-017-2812-0.
- Israel National Program for Quality Indicators in Community HealthcareLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request to email nir.tsabar@clalit.org.il. Shared data will not include exact dates, exact lab results or any data that might expose the identity of patients. Also, commercial data such as drug brands or costs may not be shared.
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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.
Nir Tsabar, MD/PhD principal investigator
ClalitHS North District Principal Geriatrist
Questions about this trial
What is this clinical trial studying?
A study testing Email in people with Weight Loss and Thinness, run by Clalit Health Services.
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 10 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 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Yes. Results are posted in the registry (first posted 29 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Death From Any Cause (time frame: 1 year). 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 NCT02476578, which also lists 8 linked publications.
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 9 Apr 2020.