Cardiovascular DiseasePSIENCT02428634
The Program SI! for Cardiovascular Health Promotion at Elementary School
A study testing PSIE13 and PSIE46 in people with Cardiovascular Disease, run by Foundation for Science, Health and Education, Spain at 1 site in Spain.
Trial summary
The objective of the study is to evaluate the effects of Program SI! for Elementary in different times of exposure for childrens and their immediate environment (teachers and parents). Read more about this study
- Who is it for?
- Ages 5 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- PSIE13 and PSIE46
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,770 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2014to Jun 2020
- 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 5 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children from public schools with canteen services located in the South Madrid Area of Education, having from 1st to 6th grades and at least two classrooms in 1st grade.
Who cannot join
- The coordination team of the SHE Foundation establishes the adherence criteria and the schools not reaching the minimum considered can be excluded. Questionnaires scoring from students with special educational needs will be excluded from the analysis of questionnaires, as well as repeat students.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Program SI! for Cardiovascular Health Promotion for Elementary Students Aged 6 to 11: a Cluster Randomized Trial
The objective of the study is to evaluate the effects of Program SI! for Elementary in different times of exposure for childrens and their immediate environment (teachers and parents). For this purpose, 48 public schools from the Community of Madrid-South Area (Spain) were randomly assigned to Program SI! during 3 or 6 academic years (intervention group) or keep their normal curriculum (control group). The main outcome is 3-year, and 6-year changes from baseline of questionnaire scoring of children, their parents and teachers in regards to a healthy lifestyle. For children were included 3-year, and 6-year changes of cardiovascular markers derived from blood pressure and anthropometry.
Read the detailed description
The Program SI! is a multilevel school-based intervention integrating four cardiovascular health-related components (diet, physical activity, human body and emotions management). Since the Program SI! for preschoolers has shown good results in improving healthy lifestyle habits in children aged 3 to 5 years, the investigators have developed the Program SI! for Elementary addressed to children from 6 to 11 years. The objective of the study is to evaluate the effects of Program SI! for Elementary in different times of exposure for childrens and their immediate environment (teachers, parents and school). In the Community of Madrid-South Area (Spain), 48 public schools from were randomly assigned to Program SI! for Elementary during 3 or 6 academic years (intervention group) or keep their normal curriculum (control group). The main outcome is 3-year, and 6-year changes from baseline of questionnaire scoring of children, and the secondary outcome is 3-year, and 6-year changes from baseline of questionnaire scoring of their parents and teachers in regards to a healthy lifestyle, as well as changes in the school environment. For children were included 3-year, and 6-year changes of cardiovascular markers derived from blood pressure and anthropometry (weight, height, waist circumference and skinfold thickness). The Program SI! for Elementary is designed for different exposures in a sample of schools never intervened to asses when the intervention has the most effectiveness. Besides, as some schools involved in the preschool study continues the Program SI! for Elementary, the investigators can be able to evaluate the impact of the Program SI! in different school stages, concluding how children keep the adoption of healthy behaviors from early in life.
- Conditions
- Cardiovascular Disease
- Being tested
- PSIE13, PSIE46
- Keywords
- Cardiovascular health promotion, Children, School intervention
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSIE13Behavioural
The Program SI! is implemented from 1st to 3rd grade of Elementary. A total of 40 hours of intervention on 1st and 2nd grade and 30 hours on 3rd grade has been established as the minimum intervention per year.
PSIE46Behavioural
The Program SI! is implemented from 4th to 6th grade of Elementary. A total of 30 hours of intervention has been established as the minimum intervention per year.
| Study group | Role | What they receive |
|---|---|---|
| Program SI! for Elementary 6 levels | Experimental | The core intervention comprises classroom activities grouped in healthy challenges (about diet, physical activity, human body and heart, and emotions management) distributed across the different levels and implemented by the corresponding teachers. All the materials, formal training and a teaching guide are provided to the school staff by the SHE Foundation. Families receive family-challenges and key messages about their children's health. The school environment is intervened mainly through an annual Healthy Fair. The intervention is implemented during all the elementary levels (PSIE13+PSIE46). Receives: Behavioral: PSIE13; Behavioral: PSIE46 |
| Normal curriculum | No intervention | The schools on the control group keep their normal curriculum and don't join any school program about health until the end of the study. |
| Program SI! for Elementary first levels | Experimental | The core intervention comprises classroom activities grouped in healthy challenges (about diet, physical activity, human body and heart, and emotions management) distributed across the different levels and implemented by the corresponding teachers. All the materials, formal training and a teaching guide are provided to the school staff by the SHE Foundation. Families receive family-challenges and key messages about their children's health. The school environment is intervened mainly through an annual Healthy Fair. To evaluate the effects of different exposures to the program, the intervention is implemented in the first three levels (PSIE13). Receives: Behavioral: PSIE13 |
| Program SI! for Elementary last levels | Experimental | The core intervention comprises classroom activities grouped in healthy challenges (about diet, physical activity, human body and heart, and emotions management) distributed across the different levels and implemented by the corresponding teachers. All the materials, formal training and a teaching guide are provided to the school staff by the SHE Foundation. Families receive family-challenges and key messages about their children's health. The school environment is intervened mainly through an annual Healthy Fair. To evaluate the effects of different exposures to the program, the intervention is implemented in the last three levels (PSIE46). Receives: Behavioral: PSIE46 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between control and intervention groups in the mean change in questionnaire's scoring from baseline to 3-year and 6-year intervention for children.
To evaluate children's lifestyle we use a specific questionnaire about knowledge, attitudes and habits in relation to the four components of Program SI! for Elementary (diet, physical activity, body and heart, and emotions management) (article under revision). A trained team of psychologist applies the children's questionnaires at the school.
Measured: 3-year, and 6-year changes from baseline of questionnaire scoring for children
Cardiovascular health markers (blood pressure, height, weight, waist circumference and triceps and subscapular skinfold thickness) of children from baseline to 3-year and 6-year intervention.
To evaluate the impact of the Program SI! for Elementary in cardiovascular health markers of children blood pressure and some anthropometric parameters are measured (height, weight, waist circumference and triceps and subscapular skinfold thickness) under standardized protocol developed in previous studies (Santos-Beneit et al. 2014).
Measured: 3-year, and 6-year changes from baseline on cardiovascular health markers of children
Secondary outcomes (3)
Difference between control and intervention groups in the mean change in questionnaire's scoring from baseline to post-intervention for families.
The family's habits are evaluated through a specific questionnaire related to key messages for families provided by the Program SI! for Elementary and some general questions about tobacco use and health status (article under revision) and stress perception (Remor 2006). Also in the questionnaire for families are included some questions about their son or daughter's habits (Serra-Majem et al 2004, Goodman 1997, Encuesta Nacional de Salud 2011/2012).
Measured: 3-year, and 6-year changes from baseline of questionnaire scoring for families
Difference between control and intervention groups in the mean change in questionnaire's scoring from baseline to post-intervention for teachers
The lifestyle of the teachers is evaluated measuring adherence to the Mediterranean lifestyle (Sotos-Prieto et al. 2014) and questions about stress perception (Remor 2006).
Measured: 3-year, and 6-year changes from baseline of questionnaire scoring for teachers
Difference between control and intervention groups in the mean change in questionnaire's scoring from baseline to post-intervention for school environment
The school environment is evaluated through questions related to the recommendations provided in the Program SI! for Elementary intervention as avoid eating commercially prepared baked foods at school.
Measured: 3-year, and 6-year changes from baseline of questionnaire scoring for school environment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startOct 2014
- Primary completionJun 2020
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,770 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Science, Health and Education, Spain
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Daniel & Nina Carasso
- Responsible party
- Sponsor
- Investigators
- Valentín Fuster, MD, PhD, Study chair, Chairman of the Foundation for Science, Health and Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02428634
- Sponsor's protocol ID
- SHE-002-SI
- Acronym
- PSIE
- Status last verified
- Feb 2021
- First submitted
- 8 Apr 2015
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Serra-Majem L, Ribas L, Ngo J, Ortega RM, Garcia A, Perez-Rodrigo C, Aranceta J. Food, youth and the Mediterranean diet in Spain. Development of KIDMED, Mediterranean Diet Quality Index in children and adolescents. Public Health Nutr. 2004 Oct;7(7):931-5. doi: 10.1079/phn2004556.
PubMed 15482620Goodman R. The Strengths and Difficulties Questionnaire: a research note. J Child Psychol Psychiatry. 1997 Jul;38(5):581-6. doi: 10.1111/j.1469-7610.1997.tb01545.x.
PubMed 9255702Sotos-Prieto M, Moreno-Franco B, Ordovas JM, Leon M, Casasnovas JA, Penalvo JL. Design and development of an instrument to measure overall lifestyle habits for epidemiological research: the Mediterranean Lifestyle (MEDLIFE) index. Public Health Nutr. 2015 Apr;18(6):959-67. doi: 10.1017/S1368980014001360. Epub 2014 Jul 15.
PubMed 25025396Remor E. Psychometric properties of a European Spanish version of the Perceived Stress Scale (PSS). Span J Psychol. 2006 May;9(1):86-93. doi: 10.1017/s1138741600006004.
PubMed 16673626Santos-Beneit G, Sotos-Prieto M, Pocock S, Redondo J, Fuster V, Penalvo JL. Association between anthropometry and high blood pressure in a representative sample of preschoolers in madrid. Rev Esp Cardiol (Engl Ed). 2015 Jun;68(6):477-84. doi: 10.1016/j.rec.2014.09.002. Epub 2014 Dec 6.
PubMed 25487220Neil-Sztramko SE, Caldwell H, Dobbins M. School-based physical activity programs for promoting physical activity and fitness in children and adolescents aged 6 to 18. Cochrane Database Syst Rev. 2021 Sep 23;9(9):CD007651. doi: 10.1002/14651858.CD007651.pub3.
PubMed 34555181Santos-Beneit G, Bodega P, de Miguel M, Rodriguez C, Carral V, Orrit X, Haro D, Carvajal I, de Cos-Gandoy A, Penalvo JL, Gomez-Pardo E, Oliva B, Ibanez B, Fernandez-Alvira JM, Fernandez-Jimenez R, Fuster V. Rationale and design of the SI! Program for health promotion in elementary students aged 6 to 11 years: A cluster randomized trial. Am Heart J. 2019 Apr;210:9-17. doi: 10.1016/j.ahj.2018.12.011. Epub 2019 Jan 8.
PubMed 30716509
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Program SI! for Cardiovascular Health Promotion for Elementary Students Aged 6 to 11: a Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT02428634
- Acronym / sponsor ID
- PSIE / SHE-002-SI
- Conditions
- Cardiovascular Disease
- Keywords
- Cardiovascular health promotion, Children, School intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,770 participants (actual)
- Lead sponsor
- Foundation for Science, Health and Education, SpainUniversity, hospital or other
- Collaborators
- Fondation Daniel & Nina Carasso
- Study start
- Oct 2014 (actual)
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 29 Apr 2015 (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.
The objective of the study is to evaluate the effects of Program SI! for Elementary in different times of exposure for childrens and their immediate environment (teachers and parents). For this purpose, 48 public schools from the Community of Madrid-South Area (Spain) were randomly assigned to Program SI! during 3 or 6 academic years (intervention group) or keep their normal curriculum (control group). The main outcome is 3-year, and 6-year changes from baseline of questionnaire scoring of children, their parents and teachers in regards to a healthy lifestyle. For children were included 3-year, and 6-year changes of cardiovascular markers derived from blood pressure and anthropometry.
Detailed description
The Program SI! is a multilevel school-based intervention integrating four cardiovascular health-related components (diet, physical activity, human body and emotions management). Since the Program SI! for preschoolers has shown good results in improving healthy lifestyle habits in children aged 3 to 5 years, the investigators have developed the Program SI! for Elementary addressed to children from 6 to 11 years. The objective of the study is to evaluate the effects of Program SI! for Elementary in different times of exposure for childrens and their immediate environment (teachers, parents and school). In the Community of Madrid-South Area (Spain), 48 public schools from were randomly assigned to Program SI! for Elementary during 3 or 6 academic years (intervention group) or keep their normal curriculum (control group). The main outcome is 3-year, and 6-year changes from baseline of questionnaire scoring of children, and the secondary outcome is 3-year, and 6-year changes from baseline of questionnaire scoring of their parents and teachers in regards to a healthy lifestyle, as well as changes in the school environment. For children were included 3-year, and 6-year changes of cardiovascular markers derived from blood pressure and anthropometry (weight, height, waist circumference and skinfold thickness). The Program SI! for Elementary is designed for different exposures in a sample of schools never intervened to asses when the intervention has the most effectiveness. Besides, as some schools involved in the preschool study continues the Program SI! for Elementary, the investigators can be able to evaluate the impact of the Program SI! in different school stages, concluding how children keep the adoption of healthy behaviors from early in life.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Program SI! for Elementary 6 levels | Experimental | Behavioral: PSIE13, Behavioral: PSIE46The core intervention comprises classroom activities grouped in healthy challenges (about diet, physical activity, human body and heart, and emotions management) distributed across the different levels and implemented by the corresponding teachers. All the materials, formal training and a teaching guide are provided to the school staff by the SHE Foundation. Families receive family-challenges and key messages about their children's health. The school environment is intervened mainly through an annual Healthy Fair. The intervention is implemented during all the elementary levels (PSIE13+PSIE46). |
| Normal curriculum | No intervention | –The schools on the control group keep their normal curriculum and don't join any school program about health until the end of the study. |
| Program SI! for Elementary first levels | Experimental | Behavioral: PSIE13The core intervention comprises classroom activities grouped in healthy challenges (about diet, physical activity, human body and heart, and emotions management) distributed across the different levels and implemented by the corresponding teachers. All the materials, formal training and a teaching guide are provided to the school staff by the SHE Foundation. Families receive family-challenges and key messages about their children's health. The school environment is intervened mainly through an annual Healthy Fair. To evaluate the effects of different exposures to the program, the intervention is implemented in the first three levels (PSIE13). |
| Program SI! for Elementary last levels | Experimental | Behavioral: PSIE46The core intervention comprises classroom activities grouped in healthy challenges (about diet, physical activity, human body and heart, and emotions management) distributed across the different levels and implemented by the corresponding teachers. All the materials, formal training and a teaching guide are provided to the school staff by the SHE Foundation. Families receive family-challenges and key messages about their children's health. The school environment is intervened mainly through an annual Healthy Fair. To evaluate the effects of different exposures to the program, the intervention is implemented in the last three levels (PSIE46). |
Who may qualify
- Ages
- 5 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children from public schools with canteen services located in the South Madrid Area of Education, having from 1st to 6th grades and at least two classrooms in 1st grade.
Key exclusion criteria (1 listed)
- The coordination team of the SHE Foundation establishes the adherence criteria and the schools not reaching the minimum considered can be excluded. Questionnaires scoring from students with special educational needs will be excluded from the analysis of questionnaires, as well as repeat students.
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 |
|---|---|---|
| PSIE13The Program SI! is implemented from 1st to 3rd grade of Elementary. A total of 40 hours of intervention on 1st and 2nd grade and 30 hours on 3rd grade has been established as the minimum intervention per year. | Behavioural | Program SI! for Elementary 6 levels, Program SI! for Elementary first levels |
| PSIE46The Program SI! is implemented from 4th to 6th grade of Elementary. A total of 30 hours of intervention has been established as the minimum intervention per year. | Behavioural | Program SI! for Elementary 6 levels, Program SI! for Elementary last levels |
Primary outcome
Difference between control and intervention groups in the mean change in questionnaire's scoring from baseline to 3-year and 6-year intervention for children.
Time frame: 3-year, and 6-year changes from baseline of questionnaire scoring for children
To evaluate children's lifestyle we use a specific questionnaire about knowledge, attitudes and habits in relation to the four components of Program SI! for Elementary (diet, physical activity, body and heart, and emotions management) (article under revision). A trained team of psychologist applies the children's questionnaires at the school.
Cardiovascular health markers (blood pressure, height, weight, waist circumference and triceps and subscapular skinfold thickness) of children from baseline to 3-year and 6-year intervention.
Time frame: 3-year, and 6-year changes from baseline on cardiovascular health markers of children
To evaluate the impact of the Program SI! for Elementary in cardiovascular health markers of children blood pressure and some anthropometric parameters are measured (height, weight, waist circumference and triceps and subscapular skinfold thickness) under standardized protocol developed in previous studies (Santos-Beneit et al. 2014).
3 secondary outcomes
Difference between control and intervention groups in the mean change in questionnaire's scoring from baseline to post-intervention for families.
Time frame: 3-year, and 6-year changes from baseline of questionnaire scoring for families
Difference between control and intervention groups in the mean change in questionnaire's scoring from baseline to post-intervention for teachers
Time frame: 3-year, and 6-year changes from baseline of questionnaire scoring for teachers
Difference between control and intervention groups in the mean change in questionnaire's scoring from baseline to post-intervention for school environment
Time frame: 3-year, and 6-year changes from baseline of questionnaire scoring for school environment
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 2 Feb 2021.
- Background: PubMed 15482620Serra-Majem L, Ribas L, Ngo J, Ortega RM, Garcia A, Perez-Rodrigo C, Aranceta J. Food, youth and the Mediterranean diet in Spain. Development of KIDMED, Mediterranean Diet Quality Index in children and adolescents. Public Health Nutr. 2004 Oct;7(7):931-5. doi: 10.1079/phn2004556.
- Background: PubMed 9255702Goodman R. The Strengths and Difficulties Questionnaire: a research note. J Child Psychol Psychiatry. 1997 Jul;38(5):581-6. doi: 10.1111/j.1469-7610.1997.tb01545.x.
- Background: PubMed 25025396Sotos-Prieto M, Moreno-Franco B, Ordovas JM, Leon M, Casasnovas JA, Penalvo JL. Design and development of an instrument to measure overall lifestyle habits for epidemiological research: the Mediterranean Lifestyle (MEDLIFE) index. Public Health Nutr. 2015 Apr;18(6):959-67. doi: 10.1017/S1368980014001360. Epub 2014 Jul 15.
- Background: PubMed 16673626Remor E. Psychometric properties of a European Spanish version of the Perceived Stress Scale (PSS). Span J Psychol. 2006 May;9(1):86-93. doi: 10.1017/s1138741600006004.
- Background: PubMed 25487220Santos-Beneit G, Sotos-Prieto M, Pocock S, Redondo J, Fuster V, Penalvo JL. Association between anthropometry and high blood pressure in a representative sample of preschoolers in madrid. Rev Esp Cardiol (Engl Ed). 2015 Jun;68(6):477-84. doi: 10.1016/j.rec.2014.09.002. Epub 2014 Dec 6.
- Derived from this study: PubMed 34555181Neil-Sztramko SE, Caldwell H, Dobbins M. School-based physical activity programs for promoting physical activity and fitness in children and adolescents aged 6 to 18. Cochrane Database Syst Rev. 2021 Sep 23;9(9):CD007651. doi: 10.1002/14651858.CD007651.pub3.
- Derived from this study: PubMed 30716509Santos-Beneit G, Bodega P, de Miguel M, Rodriguez C, Carral V, Orrit X, Haro D, Carvajal I, de Cos-Gandoy A, Penalvo JL, Gomez-Pardo E, Oliva B, Ibanez B, Fernandez-Alvira JM, Fernandez-Jimenez R, Fuster V. Rationale and design of the SI! Program for health promotion in elementary students aged 6 to 11 years: A cluster randomized trial. Am Heart J. 2019 Apr;210:9-17. doi: 10.1016/j.ahj.2018.12.011. Epub 2019 Jan 8.
- Encuesta Nacional de Salud España 2011/2012Link provided by the sponsor.
- Program SI! websiteLink provided by the sponsor.
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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.
Valentín Fuster, MD, PhD study chair
Chairman of the Foundation for Science, Health and Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSIE13 and PSIE46 in people with Cardiovascular Disease, run by Foundation for Science, Health and Education, Spain at 1 site in Spain.
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 1 inclusion and 1 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 2 Feb 2021. 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 Spain. 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. 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?
Difference between control and intervention groups in the mean change in questionnaire's scoring from baseline to 3-year and 6-year intervention for children. (time frame: 3-year, and 6-year changes from baseline of questionnaire scoring for children). 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 NCT02428634, which also lists 7 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 2 Feb 2021.