Health BehaviorNCT03904992
Intervention With a Progressive Web App for the Promotion of Healthy Habits in Preschoolers
A study testing Progressive web app in people with Health Behavior, run by Universidad Peruana Cayetano Heredia at 1 site in Peru.
Trial summary
The preschool stage has been identified as an important moment for the study of factors associated with obesity. The worrying national situation of overweight in children from 3 to 5 years old, the increase in consumption of ultra-processed foods nationwide that is associated with the increase of the body mass index… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Progressive web app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 sitePeru
- Study dates
- 7 Sep 2018to 12 Nov 2018
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Caregivers of children from 3 to 6 years old that currently attend school
- People who have access to a mid-range or high-end Smartphone with Android 6.0 operating system or higher, with Internet access, in which the application will be installed
Who cannot join
- Caregivers of children with hormonal diseases that affect the nutritional status (referred by caregiver or caregiver): hypothyroidism, hyperthyroidism, Cushing's syndrome, growth hormone deficiency, diabetes
- Caregivers of children with heart disease, kidney disease or cancer (referred by caregiver or caregiver)
- Caregivers of children with paraplegia, tetraplegia or some degree of paralysis
- Caregivers of children who are beneficiaries of the Qali Warma Program
- People who are illiterate or who have great difficulties in the operation of smartphones
Trial locations and contacts
1 site in 1 country.
About this study
The preschool stage has been identified as an important moment for the study of factors associated with obesity. The worrying national situation of overweight in children from 3 to 5 years old, the increase in consumption of ultra-processed foods nationwide that is associated with the increase of the body mass index at the national level, the reduced national scientific evidence regarding the effectiveness of interventions in promoting healthy habits, as well as the lack of tools for mothers of preschool children in nutrition and physical activity, make interventions necessary in this area. On the other hand, currently, users worldwide are installing fewer applications and, although they spend more time using mobile applications, they are limited to a handful. Therefore, developing a native mobile application that is highly consumed is very difficult and expensive. For this reason, progressive web apps emerge as an attractive alternative for users given its attractive features, cross-platform interface, lower development cost and a growing demand for such applications. Thus, this research seeks to explore a novel way to promote healthy habits in preschoolers and check their effectiveness. In this way, a precedent could be set in the use of technologies in health promotion that could be extended to other age groups.
Read the detailed description
SAMPLE SIZE The sample size was calculated using OpenEpi (www.openepi.com), with the sample size formula to compare two means, considering a confidence interval of 95%, power of 80%, ratio of sample size (group 2 / group 1) equal to 1, a minimum expected mean difference of 5 points and a standard deviation of 9.5 points for both groups. Thus, the required sample size is 114 participants (57 intervened and 57 not intervened).
TECHNIQUES AND PROCEDURES FOR DATA COLLECTION
First stage: Design of the progressive web app
In this phase, the profile of the users will be defined through a focus group. Among the information gathered is socio-demographic data, use of technology, current situation of the feeding and physical activity of the preschool, and expectations of the functions of the computer tool. In addition, a complementary bibliographic search will be carried out on the subject to expand the information necessary for the design of the PWA.
Based on the information collected, the alpha version of the application will be developed. It will undergo a validation process and based on the feedback, the application will be improved until a beta version is developed.
Second stage: intervention with the progressive web app (PWA)
ANALYSIS PLAN
The data was collected using the Magpi software. To verify the comparability of the two randomization groups based on the sociodemographic covariates through a descriptive analysis, a frequency and percentage table was constructed, which were compared by statistical tests.
In addition, the variation of the ration consumption of the food groups, the score in each component of the feeding behavior and the activity of the preschool was analyzed; the variation of the nutritional status and quality of the components of the lunch box in the control and intervention group was identified; and the variation of the Z score for the indicator of BMI for age and the consumption of the lunch box was plotted through a chart of boxes.
To determine the effect of the intervention, the differences of the measurements (post-pre) of the control and intervention groups were compared. For this, the Student t test was used for independent samples. The variables analyzed were:
- Variation of the dietetic quality of the preschool
- Variation in the nutritional status of children
- Variation of preschool feeding behavior
- Variation of the composition of the lunchbox
- Variation of the consumption of the lunchbox
- Variation of physical activity Finally, a satisfaction survey was applied to the intervention group and the results were presented using descriptive statistics.
- Conditions
- Health Behavior
- Being tested
- Progressive web app
- Keywords
- Nutrtition, Physical activity, Preescholer, Informatics
- Medical subject headings
- Health Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive web appOther
Access to a progressive web app for the promotion of healthy habits in preescholers through the participant's smatphone
| Study group | Role | What they receive |
|---|---|---|
| Non-exposed | No intervention | Subjects with access to nutritional counseling sessions every 30 days |
| Exposed | Experimental | Subjects with access to the progressive web app in their smartphones. Receives: Other: Progressive web app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of the dietary diversity of the preescholer
The difference between the scores obtained in the baseline and the evaluation using the Healthy Eating Index score
Measured: 60 days after the instalation of the Progressive Web App
Secondary outcomes (5)
Variation in preescholer's nutritional status
The difference between the Z-point values of the BMI for age pattern.
Measured: 60 days after the instalation of the Progressive Web App
Variation of the preescholer's eating behavior
The difference between the scores obtained for child's eating behavior that will be evaluated through the Children Eating Behaviour Questionnaire
Measured: 60 days after the instalation of the Progressive Web App
Variation of the composition of the lunch box
Change in the score obtained for the composition of the preescholer's lunch boxes
Measured: 60 days after the instalation of the Progressive Web App
Variation of the refreshment consumption
The change in the consumption of the refreshments (lunch box) will be determined using a food scale (grams).
Measured: 60 days after the instalation of the Progressive Web App
Variation of physical activity
A difference in the number of minutes of physical activity of the preschoolers reported by the parents using a validated questionnaire
Measured: 60 days after the instalation of the Progressive Web App
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start7 Sep 2018
- Primary completion12 Nov 2018
- Study completion12 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- First, a baseline evaluation will be made to the participants, based on the indicators of interest. During a period of 60 days, the caregivers of the intervention group had free access to the progressive web app "Nutrinidos" and received training for its use. On the other hand, nutritional counseling was available every 30 days for the participants assigned to the control group. They consisted of personalized sessions with a duration of 20 minutes in which parents and caregivers could resolve their doubts regarding the feeding of their children. In addition, they were offered physical education materials designed and adapted with content used in this study. The educational material addressed contains information about lunch boxes, eating habits, consumption of fruits and vegetables, prevention of anemia, and physical activity. After 60 days of follow-up, the evaluation of results will be carried out.
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Peruana Cayetano Heredia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oscar J Calvo Torres, BS, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03904992
- Sponsor's protocol ID
- 102342
- Status last verified
- Apr 2019
- First submitted
- 3 Apr 2019
- Last updated
- 5 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Revilla L, Alvarado C, Álvarez D, Tarqui C, Gómez G, Jacoby E, et al. Un gordo problema: Sobrepeso y Obesidad en el Perú. Editor Imprenta Sanchez SRL [Internet]. 2012;1-24. Available from: http://bvs.minsa.gob.pe/local/MINSA/1830.pdf
Tarqui C, Sánchez J, Alvarez D, Gómez G, Valdivia S. Tendencia del sobrepeso, obesidad y exceso de peso en el Perú. La Rev Peru Epidemiol [Internet]. 2013;17(3):7. Available from: http://ateneo.unmsm.edu.pe/ateneo/bitstream/123456789/3132/3/rev_peru_epidemiol04v17n3_2013.pdf%5Cnhttp://rpe.epiredperu.net/rpe_ediciones/2013_v17_n03/Original tendencia del sobrepeso y obesidad en Peru RPE 17_3.pdf
Instituto Nacional de Salud. Situación Nutricional - Obsevatorio de Nutrición y el Estudio del Sobrepeso y Obesidad [Internet]. [cited 2018 Apr 18]. Available from: http://www.observateperu.ins.gob.pe/sala-situacional/situacion-nutricional
Ruiz EF, Proano A, Ponce OJ, Curioso WH. [Mobile health for public health in Peru: lessons learned]. Rev Peru Med Exp Salud Publica. 2015 Apr-Jun;32(2):364-72. Spanish.
PubMed 26338384Santiago MA, Fernández RN, Esquirol JRL, Sánchez IP. La edad preescolar como momento singular del desarrollo humano. Rev Cubana Pediatr. 2007;79(4) Available from: http://www.aeped.es/documentos/protocolos-nutricion
Rojas A, León M, Sánchez O. Formación de hábitos alimentarios y de estilos de vida saludables. Curric Educ Inicial [Internet]. 2003;1-36. Available from: http://www.unicef.org/venezuela/spanish/educinic9.pdf
Pediatría C de N de la SU de. Guías de alimentación del niño preescolar y escolar. Arch Pediatr Urug. 2004;75(2):159-13.
Cortina LS. Protocolos de nutrición. Protoc la AEP [Internet]. 2010;297-305. Available from: http://www.aeped.es/documentos/protocolos-nutricion
Trost SG, Sirard JR, Dowda M, Pfeiffer KA, Pate RR. Physical activity in overweight and nonoverweight preschool children. Int J Obes Relat Metab Disord. 2003 Jul;27(7):834-9. doi: 10.1038/sj.ijo.0802311.
PubMed 12821970Gmbh GG, Steiner T. What is in a Web View ? An Analysis of Progressive Web App Features When the Means of Web Access is not a Web Browser. In: Companion of the The Web Conference 2018 on The Web Conference 2018. Ginebra, Suiza: International World Wide Web Conferences Steering Committee; 2018. p. 789-96.
Ater T. Building Progressive Web Apps: Bringing the Power of Native to the Browser. 1ed ed. EE.UU.: O'Reilly Media; 2017. 288 p.
Sheppard D (Computer software developer). Beginning progressive web app development creating a native app experience on the web [Internet]. EE.UU.: Apress Media LLC; 2017. Available from: https://books.google.mu/books?id=9_RADwAAQBAJ&dq=progressive+web+apps&source=gbs_navlinks_s
OPS. Alimentos y bebidas ultraprocesados en América Latina: tendencias, efecto sobre la obesidad e implicaciones para las políticas públicas [Internet]. Washington D.C.: Organización Panamericana de la Salud; 2015 [cited 2018 Apr 30]. Available from: http://iris.paho.org/xmlui/bitstream/handle/123456789/7698/9789275318645_esp.pdf
Leal KK, Schneider BC, Franca GV, Gigante DP, dos Santos I, Assuncao MC. [Diet quality of preschool children aged 2 to 5 years living in the urban area of Pelotas, Brazil]. Rev Paul Pediatr. 2015 Jul-Sep;33(3):311-8. doi: 10.1016/j.rpped.2015.05.002. Epub 2015 Jun 10.
PubMed 26122208Rauber F, da Costa Louzada ML, Vitolo MR. Healthy eating index measures diet quality of Brazilian children of low socioeconomic status. J Am Coll Nutr. 2014;33(1):26-31. doi: 10.1080/07315724.2014.869979.
PubMed 24533605
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention With a Progressive Web App for the Promotion of Healthy Habits in Preschoolers
- ClinicalTrials.gov ID
- NCT03904992
- Acronym / sponsor ID
- 102342
- Conditions
- Health Behavior
- Keywords
- Nutrtition, Physical activity, Preescholer, Informatics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Universidad Peruana Cayetano HerediaUniversity, hospital or other
- Study start
- 7 Sep 2018 (actual)
- Primary completion
- 12 Nov 2018 (actual)
- Study completion
- 12 Nov 2018 (actual)
- First posted
- 5 Apr 2019 (actual)
- 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 preschool stage has been identified as an important moment for the study of factors associated with obesity. The worrying national situation of overweight in children from 3 to 5 years old, the increase in consumption of ultra-processed foods nationwide that is associated with the increase of the body mass index at the national level, the reduced national scientific evidence regarding the effectiveness of interventions in promoting healthy habits, as well as the lack of tools for mothers of preschool children in nutrition and physical activity, make interventions necessary in this area. On the other hand, currently, users worldwide are installing fewer applications and, although they spend more time using mobile applications, they are limited to a handful. Therefore, developing a native mobile application that is highly consumed is very difficult and expensive. For this reason, progressive web apps emerge as an attractive alternative for users given its attractive features, cross-platform interface, lower development cost and a growing demand for such applications. Thus, this research seeks to explore a novel way to promote healthy habits in preschoolers and check their effectiveness. In this way, a precedent could be set in the use of technologies in health promotion that could be extended to other age groups.
Detailed description
SAMPLE SIZE The sample size was calculated using OpenEpi (www.openepi.com), with the sample size formula to compare two means, considering a confidence interval of 95%, power of 80%, ratio of sample size (group 2 / group 1) equal to 1, a minimum expected mean difference of 5 points and a standard deviation of 9.5 points for both groups. Thus, the required sample size is 114 participants (57 intervened and 57 not intervened).
TECHNIQUES AND PROCEDURES FOR DATA COLLECTION
First stage: Design of the progressive web app
In this phase, the profile of the users will be defined through a focus group. Among the information gathered is socio-demographic data, use of technology, current situation of the feeding and physical activity of the preschool, and expectations of the functions of the computer tool. In addition, a complementary bibliographic search will be carried out on the subject to expand the information necessary for the design of the PWA.
Based on the information collected, the alpha version of the application will be developed. It will undergo a validation process and based on the feedback, the application will be improved until a beta version is developed.
Second stage: intervention with the progressive web app (PWA)
ANALYSIS PLAN
The data was collected using the Magpi software. To verify the comparability of the two randomization groups based on the sociodemographic covariates through a descriptive analysis, a frequency and percentage table was constructed, which were compared by statistical tests.
In addition, the variation of the ration consumption of the food groups, the score in each component of the feeding behavior and the activity of the preschool was analyzed; the variation of the nutritional status and quality of the components of the lunch box in the control and intervention group was identified; and the variation of the Z score for the indicator of BMI for age and the consumption of the lunch box was plotted through a chart of boxes.
To determine the effect of the intervention, the differences of the measurements (post-pre) of the control and intervention groups were compared. For this, the Student t test was used for independent samples. The variables analyzed were:
- Variation of the dietetic quality of the preschool
- Variation in the nutritional status of children
- Variation of preschool feeding behavior
- Variation of the composition of the lunchbox
- Variation of the consumption of the lunchbox
- Variation of physical activity Finally, a satisfaction survey was applied to the intervention group and the results were presented using descriptive statistics.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- First, a baseline evaluation will be made to the participants, based on the indicators of interest. During a period of 60 days, the caregivers of the intervention group had free access to the progressive web app "Nutrinidos" and received training for its use. On the other hand, nutritional counseling was available every 30 days for the participants assigned to the control group. They consisted of personalized sessions with a duration of 20 minutes in which parents and caregivers could resolve their doubts regarding the feeding of their children. In addition, they were offered physical education materials designed and adapted with content used in this study. The educational material addressed contains information about lunch boxes, eating habits, consumption of fruits and vegetables, prevention of anemia, and physical activity. After 60 days of follow-up, the evaluation of results will be carried out.
| Arm | Type | Receives |
|---|---|---|
| Non-exposed | No intervention | –Subjects with access to nutritional counseling sessions every 30 days |
| Exposed | Experimental | Other: Progressive web appSubjects with access to the progressive web app in their smartphones. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Caregivers of children from 3 to 6 years old that currently attend school
- People who have access to a mid-range or high-end Smartphone with Android 6.0 operating system or higher, with Internet access, in which the application will be installed
Key exclusion criteria (5 listed)
- Caregivers of children with hormonal diseases that affect the nutritional status (referred by caregiver or caregiver): hypothyroidism, hyperthyroidism, Cushing's syndrome, growth hormone deficiency, diabetes
- Caregivers of children with heart disease, kidney disease or cancer (referred by caregiver or caregiver)
- Caregivers of children with paraplegia, tetraplegia or some degree of paralysis
- Caregivers of children who are beneficiaries of the Qali Warma Program
- People who are illiterate or who have great difficulties in the operation of smartphones
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 |
|---|---|---|
| Progressive web appAccess to a progressive web app for the promotion of healthy habits in preescholers through the participant's smatphone | Other | Exposed |
Primary outcome
Variation of the dietary diversity of the preescholer
Time frame: 60 days after the instalation of the Progressive Web App
The difference between the scores obtained in the baseline and the evaluation using the Healthy Eating Index score
5 secondary outcomes
Variation in preescholer's nutritional status
Time frame: 60 days after the instalation of the Progressive Web App
Variation of the preescholer's eating behavior
Time frame: 60 days after the instalation of the Progressive Web App
Variation of the composition of the lunch box
Time frame: 60 days after the instalation of the Progressive Web App
Variation of the refreshment consumption
Time frame: 60 days after the instalation of the Progressive Web App
Variation of physical activity
Time frame: 60 days after the instalation of the Progressive Web App
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 5 Apr 2019.
- BackgroundRevilla L, Alvarado C, Álvarez D, Tarqui C, Gómez G, Jacoby E, et al. Un gordo problema: Sobrepeso y Obesidad en el Perú. Editor Imprenta Sanchez SRL [Internet]. 2012;1-24. Available from: http://bvs.minsa.gob.pe/local/MINSA/1830.pdf
- BackgroundTarqui C, Sánchez J, Alvarez D, Gómez G, Valdivia S. Tendencia del sobrepeso, obesidad y exceso de peso en el Perú. La Rev Peru Epidemiol [Internet]. 2013;17(3):7. Available from: http://ateneo.unmsm.edu.pe/ateneo/bitstream/123456789/3132/3/rev_peru_epidemiol04v17n3_2013.pdf%5Cnhttp://rpe.epiredperu.net/rpe_ediciones/2013_v17_n03/Original tendencia del sobrepeso y obesidad en Peru RPE 17_3.pdf
- BackgroundInstituto Nacional de Salud. Situación Nutricional - Obsevatorio de Nutrición y el Estudio del Sobrepeso y Obesidad [Internet]. [cited 2018 Apr 18]. Available from: http://www.observateperu.ins.gob.pe/sala-situacional/situacion-nutricional
- Background: PubMed 26338384Ruiz EF, Proano A, Ponce OJ, Curioso WH. [Mobile health for public health in Peru: lessons learned]. Rev Peru Med Exp Salud Publica. 2015 Apr-Jun;32(2):364-72. Spanish.
- BackgroundSantiago MA, Fernández RN, Esquirol JRL, Sánchez IP. La edad preescolar como momento singular del desarrollo humano. Rev Cubana Pediatr. 2007;79(4) Available from: http://www.aeped.es/documentos/protocolos-nutricion
- BackgroundRojas A, León M, Sánchez O. Formación de hábitos alimentarios y de estilos de vida saludables. Curric Educ Inicial [Internet]. 2003;1-36. Available from: http://www.unicef.org/venezuela/spanish/educinic9.pdf
- BackgroundPediatría C de N de la SU de. Guías de alimentación del niño preescolar y escolar. Arch Pediatr Urug. 2004;75(2):159-13.
- BackgroundCortina LS. Protocolos de nutrición. Protoc la AEP [Internet]. 2010;297-305. Available from: http://www.aeped.es/documentos/protocolos-nutricion
- Background: PubMed 12821970Trost SG, Sirard JR, Dowda M, Pfeiffer KA, Pate RR. Physical activity in overweight and nonoverweight preschool children. Int J Obes Relat Metab Disord. 2003 Jul;27(7):834-9. doi: 10.1038/sj.ijo.0802311.
- BackgroundGmbh GG, Steiner T. What is in a Web View ? An Analysis of Progressive Web App Features When the Means of Web Access is not a Web Browser. In: Companion of the The Web Conference 2018 on The Web Conference 2018. Ginebra, Suiza: International World Wide Web Conferences Steering Committee; 2018. p. 789-96.
- BackgroundAter T. Building Progressive Web Apps: Bringing the Power of Native to the Browser. 1ed ed. EE.UU.: O'Reilly Media; 2017. 288 p.
- BackgroundSheppard D (Computer software developer). Beginning progressive web app development creating a native app experience on the web [Internet]. EE.UU.: Apress Media LLC; 2017. Available from: https://books.google.mu/books?id=9_RADwAAQBAJ&dq=progressive+web+apps&source=gbs_navlinks_s
- Individual participant dataSharing planned: No
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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.
Oscar J Calvo Torres, BS principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive web app in people with Health Behavior, run by Universidad Peruana Cayetano Heredia at 1 site in Peru.
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 5 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 5 Apr 2019. 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 Peru. 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?
Variation of the dietary diversity of the preescholer (time frame: 60 days after the instalation of the Progressive Web App). 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 NCT03904992, which also lists 21 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 5 Apr 2019.