Health BehaviorNCT03030534
Research Protocol On Developing an Integrated Technology-Moderated Institutional Health Promotion Model
A study testing Educational package and software package and Health promotion tips in people with Health Behavior, run by University of KwaZulu at 1 site in Nigeria.
Trial summary
The purpose of this study is to adopt an operational research approach that seeks to design, develop and pilot-test the health-promotion lifestyle model that will enhance health-promoting behaviour and lifestyle modification of university staff in Nigeria. The following are the hypotheses of the study: 1. 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?
- Educational package and software package and Health promotion tips
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteNigeria
- Study dates
- 15 Jan 2018to 9 Apr 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
- All staff of the university in the selected study centres
- Own a smartphone that can take the software application (experimental group)
Who cannot join
- Unwilling to participate in the study
- unable to use smartphone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Research Protocol On Developing an Integrated Technology-Moderated Institutional Health Promotion Model (ITIHPM)for Use in Nigeria Universities
The purpose of this study is to adopt an operational research approach that seeks to design, develop and pilot-test the health-promotion lifestyle model that will enhance health-promoting behaviour and lifestyle modification of university staff in Nigeria. The following are the hypotheses of the study:
- There will be a significant difference in the pre and post intervention practices of health promoting lifestyle behaviours (behaviour specific cognition and affect) of NOUN staff
- There will be significant association between the health promoting lifestyle behaviours (behavioural outcome) and health status of NOUN staff
- There will be a significant difference in the pre-and post-intervention health promoting lifestyle behaviours (behavioural outcome) of staff of NOUN
- There will be a significant difference in the pre-and post-intervention health status measure (specific health measurement indicators) of staff of NOUN
Read the detailed description
Health promotion is advocated worldwide as being an efficient strategy to enhance quality of life and control the increasing prevalence of non-communicable diseases. health promoting lifestyle has been linked to high prevalence of most non-communicable diseases. Efficient and effective health promoting lifestyle practices is beneficial in prevention and control of non-communicable diseases, as well as improving the quality of life. World Health Organization has established workplace and schools as priority settings for health promotion in the 21st century as locus of reaching large number of audience. Workplace and schools also offer an ideal settings and infrastructure to support the health promoting activities that will improve the quality of life of workers and students. Information and communication technologies (ICTs) has made the world a global village, both young and old engages in one form of ICTs or the other. This study aims to adopt operational research approach to design, develop and pilot-test Integrated Technology-Moderated Institutional Health Promotion Model (ITIHPM) that will enhance health promoting behaviour and lifestyle modification of staff in Nigeria universities.
The objectives of the study are:
- To determine the health-promoting behaviour of NOUN staff;
- To assess the health status of NOUN staff;
- To examine factors that influence the health promoting lifestyle behaviour of NOUN staff;
- To assess institutional policies available to encourage NOUN staff to practise health -promoting lifestyles;
- To assess resources available in the institution that encourage health-promoting behavior;
- To examine protocols in place to ensure adoption of health-promoting behaviour and healthy lifestyle of NOUN staff;
- To determine technology-moderated applications/platforms that would be useful in promoting knowledge and skills acquisition for health-promoting behaviour and lifestyle modifications among NOUN staff; and
- To determine the impact of a technologically-based institutional health promotion model among NOUN staff.
Who can participate? All staff that are on the university pay roll in the selected study centres, irrespective of their age.
What does the study involve? Two study centres will be randomly selected from the six study centers selected during the first phase of the study. The two centres are randomly allocated into two groups two (experimental group and control group). The control group will receive tips on health promoting lifestyle practices, answer health promoting lifestyle profile questionnaire before giving the tips, have their weight, height, blood pressure, fasting blood sugar, abdominal circumference and hip circumference checked. The group will further answer the questionnaire and have their weight, height, blood pressure, fasting blood sugar, abdominal circumference and hip circumference checked at 6 weeks and at 12 weeks. While the experimental group will have four weeks training (educational package) on nutrition, exercise/physical activity, stress management, health responsibility, self-actualization and interpersonal relationship through seminar and symposium for 45-60 minutes 4 times in a week for the 4 weeks. At the beginning of the training database of all the participants will be created. This will include socio-demographic data and baseline health assessment that is related to the study (weight, height, blood pressure, fasting blood sugar, abdominal circumference and hip circumference). Participants will also answer questionnaire on health promoting lifestyle practice at the beginning of the training. The same procedure will be taken at week zero (immediately after the training), at 6 weeks and at 12 weeks. In the last two sections of the meeting, participants will be informed and intimate on the use of the software package and encourage them to ask questions. The participants will receive audio and video messages on health promoting lifestyle practices once in a week. The software application will be designed in a way that both the principal investigator and participants can interact at any time. The Technology-Moderated Institutional Health Promotion Model will also give opportunity to university staff to have assessed to a Community Health Nurse Specialist (health promotion expert) at every needed time. Four sessions of Focus Group Discussions among cohorts of staff will be conducted to identify barriers to healthy lifestyle practices using the developed model.
Primary outcome measures
- Health promoting lifestyle practices of staff will be measured using health promoting lifestyle profile II at the beginning of the study.
- Effective and efficient Health promoting lifestyle practices of staff will be measured using health promoting lifestyle profile II and mobile software application at zero week, 6 weeks and 12 weeks
- Health status of staff will be measured using the following indicators: weight, height, blood pressure, fasting blood sugar, abdominal circumference and hip circumference at the beginning of the study, at zero week, 6 weeks and 12 weeks
- Resources available in the university that will enhance health promoting lifestyle practices will be measured using interview guide and checklists at the beginning of the study Secondary outcome measures
- Participants compliance to the intervention will be measured at 6 weeks and 12 weeks 2. Participants satisfaction with the intervention will be measured at 6 weeks and 12 weeks 3. Retention rate will be measured at 6 weeks and 12 weeks
The target number of participants in the pilot-testing phase is 185 Exclusion criteria
What are the possible benefits and risks of participating? We hope that the study will afford the participants the benefits of practicing health promoting lifestyle effectively and thereby help him/her to prevent non-communicable diseases (NCDs). In case the participant has been diagnosed with any NCDs, participating in this study will provide the individual with relevant information that will make him/her live a quality life. During the study if the health assessment reveals any deviation from normal, the individual will be referred to the school sickbay for appropriate treatment and the principal researcher will still follow the him/her up. The only risk anticipated in this study is that its demands the participants to be meticulous in adhering to all the health promotion activities, which are beneficial on the long to the participants.
- Conditions
- Health Behavior
- Being tested
- Educational package and software package, Health promotion tips
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational package and software packageCombination product
Also called Health promotion lifestyle activities
Using Information and communication technology to deliver health promoting activities
Health promotion tipsOther
Give general information on health promotion
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Educational Package and software package Receives: Combination Product: Educational package and software package |
| Control group | Active comparator | Health promotion tips Receives: Other: Health promotion tips |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Health promoting lifestyle practices
health promoting lifestyle profile questionnaire consist of six subclass (Nutrition, Physical activity, Health responsibility, Stress management, interpersonal relationship, self-actualization) of health promoting lifestyle activities and self-designed mobile software application
Measured: Baseline, 6 weeks and 12 weeks
Secondary outcomes (4)
BMI in kg/m^2
Assess changes in BMI
Measured: Baseline, at 6 weeks and 12 weeks
Random blood glucose in mg/dl
Assess changes in participants blood glucose
Measured: Baseline, 6 weeks and 12 weeks
Waist to Hip ratio (WHR) in cm
Assess changes in Waist to Hip ratio
Measured: Baseline, 6 weeks and 12 weeks
Blood pressure in mmHg
Assess changes in participants blood pressure
Measured: Baseline, 6 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study start15 Jan 2018
- Primary completion9 Apr 2018
- Study completion9 Apr 2018
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 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to two groups. that is two locations (study centres) will be selected for the study
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of KwaZulu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth M. Joseph-Shehu, University of KwaZulu
- Investigators
- Elizabeth M Joseph-Shehu, MSc, Principal investigator, University of KwaZulu-Natal, Durban, South Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03030534
- Sponsor's protocol ID
- DITIHPM-001
- Status last verified
- Oct 2021
- First submitted
- 19 Jan 2017
- Last updated
- 25 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All data that will be beneficial to other researchers will be sheared through journal publication and workshops. No identifying data will be published.
Publications
Şenol V, Ünalan D, Soyuer F, Argün M: The relationship between health promoting behaviors and quality of life in nursing home residents in Kayseri. Journal of Geriatrics 2014
Chronic diseases and health promotion: Global Status Report on NCDs
Oinas-Kukkonen H: Behavior change support systems: A research model and agenda. In: Persuasive Technology. edn.: Springer; 2010: 4-14.
Cowdery J, Kindred J, Michalakis A, Suggs LS: Promoting health in a virtual world: Impressions of health communication messages delivered in Second Life. First Monday 2011, 16(9).
Bock BC, Graham AL, Whiteley JA, Stoddard JL. A review of web-assisted tobacco interventions (WATIs). J Med Internet Res. 2008 Nov 6;10(5):e39. doi: 10.2196/jmir.989.
PubMed 19000979Koniak-Griffin D, Brecht ML, Takayanagi S, Villegas J, Melendrez M, Balcazar H. A community health worker-led lifestyle behavior intervention for Latina (Hispanic) women: feasibility and outcomes of a randomized controlled trial. Int J Nurs Stud. 2015 Jan;52(1):75-87. doi: 10.1016/j.ijnurstu.2014.09.005. Epub 2014 Sep 22.
PubMed 25307195Wikstrom K, Lindstrom J, Tuomilehto J, Saaristo TE, Helakorpi S, Korpi-Hyovalti E, Oksa H, Vanhala M, Keinanen-Kiukaanniemi S, Uusitupa M, Peltonen M. National diabetes prevention program (DEHKO): awareness and self-reported lifestyle changes in Finnish middle-aged population. Public Health. 2015 Mar;129(3):210-7. doi: 10.1016/j.puhe.2014.12.019. Epub 2015 Feb 26.
PubMed 25726122
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research Protocol On Developing an Integrated Technology-Moderated Institutional Health Promotion Model (ITIHPM)for Use in Nigeria Universities
- ClinicalTrials.gov ID
- NCT03030534
- Acronym / sponsor ID
- DITIHPM-001
- Conditions
- Health Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of KwaZuluUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 9 Apr 2018 (actual)
- Study completion
- 9 Apr 2018 (actual)
- First posted
- 25 Jan 2017 (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 purpose of this study is to adopt an operational research approach that seeks to design, develop and pilot-test the health-promotion lifestyle model that will enhance health-promoting behaviour and lifestyle modification of university staff in Nigeria. The following are the hypotheses of the study:
- There will be a significant difference in the pre and post intervention practices of health promoting lifestyle behaviours (behaviour specific cognition and affect) of NOUN staff
- There will be significant association between the health promoting lifestyle behaviours (behavioural outcome) and health status of NOUN staff
- There will be a significant difference in the pre-and post-intervention health promoting lifestyle behaviours (behavioural outcome) of staff of NOUN
- There will be a significant difference in the pre-and post-intervention health status measure (specific health measurement indicators) of staff of NOUN
Detailed description
Health promotion is advocated worldwide as being an efficient strategy to enhance quality of life and control the increasing prevalence of non-communicable diseases. health promoting lifestyle has been linked to high prevalence of most non-communicable diseases. Efficient and effective health promoting lifestyle practices is beneficial in prevention and control of non-communicable diseases, as well as improving the quality of life. World Health Organization has established workplace and schools as priority settings for health promotion in the 21st century as locus of reaching large number of audience. Workplace and schools also offer an ideal settings and infrastructure to support the health promoting activities that will improve the quality of life of workers and students. Information and communication technologies (ICTs) has made the world a global village, both young and old engages in one form of ICTs or the other. This study aims to adopt operational research approach to design, develop and pilot-test Integrated Technology-Moderated Institutional Health Promotion Model (ITIHPM) that will enhance health promoting behaviour and lifestyle modification of staff in Nigeria universities.
The objectives of the study are:
- To determine the health-promoting behaviour of NOUN staff;
- To assess the health status of NOUN staff;
- To examine factors that influence the health promoting lifestyle behaviour of NOUN staff;
- To assess institutional policies available to encourage NOUN staff to practise health -promoting lifestyles;
- To assess resources available in the institution that encourage health-promoting behavior;
- To examine protocols in place to ensure adoption of health-promoting behaviour and healthy lifestyle of NOUN staff;
- To determine technology-moderated applications/platforms that would be useful in promoting knowledge and skills acquisition for health-promoting behaviour and lifestyle modifications among NOUN staff; and
- To determine the impact of a technologically-based institutional health promotion model among NOUN staff.
Who can participate? All staff that are on the university pay roll in the selected study centres, irrespective of their age.
What does the study involve? Two study centres will be randomly selected from the six study centers selected during the first phase of the study. The two centres are randomly allocated into two groups two (experimental group and control group). The control group will receive tips on health promoting lifestyle practices, answer health promoting lifestyle profile questionnaire before giving the tips, have their weight, height, blood pressure, fasting blood sugar, abdominal circumference and hip circumference checked. The group will further answer the questionnaire and have their weight, height, blood pressure, fasting blood sugar, abdominal circumference and hip circumference checked at 6 weeks and at 12 weeks. While the experimental group will have four weeks training (educational package) on nutrition, exercise/physical activity, stress management, health responsibility, self-actualization and interpersonal relationship through seminar and symposium for 45-60 minutes 4 times in a week for the 4 weeks. At the beginning of the training database of all the participants will be created. This will include socio-demographic data and baseline health assessment that is related to the study (weight, height, blood pressure, fasting blood sugar, abdominal circumference and hip circumference). Participants will also answer questionnaire on health promoting lifestyle practice at the beginning of the training. The same procedure will be taken at week zero (immediately after the training), at 6 weeks and at 12 weeks. In the last two sections of the meeting, participants will be informed and intimate on the use of the software package and encourage them to ask questions. The participants will receive audio and video messages on health promoting lifestyle practices once in a week. The software application will be designed in a way that both the principal investigator and participants can interact at any time. The Technology-Moderated Institutional Health Promotion Model will also give opportunity to university staff to have assessed to a Community Health Nurse Specialist (health promotion expert) at every needed time. Four sessions of Focus Group Discussions among cohorts of staff will be conducted to identify barriers to healthy lifestyle practices using the developed model.
Primary outcome measures
- Health promoting lifestyle practices of staff will be measured using health promoting lifestyle profile II at the beginning of the study.
- Effective and efficient Health promoting lifestyle practices of staff will be measured using health promoting lifestyle profile II and mobile software application at zero week, 6 weeks and 12 weeks
- Health status of staff will be measured using the following indicators: weight, height, blood pressure, fasting blood sugar, abdominal circumference and hip circumference at the beginning of the study, at zero week, 6 weeks and 12 weeks
- Resources available in the university that will enhance health promoting lifestyle practices will be measured using interview guide and checklists at the beginning of the study Secondary outcome measures
- Participants compliance to the intervention will be measured at 6 weeks and 12 weeks 2. Participants satisfaction with the intervention will be measured at 6 weeks and 12 weeks 3. Retention rate will be measured at 6 weeks and 12 weeks
The target number of participants in the pilot-testing phase is 185 Exclusion criteria
What are the possible benefits and risks of participating? We hope that the study will afford the participants the benefits of practicing health promoting lifestyle effectively and thereby help him/her to prevent non-communicable diseases (NCDs). In case the participant has been diagnosed with any NCDs, participating in this study will provide the individual with relevant information that will make him/her live a quality life. During the study if the health assessment reveals any deviation from normal, the individual will be referred to the school sickbay for appropriate treatment and the principal researcher will still follow the him/her up. The only risk anticipated in this study is that its demands the participants to be meticulous in adhering to all the health promotion activities, which are beneficial on the long to the participants.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are assigned to two groups. that is two locations (study centres) will be selected for the study
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Combination Product: Educational package and software packageEducational Package and software package |
| Control group | Active comparator | Other: Health promotion tipsHealth promotion tips |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All staff of the university in the selected study centres
- Own a smartphone that can take the software application (experimental group)
Key exclusion criteria (2 listed)
- Unwilling to participate in the study
- unable to use smartphone
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 |
|---|---|---|
| Educational package and software packageAlso: Health promotion lifestyle activitiesUsing Information and communication technology to deliver health promoting activities | Combination product | Experimental Group |
| Health promotion tipsGive general information on health promotion | Other | Control group |
Primary outcome
Changes in Health promoting lifestyle practices
Time frame: Baseline, 6 weeks and 12 weeks
health promoting lifestyle profile questionnaire consist of six subclass (Nutrition, Physical activity, Health responsibility, Stress management, interpersonal relationship, self-actualization) of health promoting lifestyle activities and self-designed mobile software application
4 secondary outcomes
BMI in kg/m^2
Time frame: Baseline, at 6 weeks and 12 weeks
Random blood glucose in mg/dl
Time frame: Baseline, 6 weeks and 12 weeks
Waist to Hip ratio (WHR) in cm
Time frame: Baseline, 6 weeks and 12 weeks
Blood pressure in mmHg
Time frame: Baseline, 6 weeks and 12 weeks
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 25 Oct 2021.
- Results publicationŞenol V, Ünalan D, Soyuer F, Argün M: The relationship between health promoting behaviors and quality of life in nursing home residents in Kayseri. Journal of Geriatrics 2014
- Results publicationChronic diseases and health promotion: Global Status Report on NCDs
- Results publicationOinas-Kukkonen H: Behavior change support systems: A research model and agenda. In: Persuasive Technology. edn.: Springer; 2010: 4-14.
- Results publicationCowdery J, Kindred J, Michalakis A, Suggs LS: Promoting health in a virtual world: Impressions of health communication messages delivered in Second Life. First Monday 2011, 16(9).
- Results publication: PubMed 19000979Bock BC, Graham AL, Whiteley JA, Stoddard JL. A review of web-assisted tobacco interventions (WATIs). J Med Internet Res. 2008 Nov 6;10(5):e39. doi: 10.2196/jmir.989.
- Results publication: PubMed 25307195Koniak-Griffin D, Brecht ML, Takayanagi S, Villegas J, Melendrez M, Balcazar H. A community health worker-led lifestyle behavior intervention for Latina (Hispanic) women: feasibility and outcomes of a randomized controlled trial. Int J Nurs Stud. 2015 Jan;52(1):75-87. doi: 10.1016/j.ijnurstu.2014.09.005. Epub 2014 Sep 22.
- Results publication: PubMed 25726122Wikstrom K, Lindstrom J, Tuomilehto J, Saaristo TE, Helakorpi S, Korpi-Hyovalti E, Oksa H, Vanhala M, Keinanen-Kiukaanniemi S, Uusitupa M, Peltonen M. National diabetes prevention program (DEHKO): awareness and self-reported lifestyle changes in Finnish middle-aged population. Public Health. 2015 Mar;129(3):210-7. doi: 10.1016/j.puhe.2014.12.019. Epub 2015 Feb 26.
- Individual participant dataSharing planned: Undecided. All data that will be beneficial to other researchers will be sheared through journal publication and workshops. No identifying data will be published.
Related trials for Health Behavior
Active, not recruiting
HPV Multilevel Intervention Strategies Targeting Immunization in Community Settings (HPV MISTICS)
Human Papilloma Virus (HPV) Vaccine
Not yet recruiting
Reducing Stigma - A Treatment for Early Psychosis to Prevent Suicide
Suicide, Mental Health Stigma
Recruiting
DBT-P Treatment Study
Emotion Dysregulation
Not yet recruiting
A Clinician-Patient Dual Behavior Change Framework to Leverage Informed Digital Nudges to Reduce Hospital Readmissions and Improve Patient Outcomes: A Trial for Scalable Strategy to Reduce Readmissions (PREVENT-R)
Readmission, Readmission Rates
RecruitingObservational study
Geospatial Analysis of Neighborhood Environmental Stress in Relation to Biological Markers of Cardiovascular Health and Health Behaviors in Women
Cardiovascular (CV) Risk
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.
Elizabeth M Joseph-Shehu, MSc principal investigator
University of KwaZulu-Natal, Durban, South Africa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational package and software package and Health promotion tips in people with Health Behavior, run by University of KwaZulu at 1 site in Nigeria.
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 25 Oct 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 Nigeria. 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?
Changes in Health promoting lifestyle practices (time frame: Baseline, 6 weeks and 12 weeks). 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 NCT03030534, 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 25 Oct 2021.