Healthy LifestyleNCT06025019
Effectiveness of Parent-based Electronic Health (eHealth) Intervention on Preschoolers' Physical Activity, Dietary Behaviors, and Sleep Problems
A study testing parent-based Electronic Health intervention in people with Healthy Lifestyle and Physical Activity, run by Hong Kong Baptist University.
Trial summary
Background: Preschoolers' lifestyles have become physically inactive and sedentary, their eating habits unhealthy, and their sleep routines increasingly disturbed. Parental involvement appears to be crucial to combat unhealthy lifestyle of preschoolers. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Lifestyle, Physical Activity, Dietary Behaviors
- What is being tested?
- parent-based Electronic Health intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 512 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 31 May 2024
- 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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parents are beyond 21 years old and have 4-6-year-old children. Selection of this child's age range was based on two factors. First of all, the age ranges from 4 to 6 have been found to be a strong predictor of future health. Secondly, a significant barrier to healthy DB is food neophobia, commonly known as picky or fussy eating, a reluctance, fear, or refusal to have new foods that is common in young children aged from 4 to 7.5 years.
- Parental commitment to participate in the overall 6-month intervention.
- Parents have access to mobile technology.
- Parents and children must be healthy (refer to a state of physical, mental, social, intellectual, and emotional well-being and the absence of disease) and can participate in normal PA.
- Parents must reside with participating child for at least four days a week (for the children to be adequately exposed to the intervention that parents may implement).
Who cannot join
- if they meet the WHO criteria for preschool age children in terms of PA (i.e., 180 minutes of in a variety of PA at any intensity, of which 60 minutes is MVPA), sedentary behaviors (i.e., no more than 1 hour at a time being sedentary such as sit in car, no more than 1 hour per day in screen time such as TV, phone, and computer), DB (such as daily salt intake should be less than 5g), and sleep time (i.e., over 10 hours good quality sleep including nap, with regular sleep and wake time).
- they diagnosed with neurological or physically disable and children who have a parent suffering from a serious physical or psychological disease making the study too demanding for the family will be excluded from the study.
- if they have special dietary requirements or allergies that would necessitate the tailoring intervention or that may be adversely affected by the intervention. Eligible participants will be required to provide informed consent by completing a written consent form after reading the participant information.
Trial locations and contacts
No sites are listed yet.
About this study
Background: Preschoolers' lifestyles have become physically inactive and sedentary, their eating habits unhealthy, and their sleep routines increasingly disturbed. Parental involvement appears to be crucial to combat unhealthy lifestyle of preschoolers. Because of recognized barriers of traditional face-to-face interventions (such as time commitment for parents), easy access and lower costs make electronic health (eHealth) interventions appealing. Previous studies that examined the effectiveness of parent-based eHealth on preschooler's (physical activity) PA, dietary behaviors (DB), and sleep have either emphasized on one variable or failed to balance the dosage of PA, diet, and sleep modules or consider the intervention sequence during the intervention period and there is an acknowledged gap in parent-based eHealth interventions which target preschoolers raised in Chinese cultural contexts.
Objective: This study aims to investigate the effectiveness of parent-based eHealth intervention on Chinese preschoolers' PA, DB, and sleep problems.
Read more
Methods: This two-arm parallel randomized controlled trial comprises a 12-week intervention with a 12-week follow-up. 206 parent-child dyads will be randomized to either eHealth intervention group or control group. Participants allocated to the eHealth intervention will receive 12 interactive modules on PA, DB, and sleep, with each module rot on a weekly basis to reduce the sequence effect on variable outcomes. The intervention is grounded upon Social Cognitive Theory and will be delivered through social media, where parents can obtain valid and updated educational information, social rapport, and interact with other group members and facilitators. Participants in the control group will receive weekly brochures on PA, DB, and sleep recommendations from the kindergarten teachers, but they will not receive any interactive components. Data will be collected at baseline, 3 months, and 6 months. The primary outcome will be the preschooler's physical activity. The secondary outcomes will be the preschooler's dietary behaviors, preschooler's sleep duration, and preschooler's sleep problems, parent's PA, parenting style, and parental feeding style.
Significance of this study: The parent-based eHealth intervention has potential to overcome the aforementioned barriers of face-to-face interventions, which will offer a novel approach for promoting healthy lifestyle of preschoolers. If found to be efficacious, the prevalence of unhealthy lifestyles among preschoolers may be alleviated at a low cost, which not only has a positive influence on the health of the individual and the well-being of the family but also reduces the financial pressure on society to treat diseases caused by poor lifestyle habits.
- Conditions
- Healthy Lifestyle, Physical Activity, Dietary Behaviors, Sleep
- Being tested
- parent-based Electronic Health intervention
- Keywords
- physical activity, dietary behaviors, sleep, parent-based intervention
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
parent-based Electronic Health interventionBehavioural
The eHealth intervention comprises 12 modules on three interaction modules related to physical activity, dietary behavior, and sleep. The intervention groups will be invited to a "WeChat group". A 3-minute video (made on the TikTok APP) will be sent to each WeChat group. Based upon the social media studies recommendation, five to nine members in a group will produce the desirable group interactive effect. Therefore, the present study allocates eight parents to one WeChat group. In total, there will be 26 groups (206 parents) according to the sample size calculation. Consistent with Social Cognitive THeory, the content of each module will follow the four steps: 1. Attention (Read educational material and watch TikTok/Douyin video (less than 3 minutes). 2.Retention (parental interaction). 3.Reproduction (Set goals and conduct behaviors). 4.Motivation (feedback and making changes).
| Study group | Role | What they receive |
|---|---|---|
| Electronic Health (eHealth) | Experimental | Participants allocated to the eHealth intervention group will be delivered the evidence-based information and interactive components via social media (i.e., WeChat, similar to WhatsApp; and TikTok/Douyin, similar to YouTube). The interactive components include game, push notification, social rapport, influence agent, goal setting and personalized feedback. Receives: Behavioral: parent-based Electronic Health intervention |
| Control group | No intervention | Participants allocated to the control group will be delivered printed evidence-based educational materials on standard recommendations for PA, diet, and sleep, without interactive components. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of preschoolers' physical activity
Preschoolers' PA will be assessed baseline, at the end of 12-week post-intervention, and at the end of 12-week follow-up, using Garmin vivofit Jr 3 Fitness Tracker for Kids, which is a wrist-wear watch designed specifically for children from 4 to 9 years old to track PA in terms of steps and moderate-to-vigorous physical activity (MVPA) in minutes per day but not energy expenditure. This device has shown to be valid and accurate in assessing PA in preschoolers.
Measured: Through study completion, 24 weeks
Secondary outcomes (6)
Change of preschoolers' dietary behaviors
Preschoolers' dietary behaviors will be assessed at baseline, at the end of 12-week post-intervention, and at the end of 12-week follow-up, using Children's Eating Behavior Questionnaire (CEBQ), which has been examined the validity in Chinese preschool-age children. The scales have high internal consistency reliability (range .72-.91) and test-retest reliability (range .52-.87).
Measured: Through study completion, 24 weeks
Change of preschoolers' sleep duration
Preschoolers' sleep duration will be assessed at baseline, at the end of 12-week post-intervention, and at the end of 12-week follow-up, using Garmin Vivofit Jr 3 Fitness Tracker for kids. According to the manufacturer, Vivofit Jr 3 can track sleep, as well as work as an alarm clock, timer, and watch. Vivofit can be placed in sleep mode to track sleep time, amount of restful sleep, and movement during sleep. The Vivofit data can be uploaded to a personal computer via a wireless USB ANT StickTM and viewed on the software created by the manufacturer.
Measured: Through study completion, 24 weeks
Change of preschoolers' sleep problems
Children's sleep problems will be examined at baseline, at the end of 12-week post-intervention, and at the end of 12-week follow-up, using the Chinese version of the Children's Sleep Habits Questionnaire (CSHQ), which has been a frequently used parent survey to screen children aged from 4 to 10. It contains 33 items to form a different set of eight domains: bedtime resistance, sleep onset delay, sleep duration, sleep anxiety, night waking, parasomnia, sleep-disordered breathing, and daytime sleepiness. Each scored question is rated on a 3-point scale as "usually if something occurs 5 or more times in a week" (scored 3), "sometimes if something occurs 2-4 times in a week" (scored 2), "rarely if something occurs never or 1 time during a week" (scored 1). Higher scores represent greater sleep problems. The CSHQ has shown good reliability (Cronbach's Alpha is 0.73) and validity.
Measured: Through study completion, 24 weeks
Change of parents' physical activity
Parent's PA will be assessed baseline, at the end of 12-week post-intervention, and at the end of 12-week follow-up, using the Chinese Version of the International Physical Activity-Long Form (IPAQ-L). The IPAQ-L has been shown to be a reliable and validated measure for assessing PA levels in Chinese cities.
Measured: Through study completion, 24 weeks
Change of parenting style
Parenting style will be assessed baseline, at the end of 12-week post-intervention, and at the end of 12-week follow-up, using the Chinese version of parenting Style \& Dimension Questionnaire, which is a self-report instrument designed to measure authoritarian (e.g., I yell when I disapprove of my child's behavior), authoritative (e.g., I am responsive to my child's feelings and needs), and permissive parenting style (e.g., I find it difficult to discipline my child) of 4-12 years old children's parents. This scale comprises 32 items, with each item of scale evaluated by the five points Likert described as "never", "once in a while", "about half of the time", "very often" and "always". The overall Cronbach Alpha is 0.87
Measured: Through study completion, 24 weeks
Change of parenting feeding style
Parenting feeding style will be assessed baseline, at the end of 12-week post-intervention, and at the end of 12-week follow-up, using the Chinese Version of the Parent Feeding Style Questionnaire, which consists of 4 parts: instrumental feeding (4 items), emotional feeding (5 items), prompting or encouragement to eat (8 items), and control over eating (10 items). Respondents will be asked to choose from a 5-point Likert scale (ranging from "never" to "always"). For example, "I allow my child to choose which food to have for meals, I encourage my child to look forward to the meal." The average score on each scale will be calculated and a higher score indicated a greater tendency for parents to feed their children in that style. The overall Cronbach's Alpha is 0.75.
Measured: Through study completion, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start1 Sep 2023 (estimated)
- Primary completion31 Jan 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy LifestyleStudies 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
- Model description
- This study is a two parallel-group, single-blinded randomized controlled trial designed to promote preschoolers' PA, and DB, and reduce sleep problems by providing parents with relevant health information through the eHealth modality. The two arms comprise (1) eHealth intervention and (2) control group.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 512 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Kong Baptist University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Normal University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06025019
- Sponsor's protocol ID
- HKBU21481504ZP
- Status last verified
- May 2023
- First submitted
- 9 Jul 2023
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Peng Z, Wen LM, Lau PWC. Effectiveness of a Parent-Based eHealth Intervention on Physical Activity, Dietary Behaviors, and Sleep in Preschoolers: Randomized Controlled Trial. J Med Internet Res. 2025 Sep 2;27:e70886. doi: 10.2196/70886.
PubMed 40896827Peng Z, Lau PW, Wen LM. Moderating effects of demographic characteristics on the relationship between parenting practices and energy balance related behaviors of Chinese preschoolers. Front Public Health. 2024 Dec 24;12:1476733. doi: 10.3389/fpubh.2024.1476733. eCollection 2024.
PubMed 39776485Zhou P, Song H, Lau PWC, Shi L, Wang J. Effectiveness of a Parent-Based eHealth Intervention for Physical Activity, Dietary Behavior, and Sleep Among Preschoolers: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Sep 12;13:e58344. doi: 10.2196/58344.
PubMed 39264108
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Parent-based Electronic Health (eHealth) Intervention on Preschoolers' Physical Activity, Dietary Behaviors, and Sleep Problems
- ClinicalTrials.gov ID
- NCT06025019
- Acronym / sponsor ID
- HKBU21481504ZP
- Conditions
- Healthy Lifestyle, Physical Activity, Dietary Behaviors, Sleep
- Keywords
- physical activity, dietary behaviors, sleep, parent-based intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 512 participants (estimated)
- Lead sponsor
- Hong Kong Baptist UniversityUniversity, hospital or other
- Collaborators
- Beijing Normal University
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 6 Sep 2023 (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.
Background: Preschoolers' lifestyles have become physically inactive and sedentary, their eating habits unhealthy, and their sleep routines increasingly disturbed. Parental involvement appears to be crucial to combat unhealthy lifestyle of preschoolers. Because of recognized barriers of traditional face-to-face interventions (such as time commitment for parents), easy access and lower costs make electronic health (eHealth) interventions appealing. Previous studies that examined the effectiveness of parent-based eHealth on preschooler's (physical activity) PA, dietary behaviors (DB), and sleep have either emphasized on one variable or failed to balance the dosage of PA, diet, and sleep modules or consider the intervention sequence during the intervention period and there is an acknowledged gap in parent-based eHealth interventions which target preschoolers raised in Chinese cultural contexts.
Objective: This study aims to investigate the effectiveness of parent-based eHealth intervention on Chinese preschoolers' PA, DB, and sleep problems.
Methods: This two-arm parallel randomized controlled trial comprises a 12-week intervention with a 12-week follow-up. 206 parent-child dyads will be randomized to either eHealth intervention group or control group. Participants allocated to the eHealth intervention will receive 12 interactive modules on PA, DB, and sleep, with each module rot on a weekly basis to reduce the sequence effect on variable outcomes. The intervention is grounded upon Social Cognitive Theory and will be delivered through social media, where parents can obtain valid and updated educational information, social rapport, and interact with other group members and facilitators. Participants in the control group will receive weekly brochures on PA, DB, and sleep recommendations from the kindergarten teachers, but they will not receive any interactive components. Data will be collected at baseline, 3 months, and 6 months. The primary outcome will be the preschooler's physical activity. The secondary outcomes will be the preschooler's dietary behaviors, preschooler's sleep duration, and preschooler's sleep problems, parent's PA, parenting style, and parental feeding style.
Significance of this study: The parent-based eHealth intervention has potential to overcome the aforementioned barriers of face-to-face interventions, which will offer a novel approach for promoting healthy lifestyle of preschoolers. If found to be efficacious, the prevalence of unhealthy lifestyles among preschoolers may be alleviated at a low cost, which not only has a positive influence on the health of the individual and the well-being of the family but also reduces the financial pressure on society to treat diseases caused by poor lifestyle habits.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- This study is a two parallel-group, single-blinded randomized controlled trial designed to promote preschoolers' PA, and DB, and reduce sleep problems by providing parents with relevant health information through the eHealth modality. The two arms comprise (1) eHealth intervention and (2) control group.
| Arm | Type | Receives |
|---|---|---|
| Electronic Health (eHealth) | Experimental | Behavioral: parent-based Electronic Health interventionParticipants allocated to the eHealth intervention group will be delivered the evidence-based information and interactive components via social media (i.e., WeChat, similar to WhatsApp; and TikTok/Douyin, similar to YouTube). The interactive components include game, push notification, social rapport, influence agent, goal setting and personalized feedback. |
| Control group | No intervention | –Participants allocated to the control group will be delivered printed evidence-based educational materials on standard recommendations for PA, diet, and sleep, without interactive components. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Parents are beyond 21 years old and have 4-6-year-old children. Selection of this child's age range was based on two factors. First of all, the age ranges from 4 to 6 have been found to be a strong predictor of future health. Secondly, a significant barrier to healthy DB is food neophobia, commonly known as picky or fussy eating, a reluctance, fear, or refusal to have new foods that is common in young children aged from 4 to 7.5 years.
- Parental commitment to participate in the overall 6-month intervention.
- Parents have access to mobile technology.
- Parents and children must be healthy (refer to a state of physical, mental, social, intellectual, and emotional well-being and the absence of disease) and can participate in normal PA.
- Parents must reside with participating child for at least four days a week (for the children to be adequately exposed to the intervention that parents may implement).
Key exclusion criteria (3 listed)
- if they meet the WHO criteria for preschool age children in terms of PA (i.e., 180 minutes of in a variety of PA at any intensity, of which 60 minutes is MVPA), sedentary behaviors (i.e., no more than 1 hour at a time being sedentary such as sit in car, no more than 1 hour per day in screen time such as TV, phone, and computer), DB (such as daily salt intake should be less than 5g), and sleep time (i.e., over 10 hours good quality sleep including nap, with regular sleep and wake time).
- they diagnosed with neurological or physically disable and children who have a parent suffering from a serious physical or psychological disease making the study too demanding for the family will be excluded from the study.
- if they have special dietary requirements or allergies that would necessitate the tailoring intervention or that may be adversely affected by the intervention. Eligible participants will be required to provide informed consent by completing a written consent form after reading the participant information.
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 |
|---|---|---|
| parent-based Electronic Health interventionThe eHealth intervention comprises 12 modules on three interaction modules related to physical activity, dietary behavior, and sleep. The intervention groups will be invited to a "WeChat group". A 3-minute video (made on the TikTok APP) will be sent to each WeChat group. Based upon the social media studies recommendation, five to nine members in a group will produce the desirable group interactive effect. Therefore, the present study allocates eight parents to one WeChat group. In total, there will be 26 groups (206 parents) according to the sample size calculation. Consistent with Social Cognitive THeory, the content of each module will follow the four steps: 1. Attention (Read educational material and watch TikTok/Douyin video (less than 3 minutes). 2.Retention (parental interaction). 3.Reproduction (Set goals and conduct behaviors). 4.Motivation (feedback and making changes). | Behavioural | Electronic Health (eHealth) |
Primary outcome
Change of preschoolers' physical activity
Time frame: Through study completion, 24 weeks
Preschoolers' PA will be assessed baseline, at the end of 12-week post-intervention, and at the end of 12-week follow-up, using Garmin vivofit Jr 3 Fitness Tracker for Kids, which is a wrist-wear watch designed specifically for children from 4 to 9 years old to track PA in terms of steps and moderate-to-vigorous physical activity (MVPA) in minutes per day but not energy expenditure. This device has shown to be valid and accurate in assessing PA in preschoolers.
6 secondary outcomes
Change of preschoolers' dietary behaviors
Time frame: Through study completion, 24 weeks
Change of preschoolers' sleep duration
Time frame: Through study completion, 24 weeks
Change of preschoolers' sleep problems
Time frame: Through study completion, 24 weeks
Change of parents' physical activity
Time frame: Through study completion, 24 weeks
Change of parenting style
Time frame: Through study completion, 24 weeks
Change of parenting feeding style
Time frame: Through study completion, 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Derived from this study: PubMed 40896827Peng Z, Wen LM, Lau PWC. Effectiveness of a Parent-Based eHealth Intervention on Physical Activity, Dietary Behaviors, and Sleep in Preschoolers: Randomized Controlled Trial. J Med Internet Res. 2025 Sep 2;27:e70886. doi: 10.2196/70886.
- Derived from this study: PubMed 39776485Peng Z, Lau PW, Wen LM. Moderating effects of demographic characteristics on the relationship between parenting practices and energy balance related behaviors of Chinese preschoolers. Front Public Health. 2024 Dec 24;12:1476733. doi: 10.3389/fpubh.2024.1476733. eCollection 2024.
- Derived from this study: PubMed 39264108Zhou P, Song H, Lau PWC, Shi L, Wang J. Effectiveness of a Parent-Based eHealth Intervention for Physical Activity, Dietary Behavior, and Sleep Among Preschoolers: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Sep 12;13:e58344. doi: 10.2196/58344.
- Individual participant dataSharing planned: No
Related trials for Healthy Lifestyle
Recruiting
Yoga vs. Stretching-Strengthening: Physical Fitness in Sedentary Young Adults
Sedentary Lifestlye, Exercise
Active, not recruiting
Italian Digital Primary Cardiovascular Prevention Study
Healthy Population
Active, not recruiting
Healthy for my Baby- RCT of a Lifestyle Intervention for Overweight Women in Preconception
Overweight and Obesity, Pregnancy Complications
Recruiting
LIfestyle MEtabotype Study B (LIME-B)
Nutritional and Metabolic Diseases, Prediabetes
Recruiting
Implementation of a Multiple Intervention to Promote Healthy Lifestyles in Patients With Depression
Major Depressive Disorder (MDD)
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.
Questions about this trial
What is this clinical trial studying?
A study testing parent-based Electronic Health intervention in people with Healthy Lifestyle and Physical Activity, run by Hong Kong Baptist University.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 6 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lau Wing Chung, Ph.D (34115634, wclau@hkbu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of preschoolers' physical activity (time frame: Through study completion, 24 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 NCT06025019, which also lists 3 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 6 Sep 2023.