ObesityNCT06125600
Clusters in Obesity: Intuitive Eating and Mental Health Key for Personalisation
An observational study of Obesity and Anxiety, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Objective: To determine clusters among weight-loss-seeking individuals for personalised obesity management and find questionnaires to help identify those who could benefit from psychological support. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Clustering of people living with obesity using behavioural questionnaires
- How many people
- 989 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2023to 15 Sep 2023
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All persons who provided informed consent by accepting the Aviitam platform's General Terms and Conditions of Use (GTCU). The study uses an online platform (my.aviitam.com) which enables patients to provide personal information, respond to health questionnaires (validated or specific to the platform) and receive educational content about their pathology. An automatic summary is generated by the platform to facilitate patient care by the practitioner. The platform is accessible throughout France and is free of charge for both healthcare providers and patients. Furthermore, the online platform is a patient follow-up tool, with patients and healthcare professionals having access to the platform for patient management.
Who may be able to join
- Body Mass Index (BMI) ≥ 25 kg/m² who agreed to the terms of use for their data to be included in the study.
- Answered to, at least, IES2 and HAD questionaries threw online digital platform (Aviitam®)
Who cannot join
- non-completion of mandatory questionnaires and a delay of more than 90 days between weight measurement and questionnaire completion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Obesity Clusters Using an Online Responsive-Design Platform: Intuitive Eating and Mental Health Key for Personalised Medicine
Objective: To determine clusters among weight-loss-seeking individuals for personalised obesity management and find questionnaires to help identify those who could benefit from psychological support.
Design: In a cross-sectional analysis using an online platform (Aviitam®), a cluster analysis was carried out in overweight/obese adults. The following questionnaires were studied: Hospital Anxiety and Depression Scale (HADS), Perceived Stress Scale (PSS), Epworth Sleepiness Scale, Morin's Insomnia Scale, Intuitive Eating Scale-2 (IES-2), Binge Eating Scale (BES), a Physical Activity questionnaire and EQ-5D Quality-of-Life questionnaire.
Read more
Setting: An online weight management platform (Aviitam®) used by adults with obesity across France.
Participants: Adults with body mass index (BMI) >25 kg/m² participating in a weight management pathway who completed validated questionnaires assessing psychological and lifestyle factors.
Main Outcomes: Identification of clusters based on questionnaire responses, BMI, age and gender.
Read the detailed description
Obesity, a rapidly escalating public health issue worldwide, affects over 650 million adults. It leads to serious health consequences such as cardiovascular disease, hepatic steatosis, cancer and Obstructive Sleep Apnea syndrome (OSA). Obesity also has several social repercussions impacting quality of life. These multifaceted health issues emerge from an intricate interplay of biological, environmental and psychological factors.
Managing obese individuals in a primary care setting is difficult and time-consuming. It requires addressing related conditions such as perceived stress, sleep disorders as well as mental health issues including anxiety and depression. All of these conditions can influence a patient's ability to lose weight and maintain weight loss over time. Moreover, factors such as eating habits, compulsive eating and physical activity levels also play critical roles.
In response to these challenges, the investigators have developed an online platform (Avittam®), a digitally-enabled, person-centred online platform designed not only for obesity but also for various chronic conditions including Type 2 diabetes, sleep disorders, childhood obesity, bariatric surgery pathways and even rare diseases like tuberous sclerosis. The online platform (Aviitam®) streamlines healthcare consultations by providing a library of self-administered questionnaires covering an array of factors such as nutrition, physical activity, sleep, mental health, quality of life and medication adherence (Supplementary data eTable 1). Operational since 2014, the platform serves nearly 3000 healthcare professionals and around 18,000 patients across France.
This study focused exclusively on those who had engaged with the online platform's obesity management pathways. It aimed to identify distinct psychological and behavioural clusters among individuals seeking weight loss, thereby informing a more personalised, psychologically supportive treatment strategy.
METHODS Study design This study is an exploratory, observational and cross-sectional analysis of data collected from patients using the online platform. The primary aim was to identify patient clusters based on various self-reported and clinically validated variables. The study was approved by the Institutional Review Board (IRB) of the University Hospital of Montpellier, France (identification number: IRB-MTP_2023_02_202301328). All participants in this study provided informed consent by accepting the online platform's General Terms and Conditions of Use (GTCU), which explicitly state that their data may be used for research purposes. The online platform has received approval from the French data protection authority, the "Commission Nationale de l'Informatique et des Libertés" (CNIL), ensuring GDPR compliance and the confidentiality and protection of participants' rights. To maintain privacy, all data used in this study were anonymised. Patients or the public were not involved in the design, or conduct, or reporting, or dissemination plans of the research.
Setting The study uses an online platform (my.aviitam.com) which enables patients to provide personal information, respond to health questionnaires (validated or specific to the platform) and receive educational content about their pathology. An automatic summary is generated by the platform to facilitate patient care by the practitioner. The platform is accessible throughout France and is free of charge for both healthcare providers and patients. Furthermore, the online platform is a patient follow-up tool, with patients and healthcare professionals having access to the platform for patient management.
Participants the investigators included adult participants (Age ≥ 18) with a Body Mass Index (BMI) ≥ 25 kg/m² who agreed to the terms of use for their data to be included in the study. Exclusion criteria were the non-completion of mandatory questionnaires and a delay of more than 90 days between weight measurement and questionnaire completion.
Variables The primary outcomes of the study were the psychological health, physical health and eating behaviours of individuals, assessed through scores on various questionnaires. These include the Hospital Anxiety and Depression Scale (HADS), the Perceived Stress Scale (PSS), the Epworth Sleepiness Scale, Morin's Insomnia Scale, the Intuitive Eating Scale-2 (IES-2), the Binge Eating Scale (BES) and a Physical Activity questionnaire. A secondary outcome was Quality of Life, assessed using the EQ-5D questionnaire, which was added nine months after the initial launch of the obesity pathway on the online platform.
The study considered age and self-reported BMI which was subsequently validated by healthcare providers.
Predictors for the study were the scores on the mental, eating behaviour, physical health and quality of life questionnaires.
The following potential confounders were accounted for in the analysis: age, sex and time interval between weight measurement and questionnaire completion.
Effect modifiers were not explicitly investigated in this study. Inclusion criteria for participation in the study included: (i) age, (ii) BMI≥25 kg/m², (iii) completing all study questionnaires (except the EQ-5D) and (iv) agreeing to the use of their data for research purposes by accepting the platform's terms of use.
Data Sources/Measurement All data were initially self-reported via the online platform and later validated by healthcare providers during clinical consultations. Data were collected over a period of 67 months.
Bias The data were initially self-reported but then validated by healthcare providers during medical visits to mitigate self-reporting biases.
Study Size All users meeting the eligibility criteria and with valid data were included in our analysis. the investigators did not pre-calculate the sample size due to the exploratory nature of the study and the availability of a large patient population.
Quantitative Variables Age and BMI were treated as continuous variables. The questionnaires provided scores that were treated as continuous variables for analysis.
Data Sources and Variables The variables included in our analysis were age, BMI and overall scores from all questionnaires. The questionnaires were used to assess the participants' mental and physical health status, eating behaviours, physical activity and quality of life.
To ensure that the data were complete, the investigators included only participants who had filled in all questionnaires, in addition to their age, sex, weight and height. As a result, there were no missing data.
Statistical Analysis The statistical analysis was planned in advance of the data collection, with the aim of identifying phenotypes of obese patients using clustering methods. The analysis primarily used non-parametric methods, such as the Kruskal-Wallis and Chi-squared tests, for data interpretation.
The investigators categorised BMI according to the WHO classification: underweight, normal weight, overweight and varying grades of obesity .
Initial focus was on patients who completed all of the necessary questionnaires except the EQ-5D and who provided their weight, height and gender data. A subsequent sensitivity analysis was planned on a subset of patients who also completed the EQ-5D.
An effect size analysis was also conducted to highlight the main differences between the patient groups identified.
All statistical tests were deemed significant at a two-sided p-value of less than 0.05. Adjustments for multiple testing were made using the Bonferroni's correction.
- Being tested
- Clustering of people living with obesity using behavioural questionnaires
- Medical subject headings
- Obesity, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clustering of people living with obesity using behavioural questionnairesOther
In a cross-sectional analysis using the online Aviitam® platform, a cluster analysis was carried out in overweight/obese adults. The following questionnaires were studied: Hospital Anxiety and Depression Scale (HADS), Perceived Stress Scale (PSS), Epworth Sleepiness Scale, Morin's Insomnia Scale, Intuitive Eating Scale-2 (IES-2), Binge Eating Scale (BES), Ricci/Gagnon Physical Activity questionnaire and EQ-5D Quality-of-Life questionnaire.
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Anxiety and Depression Scale (HADS)
Self-assessment questionnaire for anxiety and depression. The higher the score, the greater the anxiety and depression. Continuous variable. No threshold value for this study.
Measured: 90 days after registry in the platform
The Perceived Stress Scale (PSS)
Self-assessment questionnaire for stress. The higher the score, the greater the stress. Continuous variable. No threshold value for this study.
Measured: 90 days after registry in the platform
The Epworth Sleepiness Scale
Self-questionnaire to measure drowsiness. The higher the score, the greater the drowsiness. Continuous variable. No threshold value for this study.
Measured: 90 days after registry in the platform
"Morin's Insomnia" Scale
Self-questionnaire to measure insomnia. The higher the score, the greater the insomnia. Continuous variable. No threshold value for this study.
Measured: 90 days after registry in the platform
The Intuitive Eating Scale-2 (IES-2)
self-administered questionnaire measuring intuitive nutrition. The higher the score, the greater the degree of intuitive nutrition. Continuous variable. No threshold value for this study.
Measured: 90 days after registry in the platform
The Binge Eating Scale (BES)
self-administered questionnaire measuring compulsive eating. the higher the score, the greater the degree of compulsive eating. Continuous variable. No threshold value for this study.
Measured: 90 days after registry in the platform
"Ricci and Gagnon" Physical Activity questionnaire
self-administered questionnaire to measure physical fitness. The higher the score, the greater the fitness. Continuous variable. No threshold value for this study.
Measured: 90 days after registry in the platform
Secondary outcomes (1)
self-reported BMI
self-reported BMI
Measured: 90 days after registry in the platform
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start1 Aug 2023
- Primary completion15 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 989 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Baptiste BONNET, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06125600
- Sponsor's protocol ID
- IRB-MTP_2023_02_202301328
- Status last verified
- Nov 2023
- First submitted
- 29 Oct 2023
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data underlying this article will be shared on reasonable request to the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity Clusters Using an Online Responsive-Design Platform: Intuitive Eating and Mental Health Key for Personalised Medicine
- ClinicalTrials.gov ID
- NCT06125600
- Acronym / sponsor ID
- IRB-MTP_2023_02_202301328
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 989 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 9 Nov 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.
Objective: To determine clusters among weight-loss-seeking individuals for personalised obesity management and find questionnaires to help identify those who could benefit from psychological support.
Design: In a cross-sectional analysis using an online platform (Aviitam®), a cluster analysis was carried out in overweight/obese adults. The following questionnaires were studied: Hospital Anxiety and Depression Scale (HADS), Perceived Stress Scale (PSS), Epworth Sleepiness Scale, Morin's Insomnia Scale, Intuitive Eating Scale-2 (IES-2), Binge Eating Scale (BES), a Physical Activity questionnaire and EQ-5D Quality-of-Life questionnaire.
Setting: An online weight management platform (Aviitam®) used by adults with obesity across France.
Participants: Adults with body mass index (BMI) >25 kg/m² participating in a weight management pathway who completed validated questionnaires assessing psychological and lifestyle factors.
Main Outcomes: Identification of clusters based on questionnaire responses, BMI, age and gender.
Detailed description
Obesity, a rapidly escalating public health issue worldwide, affects over 650 million adults. It leads to serious health consequences such as cardiovascular disease, hepatic steatosis, cancer and Obstructive Sleep Apnea syndrome (OSA). Obesity also has several social repercussions impacting quality of life. These multifaceted health issues emerge from an intricate interplay of biological, environmental and psychological factors.
Managing obese individuals in a primary care setting is difficult and time-consuming. It requires addressing related conditions such as perceived stress, sleep disorders as well as mental health issues including anxiety and depression. All of these conditions can influence a patient's ability to lose weight and maintain weight loss over time. Moreover, factors such as eating habits, compulsive eating and physical activity levels also play critical roles.
In response to these challenges, the investigators have developed an online platform (Avittam®), a digitally-enabled, person-centred online platform designed not only for obesity but also for various chronic conditions including Type 2 diabetes, sleep disorders, childhood obesity, bariatric surgery pathways and even rare diseases like tuberous sclerosis. The online platform (Aviitam®) streamlines healthcare consultations by providing a library of self-administered questionnaires covering an array of factors such as nutrition, physical activity, sleep, mental health, quality of life and medication adherence (Supplementary data eTable 1). Operational since 2014, the platform serves nearly 3000 healthcare professionals and around 18,000 patients across France.
This study focused exclusively on those who had engaged with the online platform's obesity management pathways. It aimed to identify distinct psychological and behavioural clusters among individuals seeking weight loss, thereby informing a more personalised, psychologically supportive treatment strategy.
METHODS Study design This study is an exploratory, observational and cross-sectional analysis of data collected from patients using the online platform. The primary aim was to identify patient clusters based on various self-reported and clinically validated variables. The study was approved by the Institutional Review Board (IRB) of the University Hospital of Montpellier, France (identification number: IRB-MTP_2023_02_202301328). All participants in this study provided informed consent by accepting the online platform's General Terms and Conditions of Use (GTCU), which explicitly state that their data may be used for research purposes. The online platform has received approval from the French data protection authority, the "Commission Nationale de l'Informatique et des Libertés" (CNIL), ensuring GDPR compliance and the confidentiality and protection of participants' rights. To maintain privacy, all data used in this study were anonymised. Patients or the public were not involved in the design, or conduct, or reporting, or dissemination plans of the research.
Setting The study uses an online platform (my.aviitam.com) which enables patients to provide personal information, respond to health questionnaires (validated or specific to the platform) and receive educational content about their pathology. An automatic summary is generated by the platform to facilitate patient care by the practitioner. The platform is accessible throughout France and is free of charge for both healthcare providers and patients. Furthermore, the online platform is a patient follow-up tool, with patients and healthcare professionals having access to the platform for patient management.
Participants the investigators included adult participants (Age ≥ 18) with a Body Mass Index (BMI) ≥ 25 kg/m² who agreed to the terms of use for their data to be included in the study. Exclusion criteria were the non-completion of mandatory questionnaires and a delay of more than 90 days between weight measurement and questionnaire completion.
Variables The primary outcomes of the study were the psychological health, physical health and eating behaviours of individuals, assessed through scores on various questionnaires. These include the Hospital Anxiety and Depression Scale (HADS), the Perceived Stress Scale (PSS), the Epworth Sleepiness Scale, Morin's Insomnia Scale, the Intuitive Eating Scale-2 (IES-2), the Binge Eating Scale (BES) and a Physical Activity questionnaire. A secondary outcome was Quality of Life, assessed using the EQ-5D questionnaire, which was added nine months after the initial launch of the obesity pathway on the online platform.
The study considered age and self-reported BMI which was subsequently validated by healthcare providers.
Predictors for the study were the scores on the mental, eating behaviour, physical health and quality of life questionnaires.
The following potential confounders were accounted for in the analysis: age, sex and time interval between weight measurement and questionnaire completion.
Effect modifiers were not explicitly investigated in this study. Inclusion criteria for participation in the study included: (i) age, (ii) BMI≥25 kg/m², (iii) completing all study questionnaires (except the EQ-5D) and (iv) agreeing to the use of their data for research purposes by accepting the platform's terms of use.
Data Sources/Measurement All data were initially self-reported via the online platform and later validated by healthcare providers during clinical consultations. Data were collected over a period of 67 months.
Bias The data were initially self-reported but then validated by healthcare providers during medical visits to mitigate self-reporting biases.
Study Size All users meeting the eligibility criteria and with valid data were included in our analysis. the investigators did not pre-calculate the sample size due to the exploratory nature of the study and the availability of a large patient population.
Quantitative Variables Age and BMI were treated as continuous variables. The questionnaires provided scores that were treated as continuous variables for analysis.
Data Sources and Variables The variables included in our analysis were age, BMI and overall scores from all questionnaires. The questionnaires were used to assess the participants' mental and physical health status, eating behaviours, physical activity and quality of life.
To ensure that the data were complete, the investigators included only participants who had filled in all questionnaires, in addition to their age, sex, weight and height. As a result, there were no missing data.
Statistical Analysis The statistical analysis was planned in advance of the data collection, with the aim of identifying phenotypes of obese patients using clustering methods. The analysis primarily used non-parametric methods, such as the Kruskal-Wallis and Chi-squared tests, for data interpretation.
The investigators categorised BMI according to the WHO classification: underweight, normal weight, overweight and varying grades of obesity .
Initial focus was on patients who completed all of the necessary questionnaires except the EQ-5D and who provided their weight, height and gender data. A subsequent sensitivity analysis was planned on a subset of patients who also completed the EQ-5D.
An effect size analysis was also conducted to highlight the main differences between the patient groups identified.
All statistical tests were deemed significant at a two-sided p-value of less than 0.05. Adjustments for multiple testing were made using the Bonferroni's correction.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All persons who provided informed consent by accepting the Aviitam platform's General Terms and Conditions of Use (GTCU). The study uses an online platform (my.aviitam.com) which enables patients to provide personal information, respond to health questionnaires (validated or specific to the platform) and receive educational content about their pathology. An automatic summary is generated by the platform to facilitate patient care by the practitioner. The platform is accessible throughout France and is free of charge for both healthcare providers and patients. Furthermore, the online platform is a patient follow-up tool, with patients and healthcare professionals having access to the platform for patient management.
Key inclusion criteria (2 listed)
- Body Mass Index (BMI) ≥ 25 kg/m² who agreed to the terms of use for their data to be included in the study.
- Answered to, at least, IES2 and HAD questionaries threw online digital platform (Aviitam®)
Key exclusion criteria (1 listed)
- non-completion of mandatory questionnaires and a delay of more than 90 days between weight measurement and questionnaire completion.
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 |
|---|---|---|
| Clustering of people living with obesity using behavioural questionnairesIn a cross-sectional analysis using the online Aviitam® platform, a cluster analysis was carried out in overweight/obese adults. The following questionnaires were studied: Hospital Anxiety and Depression Scale (HADS), Perceived Stress Scale (PSS), Epworth Sleepiness Scale, Morin's Insomnia Scale, Intuitive Eating Scale-2 (IES-2), Binge Eating Scale (BES), Ricci/Gagnon Physical Activity questionnaire and EQ-5D Quality-of-Life questionnaire. | Other | – |
Primary outcome
Hospital Anxiety and Depression Scale (HADS)
Time frame: 90 days after registry in the platform
Self-assessment questionnaire for anxiety and depression. The higher the score, the greater the anxiety and depression. Continuous variable. No threshold value for this study.
The Perceived Stress Scale (PSS)
Time frame: 90 days after registry in the platform
Self-assessment questionnaire for stress. The higher the score, the greater the stress. Continuous variable. No threshold value for this study.
The Epworth Sleepiness Scale
Time frame: 90 days after registry in the platform
Self-questionnaire to measure drowsiness. The higher the score, the greater the drowsiness. Continuous variable. No threshold value for this study.
"Morin's Insomnia" Scale
Time frame: 90 days after registry in the platform
Self-questionnaire to measure insomnia. The higher the score, the greater the insomnia. Continuous variable. No threshold value for this study.
The Intuitive Eating Scale-2 (IES-2)
Time frame: 90 days after registry in the platform
self-administered questionnaire measuring intuitive nutrition. The higher the score, the greater the degree of intuitive nutrition. Continuous variable. No threshold value for this study.
The Binge Eating Scale (BES)
Time frame: 90 days after registry in the platform
self-administered questionnaire measuring compulsive eating. the higher the score, the greater the degree of compulsive eating. Continuous variable. No threshold value for this study.
"Ricci and Gagnon" Physical Activity questionnaire
Time frame: 90 days after registry in the platform
self-administered questionnaire to measure physical fitness. The higher the score, the greater the fitness. Continuous variable. No threshold value for this study.
1 secondary outcome
self-reported BMI
Time frame: 90 days after registry in the platform
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 9 Nov 2023.
- Individual participant dataSharing planned: Yes. The data underlying this article will be shared on reasonable request to the corresponding author.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Anxiety, run by University Hospital, Montpellier at 1 site in France.
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 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 9 Nov 2023. 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 France. 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?
Hospital Anxiety and Depression Scale (HADS) (time frame: 90 days after registry in the platform). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.