Pediatric ObesityNCT04642222
APOLO-Teens, a Web-based Intervention For Adolescents With Overweight/Obesity
A study testing APOLO-Teens web-based intervention and Treatment as Usual for Pediatric Obesity in people with Pediatric Obesity, run by University of Minho at 2 sites in Portugal.
Trial summary
With the demand for weight-loss interventions likely to continue its upward trend over the next decades, the question remains on how to continuously monitor and support overweight and obese adolescents, particularly in the long-term. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- APOLO-Teens web-based intervention and Treatment as Usual for Pediatric Obesity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesPortugal
- Study dates
- 1 Oct 2015to Mar 2022
- 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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants with overweight or obesity (BMI z-score ≥ 1/BMI percentile ≥ 85th);
- Enrolled in ambulatory treatment for overweight/obesity in a public Portuguese health care center;
- Having a Facebook® account;
- Having access to the Internet at least three times per week.
Who cannot join
- Medical conditions that affect weight;
- Intellectual disabilities (Specific learning difficulties that prevented adolescents from reading and understanding written text);
- Ambulatory movement limitations (e.g., use of the walking stick, morpho-functional alterations as lower limb amputation, etc.);
- Not being under other interventions for weight loss at the time of enrollment.
Trial locations and contacts
2 sites in 1 country.
Portugal2 sites
Centro Hospitalar Universitário do Porto (Centro Materno Infantil do Norte)
Porto, 4050-651
Centro Hospitalar Universitário de São João
Porto, 4200-319
About this study
Official title: APOLO-Teens, a Web-based Intervention For Treatment-seeking Adolescents With Overweight/Obesity: A Multicenter Randomized Controlled Trial
With the demand for weight-loss interventions likely to continue its upward trend over the next decades, the question remains on how to continuously monitor and support overweight and obese adolescents, particularly in the long-term. Moreover, as the burden of the obesity rates increases in health care centers, the development of alternative delivering strategies gains attention. In an environment of limited resources, the development of new-technology based programs seems a promising area to deliver cost-effective interventions to a wide number of individuals. However, the existing studies present several limitations and a challenging aspect of treating obesity in adolescents is the presence of high rates of disordered eating behaviors.
The objective of this study is to develop and test the effectiveness of a web-based Cognitive Behavioral Therapy intervention, for adolescents with overweight/obesity. A Randomized Controlled Trial will compare a control group receiving medical treatment as usual (TAU), and an intervention group receiving TAU plus a psychological/behavioral intervention delivered via the internet.
Read the detailed description
This research project intends to examine the effectiveness of a Cognitive Behavioral Therapy and psychoeducational based program for adolescents with overweight and obesity delivered as a web-based intervention: APOLO-Teens. Therefore, a randomized controlled trial will compare a control group receiving medical treatment as usual for pediatric obesity in public health care centers in Portugal, and an intervention group receiving TAU plus the APOLO-Teens web-based intervention.
The APOLO-Teens web-based intervention was designed to optimize treatment as usual for pediatric obesity, promoting the adoption of healthy eating habits and lifestyle behaviors. Particularly it aims to promote higher consumption of fruits and vegetables, increase physical activity levels, reduce sedentary time, enhance psychological well-being, and facilitating weight loss.
All participants will be assessed at baseline, 3 months after the beginning of the research protocol/intervention, end of the web-based intervention, and at 6 and 12 months follow-up. All the assessments will be conducted in Qualtrics: Online Survey Software. Repeated Paired Samples T-test will explore differences between the two groups across the assessment times. Multiple linear regression analysis will be applied to explore predictors of weight loss and weight regain, and survival analyses to identify participants with the highest probability to regain weight. Additionally, 3-Level Hierarchical Linear Models will be conducted to explore the temporal occurrence and patterns of change of eating-related variables, physical activity, and BMI z-score in participants from the two groups.
It is expected that the intervention group participants will present a higher frequency of healthy food consumption (fruit/vegetables) and increased physical activity levels at the end of the web-based intervention when compared with TAU group participants. We further expect, differences between the groups regarding eating behavior-related variables, as well as in the psychological features assessed throughout the different assessment points, and ultimately in weight maintenance or regain, with the intervention group presenting lower scores/weight.
- Conditions
- Pediatric Obesity
- Being tested
- APOLO-Teens web-based intervention, Treatment as Usual for Pediatric Obesity
- Keywords
- Adolescent, Web-based intervention, Health promotion, Eating Behaviors
- Medical subject headings
- Pediatric Obesity, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APOLO-Teens web-based interventionBehavioural
The APOLO-Teens web-based intervention is a 6-month cognitive-behavioral lifestyle program developed to optimize treatment as usual for pediatric obesity in public portuguese hospitals.
Treatment as Usual for Pediatric ObesityOther
Treatment as Usual for pediatric obesity in portuguese public hospitals.
| Study group | Role | What they receive |
|---|---|---|
| APOLO-Teens Intervention Group (APOLO-Teens group) | Experimental | In addition to the Treatment As Usual for pediatric obesity offered in Portuguese public hospitals, participants in this group receive the APOLO-Teens web-based intervention. It comprises three key components: 1) a manualized psychoeducational intervention implemented via Facebook® private groups, including cognitive-behavioral therapy strategies; 2) A weekly self-monitoring system (the APOLO-Teens web application) with automatic feedback messages assessing hours of physical activity, sedentary time, and consumption of fruits and vegetables; and 3) Monthly chat sessions. Receives: Behavioral: APOLO-Teens web-based intervention |
| Treatment As Usual (TAU) Control Group (TAU control group) | Active comparator | Treatment As Usual control group receives the standard intervention for pediatric obesity offered in Portuguese public hospitals. It comprises pediatric or/and nutritional appointments, usually a 30-minute appointment every 3 months. These appointments usually include a physical examination (weight, height) and personalized dietary/lifestyle recommendations. The Treatment As Usual intervention is common to the APOLO-Teens group and TAU control groups. Receives: Other: Treatment as Usual for Pediatric Obesity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foods/beverages intake
Food/beverages frequency questionnaire, which assesses the frequency of soup, fruit, vegetables on the plate, sweetened beverages drinks and pastries/sweets intake in the previous week.
Measured: Change from baseline, to 3 months after the begging if the intervention, end of intervention (after 6-months of baseline assessment), 6 and 12 months follow-up. Specific duration of time over which participant change is assessed: 18 months.
Minutes of moderate-to-vigorous physical activity per week at school
Youth Activity Profile (YAP): This is a 15 items questionnaire to evaluate psychical activity and sedentary behaviors in youth on the previous seven days.
Measured: Change from baseline, to 3 months after the begging if the intervention, end of intervention (after 6-months of baseline assessment), 6 and 12 months follow-up. Specific duration of time over which participant change is assessed: 18 months.
Minutes per week spent in sedentary behaviors
Youth Activity Profile (YAP): This is a 15 items questionnaire to evaluate psychical activity and sedentary behaviors in youth on the previous seven days.
Measured: Change from baseline, to 3 months after the begging if the intervention, end of intervention (after 6-months of baseline assessment), 6 and 12 months follow-up. Specific duration of time over which participant change is assessed: 18 months.
Minutes of moderate-to-vigorous physical activity out-of-school per week
Youth Activity Profile (YAP): This is a 15 items questionnaire to evaluate psychical activity and sedentary behaviors in youth on the previous seven days.
Measured: Change from baseline, to 3 months after the begging if the intervention, end of intervention (after 6-months of baseline assessment), 6 and 12 months follow-up. Specific duration of time over which participant change is assessed: 18 months.
Secondary outcomes (5)
Eating disturbance
Children's Eating Attitudes Test (ChEAT). Higher scores indicate more eating disturbance.
Measured: Baseline (before the intervention), 3 months after the begging if the intervention, end of intervention (after 6-months of baseline assessment), 6 and 12 months follow-up. Specific duration of time over which participant is assessed: 18 months.
Grazing eating pattern
Repetitive Eating Questionnaire (Rep(eat)-Q). Higher scores indicate the existence of a grazing-type eating pattern.
Measured: Baseline (before the intervention), 3 months after the begging if the intervention, end of intervention (after 6-months of baseline assessment), 6 and 12 months follow-up. Specific duration of time over which participant is assessed: 18 months.
Psychological Distress (depression, anxiety and stress)
Depression Anxiety Stress Scales (DASS-21). Higher scores indicating more anxiety, stress and depressive symptomatology.
Measured: Baseline (before the intervention), 3 months after the begging if the intervention, end of intervention (after 6-months of baseline assessment), 6 and 12 months follow-up. Specific duration of time over which participant is assessed: 18 months.
Health-related quality of life
Pediatric Quality of Life Inventory. Higher scores indicate more health-related quality of life.
Measured: Baseline (before the intervention), 3 months after the begging if the intervention, end of intervention (after 6-months of baseline assessment), 6 and 12 months follow-up. Specific duration of time over which participant is assessed: 18 months.
BMI z-score
Calculated by WHO Anthroplus software 3.2.2. version
Measured: Baseline (before the intervention), 3 months after the begging if the intervention, end of intervention (after 6-months of baseline assessment), 6 and 12 months follow-up. Specific duration of time over which participant is assessed: 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start1 Oct 2015
- Primary completionMar 2022
- Study completionMar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized control trial with two groups: the Treatment As Usual control group (TAU group) and the APOLO-Teens web-based intervention group (APOLO-Teens group). Adolescents attending a medical appointment scheduled for any multidisciplinary obesity appointment at a public Portuguese health facility will be invited to participate. The criteria for inclusion/exclusion will be given to the healthcare professionals conducting these medical appointments, to screen for potential participants. After completing the baseline assessment participants will be consecutively randomized to the Treatment As Usual control group (TAU group) or the APOLO-Teens web-based intervention group (APOLO-Teens group). Participants in the APOLO-Teens group received the APOLO-Teens web-based intervention in addition to their treatment as usual (TAU).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Conceição, University of Minho
- Investigators
- Eva M Conceição, Ph.D., Principal investigator, University of Minho, School of Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04642222
- Sponsor's protocol ID
- SECVS 142/2015
- Other IDs
- POCI-01- 0145-FEDER-028209
- Status last verified
- May 2023
- First submitted
- 17 Nov 2020
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The type of data to collect include sensitive and personal health information protected by the Portuguese Law.
Publications
Ramalho S, Saint-Maurice PF, Silva D, Mansilha HF, Silva C, Goncalves S, Machado P, Conceicao E. APOLO-Teens, a web-based intervention for treatment-seeking adolescents with overweight or obesity: study protocol and baseline characterization of a Portuguese sample. Eat Weight Disord. 2020 Apr;25(2):453-463. doi: 10.1007/s40519-018-0623-x. Epub 2018 Dec 5.
PubMed 30519810
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- APOLO-Teens, a Web-based Intervention For Treatment-seeking Adolescents With Overweight/Obesity: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04642222
- Acronym / sponsor ID
- SECVS 142/2015
- Conditions
- Pediatric Obesity
- Keywords
- Adolescent, Web-based intervention, Health promotion, Eating Behaviors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University of MinhoUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- Mar 2022 (actual)
- Study completion
- Mar 2022 (actual)
- First posted
- 24 Nov 2020 (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.
With the demand for weight-loss interventions likely to continue its upward trend over the next decades, the question remains on how to continuously monitor and support overweight and obese adolescents, particularly in the long-term. Moreover, as the burden of the obesity rates increases in health care centers, the development of alternative delivering strategies gains attention. In an environment of limited resources, the development of new-technology based programs seems a promising area to deliver cost-effective interventions to a wide number of individuals. However, the existing studies present several limitations and a challenging aspect of treating obesity in adolescents is the presence of high rates of disordered eating behaviors.
The objective of this study is to develop and test the effectiveness of a web-based Cognitive Behavioral Therapy intervention, for adolescents with overweight/obesity. A Randomized Controlled Trial will compare a control group receiving medical treatment as usual (TAU), and an intervention group receiving TAU plus a psychological/behavioral intervention delivered via the internet.
Detailed description
This research project intends to examine the effectiveness of a Cognitive Behavioral Therapy and psychoeducational based program for adolescents with overweight and obesity delivered as a web-based intervention: APOLO-Teens. Therefore, a randomized controlled trial will compare a control group receiving medical treatment as usual for pediatric obesity in public health care centers in Portugal, and an intervention group receiving TAU plus the APOLO-Teens web-based intervention.
The APOLO-Teens web-based intervention was designed to optimize treatment as usual for pediatric obesity, promoting the adoption of healthy eating habits and lifestyle behaviors. Particularly it aims to promote higher consumption of fruits and vegetables, increase physical activity levels, reduce sedentary time, enhance psychological well-being, and facilitating weight loss.
All participants will be assessed at baseline, 3 months after the beginning of the research protocol/intervention, end of the web-based intervention, and at 6 and 12 months follow-up. All the assessments will be conducted in Qualtrics: Online Survey Software. Repeated Paired Samples T-test will explore differences between the two groups across the assessment times. Multiple linear regression analysis will be applied to explore predictors of weight loss and weight regain, and survival analyses to identify participants with the highest probability to regain weight. Additionally, 3-Level Hierarchical Linear Models will be conducted to explore the temporal occurrence and patterns of change of eating-related variables, physical activity, and BMI z-score in participants from the two groups.
It is expected that the intervention group participants will present a higher frequency of healthy food consumption (fruit/vegetables) and increased physical activity levels at the end of the web-based intervention when compared with TAU group participants. We further expect, differences between the groups regarding eating behavior-related variables, as well as in the psychological features assessed throughout the different assessment points, and ultimately in weight maintenance or regain, with the intervention group presenting lower scores/weight.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized control trial with two groups: the Treatment As Usual control group (TAU group) and the APOLO-Teens web-based intervention group (APOLO-Teens group). Adolescents attending a medical appointment scheduled for any multidisciplinary obesity appointment at a public Portuguese health facility will be invited to participate. The criteria for inclusion/exclusion will be given to the healthcare professionals conducting these medical appointments, to screen for potential participants. After completing the baseline assessment participants will be consecutively randomized to the Treatment As Usual control group (TAU group) or the APOLO-Teens web-based intervention group (APOLO-Teens group). Participants in the APOLO-Teens group received the APOLO-Teens web-based intervention in addition to their treatment as usual (TAU).
| Arm | Type | Receives |
|---|---|---|
| APOLO-Teens Intervention Group (APOLO-Teens group) | Experimental | Behavioral: APOLO-Teens web-based interventionIn addition to the Treatment As Usual for pediatric obesity offered in Portuguese public hospitals, participants in this group receive the APOLO-Teens web-based intervention. It comprises three key components: 1) a manualized psychoeducational intervention implemented via Facebook® private groups, including cognitive-behavioral therapy strategies; 2) A weekly self-monitoring system (the APOLO-Teens web application) with automatic feedback messages assessing hours of physical activity, sedentary time, and consumption of fruits and vegetables; and 3) Monthly chat sessions. |
| Treatment As Usual (TAU) Control Group (TAU control group) | Active comparator | Other: Treatment as Usual for Pediatric ObesityTreatment As Usual control group receives the standard intervention for pediatric obesity offered in Portuguese public hospitals. It comprises pediatric or/and nutritional appointments, usually a 30-minute appointment every 3 months. These appointments usually include a physical examination (weight, height) and personalized dietary/lifestyle recommendations. The Treatment As Usual intervention is common to the APOLO-Teens group and TAU control groups. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Participants with overweight or obesity (BMI z-score ≥ 1/BMI percentile ≥ 85th);
- Enrolled in ambulatory treatment for overweight/obesity in a public Portuguese health care center;
- Having a Facebook® account;
- Having access to the Internet at least three times per week.
Key exclusion criteria (4 listed)
- Medical conditions that affect weight;
- Intellectual disabilities (Specific learning difficulties that prevented adolescents from reading and understanding written text);
- Ambulatory movement limitations (e.g., use of the walking stick, morpho-functional alterations as lower limb amputation, etc.);
- Not being under other interventions for weight loss at the time of enrollment.
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 |
|---|---|---|
| APOLO-Teens web-based interventionThe APOLO-Teens web-based intervention is a 6-month cognitive-behavioral lifestyle program developed to optimize treatment as usual for pediatric obesity in public portuguese hospitals. | Behavioural | APOLO-Teens Intervention Group (APOLO-Teens group) |
| Treatment as Usual for Pediatric ObesityTreatment as Usual for pediatric obesity in portuguese public hospitals. | Other | Treatment As Usual (TAU) Control Group (TAU control group) |
Primary outcome
Foods/beverages intake
Time frame: Change from baseline, to 3 months after the begging if the intervention, end of intervention (after 6-months of baseline assessment), 6 and 12 months follow-up. Specific duration of time over which participant change is assessed: 18 months.
Food/beverages frequency questionnaire, which assesses the frequency of soup, fruit, vegetables on the plate, sweetened beverages drinks and pastries/sweets intake in the previous week.
Minutes of moderate-to-vigorous physical activity per week at school
Time frame: Change from baseline, to 3 months after the begging if the intervention, end of intervention (after 6-months of baseline assessment), 6 and 12 months follow-up. Specific duration of time over which participant change is assessed: 18 months.
Youth Activity Profile (YAP): This is a 15 items questionnaire to evaluate psychical activity and sedentary behaviors in youth on the previous seven days.
Minutes per week spent in sedentary behaviors
Time frame: Change from baseline, to 3 months after the begging if the intervention, end of intervention (after 6-months of baseline assessment), 6 and 12 months follow-up. Specific duration of time over which participant change is assessed: 18 months.
Youth Activity Profile (YAP): This is a 15 items questionnaire to evaluate psychical activity and sedentary behaviors in youth on the previous seven days.
Minutes of moderate-to-vigorous physical activity out-of-school per week
Time frame: Change from baseline, to 3 months after the begging if the intervention, end of intervention (after 6-months of baseline assessment), 6 and 12 months follow-up. Specific duration of time over which participant change is assessed: 18 months.
Youth Activity Profile (YAP): This is a 15 items questionnaire to evaluate psychical activity and sedentary behaviors in youth on the previous seven days.
5 secondary outcomes
Eating disturbance
Time frame: Baseline (before the intervention), 3 months after the begging if the intervention, end of intervention (after 6-months of baseline assessment), 6 and 12 months follow-up. Specific duration of time over which participant is assessed: 18 months.
Grazing eating pattern
Time frame: Baseline (before the intervention), 3 months after the begging if the intervention, end of intervention (after 6-months of baseline assessment), 6 and 12 months follow-up. Specific duration of time over which participant is assessed: 18 months.
Psychological Distress (depression, anxiety and stress)
Time frame: Baseline (before the intervention), 3 months after the begging if the intervention, end of intervention (after 6-months of baseline assessment), 6 and 12 months follow-up. Specific duration of time over which participant is assessed: 18 months.
Health-related quality of life
Time frame: Baseline (before the intervention), 3 months after the begging if the intervention, end of intervention (after 6-months of baseline assessment), 6 and 12 months follow-up. Specific duration of time over which participant is assessed: 18 months.
BMI z-score
Time frame: Baseline (before the intervention), 3 months after the begging if the intervention, end of intervention (after 6-months of baseline assessment), 6 and 12 months follow-up. Specific duration of time over which participant is assessed: 18 months.
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 May 2023.
- Background: PubMed 30519810Ramalho S, Saint-Maurice PF, Silva D, Mansilha HF, Silva C, Goncalves S, Machado P, Conceicao E. APOLO-Teens, a web-based intervention for treatment-seeking adolescents with overweight or obesity: study protocol and baseline characterization of a Portuguese sample. Eat Weight Disord. 2020 Apr;25(2):453-463. doi: 10.1007/s40519-018-0623-x. Epub 2018 Dec 5.
- Individual participant dataSharing planned: No. The type of data to collect include sensitive and personal health information protected by the Portuguese Law.
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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.
Eva M Conceição, Ph.D. principal investigator
University of Minho, School of Psychology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APOLO-Teens web-based intervention and Treatment as Usual for Pediatric Obesity in people with Pediatric Obesity, run by University of Minho at 2 sites in Portugal.
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 4 inclusion and 4 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 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal. 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?
Foods/beverages intake (time frame: Change from baseline, to 3 months after the begging if the intervention, end of intervention (after 6-months of baseline assessment), 6 and 12 months follow-up. Specific duration of time over which participant change is assessed: 18 months.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04642222, which also lists 1 linked publication.
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 May 2023.