Diabetes Mellitus, Type 2NCT03609463
Promoting Weight Loss and Stress Reduction in Overweight and Obese Patients With Type 2 Diabetes
A study testing Small change intervention, Well-being intervention and Treatment as usual in people with Diabetes Mellitus, Type 2 and Overweight and Obesity, run by Chiara Rafanelli at 2 sites in Italy.
Trial summary
This is a feasibility and acceptability study of a 16-month single-blind randomized controlled trial (RCT) designed to test the initial effectiveness of a well-being and small lifestyle changes intervention aimed at promoting weight loss and stress reduction in overweight and obese patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Overweight and Obesity
- What is being tested?
- Small change intervention, Well-being intervention and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 2 sitesItaly
- Study dates
- 27 Mar 2018to 18 Nov 2020
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI ≥ 25;
- Age ≥ 18;
- Diagnosis of type 2 diabetes;
- Fluent English or Italian.
Who cannot join
- Inability to provide informed consent to participate in the study for any reason, including cognitive impairment and psychiatric illness;
- Presence of any medical condition that would make participation in the study difficult and/or unsafe;
- Presence of any medical condition associated with unintentional weight loss or gain;
- Presence of untreated, severe and/or recently diagnosed (≤ 6 months) mental illness and/or presence of a severe personality disorder;
- History of eating disorders and/or substance abuse;
- Use of drugs for weight loss;
Show all 11Show fewer
- Participation in another weight loss program or in any other trial;
- Participation in an individual or group psychological intervention;
- Weight loss surgery within the year;
- Pregnant or are planning to become pregnant within the year
- Inability to control meal contents (e.g. institutionalized patients).
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Struttura Semplice di Endocrinologia e Metabolismo, Ospedale Oglio Po
Casalmaggiore, Cremona, 26041
Servizio Endocrinologia e Diabetologia, Ospedale Bufalini
Cesena, Forlì-Cesena, 47521
About this study
Official title: Promoting Weight Loss and Stress Reduction in Overweight and Obese Patients With Type 2 Diabetes: a Feasibility Study of a Combination of a Small Change and Well-Being Intervention
This is a feasibility and acceptability study of a 16-month single-blind randomized controlled trial (RCT) designed to test the initial effectiveness of a well-being and small lifestyle changes intervention aimed at promoting weight loss and stress reduction in overweight and obese patients with type 2 diabetes. Primary goals of this study are to 1) evaluate study feasibility and patient acceptability, 2) develop a tailored protocol of a behavioral intervention for overweight or obese patients with type 2 diabetes that takes stress and well-being into consideration, 3) evaluate appropriateness of research procedures and measures, 4) examine effect size estimates of key outcomes to provide essential data to inform a larger efficacy trial, 5) determine whether clinically significant improvements occurred in any key outcomes.
Read the detailed description
Overweight and obese patients with type 2 diabetes will be recruited at 2 different diabetes clinics. Physicians will screen every patient attending to each clinic during the enrollment period for the presence of main eligibility criteria. Those patients who appear to be eligible will be introduced to the study and referred to a researcher for a more in-depth screening evaluation. Eligible patients who are interested in participating in the study will be asked to sign the informed consent. Consecutive patients will be randomly assigned in a 1:1 ratio to an experimental group or a control group. During the first month, participants in the experimental group will receive a well-being promoting intervention in adjunction to the treatment as usual (TAU), while those in the control group will be asked to follow the TAU. In the following 3 months participants in both groups will receive the small change intervention in adjunction to the the TAU. All in person sessions of the intervention will take place in an office of both the 2 diabetes clinics involved. Data about psychological and clinical variables will be collected for each participant through questionnaires and interviews at baseline, at post-intervention, and at 6 and 12 months of follow-up. Participants' weight will be measured at each assessment point using a scale. Medical charts will be accessed to collect further data about physiological parameters, treatment received and medical history.
- Conditions
- Diabetes Mellitus, Type 2, Overweight and Obesity
- Being tested
- Small change intervention, Well-being intervention, Treatment as usual
- Keywords
- diabetes, overweight, obesity, well-being, behavioral, small change, weight loss
- Medical subject headings
- Diabetes Mellitus, Type 2, Overweight, Obesity, Diabetes Mellitus, Behavior, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small change interventionBehavioural
The small change intervention is a behavioral intervention to help people gradually lose weight by making small changes in their lifestyle. At the beginning of the intervention participants will be met in person to be guided in setting an eating and a physical activity goal. Participants will be then contacted through the phone or met in person weekly for 3 months to check on their adherence to the selected goals and to discuss about facilitators and barriers to goal completion, in order to increase their motivation and problem solving skills. Every weekly contact will last about an hour and will be administered in an individual setting. At each contact selected goals can be revised, changed or another goal can be added based on levels of adherence.
Well-being interventionBehavioural
The well-being intervention is a coaching intervention aimed at motivating people in making lifestyle changes by reducing levels of stress through the promotion of psychological well-being. It will consists in 4 weekly sessions to be held before starting the small change intervention. Each session will last about an hour and will be administered in an individual setting.
Treatment as usualOther
The treatment as usual includes any recommendation given to the participants by their physicians, including diet, physical activity, medication and glycemic control instructions.
| Study group | Role | What they receive |
|---|---|---|
| Well-being and small change | Experimental | Participants will be randomized to receive 4 individual 1-hour weekly sessions of the well-being intervention before starting the 12 individual 1-hour weekly sessions of the small change intervention in addition to the treatment as usual. Receives: Behavioral: Small change intervention; Behavioral: Well-being intervention; Other: Treatment as usual |
| Small change | Active comparator | Participants will be randomized to receive 12 individual 1-hour weekly sessions of the small change intervention in addition to the treatment as usual. Receives: Behavioral: Small change intervention; Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility (Recruitment)
Measured as the acceptance rate (total number of participants enrolled out of the total number of eligible candidates approached).
Measured: Baseline
Feasibility (Retention)
Measured as drop-out rates (total number of participants who withdraw out of the total number enrolled).
Measured: Through study completion, intended to be 16 months
Feasibility (Acceptability of Intervention)
Measured as total number of sessions attended and number of weeks needed to complete the intervention. Semi-structured interviews will be conducted to estimate patients' satisfaction and provide data on optimal timing, dosing, and delivery.
Measured: Post-intervention, intended to be 4 months
Secondary outcomes (4)
Change in Psychological Distress
Measured by the Symptoms Questionnaire (SQ), a 92-item self-rating scale with yes/no responses (or true/false for some questions to avoid double-negative statements) divided into four domains: anxiety, depression, somatic, and anger-hostility.
Each domain is further divided into two sub-scales: one sub-scale with 17 symptom questions and one sub-scale with 6 questions that are antonyms of some of the symptom questions in order to measure well-being.
A response of yes/true for a symptom question gives 1 point, and a response of no/false for a well-being question gives 1 point for a score ranging from 0-17 for each symptom sub-scale and 0-6 for each well-being sub-scale, where a higher score indicates greater distress. If the well-being score is calculated separately the raw score can be subtracted from 6 for a score ranging from 0-6, where a higher score indicates greater well-being.
Measured: Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention
Change in Psychological Distress and Well-Being
Measured by the Psychosocial Index (PSI), a 55-item self-rating scale divided into five domains:
Sociodemographic and clinical data: 12 questions including routine medical and demographic information. Stress: 17 yes/no questions with a score from 0-17. A higher score indicates greater stress. Well-being: 6 yes/no questions with a score from 0-6. A higher score indicates greater psychological well-being. Psychological distress: 15 four-point questions from 0-3, with a total score from 0-45. A higher score indicates greater psychological distress. 4 questions referring to sleep may be scored separately. Abnormal illness behavior: 3 four-point questions from 0-3, with a total score from 0-9. A higher score indicates more severe abnormal illness behavior. Quality of life: 1 four-point question, with a score from 0 to 4. A higher score indicates a higher quality of life. Psychological well-being and quality of life scores can be summed for a global well-being score from 0-10.
Measured: Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention
Change in Psychological Well-Being
Measured by the Psychological Well-Being scale (PWB), a 42-question self-rating scale for the assessment of 6 dimensions: self-acceptance, positive relations with others, autonomy, environmental mastery, purpose in life and personal growth. Each of the 42 six-point response questions are given a score from 1-6, with questions phrased in the negative reversed (e.g. 1 to 6, 6 to 1). The total score in each dimension ranges from 7-42, and all the dimensions scores are summed to give a final total ranging from 42-252, with higher scores indicating greater psychological well-being.
Measured: Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention
% Weight Change
Measured in kg.
Measured: Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start27 Mar 2018
- Primary completion18 Nov 2020
- Study completion18 Nov 2020
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 Diabetes Mellitus, Type 2Studies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiara Rafanelli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chiara Rafanelli, University of Bologna
- Investigators
- Chiara Rafanelli, MD, PhD, Study director, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03609463
- Sponsor's protocol ID
- PWLPWB-CVD
- Status last verified
- Mar 2021
- First submitted
- 11 Jul 2018
- Last updated
- 12 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hill JO. Can a small-changes approach help address the obesity epidemic? A report of the Joint Task Force of the American Society for Nutrition, Institute of Food Technologists, and International Food Information Council. Am J Clin Nutr. 2009 Feb;89(2):477-84. doi: 10.3945/ajcn.2008.26566. Epub 2008 Dec 16.
PubMed 19088151Phillips-Caesar EG, Winston G, Peterson JC, Wansink B, Devine CM, Kanna B, Michelin W, Wethington E, Wells M, Hollenberg J, Charlson ME. Small Changes and Lasting Effects (SCALE) Trial: the formation of a weight loss behavioral intervention using EVOLVE. Contemp Clin Trials. 2015 Mar;41:118-28. doi: 10.1016/j.cct.2015.01.003. Epub 2015 Jan 26.
PubMed 25633208Phillips EG, Wells MT, Winston G, Ramos R, Devine CM, Wethington E, Peterson JC, Wansink B, Charlson M. Innovative approaches to weight loss in a high-risk population: The small changes and lasting effects (SCALE) trial. Obesity (Silver Spring). 2017 May;25(5):833-841. doi: 10.1002/oby.21780. Epub 2017 Apr 5.
PubMed 28382755Geiker NRW, Astrup A, Hjorth MF, Sjodin A, Pijls L, Markus CR. Does stress influence sleep patterns, food intake, weight gain, abdominal obesity and weight loss interventions and vice versa? Obes Rev. 2018 Jan;19(1):81-97. doi: 10.1111/obr.12603. Epub 2017 Aug 28.
PubMed 28849612Fava GA. Well-Being Therapy: Current Indications and Emerging Perspectives. Psychother Psychosom. 2016;85(3):136-45. doi: 10.1159/000444114. Epub 2016 Apr 5. No abstract available.
PubMed 27043240Ryff CD. Psychological well-being revisited: advances in the science and practice of eudaimonia. Psychother Psychosom. 2014;83(1):10-28. doi: 10.1159/000353263. Epub 2013 Nov 19.
PubMed 24281296Benasi G, Gostoli S, Zhu B, Offidani E, Artin MG, Gagliardi L, Rignanese G, Sassi G, Fava GA, Rafanelli C. Well-Being Therapy and Lifestyle Intervention in Type 2 Diabetes: A Pilot Randomized Controlled Trial. Psychosom Med. 2022 Nov-Dec 01;84(9):1041-1049. doi: 10.1097/PSY.0000000000001115. Epub 2022 Aug 2.
PubMed 36346956
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Weight Loss and Stress Reduction in Overweight and Obese Patients With Type 2 Diabetes: a Feasibility Study of a Combination of a Small Change and Well-Being Intervention
- ClinicalTrials.gov ID
- NCT03609463
- Acronym / sponsor ID
- PWLPWB-CVD
- Conditions
- Diabetes Mellitus, Type 2, Overweight and Obesity
- Keywords
- diabetes, overweight, obesity, well-being, behavioral, small change, weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Chiara RafanelliUniversity, hospital or other
- Study start
- 27 Mar 2018 (actual)
- Primary completion
- 18 Nov 2020 (actual)
- Study completion
- 18 Nov 2020 (actual)
- First posted
- 1 Aug 2018 (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.
This is a feasibility and acceptability study of a 16-month single-blind randomized controlled trial (RCT) designed to test the initial effectiveness of a well-being and small lifestyle changes intervention aimed at promoting weight loss and stress reduction in overweight and obese patients with type 2 diabetes. Primary goals of this study are to 1) evaluate study feasibility and patient acceptability, 2) develop a tailored protocol of a behavioral intervention for overweight or obese patients with type 2 diabetes that takes stress and well-being into consideration, 3) evaluate appropriateness of research procedures and measures, 4) examine effect size estimates of key outcomes to provide essential data to inform a larger efficacy trial, 5) determine whether clinically significant improvements occurred in any key outcomes.
Detailed description
Overweight and obese patients with type 2 diabetes will be recruited at 2 different diabetes clinics. Physicians will screen every patient attending to each clinic during the enrollment period for the presence of main eligibility criteria. Those patients who appear to be eligible will be introduced to the study and referred to a researcher for a more in-depth screening evaluation. Eligible patients who are interested in participating in the study will be asked to sign the informed consent. Consecutive patients will be randomly assigned in a 1:1 ratio to an experimental group or a control group. During the first month, participants in the experimental group will receive a well-being promoting intervention in adjunction to the treatment as usual (TAU), while those in the control group will be asked to follow the TAU. In the following 3 months participants in both groups will receive the small change intervention in adjunction to the the TAU. All in person sessions of the intervention will take place in an office of both the 2 diabetes clinics involved. Data about psychological and clinical variables will be collected for each participant through questionnaires and interviews at baseline, at post-intervention, and at 6 and 12 months of follow-up. Participants' weight will be measured at each assessment point using a scale. Medical charts will be accessed to collect further data about physiological parameters, treatment received and medical history.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Well-being and small change | Experimental | Behavioral: Small change intervention, Behavioral: Well-being intervention, Other: Treatment as usualParticipants will be randomized to receive 4 individual 1-hour weekly sessions of the well-being intervention before starting the 12 individual 1-hour weekly sessions of the small change intervention in addition to the treatment as usual. |
| Small change | Active comparator | Behavioral: Small change intervention, Other: Treatment as usualParticipants will be randomized to receive 12 individual 1-hour weekly sessions of the small change intervention in addition to the treatment as usual. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI ≥ 25;
- Age ≥ 18;
- Diagnosis of type 2 diabetes;
- Fluent English or Italian.
Key exclusion criteria (11 listed)
- Inability to provide informed consent to participate in the study for any reason, including cognitive impairment and psychiatric illness;
- Presence of any medical condition that would make participation in the study difficult and/or unsafe;
- Presence of any medical condition associated with unintentional weight loss or gain;
- Presence of untreated, severe and/or recently diagnosed (≤ 6 months) mental illness and/or presence of a severe personality disorder;
- History of eating disorders and/or substance abuse;
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 |
|---|---|---|
| Small change interventionThe small change intervention is a behavioral intervention to help people gradually lose weight by making small changes in their lifestyle. At the beginning of the intervention participants will be met in person to be guided in setting an eating and a physical activity goal. Participants will be then contacted through the phone or met in person weekly for 3 months to check on their adherence to the selected goals and to discuss about facilitators and barriers to goal completion, in order to increase their motivation and problem solving skills. Every weekly contact will last about an hour and will be administered in an individual setting. At each contact selected goals can be revised, changed or another goal can be added based on levels of adherence. | Behavioural | Small change, Well-being and small change |
| Well-being interventionThe well-being intervention is a coaching intervention aimed at motivating people in making lifestyle changes by reducing levels of stress through the promotion of psychological well-being. It will consists in 4 weekly sessions to be held before starting the small change intervention. Each session will last about an hour and will be administered in an individual setting. | Behavioural | Well-being and small change |
| Treatment as usualThe treatment as usual includes any recommendation given to the participants by their physicians, including diet, physical activity, medication and glycemic control instructions. | Other | Small change, Well-being and small change |
Primary outcome
Feasibility (Recruitment)
Time frame: Baseline
Measured as the acceptance rate (total number of participants enrolled out of the total number of eligible candidates approached).
Feasibility (Retention)
Time frame: Through study completion, intended to be 16 months
Measured as drop-out rates (total number of participants who withdraw out of the total number enrolled).
Feasibility (Acceptability of Intervention)
Time frame: Post-intervention, intended to be 4 months
Measured as total number of sessions attended and number of weeks needed to complete the intervention. Semi-structured interviews will be conducted to estimate patients' satisfaction and provide data on optimal timing, dosing, and delivery.
4 secondary outcomes
Change in Psychological Distress
Time frame: Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention
Change in Psychological Distress and Well-Being
Time frame: Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention
Change in Psychological Well-Being
Time frame: Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention
% Weight Change
Time frame: Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention
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 12 Mar 2021.
- Background: PubMed 19088151Hill JO. Can a small-changes approach help address the obesity epidemic? A report of the Joint Task Force of the American Society for Nutrition, Institute of Food Technologists, and International Food Information Council. Am J Clin Nutr. 2009 Feb;89(2):477-84. doi: 10.3945/ajcn.2008.26566. Epub 2008 Dec 16.
- Background: PubMed 25633208Phillips-Caesar EG, Winston G, Peterson JC, Wansink B, Devine CM, Kanna B, Michelin W, Wethington E, Wells M, Hollenberg J, Charlson ME. Small Changes and Lasting Effects (SCALE) Trial: the formation of a weight loss behavioral intervention using EVOLVE. Contemp Clin Trials. 2015 Mar;41:118-28. doi: 10.1016/j.cct.2015.01.003. Epub 2015 Jan 26.
- Background: PubMed 28382755Phillips EG, Wells MT, Winston G, Ramos R, Devine CM, Wethington E, Peterson JC, Wansink B, Charlson M. Innovative approaches to weight loss in a high-risk population: The small changes and lasting effects (SCALE) trial. Obesity (Silver Spring). 2017 May;25(5):833-841. doi: 10.1002/oby.21780. Epub 2017 Apr 5.
- Background: PubMed 28849612Geiker NRW, Astrup A, Hjorth MF, Sjodin A, Pijls L, Markus CR. Does stress influence sleep patterns, food intake, weight gain, abdominal obesity and weight loss interventions and vice versa? Obes Rev. 2018 Jan;19(1):81-97. doi: 10.1111/obr.12603. Epub 2017 Aug 28.
- Background: PubMed 27043240Fava GA. Well-Being Therapy: Current Indications and Emerging Perspectives. Psychother Psychosom. 2016;85(3):136-45. doi: 10.1159/000444114. Epub 2016 Apr 5. No abstract available.
- Background: PubMed 24281296Ryff CD. Psychological well-being revisited: advances in the science and practice of eudaimonia. Psychother Psychosom. 2014;83(1):10-28. doi: 10.1159/000353263. Epub 2013 Nov 19.
- Derived from this study: PubMed 36346956Benasi G, Gostoli S, Zhu B, Offidani E, Artin MG, Gagliardi L, Rignanese G, Sassi G, Fava GA, Rafanelli C. Well-Being Therapy and Lifestyle Intervention in Type 2 Diabetes: A Pilot Randomized Controlled Trial. Psychosom Med. 2022 Nov-Dec 01;84(9):1041-1049. doi: 10.1097/PSY.0000000000001115. Epub 2022 Aug 2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chiara Rafanelli, MD, PhD study director
University of Bologna
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Small change intervention, Well-being intervention and Treatment as usual in people with Diabetes Mellitus, Type 2 and Overweight and Obesity, run by Chiara Rafanelli at 2 sites in Italy.
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 11 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 12 Mar 2021. 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 Italy. 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?
Feasibility (Recruitment) (time frame: Baseline). The study lists 3 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 NCT03609463, 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 12 Mar 2021.