Binge-Eating DisorderNCT01757847
Acceptance-based Group Intervention for Binge Eating
A study testing Acceptance and Commitment Therapy (ACT) in people with Binge-Eating Disorder, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This study proposes to compare a brief Acceptance and Commitment Therapy (ACT) group intervention to an active control group in a sample of 154 overweight or obese binge eating Veterans who have completed the VA's national behavioral weight management program (MOVE!). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Binge-Eating Disorder
- What is being tested?
- Acceptance and Commitment Therapy (ACT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Diagnosis of overweight or obesity (i.e., BMI > 25 kg/m2), as verified by a study physician after a medical evaluation and examination of medical records;
- Attendance of at least 60% of weight loss sessions of the MOVE! program (i.e., 5 of 8 sessions).
- At least 18 years old
Who cannot join
- Serious or unstable medical or psychiatric illness (i.e., current unmanaged psychosis, manic episode, anorexia nervosa, bulimia nervosa, or substance abuse within the past year) or psychosocial instability (e.g., homelessness) that could compromise study participation;
- Conditions in which exercise or weight loss will be detrimental to one's health (e.g., pregnancy);
- Active suicidal ideation or history of suicide attempt within 5 years;
- Pharmacotherapy for obesity (e.g., Orlistat or Meridia) or bariatric surgery within the past 6 months or planning to start such treatments in the next 6 months;
- Current participation in group or individual psychotherapy for weight management or binge eating;
- Previous treatment with ACT;
- Unwillingness to agree not to change professionally delivered mood treatments and psychotherapy (e.g., begin new therapy or group; discontinue a treatment; increase the dose of medication) for the duration of 4-week study treatment period unless medically necessary.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161
About this study
This study proposes to compare a brief Acceptance and Commitment Therapy (ACT) group intervention to an active control group in a sample of 154 overweight or obese binge eating Veterans who have completed the VA's national behavioral weight management program (MOVE!). This study anticipates that the ACT intervention will reduce binge eating and distress while improving functioning and maintenance of weight loss.
Read the detailed description
Approximately two-thirds of all adults and close to 75% of Veterans are overweight or obese, making obesity a national epidemic with significant impairments in physical and psychological functioning, increasing healthcare costs, and high mortality rates. A significant proportion of overweight and obese individuals binge eat in response to stress or negative emotions, further contributing to obesity. Obesity and binge eating are independently related to a number of physical and mental health co-morbidities such as diabetes, coronary heart disease, osteoarthritis, respiratory symptoms, depression, and anxiety. Although behavioral weight loss interventions have been partially effective, few show long-term maintenance of weight loss, especially for patients with binge eating behavior. Thus, a stepped-care approach that provides more intensive treatment to specifically address the emotional and behavioral factors associated with problematic eating and obesity may be necessary. Acceptance and Commitment Therapy (ACT), an empirically-supported intervention that is being rolled out nationally by the VA, has been effective in reducing distress, increasing quality of life, and improving other indices of health in a wide range of conditions from depression to diabetes. The investigator's preliminary findings suggest that a brief ACT-based group intervention for patients with overweight or obesity can substantially reduce binge eating and distress, and improve functioning. This study proposes to test the efficacy of an ACT intervention for binge eating in conjunction with a standard behavioral weight loss intervention, Managing Overweight and/or Obesity for Veterans Everywhere (MOVE!), at the VA San Diego Healthcare System (VASDHS). Patients (N = 154) who are overweight or obese (body mass index > 25 kg/m2) and meet the clinical criteria for binge eating will be randomized to receive either four 2-hour weekly ACT intervention groups or brief MOVE-II active control groups after their participation in MOVE!. This study hypothesizes that: 1) patients in the ACT intervention will experience significantly greater reductions in binge eating severity than patients in the brief MOVE-II active control group (primary outcome); 2) patients in the ACT intervention will experience significantly greater improvements in physical and mental health functioning, obesity-related quality of life, physical activity levels, caloric and nutrient intake, emotional distress symptoms, binge frequency, and other forms of emotional eating than patients in the brief MOVE-II active control group; 3) gains associated with the ACT intervention will be maintained longer than gains associated with the brief MOVE-II active control group; 4) at 3-month and 6-month follow-ups, patients in the ACT intervention will have greater decreases in body mass index compared to patients in the brief MOVE-II active control group; and 5) measures of acceptance and action will mediate treatment response in the ACT intervention on outcomes of interest. Given the significant physical and psychological sequelae of binge eating and obesity, a brief intervention that can reduce disordered eating, enhance the maintenance of weight loss, and improve functioning among patients who suffer from binge eating, could be critical in the comprehensive approach to patient care at the VA.
- Conditions
- Binge-Eating Disorder
- Being tested
- Acceptance and Commitment Therapy (ACT), Brief MOVE-II control group intervention
- Keywords
- Binge-Eating Disorder, Obesity, emotional eating
- Medical subject headings
- Binge-Eating Disorder, Obesity, Emotional Eating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment Therapy (ACT)Behavioural
Also called ACT
The ACT group protocol consists of four 2-hour weekly sessions focusing on a) thoughts, feelings, and bodily sensations in the context of efforts to lose weight; b) limitations of efforts to control or eliminate negative thoughts or emotions, stress, or food cravings; c) changing expectations and goals from elimination of stress or cravings to living as well as possible with such feelings; d) mindfulness exercises to increase awareness; and e) identification of personal values and goals to achieve improved quality of life.
Brief MOVE-II control group interventionBehavioural
The MOVE-II protocol was designed to reinforce the weight-loss principles that patients learn in MOVE! and to provide support in continued weight loss. The brief MOVE-II active control group protocol will be delivered in four 2-hour weekly group sessions. This protocol includes a psycho-educational component that reinforces the key information from the medical, nutrition, and weight loss strategies modules of the MOVE! program. After review of the psycho-educational components, patients have the opportunity to share their challenges with binge eating and weight loss. Patients will then be able to receive support and feedback from other group members and the therapist. In addition to reinforcing the strategies taught during MOVE! and to provide support in implementing those strategies, the active control group focuses on increasing self-esteem and self-efficacy by exploring patient strengths and maintaining therapeutic alliance and optimism.
| Study group | Role | What they receive |
|---|---|---|
| Brief MOVE-II active control group intervention | Active comparator | The MOVE-II protocol was designed to reinforce the weight-loss principles that patients learn in MOVE! and to provide support in continued weight loss. This protocol includes a psycho-educational component that reinforces the key information from the medical, nutrition, and weight loss strategies modules of the MOVE! program. After review of the psycho-educational components, patients have the opportunity to share their challenges with binge eating and weight loss. Patients will then be able to receive support and feedback from other group members and the therapist. In addition, the active control group focuses on increasing self-esteem and self-efficacy by exploring patient strengths and maintaining therapeutic alliance and optimism. The brief MOVE-II active control group protocol will be delivered in four 2-hour weekly group sessions to patient with overweight or obesity who have completed the VA San Diego MOVE program. Receives: Behavioral: Brief MOVE-II control group intervention |
| Acceptance and Commitment Therapy (ACT) | Experimental | Acceptance and Commitment Therapy (ACT), has been effective in reducing distress, increasing quality of life, and improving other indices of health in a wide range of conditions from depression to diabetes. The ACT protocol for this study focuses on reducing binge eating and distress and improving functioning in individual who are overweight or obese. The protocol focuses on a) thoughts, feelings, and bodily sensations in the context of efforts to lose weight; b) limitations of efforts to control or eliminate negative thoughts or emotions, stress, or food cravings; c) changing expectations and goals from elimination of stress or cravings to living as well as possible with such feelings; d) mindfulness exercises to increase awareness; and e) identification of personal values and goals to achieve improved quality of life. The protocol will be delivered in four 2-hour weekly group sessions to patients with overweight or obesity who have completed the VA San Diego MOVE program. Receives: Behavioral: Acceptance and Commitment Therapy (ACT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Binge Eating Scale (BES) at 4 Weeks, 3 Months and 6 Months
This measure contains 16 questions that describe both behavioral and emotional manifestations of a binge episode. This scale was specifically developed to assess binge eating severity and associated emotional distress in overweight and obese individuals. The total score for the measure ranges from 0-46 points with higher scores indicating greater problems with binge eating and lower scores indicating better outcome.
Measured: post treatment (4 weeks), 3 months, 6 months
Secondary outcomes (1)
Change From Baseline in The Obesity-related Well Being Scale (ORWELL-97) at 4 Weeks, 3 Months, and 6 Months
The ORWELL-97 is a self-report measure of obesity-related quality of life. It has been validated on obese patients. The total score ranges from 0-162 with higher scores indicating lower quality of life and decreasing scores indicating improvement in the outcome.
Measured: post treatment (4 weeks), 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionJun 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Binge-Eating DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Niloofar Afari, PhD, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01757847
- Sponsor's protocol ID
- F7400-R
- Status last verified
- Oct 2016
- First submitted
- 11 Dec 2012
- Last updated
- 21 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Individual participant data is not available for data sharing but aggregate data may be available by contacting the PI.
Publications
Morse JL, Fishbein JN, Wooldridge JS, Herbert MS, Afari N. Posttraumatic Stress Disorder and Weight Loss in Male and Female Active-duty Service Members: A Weight Management Study. Mil Med. 2025 Sep 1;190(9-10):e1784-e1791. doi: 10.1093/milmed/usae561.
PubMed 39797515Morse JL, Wooldridge JS, Herbert MS, Afari N. The Impact of COVID-19 on Health Behavior Engagement and Psychological and Physical Health Among Active Duty Military Enrolled in a Weight Management Intervention: An Exploratory Study. Mil Med. 2024 Aug 30;189(9-10):e1840-e1845. doi: 10.1093/milmed/usae092.
PubMed 38518071Afari N, Herbert MS, Godfrey KM, Cuneo JG, Salamat JS, Mostoufi S, Gasperi M, Ober K, Backhaus A, Rutledge T, Wetherell JL. Acceptance and commitment therapy as an adjunct to the MOVE! programme: a randomized controlled trial. Obes Sci Pract. 2019 Aug 16;5(5):397-407. doi: 10.1002/osp4.356. eCollection 2019 Oct.
PubMed 31687165
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance-based Group Intervention for Binge Eating
- ClinicalTrials.gov ID
- NCT01757847
- Acronym / sponsor ID
- F7400-R
- Conditions
- Binge-Eating Disorder
- Keywords
- Binge-Eating Disorder, Obesity, emotional eating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Jan 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 31 Dec 2012 (estimated)
- Results
- Posted 6 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study proposes to compare a brief Acceptance and Commitment Therapy (ACT) group intervention to an active control group in a sample of 154 overweight or obese binge eating Veterans who have completed the VA's national behavioral weight management program (MOVE!). This study anticipates that the ACT intervention will reduce binge eating and distress while improving functioning and maintenance of weight loss.
Detailed description
Approximately two-thirds of all adults and close to 75% of Veterans are overweight or obese, making obesity a national epidemic with significant impairments in physical and psychological functioning, increasing healthcare costs, and high mortality rates. A significant proportion of overweight and obese individuals binge eat in response to stress or negative emotions, further contributing to obesity. Obesity and binge eating are independently related to a number of physical and mental health co-morbidities such as diabetes, coronary heart disease, osteoarthritis, respiratory symptoms, depression, and anxiety. Although behavioral weight loss interventions have been partially effective, few show long-term maintenance of weight loss, especially for patients with binge eating behavior. Thus, a stepped-care approach that provides more intensive treatment to specifically address the emotional and behavioral factors associated with problematic eating and obesity may be necessary. Acceptance and Commitment Therapy (ACT), an empirically-supported intervention that is being rolled out nationally by the VA, has been effective in reducing distress, increasing quality of life, and improving other indices of health in a wide range of conditions from depression to diabetes. The investigator's preliminary findings suggest that a brief ACT-based group intervention for patients with overweight or obesity can substantially reduce binge eating and distress, and improve functioning. This study proposes to test the efficacy of an ACT intervention for binge eating in conjunction with a standard behavioral weight loss intervention, Managing Overweight and/or Obesity for Veterans Everywhere (MOVE!), at the VA San Diego Healthcare System (VASDHS). Patients (N = 154) who are overweight or obese (body mass index > 25 kg/m2) and meet the clinical criteria for binge eating will be randomized to receive either four 2-hour weekly ACT intervention groups or brief MOVE-II active control groups after their participation in MOVE!. This study hypothesizes that: 1) patients in the ACT intervention will experience significantly greater reductions in binge eating severity than patients in the brief MOVE-II active control group (primary outcome); 2) patients in the ACT intervention will experience significantly greater improvements in physical and mental health functioning, obesity-related quality of life, physical activity levels, caloric and nutrient intake, emotional distress symptoms, binge frequency, and other forms of emotional eating than patients in the brief MOVE-II active control group; 3) gains associated with the ACT intervention will be maintained longer than gains associated with the brief MOVE-II active control group; 4) at 3-month and 6-month follow-ups, patients in the ACT intervention will have greater decreases in body mass index compared to patients in the brief MOVE-II active control group; and 5) measures of acceptance and action will mediate treatment response in the ACT intervention on outcomes of interest. Given the significant physical and psychological sequelae of binge eating and obesity, a brief intervention that can reduce disordered eating, enhance the maintenance of weight loss, and improve functioning among patients who suffer from binge eating, could be critical in the comprehensive approach to patient care at the VA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief MOVE-II active control group intervention | Active comparator | Behavioral: Brief MOVE-II control group interventionThe MOVE-II protocol was designed to reinforce the weight-loss principles that patients learn in MOVE! and to provide support in continued weight loss. This protocol includes a psycho-educational component that reinforces the key information from the medical, nutrition, and weight loss strategies modules of the MOVE! program. After review of the psycho-educational components, patients have the opportunity to share their challenges with binge eating and weight loss. Patients will then be able to receive support and feedback from other group members and the therapist. In addition, the active control group focuses on increasing self-esteem and self-efficacy by exploring patient strengths and maintaining therapeutic alliance and optimism. The brief MOVE-II active control group protocol will be delivered in four 2-hour weekly group sessions to patient with overweight or obesity who have completed the VA San Diego MOVE program. |
| Acceptance and Commitment Therapy (ACT) | Experimental | Behavioral: Acceptance and Commitment Therapy (ACT)Acceptance and Commitment Therapy (ACT), has been effective in reducing distress, increasing quality of life, and improving other indices of health in a wide range of conditions from depression to diabetes. The ACT protocol for this study focuses on reducing binge eating and distress and improving functioning in individual who are overweight or obese. The protocol focuses on a) thoughts, feelings, and bodily sensations in the context of efforts to lose weight; b) limitations of efforts to control or eliminate negative thoughts or emotions, stress, or food cravings; c) changing expectations and goals from elimination of stress or cravings to living as well as possible with such feelings; d) mindfulness exercises to increase awareness; and e) identification of personal values and goals to achieve improved quality of life. The protocol will be delivered in four 2-hour weekly group sessions to patients with overweight or obesity who have completed the VA San Diego MOVE program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of overweight or obesity (i.e., BMI > 25 kg/m2), as verified by a study physician after a medical evaluation and examination of medical records;
- Attendance of at least 60% of weight loss sessions of the MOVE! program (i.e., 5 of 8 sessions).
- At least 18 years old
Key exclusion criteria (7 listed)
- Serious or unstable medical or psychiatric illness (i.e., current unmanaged psychosis, manic episode, anorexia nervosa, bulimia nervosa, or substance abuse within the past year) or psychosocial instability (e.g., homelessness) that could compromise study participation;
- Conditions in which exercise or weight loss will be detrimental to one's health (e.g., pregnancy);
- Active suicidal ideation or history of suicide attempt within 5 years;
- Pharmacotherapy for obesity (e.g., Orlistat or Meridia) or bariatric surgery within the past 6 months or planning to start such treatments in the next 6 months;
- Current participation in group or individual psychotherapy for weight management or binge eating;
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 |
|---|---|---|
| Acceptance and Commitment Therapy (ACT)Also: ACTThe ACT group protocol consists of four 2-hour weekly sessions focusing on a) thoughts, feelings, and bodily sensations in the context of efforts to lose weight; b) limitations of efforts to control or eliminate negative thoughts or emotions, stress, or food cravings; c) changing expectations and goals from elimination of stress or cravings to living as well as possible with such feelings; d) mindfulness exercises to increase awareness; and e) identification of personal values and goals to achieve improved quality of life. | Behavioural | Acceptance and Commitment Therapy (ACT) |
| Brief MOVE-II control group interventionThe MOVE-II protocol was designed to reinforce the weight-loss principles that patients learn in MOVE! and to provide support in continued weight loss. The brief MOVE-II active control group protocol will be delivered in four 2-hour weekly group sessions. This protocol includes a psycho-educational component that reinforces the key information from the medical, nutrition, and weight loss strategies modules of the MOVE! program. After review of the psycho-educational components, patients have the opportunity to share their challenges with binge eating and weight loss. Patients will then be able to receive support and feedback from other group members and the therapist. In addition to reinforcing the strategies taught during MOVE! and to provide support in implementing those strategies, the active control group focuses on increasing self-esteem and self-efficacy by exploring patient strengths and maintaining therapeutic alliance and optimism. | Behavioural | Brief MOVE-II active control group intervention |
Primary outcome
Change From Baseline in Binge Eating Scale (BES) at 4 Weeks, 3 Months and 6 Months
Time frame: post treatment (4 weeks), 3 months, 6 months
This measure contains 16 questions that describe both behavioral and emotional manifestations of a binge episode. This scale was specifically developed to assess binge eating severity and associated emotional distress in overweight and obese individuals. The total score for the measure ranges from 0-46 points with higher scores indicating greater problems with binge eating and lower scores indicating better outcome.
1 secondary outcome
Change From Baseline in The Obesity-related Well Being Scale (ORWELL-97) at 4 Weeks, 3 Months, and 6 Months
Time frame: post treatment (4 weeks), 3 months, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39797515Morse JL, Fishbein JN, Wooldridge JS, Herbert MS, Afari N. Posttraumatic Stress Disorder and Weight Loss in Male and Female Active-duty Service Members: A Weight Management Study. Mil Med. 2025 Sep 1;190(9-10):e1784-e1791. doi: 10.1093/milmed/usae561.
- Derived from this study: PubMed 38518071Morse JL, Wooldridge JS, Herbert MS, Afari N. The Impact of COVID-19 on Health Behavior Engagement and Psychological and Physical Health Among Active Duty Military Enrolled in a Weight Management Intervention: An Exploratory Study. Mil Med. 2024 Aug 30;189(9-10):e1840-e1845. doi: 10.1093/milmed/usae092.
- Derived from this study: PubMed 31687165Afari N, Herbert MS, Godfrey KM, Cuneo JG, Salamat JS, Mostoufi S, Gasperi M, Ober K, Backhaus A, Rutledge T, Wetherell JL. Acceptance and commitment therapy as an adjunct to the MOVE! programme: a randomized controlled trial. Obes Sci Pract. 2019 Aug 16;5(5):397-407. doi: 10.1002/osp4.356. eCollection 2019 Oct.
- Individual participant dataSharing planned: No. Individual participant data is not available for data sharing but aggregate data may be available by contacting the PI.
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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.
Niloofar Afari, PhD principal investigator
VA San Diego Healthcare System, San Diego, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy (ACT) in people with Binge-Eating Disorder, run by VA Office of Research and Development at 1 site in United States.
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 3 inclusion and 7 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 21 Nov 2016. 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 United States. 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?
Yes. Results are posted in the registry (first posted 6 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Binge Eating Scale (BES) at 4 Weeks, 3 Months and 6 Months (time frame: post treatment (4 weeks), 3 months, 6 months). 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 NCT01757847, 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 21 Nov 2016.