OverweightNCT02783521
Gender- and Culturally-Sensitive Weight Loss Intervention for Hispanic Males
A study testing Counseling sessions in people with Overweight and Obesity, run by University of Arizona at 1 site in United States.
Trial summary
The investigators propose to 1) assess the feasibility, acceptability and preliminary efficacy of a gender- and culturally-sensitive weight loss intervention in 48 overweight/obese Hispanic males ages 18-64 over 12 weeks; 2) assess participant characteristics and process measures related to the uptake of mobile-health… Read more about this study
- Who is it for?
- Ages 18 to 64 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Counseling sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Feb 2017
- 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 64 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-64 years of age
- BMI between 25 to 45.0 kg/m² (NOTE: The investigators elected to cap this at 45.0 kg/m² to minimize potential risks and to reduce the potential for obesity to limit exercise participation)
- Ability to provide informed consent and health risk assessment prior to participation in this study
- Speak, read, and write either English and/or Spanish
Who cannot join
- Uncontrolled diabetes mellitus
- History of bariatric surgery
- Report medical condition or treatment for a medical condition that could affect body weight or ability to engage in structured physical activity that is consistent with the intervention for this study
- Current congestive heart failure, angina, uncontrolled arrhythmia, or other symptoms indicative of an increased acute risk for a cardiovascular event
- Resting systolic blood pressure of ≥150 mmHg or resting diastolic blood pressure of ≥90 mmHg
- Eating disorders that would contraindicate weight loss or physical activity
Show all 11Show fewer
- Alcohol or substance abuse
- Currently treated for psychological issues (i.e. depression, bipolar disorder, etc.), taking psychotropic medications with the previous 12 months, or hospitalized for depression within the previous 5 years
- Report exercise on ≥3 days per week for ≥ 20 minutes per day over the past 3 months
- Report weight loss of ≥5% or participating in a weight reduction diet program in the past 3 months
- Report plans to relocate to a location that limits their access to the study site or having employment, personal, or travel commitments that prohibit attendance to all of the scheduled assessments
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arizona Collaboratory for Metabolic Disease Prevention and Treatment
Tucson, Arizona, 85714
About this study
Official title: Feasibility of a Gender- and Culturally-Sensitive Weight Loss Intervention for Hispanic Males
The investigators propose to 1) assess the feasibility, acceptability and preliminary efficacy of a gender- and culturally-sensitive weight loss intervention in 48 overweight/obese Hispanic males ages 18-64 over 12 weeks; 2) assess participant characteristics and process measures related to the uptake of mobile-health (mHealth) technology in overweight/obese Hispanic males over 12 weeks; and 3) assess pathologic changes in the liver in Hispanic men enrolled in a 12-week weight loss intervention using a non-invasive MRI as a therapeutic response biomarker.
Read the detailed description
In the U.S., Hispanic males have the highest rate of overweight and obesity when compared to males of other racial/ethnic groups placing them at greater risk for obesity-related disease. Yet, current literature is lacking to inform on best practices to engage Hispanic males in weight loss and/or to promote a successful weight loss trajectory. Without this information the health disparities associated with obesity and obesity-related chronic disease will continue. Evidence exists to support behavioral weight loss in reducing obesity-related health risks. There are limited data to suggest these programs are effective for men and no data to support the feasibility and effectiveness of these programs among Hispanic males despite this being the fastest growing and highest burdened group for obesity-related disease within the U.S. population. Using existing practice guidelines and evidence from recently completed in-depth qualitative interviews in overweight/obese Hispanic males, the investigators will test a novel intervention approach to address this gap in knowledge. The investigators propose to 1) assess the feasibility, acceptability and preliminary efficacy of a gender- and culturally-sensitive weight loss intervention in 48 overweight/obese Hispanic males ages 18-64 over 12 weeks; 2) assess participant characteristics and process measures related to the uptake of mobile-health (mHealth) technology in overweight/obese Hispanic males over 12 weeks; and 3) assess pathologic changes in the liver in Hispanic men enrolled in a 12-week weight loss intervention using a non-invasive MRI as a therapeutic response biomarker. This project will challenge current research paradigms for Hispanic males by testing a gender- and culturally-sensitive weight loss intervention and providing highly impactful formative research on the use of novel mHealth self-monitoring technologies to facilitate dietary/physical activity behavior changes. Given the Hispanic population is the fastest growing in the U.S., efforts to identify strategies to promote weight control among Hispanic males has potential to significantly impact public health. The expected outcome of the proposed project is the identification of feasible and appropriate weight loss intervention strategies to improve engagement and weight management in this vulnerable ethnic group.
- Conditions
- Overweight, Obesity
- Being tested
- Counseling sessions, Wait List Control
- Keywords
- Hispanic men, Weight loss, Diet, Physical activity, Intervention
- Medical subject headings
- Overweight, Obesity, Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counseling sessionsBehavioural
During the first 12 weeks, intervention participants will attend weekly 30-45-minute individual counseling sessions guided by a trained bilingual Hispanic male lifestyle coach. Counseling sessions will be tailored to the needs of the participants (e.g., evening/weekend sessions, waiting/childcare area). After 12 weeks, intervention group participants will receive bi-weekly phone calls across a 12-week follow-up. Phone calls will last approximately 10 minutes in duration and study staff will follow a script to review current body weight, eating and activity behaviors, and specific barriers for weight loss/maintenance or diet/physical activity behaviors.
Wait List ControlBehavioural
After 12 weeks, the wait list control will receive the weight loss intervention plus mHealth technology support. It will include tailored, targeted text messaging and real-time self-monitoring support including beverage tracking cups, which provide the amount of calories users are consuming through beverages on a daily basis, and wearable activity monitors.Behavioral constructs used for the intervention group will be maintained during this intervention delivery thereby ensuring all participants have the appropriate tools to continue weight loss efforts regardless of mHealth use.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Includes changing eating behaviors, increasing physical activity, and attending regular in-person weight loss meetings for 12 weeks. To support additional weight loss/weight maintenance, participants will receive bi-weekly phone calls across a 12 week follow-up. Receives: Behavioral: Counseling sessions |
| Wait List Control | Other | Wait-list control participants will not receive any intervention for the first 12 weeks. After 12 weeks, participants will receive the weight loss intervention plus mHealth technology support. Receives: Behavioral: Wait List Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Recruitment: Interest in Participation
The number of Hispanic men who contact the researchers and express interest in participation.
Measured: Baseline
Study Recruitment: Screened for Eligibility
The number of Hispanic men screened for eligibility.
Measured: Baseline
Study Recruitment: Eligibility
The number of Hispanic men eligible/ineligible for study inclusion and reason for ineligibility.
Measured: Baseline
Study Recruitment: Enrollment
The number of Hispanic men enrolled in the study.
Measured: Baseline
Retention
Retention will be measured as the number of participants who remain in the study at 24 weeks, divided by the number enrolled.
Measured: Week 24
Treatment Satisfaction/Acceptability
Participants will be asked to rate their overall satisfaction with the intervention at 24 weeks and if they would recommend the program to others. Participants will also be asked questions regarding satisfaction with their overall progress and for changing dietary and PA habits, and weight
Measured: Week 24
Secondary outcomes (4)
Change in body weight.
Body weight will be measured on a digital scale to assess change in body weight over the intervention period.
Measured: 6, 12, 18, and 24 weeks
Change in physical activity
A questionnaire will be used to measure and quantify energy expenditure from physical activity.
Measured: 6, 12, 18, and 24 weeks
Change in dietary intake
A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates used.
Measured: 12 and 24 weeks
Change in liver fat content (intervention only)
A non-invasive MRI will be used to assess changes in liver fat content for intervention participants at week 12.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study startMay 2016
- Primary completionFeb 2017
- Study completionFeb 2017
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 OverweightStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David O. Garcia, PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02783521
- Sponsor's protocol ID
- 1604536275
- Status last verified
- Oct 2017
- First submitted
- 20 May 2016
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732.
PubMed 24570244Lindberg NM, Stevens VJ, Halperin RO. Weight-loss interventions for Hispanic populations: the role of culture. J Obes. 2013;2013:542736. doi: 10.1155/2013/542736. Epub 2013 Feb 26.
PubMed 23533725Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, Hu FB, Hubbard VS, Jakicic JM, Kushner RF, Loria CM, Millen BE, Nonas CA, Pi-Sunyer FX, Stevens J, Stevens VJ, Wadden TA, Wolfe BM, Yanovski SZ; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Obesity Society. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):2985-3023. doi: 10.1016/j.jacc.2013.11.004. Epub 2013 Nov 12. No abstract available.
PubMed 24239920Pagoto SL, Schneider KL, Oleski JL, Luciani JM, Bodenlos JS, Whited MC. Male inclusion in randomized controlled trials of lifestyle weight loss interventions. Obesity (Silver Spring). 2012 Jun;20(6):1234-9. doi: 10.1038/oby.2011.140. Epub 2011 Jun 2.
PubMed 21633403Garcia DO, Valdez LA, Hooker SP. Hispanic Male's Perspectives of Health Behaviors Related to Weight Management. Am J Mens Health. 2017 Sep;11(5):1547-1559. doi: 10.1177/1557988315619470. Epub 2015 Dec 3.
PubMed 26634854Garcia DO, Valdez LA, Aceves B, Bell ML, Rabe BA, Villavicencio EA, Marrero DG, Melton F, Hooker SP. mHealth-Supported Gender- and Culturally Sensitive Weight Loss Intervention for Hispanic Men With Overweight and Obesity: Single-Arm Pilot Study. JMIR Form Res. 2022 Sep 21;6(9):e37637. doi: 10.2196/37637.
PubMed 36129735Garcia DO, Valdez LA, Bell ML, Humphrey K, Hingle M, McEwen M, Hooker SP. A gender- and culturally-sensitive weight loss intervention for Hispanic males: The ANIMO randomized controlled trial pilot study protocol and recruitment methods. Contemp Clin Trials Commun. 2018 Feb 9;9:151-163. doi: 10.1016/j.conctc.2018.01.010. eCollection 2018 Mar.
PubMed 29696238
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Gender- and Culturally-Sensitive Weight Loss Intervention for Hispanic Males
- ClinicalTrials.gov ID
- NCT02783521
- Acronym / sponsor ID
- 1604536275
- Conditions
- Overweight, Obesity
- Keywords
- Hispanic men, Weight loss, Diet, Physical activity, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 26 May 2016 (estimated)
- 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.
The investigators propose to 1) assess the feasibility, acceptability and preliminary efficacy of a gender- and culturally-sensitive weight loss intervention in 48 overweight/obese Hispanic males ages 18-64 over 12 weeks; 2) assess participant characteristics and process measures related to the uptake of mobile-health (mHealth) technology in overweight/obese Hispanic males over 12 weeks; and 3) assess pathologic changes in the liver in Hispanic men enrolled in a 12-week weight loss intervention using a non-invasive MRI as a therapeutic response biomarker.
Detailed description
In the U.S., Hispanic males have the highest rate of overweight and obesity when compared to males of other racial/ethnic groups placing them at greater risk for obesity-related disease. Yet, current literature is lacking to inform on best practices to engage Hispanic males in weight loss and/or to promote a successful weight loss trajectory. Without this information the health disparities associated with obesity and obesity-related chronic disease will continue. Evidence exists to support behavioral weight loss in reducing obesity-related health risks. There are limited data to suggest these programs are effective for men and no data to support the feasibility and effectiveness of these programs among Hispanic males despite this being the fastest growing and highest burdened group for obesity-related disease within the U.S. population. Using existing practice guidelines and evidence from recently completed in-depth qualitative interviews in overweight/obese Hispanic males, the investigators will test a novel intervention approach to address this gap in knowledge. The investigators propose to 1) assess the feasibility, acceptability and preliminary efficacy of a gender- and culturally-sensitive weight loss intervention in 48 overweight/obese Hispanic males ages 18-64 over 12 weeks; 2) assess participant characteristics and process measures related to the uptake of mobile-health (mHealth) technology in overweight/obese Hispanic males over 12 weeks; and 3) assess pathologic changes in the liver in Hispanic men enrolled in a 12-week weight loss intervention using a non-invasive MRI as a therapeutic response biomarker. This project will challenge current research paradigms for Hispanic males by testing a gender- and culturally-sensitive weight loss intervention and providing highly impactful formative research on the use of novel mHealth self-monitoring technologies to facilitate dietary/physical activity behavior changes. Given the Hispanic population is the fastest growing in the U.S., efforts to identify strategies to promote weight control among Hispanic males has potential to significantly impact public health. The expected outcome of the proposed project is the identification of feasible and appropriate weight loss intervention strategies to improve engagement and weight management in this vulnerable ethnic group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Counseling sessionsIncludes changing eating behaviors, increasing physical activity, and attending regular in-person weight loss meetings for 12 weeks. To support additional weight loss/weight maintenance, participants will receive bi-weekly phone calls across a 12 week follow-up. |
| Wait List Control | Other | Behavioral: Wait List ControlWait-list control participants will not receive any intervention for the first 12 weeks. After 12 weeks, participants will receive the weight loss intervention plus mHealth technology support. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-64 years of age
- BMI between 25 to 45.0 kg/m² (NOTE: The investigators elected to cap this at 45.0 kg/m² to minimize potential risks and to reduce the potential for obesity to limit exercise participation)
- Ability to provide informed consent and health risk assessment prior to participation in this study
- Speak, read, and write either English and/or Spanish
Key exclusion criteria (11 listed)
- Uncontrolled diabetes mellitus
- History of bariatric surgery
- Report medical condition or treatment for a medical condition that could affect body weight or ability to engage in structured physical activity that is consistent with the intervention for this study
- Current congestive heart failure, angina, uncontrolled arrhythmia, or other symptoms indicative of an increased acute risk for a cardiovascular event
- Resting systolic blood pressure of ≥150 mmHg or resting diastolic blood pressure of ≥90 mmHg
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 |
|---|---|---|
| Counseling sessionsDuring the first 12 weeks, intervention participants will attend weekly 30-45-minute individual counseling sessions guided by a trained bilingual Hispanic male lifestyle coach. Counseling sessions will be tailored to the needs of the participants (e.g., evening/weekend sessions, waiting/childcare area). After 12 weeks, intervention group participants will receive bi-weekly phone calls across a 12-week follow-up. Phone calls will last approximately 10 minutes in duration and study staff will follow a script to review current body weight, eating and activity behaviors, and specific barriers for weight loss/maintenance or diet/physical activity behaviors. | Behavioural | Intervention |
| Wait List ControlAfter 12 weeks, the wait list control will receive the weight loss intervention plus mHealth technology support. It will include tailored, targeted text messaging and real-time self-monitoring support including beverage tracking cups, which provide the amount of calories users are consuming through beverages on a daily basis, and wearable activity monitors.Behavioral constructs used for the intervention group will be maintained during this intervention delivery thereby ensuring all participants have the appropriate tools to continue weight loss efforts regardless of mHealth use. | Behavioural | Wait List Control |
Primary outcome
Study Recruitment: Interest in Participation
Time frame: Baseline
The number of Hispanic men who contact the researchers and express interest in participation.
Study Recruitment: Screened for Eligibility
Time frame: Baseline
The number of Hispanic men screened for eligibility.
Study Recruitment: Eligibility
Time frame: Baseline
The number of Hispanic men eligible/ineligible for study inclusion and reason for ineligibility.
Study Recruitment: Enrollment
Time frame: Baseline
The number of Hispanic men enrolled in the study.
Retention
Time frame: Week 24
Retention will be measured as the number of participants who remain in the study at 24 weeks, divided by the number enrolled.
Treatment Satisfaction/Acceptability
Time frame: Week 24
Participants will be asked to rate their overall satisfaction with the intervention at 24 weeks and if they would recommend the program to others. Participants will also be asked questions regarding satisfaction with their overall progress and for changing dietary and PA habits, and weight
4 secondary outcomes
Change in body weight.
Time frame: 6, 12, 18, and 24 weeks
Change in physical activity
Time frame: 6, 12, 18, and 24 weeks
Change in dietary intake
Time frame: 12 and 24 weeks
Change in liver fat content (intervention only)
Time frame: 12 weeks
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 1 Nov 2017.
- Background: PubMed 24570244Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732.
- Background: PubMed 23533725Lindberg NM, Stevens VJ, Halperin RO. Weight-loss interventions for Hispanic populations: the role of culture. J Obes. 2013;2013:542736. doi: 10.1155/2013/542736. Epub 2013 Feb 26.
- Background: PubMed 24239920Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, Hu FB, Hubbard VS, Jakicic JM, Kushner RF, Loria CM, Millen BE, Nonas CA, Pi-Sunyer FX, Stevens J, Stevens VJ, Wadden TA, Wolfe BM, Yanovski SZ; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Obesity Society. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):2985-3023. doi: 10.1016/j.jacc.2013.11.004. Epub 2013 Nov 12. No abstract available.
- Background: PubMed 21633403Pagoto SL, Schneider KL, Oleski JL, Luciani JM, Bodenlos JS, Whited MC. Male inclusion in randomized controlled trials of lifestyle weight loss interventions. Obesity (Silver Spring). 2012 Jun;20(6):1234-9. doi: 10.1038/oby.2011.140. Epub 2011 Jun 2.
- Background: PubMed 26634854Garcia DO, Valdez LA, Hooker SP. Hispanic Male's Perspectives of Health Behaviors Related to Weight Management. Am J Mens Health. 2017 Sep;11(5):1547-1559. doi: 10.1177/1557988315619470. Epub 2015 Dec 3.
- Derived from this study: PubMed 36129735Garcia DO, Valdez LA, Aceves B, Bell ML, Rabe BA, Villavicencio EA, Marrero DG, Melton F, Hooker SP. mHealth-Supported Gender- and Culturally Sensitive Weight Loss Intervention for Hispanic Men With Overweight and Obesity: Single-Arm Pilot Study. JMIR Form Res. 2022 Sep 21;6(9):e37637. doi: 10.2196/37637.
- Derived from this study: PubMed 29696238Garcia DO, Valdez LA, Bell ML, Humphrey K, Hingle M, McEwen M, Hooker SP. A gender- and culturally-sensitive weight loss intervention for Hispanic males: The ANIMO randomized controlled trial pilot study protocol and recruitment methods. Contemp Clin Trials Commun. 2018 Feb 9;9:151-163. doi: 10.1016/j.conctc.2018.01.010. eCollection 2018 Mar.
- 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.
David O. Garcia, PhD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counseling sessions in people with Overweight and Obesity, run by University of Arizona 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 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 1 Nov 2017. 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?
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?
Study Recruitment: Interest in Participation (time frame: Baseline). The study lists 6 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 NCT02783521, 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 1 Nov 2017.