OverweightNCT01606813
The Impact of Integrating an Internet Weight Control Program Into Primary Care
A study testing Brief Physician Counseling and Brief follow up email notes from PCPs in people with Overweight and Obese, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The investigators will conduct a randomized controlled trial comparing the effects of three interventions on weight loss at 12 months. The investigators propose to test the impact of integrating an effective automated Internet weight control program into primary care by recruiting patients and randomizing them to one… Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obese
- What is being tested?
- Brief Physician Counseling and Brief follow up email notes from PCPs
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 611 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Nov 2016
- 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 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Physicians and Mid-level providers (Focus group and RCT):
- Has medical license to practice primary care
- Practice within 60 miles (focus group)/100 miles (RCT) of Penn State Hershey Medical Center
- Practice not located at Penn State Hershey Medical Center campus (focus group)
- Be active primary care providers (provide primary care at least 2 half days per week at one practice)
- Not have had completed a weight management fellowship
Show all 20Show fewer
- Use internet in their office
- Patients (Focus group only):
- Ages 21-60
- Body Mass Index between 25.0-50.0 kg/m2
- Have internet access at home or work
- Patient of a primary care provider who practices Internal Medicine or Family Community Medicine
- Has seen primary care provider in the last year, not including acute care
- Patients (RCT only)
- Ages 21-70
- Body Mass Index between 25.0-50.0 kg/m2
- Have internet access at home or work
- Patient of a PCP who is participating in the study
- Patient has been seeing the PCP for at least 12 months and has no other PCP
- The PCP must approve the patients' participation
Who cannot join
- Physicians and Mid-level providers (RCT only)
- Practice serves a specialty care population
- Pregnant or planning to become pregnant in the next 3 months
- Planning on changing practice locations in the next 12 months
- Planning on retiring in the next 12 months
- Patients (Focus group and RCT)
Show all 28Show fewer
- Losing >5% of current body weight in the previous 6 months
- Participating in a research project involving weight loss or physical activity in the previous 6 months
- Pregnancy during the previous 6 months, lactating, or planning to become pregnant in the next 3 months (focus group)/12 months (RCT)
- Planning on moving out of the area in the next 3 months (focus group)/12 months (RCT)
- Current treatment for a condition or with a medication that could impact weight (Orlistat - aka. Alli, Phentermine, Topiramate - aka. Topamax) and are not willing to stop for duration of the study
- Hospitalization for psychiatric problems during the prior year
- Patients (RCT only)
- Had weight loss surgery
- Planning on changing primary care provider in the next 12 months
- Participating in an online or community weight loss program (e.g., Weight Watchers) and not willing to stop for the duration of the study
- Doctor has diagnosed a heart condition and said should only do physical activity recommended by doctor
- Feel pain in chest when doing physical activity
- In the past month, have had chest pain when not doing physical activity
- In the end stages of renal, liver or kidney diseases
- Has heart failure
- Has/had cancer in past 5 years (except non-melanoma skin cancer)
- Cannot walk for exercise for 10 minutes
- Not willing to participate in 12-month intervention
- Taking insulin
- Treated for or diagnosed with an eating disorder
- Diagnosed with HIV
- Two weeks of steroid use in past year
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
The investigators will conduct a randomized controlled trial comparing the effects of three interventions on weight loss at 12 months. The investigators propose to test the impact of integrating an effective automated Internet weight control program into primary care by recruiting patients and randomizing them to one of three conditions: A) Brief physician counseling plus usual care, B) Brief physician counseling plus referral and access to the Internet weight control program and, C) Brief physician counseling plus referral and access to the Internet weight control program plus brief follow-up email notes of support and accountability from Primary Care Physicians. The investigators hypothesize that an online program for weight control can be more effective by enhancing online follow-up with PCPs.
Read the detailed description
Every year, roughly 700 of the 750 million visits that overweight and obese patients make with primary care providers (PCPs) occur without any weight counseling. The main reasons for this are that PCPs are poorly trained to help their patients lose weight and that there are no consistently effective interventions for primary care settings. Though in-person and telephone-based weight control programs have been difficult to disseminate in primary care, online weight control programs are increasingly effective and may lend themselves to be used in these settings. Given the growing number of effective online programs, for obesity and for other conditions seen in primary care (e.g., depression, insomnia) it is important to understand whether these programs can be effective when integrated into primary care and whether they are enhanced by provider involvement. Research on the 5 A's model of primary care behavior change suggests that the most effective, yet least used feature of primary care interventions is arranging follow-up, where providers hold patients accountable to adhering to treatments and achieving specific outcomes.
The 5 A's model provides a useful framework for integrating behavior change interventions into primary care. In this model, providers ASK about weight, ADVISE patients to lose weight, ASSESS readiness to change, ASSIST the patient in making changes and ARRANGE follow-up. Unfortunately, though PCPs are uniquely positioned to ARRANGE follow-up, given their long-term relationship with the patient, and studies show that ARRANGING follow-up may be the most effective of the 5 A's, it is the least often used. In a study of 481 encounters with overweight patients, Pollak (Consultant) and colleagues observed that PCPs ARRANGED follow-up in only 5% of visits, though it was the only one of the 5 A's associated with future weight loss. Kottke and colleagues similarly observed that primary care smoking cessation interventions that included more "reinforcing sessions" with PCPs were the most effective. This is consistent with conclusions by Whitlock and colleagues that "Simply notifying patients that follow-up will occur seems to be a powerful motivating factor". These findings have been extended to online interventions, where two meta-analyses concluded that the impact of online interventions for depression and anxiety is enhanced by follow-up that includes being accountable to and supported by a human being.
The investigators have created a simple method for integrating an Internet weight control program into primary care settings, by allowing PCPs to monitor their patients' adherence and outcomes and email them pre-written, tailored follow-up messages. PCPs in the investigators' pilot work believed that this would help to overcome key barriers to helping their patients lose weight.
- Conditions
- Overweight, Obese
- Being tested
- Usual Care, Brief Physician Counseling, Referral and access to an internet weight control program, Brief follow up email notes from PCPs
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareOther
Standard care
Brief Physician CounselingBehavioural
Primary Care Physician (PCP) will review a goal setting worksheet for weight loss with the participant and then collaboratively set a goal for weight loss.
Referral and access to an internet weight control programBehavioural
Participants will receive a login and password for the weight loss website. The website will encourage patients to set a new weight goal every 3 months and work towards a total weight loss goal of 10%. Patients will also receive an email prompt each week alerting them to new content and reminding them to check-in to the website to report their weight, intake and activity.
Brief follow up email notes from PCPsBehavioural
Patients will receive a biweekly email from their primary care physician on how they are doing with their weight loss.
| Study group | Role | What they receive |
|---|---|---|
| Brief physician counseling (BPC) + Usual care (UC) | Active comparator | The participant will receive standard care. They will receive BPC from their PCP on weight loss by reviewing a goal setting worksheet and collaboratively setting a goal for weight loss. Receives: Other: Usual Care; Behavioral: Brief Physician Counseling |
| BPC + Internet Weight Control Program (IWCP) | Experimental | The participant will receive BPC from their PCP by reviewing a goal setting worksheet and collaboratively setting a goal for weight loss. They will receive referral and access to an internet weight control program. Receives: Behavioral: Brief Physician Counseling; Behavioral: Referral and access to an internet weight control program |
| BPC + IWCP + Follow up email notes from PCP | Experimental | The participant will receive BPC form their PCP by reviewing a goal setting worksheet and collaboratively setting a goal for weight loss. They will receive referral and access to an internet weight control program. And they will receive brief follow up email notes from PCPs on how their weight loss is going (from data collected from the weight loss website). Receives: Behavioral: Brief Physician Counseling; Behavioral: Referral and access to an internet weight control program; Behavioral: Brief follow up email notes from PCPs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
Body weight and height will be measured by a research assistant using a portable, calibrated stadiometer (Tanita, Inc). Waist circumference will be measured using standard procedures, recorded to the nearest millimeter.
Measured: 12 months
Secondary outcomes (20)
Block Food Frequency Questionnaire
This questionnaire asks participants to estimate how often they consume a variety of specific foods.
Measured: 12 months
Paffenbarger Activity Questionnaire
This instrument has been used to estimate leisure time activity in many studies of weight loss (78, 112-113) and changes in energy expenditure using this measure correlate with changes in body weight over at least an 18 month period (114). A scoring algorithm allows the calculation of caloric expenditure overall as well as in activities of light, medium and high intensity.
Measured: 12 months
Patterns of medical care
After 12 months, data will be collected from medical charts using a standardized form to identify: 1) number of PCP visits, 2) use of any approved (e.g., Xenical) or off-label (e.g., Topiramate) weight loss medications after randomization, and 3) evaluations by a surgical weight control program.
Measured: 6 months
Use of the 5 A's during PCP Visits
After the index PCP visit and quarterly, subjects will complete a survey detailing the use the 5 A's (Ask, Advise, Assess, Assist and Arrange) during visits. Within 24-72 hours after the index visit, subjects will be called to complete the exit interview.
Measured: 12 months
Sociodemographics and tobacco use
Age, gender, race and ethnicity, smoking status, education and other demographics, will be measured based on standard self-report.
Measured: 12 months
Weight History Questionnaire
To measure past weight, past weight loss attempts and methods used to lose weight in the past, we will use the Weight History Questionnaire (WHQ) from the National Health and Nutrition Examination Survey (NHANES).
Measured: 12 months
Health Literacy
To measure health literacy, the Newest Vital Sign (NVS), a nutrition label that is accompanied by 6 questions that requires 3 minutes for administration will be used.
Measured: 12 months
Three-Factor Eating Questionnaire (TFEQ)
The TFEQ measures three dimensions of dietary restraint: cognitive restraint, disinhibition, perceived hunger.
Measured: 12 months
Depressive Symptoms
Depressive symptoms have been associated with body weight changes, so these symptoms will be measured with the 20-item Centers for Epidemiological Studies Depression Scale (CES-D). *If a patient scores a 25 or higher on the scale, research staff will notify their primary care physician; however, this does not make them ineligible for the study.
Measured: 12 months
Treatment Self-Regulation Scale (TSRQ)
The TSRQ will be used to measure autonomous (5 items) versus controlled (8 items) motivations, as well as total motivation (autonomous + controlled).
Measured: 12 months
Weight Control Self-Efficacy
Perceived competence in weight control will be measured using the Efficacy Life-Style Questionnaire (WEL). The WEL is a 20-item instrument consisting of five situational factors (Negative Emotions, Availability, Social Pressure, Physical Discomfort, and Positive Activities).
Measured: 12 months
Patient Satisfaction and Accountability
Patient satisfaction will be measured with the Patient Satisfaction Questionnaire 18 (PSQ18), which includes scales to measure technical quality, interpersonal manner, communication and time spent with the doctor with scale reliability between 0.79 and 0.93. Accountability will be measured with a 6-item measure developed by Mohr and colleagues (consultant), which measures the extent to which subjects believe that they are being monitored and the extent to which they are concerned about being judged by the monitor.
Measured: 12 months
Sedentary Behavior
This validated questionnaire asks participants about the duration of specific sedentary behaviors during a typical weekday and weekend day.
Measured: 12 months
Physical Activity Self Efficacy
This questionnaire asks about participants about their level of confidence in doing physical activity in certain situations.
Measured: 12 months
Eating Behavior Inventory
The Eating Behavior Inventory (EBI) is a validated questionnaire used by obesity researchers to measure the adoption of specific behaviors linked with weight-loss success.
Measured: 12 months
Internet Usage
This questionnaire asks participants about the frequency of their Internet use and the ways in which they use the Internet
Measured: 12 months
Analysis of text edits in PCP emails
We will analyze 100% of the personal notes added by PCPs to messages sent to patients in Condition C. Using a grounded theory approach, Dr. Hwang will analyze the content in the notes from PCPs and create a codebook and categories for these notes.
Measured: 12 months
Blood pressure
Blood pressure will be measured by a research assistant using an automatic blood pressure monitor (Omron) and standard procedures.
Measured: 12 months
Adherence (logins to website)
We will examine login data (overall and percentage of weeks logging in) as a mean and median, as well as a monthly percentage.
Measured: 12 months
Medication
Participants will be asked to bring their current prescription medications. The research coordinator will record the name and dose of each.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2012 (estimated)
- Study startOct 2012
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 611 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of North Carolina, Chapel Hill, The University of Texas Health Science Center, Houston
- Responsible party
- Principal investigator, Christopher Sciamanna, MD, MPH, Milton S. Hershey Medical Center
- Investigators
- Christopher Sciamanna, MD, MPH, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01606813
- Sponsor's protocol ID
- 39237EP
- Other IDs
- 1R01DK095078-01
- Status last verified
- Dec 2016
- First submitted
- 24 May 2012
- Last updated
- 8 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Integrating an Internet Weight Control Program Into Primary Care
- ClinicalTrials.gov ID
- NCT01606813
- Acronym / sponsor ID
- 39237EP
- Conditions
- Overweight, Obese
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 611 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of North Carolina, Chapel Hill, The University of Texas Health Science Center, Houston
- Study start
- Oct 2012
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 28 May 2012 (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 will conduct a randomized controlled trial comparing the effects of three interventions on weight loss at 12 months. The investigators propose to test the impact of integrating an effective automated Internet weight control program into primary care by recruiting patients and randomizing them to one of three conditions: A) Brief physician counseling plus usual care, B) Brief physician counseling plus referral and access to the Internet weight control program and, C) Brief physician counseling plus referral and access to the Internet weight control program plus brief follow-up email notes of support and accountability from Primary Care Physicians. The investigators hypothesize that an online program for weight control can be more effective by enhancing online follow-up with PCPs.
Detailed description
Every year, roughly 700 of the 750 million visits that overweight and obese patients make with primary care providers (PCPs) occur without any weight counseling. The main reasons for this are that PCPs are poorly trained to help their patients lose weight and that there are no consistently effective interventions for primary care settings. Though in-person and telephone-based weight control programs have been difficult to disseminate in primary care, online weight control programs are increasingly effective and may lend themselves to be used in these settings. Given the growing number of effective online programs, for obesity and for other conditions seen in primary care (e.g., depression, insomnia) it is important to understand whether these programs can be effective when integrated into primary care and whether they are enhanced by provider involvement. Research on the 5 A's model of primary care behavior change suggests that the most effective, yet least used feature of primary care interventions is arranging follow-up, where providers hold patients accountable to adhering to treatments and achieving specific outcomes.
The 5 A's model provides a useful framework for integrating behavior change interventions into primary care. In this model, providers ASK about weight, ADVISE patients to lose weight, ASSESS readiness to change, ASSIST the patient in making changes and ARRANGE follow-up. Unfortunately, though PCPs are uniquely positioned to ARRANGE follow-up, given their long-term relationship with the patient, and studies show that ARRANGING follow-up may be the most effective of the 5 A's, it is the least often used. In a study of 481 encounters with overweight patients, Pollak (Consultant) and colleagues observed that PCPs ARRANGED follow-up in only 5% of visits, though it was the only one of the 5 A's associated with future weight loss. Kottke and colleagues similarly observed that primary care smoking cessation interventions that included more "reinforcing sessions" with PCPs were the most effective. This is consistent with conclusions by Whitlock and colleagues that "Simply notifying patients that follow-up will occur seems to be a powerful motivating factor". These findings have been extended to online interventions, where two meta-analyses concluded that the impact of online interventions for depression and anxiety is enhanced by follow-up that includes being accountable to and supported by a human being.
The investigators have created a simple method for integrating an Internet weight control program into primary care settings, by allowing PCPs to monitor their patients' adherence and outcomes and email them pre-written, tailored follow-up messages. PCPs in the investigators' pilot work believed that this would help to overcome key barriers to helping their patients lose weight.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brief physician counseling (BPC) + Usual care (UC) | Active comparator | Other: Usual Care, Behavioral: Brief Physician CounselingThe participant will receive standard care. They will receive BPC from their PCP on weight loss by reviewing a goal setting worksheet and collaboratively setting a goal for weight loss. |
| BPC + Internet Weight Control Program (IWCP) | Experimental | Behavioral: Brief Physician Counseling, Behavioral: Referral and access to an internet weight control programThe participant will receive BPC from their PCP by reviewing a goal setting worksheet and collaboratively setting a goal for weight loss. They will receive referral and access to an internet weight control program. |
| BPC + IWCP + Follow up email notes from PCP | Experimental | Behavioral: Brief Physician Counseling, Behavioral: Referral and access to an internet weight control program, Behavioral: Brief follow up email notes from PCPsThe participant will receive BPC form their PCP by reviewing a goal setting worksheet and collaboratively setting a goal for weight loss. They will receive referral and access to an internet weight control program. And they will receive brief follow up email notes from PCPs on how their weight loss is going (from data collected from the weight loss website). |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Has medical license to practice primary care
- Practice within 60 miles (focus group)/100 miles (RCT) of Penn State Hershey Medical Center
- Practice not located at Penn State Hershey Medical Center campus (focus group)
- Be active primary care providers (provide primary care at least 2 half days per week at one practice)
- Not have had completed a weight management fellowship
Key exclusion criteria (28 listed)
- Physicians and Mid-level providers (RCT only)
- Practice serves a specialty care population
- Pregnant or planning to become pregnant in the next 3 months
- Planning on changing practice locations in the next 12 months
- Planning on retiring in the next 12 months
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 |
|---|---|---|
| Usual CareStandard care | Other | Brief physician counseling (BPC) + Usual care (UC) |
| Brief Physician CounselingPrimary Care Physician (PCP) will review a goal setting worksheet for weight loss with the participant and then collaboratively set a goal for weight loss. | Behavioural | BPC + IWCP + Follow up email notes from PCP, BPC + Internet Weight Control Program (IWCP), Brief physician counseling (BPC) + Usual care (UC) |
| Referral and access to an internet weight control programParticipants will receive a login and password for the weight loss website. The website will encourage patients to set a new weight goal every 3 months and work towards a total weight loss goal of 10%. Patients will also receive an email prompt each week alerting them to new content and reminding them to check-in to the website to report their weight, intake and activity. | Behavioural | BPC + IWCP + Follow up email notes from PCP, BPC + Internet Weight Control Program (IWCP) |
| Brief follow up email notes from PCPsPatients will receive a biweekly email from their primary care physician on how they are doing with their weight loss. | Behavioural | BPC + IWCP + Follow up email notes from PCP |
Primary outcome
Body Weight
Time frame: 12 months
Body weight and height will be measured by a research assistant using a portable, calibrated stadiometer (Tanita, Inc). Waist circumference will be measured using standard procedures, recorded to the nearest millimeter.
20 secondary outcomes
Block Food Frequency Questionnaire
Time frame: 12 months
Paffenbarger Activity Questionnaire
Time frame: 12 months
Patterns of medical care
Time frame: 6 months
Use of the 5 A's during PCP Visits
Time frame: 12 months
Sociodemographics and tobacco use
Time frame: 12 months
Weight History Questionnaire
Time frame: 12 months
Health Literacy
Time frame: 12 months
Three-Factor Eating Questionnaire (TFEQ)
Time frame: 12 months
Depressive Symptoms
Time frame: 12 months
Treatment Self-Regulation Scale (TSRQ)
Time frame: 12 months
Weight Control Self-Efficacy
Time frame: 12 months
Patient Satisfaction and Accountability
Time frame: 12 months
Sedentary Behavior
Time frame: 12 months
Physical Activity Self Efficacy
Time frame: 12 months
Eating Behavior Inventory
Time frame: 12 months
Internet Usage
Time frame: 12 months
Analysis of text edits in PCP emails
Time frame: 12 months
Blood pressure
Time frame: 12 months
Adherence (logins to website)
Time frame: 12 months
Medication
Time frame: 12 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 8 Dec 2016.
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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.
Christopher Sciamanna, MD, MPH principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Physician Counseling and Brief follow up email notes from PCPs in people with Overweight and Obese, run by Milton S. Hershey Medical Center 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 20 inclusion and 28 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 8 Dec 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?
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?
Body Weight (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2016.