OverweightNCT02124460
Connect 4 Health: An Intervention to Improve Childhood Obesity Outcomes
A study testing Health Coaching in people with Overweight and Obesity, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Health care system (HCS)-based interventions have been limited by their inattention to social and environmental barriers that impede improvement in obesity-related behaviors. Additionally, current pediatric obesity care delivery relies on an outdated provider:patient paradigm which is ill-suited for a problem as… Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Health Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 721 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Nov 2016
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- child is age 2.0 through 12.9 years at baseline primary care visit,
- child's BMI is equal to or exceeds the 85th percentile for age and sex at baseline primary care visit,
- at least 1 parent has an active email address,
- at least one parent is comfortable reading and speaking in English.
Who cannot join
- children who do not have at least one parent/legal guardian who is able to follow study procedures for 1 year,
- families who plan to leave HVMA within the study time frame,
- families for whom the primary care clinician thinks the intervention is inappropriate, e.g., emotional or cognitive difficulties,
- children who have a sibling already enrolled in the study,
- children with chronic conditions that substantially interfere with growth or physical activity participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Harvard Vanguard Medical Associates
Boston, Massachusetts, 02215
About this study
Official title: Improving Childhood Obesity Outcomes: Testing Best Practices of Positive Outliers
Health care system (HCS)-based interventions have been limited by their inattention to social and environmental barriers that impede improvement in obesity-related behaviors. Additionally, current pediatric obesity care delivery relies on an outdated provider:patient paradigm which is ill-suited for a problem as prevalent as obesity. HCSs often lack the organizational structure to provide longitudinal care for children with chronic illnesses, the clinicians to manage and support patients with chronic illnesses outside of clinic, and/or the health information systems that support the use of evidence-based practices at the point-of-care. Thus, the research question this study is designed to address is whether a novel approach to care delivery that leverages delivery system and community resources and addresses socio-contextual factors will improve family-centered childhood obesity outcomes.
The primary specific aims are to examine the extent to which the intervention, compared to the control condition, results in:
Read more
- A smaller age-associated increase in BMI over a 12-month period.
- Improved parental and child ratings of pediatric health-related quality of life.
The secondary aims are:
- To examine parental ratings of quality and family-centeredness of pediatric obesity care and compare outcomes among participants in the intervention with the control condition
- To assess change in weight-related behaviors and compare outcomes among participants in the intervention with the control condition
- To assess the following process measures:
- Reach
- Extent of implementation
- Fidelity to protocol
- Parent satisfaction
- To examine the extent to which neighborhood environments modify observed intervention effects
- To assess the documentation of Healthcare Effectiveness Data and Information Set (HEDIS) measures in participant medical records
- Conditions
- Overweight, Obesity
- Being tested
- Health Coaching
- Keywords
- Pediatric, Obesity, Overweight, Intervention
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health CoachingBehavioural
Parent/child duos enrolled in the intervention group will participate in a total of six visits with a trained health coach. During these visits, the health coach will coach the parent/child duos on improving obesity-related behaviors .
The health coach will also help the family identify supports to assist with behavior change; discuss family health habits and the home environment; and review and encourage use of materials related to both specific target behaviors and available resources in the community.
Following the first call with the health coach, parents will receive semi-weekly text messages designed by the study team. The messages will alternate in structure between 2 types of messages; 1) skills training messages will deliver tips and motivational messages to help their child practice the study's goals and 2) self monitoring messages will ask parents to respond to the message and track health behaviors important to this study.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Primary Care | No intervention | We will provide current "best practice" to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages. |
| Health Coaching | Experimental | The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program. Receives: Behavioral: Health Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BMI z Score
Height and weight will be measured by the medical assistants at each site using standard protocols. BMI measures will be obtained from the electronic health record (EHR) as provided through usual care. BMI measures will be converted to z-scores using CDC age and sex-specific normative data for children between 2 and 20 years old. This will allow the research team to combine data across children of different ages.
Measured: baseline and one year
Change in Quality of Life
The PedsQL is an extensively validated, widely used, 23-item measure of health-related quality of life in children with chronic conditions such as obesity. Parents will be asked to complete 4 subscales: physical health, school, social, and emotional functioning which exists for parental report of children as young as 2 years of age. Items are reverse-scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0), so that higher scores indicate better HRQOL. Scale Scores are computed as the sum of the items divided by the number of items answered (this accounts for missing data). If more than 50% of the items in the scale are missing, the Scale Score is not computed.
Measured: baseline and one year
Change in Parent Resource Empowerment
The five items in the scale assessed parents' perceived knowledge of resources, ability to access resources, comfort with accessing resources, knowledge of how to find resources, and ability to acquire resources related to child weight management. For each question, parents responded strongly disagree, disagree, agree, or strongly agree, which were worth 1 to 4 points, respectively. Items were averaged to create a summary parental resource empowerment score (range= 1-4), where a higher score indicated greater perceived knowledge and ability to access resources related to weight management. Cronbach's α for this score was 0.87.
Measured: Baseline to one-year follow-up
Secondary outcomes (5)
Change in Screen Time
Average hours/day spent watching television, videos, or playing games displayed on media such as television, desktop computers, laptops, portable DVD players, iPads or smartphones.
Measured: baseline and one year
Change in Sleep
Average hours/day spent sleeping
Measured: baseline and 1 year
Change in Physical Activity
In the past week, how many days the child was physically active for a total of at least 60 minutes per day.
Measured: baseline and 1 year
Change in Fruit and Vegetable Consumption
Number of times the child consumed of vegetables and fruits yesterday
Measured: baseline and 1 year
Change in Consumption of Sugar-sweetened Beverages and Juice
Number of time child consumed juice (e.g., orange juice, apple juice, or grape juice), fruit-flavored drinks (e.g., Kool-Aid, sports drinks, Goya juice, etc.), regular soda, soft drinks, or Malta yesterday.
Measured: baseline and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2016
- Study completionNov 2016
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 (8)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- 721 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard Vanguard Medical Associates, Brigham and Women's Hospital
- Responsible party
- Principal investigator, Elsie Taveras, MD, Massachusetts General Hospital
- Investigators
- Elsie M Taveras, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02124460
- Sponsor's protocol ID
- IH-1304-6739
- Status last verified
- Feb 2017
- First submitted
- 14 Apr 2014
- Last updated
- 10 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Simione M, Ferreira P, Luo M, Hoover C, Perkins M, Fiechtner L, Taveras EM. Psychometrics of the modified family-centered care assessment short version for childhood obesity. Health Qual Life Outcomes. 2024 Sep 2;22(1):71. doi: 10.1186/s12955-024-02284-5.
PubMed 39218948Simione M, Ferreira P, Luo M, Hoover C, Perkins M, Fiechtner L, Taveras EM. Psychometrics of the modified Family-Centered Care Assessment short version for childhood obesity. Res Sq [Preprint]. 2024 May 15:rs.3.rs-4365570. doi: 10.21203/rs.3.rs-4365570/v1.
PubMed 38798356Simione M, Sharifi M, Gerber MW, Marshall R, Avalon E, Fiechtner L, Horan C, Orav EJ, Skelton J, Taveras EM. Family-centeredness of childhood obesity interventions: psychometrics & outcomes of the family-centered care assessment tool. Health Qual Life Outcomes. 2020 Jun 11;18(1):179. doi: 10.1186/s12955-020-01431-y.
PubMed 32527270Baskind MJ, Taveras EM, Gerber MW, Fiechtner L, Horan C, Sharifi M. Parent-Perceived Stress and Its Association With Children's Weight and Obesity-Related Behaviors. Prev Chronic Dis. 2019 Mar 28;16:E39. doi: 10.5888/pcd16.180368.
PubMed 30925139Bala N, Price SN, Horan CM, Gerber MW, Taveras EM. Use of Telehealth to Enhance Care in a Family-Centered Childhood Obesity Intervention. Clin Pediatr (Phila). 2019 Jun;58(7):789-797. doi: 10.1177/0009922819837371. Epub 2019 Mar 20.
PubMed 30894004Fiechtner L, Puente GC, Sharifi M, Block JP, Price S, Marshall R, Blossom J, Gerber MW, Taveras EM. A Community Resource Map to Support Clinical-Community Linkages in a Randomized Controlled Trial of Childhood Obesity, Eastern Massachusetts, 2014-2016. Prev Chronic Dis. 2017 Jul 6;14:E53. doi: 10.5888/pcd14.160577.
PubMed 28682745Taveras EM, Marshall R, Sharifi M, Avalon E, Fiechtner L, Horan C, Gerber MW, Orav EJ, Price SN, Sequist T, Slater D. Comparative Effectiveness of Clinical-Community Childhood Obesity Interventions: A Randomized Clinical Trial. JAMA Pediatr. 2017 Aug 7;171(8):e171325. doi: 10.1001/jamapediatrics.2017.1325. Epub 2017 Aug 7.
PubMed 28586856Taveras EM, Marshall R, Sharifi M, Avalon E, Fiechtner L, Horan C, Orav J, Price SN, Sequist T, Slater D. Connect for Health: Design of a clinical-community childhood obesity intervention testing best practices of positive outliers. Contemp Clin Trials. 2015 Nov;45(Pt B):287-295. doi: 10.1016/j.cct.2015.09.022. Epub 2015 Sep 30.
PubMed 26427562
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Childhood Obesity Outcomes: Testing Best Practices of Positive Outliers
- ClinicalTrials.gov ID
- NCT02124460
- Acronym / sponsor ID
- IH-1304-6739
- Conditions
- Overweight, Obesity
- Keywords
- Pediatric, Obesity, Overweight, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 721 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Harvard Vanguard Medical Associates, Brigham and Women's Hospital
- Study start
- Jun 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 28 Apr 2014 (estimated)
- Results
- Posted 10 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Health care system (HCS)-based interventions have been limited by their inattention to social and environmental barriers that impede improvement in obesity-related behaviors. Additionally, current pediatric obesity care delivery relies on an outdated provider:patient paradigm which is ill-suited for a problem as prevalent as obesity. HCSs often lack the organizational structure to provide longitudinal care for children with chronic illnesses, the clinicians to manage and support patients with chronic illnesses outside of clinic, and/or the health information systems that support the use of evidence-based practices at the point-of-care. Thus, the research question this study is designed to address is whether a novel approach to care delivery that leverages delivery system and community resources and addresses socio-contextual factors will improve family-centered childhood obesity outcomes.
The primary specific aims are to examine the extent to which the intervention, compared to the control condition, results in:
- A smaller age-associated increase in BMI over a 12-month period.
- Improved parental and child ratings of pediatric health-related quality of life.
The secondary aims are:
- To examine parental ratings of quality and family-centeredness of pediatric obesity care and compare outcomes among participants in the intervention with the control condition
- To assess change in weight-related behaviors and compare outcomes among participants in the intervention with the control condition
- To assess the following process measures:
- Reach
- Extent of implementation
- Fidelity to protocol
- Parent satisfaction
- To examine the extent to which neighborhood environments modify observed intervention effects
- To assess the documentation of Healthcare Effectiveness Data and Information Set (HEDIS) measures in participant medical records
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Primary Care | No intervention | –We will provide current "best practice" to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages. |
| Health Coaching | Experimental | Behavioral: Health CoachingThe intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- child is age 2.0 through 12.9 years at baseline primary care visit,
- child's BMI is equal to or exceeds the 85th percentile for age and sex at baseline primary care visit,
- at least 1 parent has an active email address,
- at least one parent is comfortable reading and speaking in English.
Key exclusion criteria (5 listed)
- children who do not have at least one parent/legal guardian who is able to follow study procedures for 1 year,
- families who plan to leave HVMA within the study time frame,
- families for whom the primary care clinician thinks the intervention is inappropriate, e.g., emotional or cognitive difficulties,
- children who have a sibling already enrolled in the study,
- children with chronic conditions that substantially interfere with growth or physical activity participation.
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 |
|---|---|---|
| Health CoachingParent/child duos enrolled in the intervention group will participate in a total of six visits with a trained health coach. During these visits, the health coach will coach the parent/child duos on improving obesity-related behaviors . The health coach will also help the family identify supports to assist with behavior change; discuss family health habits and the home environment; and review and encourage use of materials related to both specific target behaviors and available resources in the community. Following the first call with the health coach, parents will receive semi-weekly text messages designed by the study team. The messages will alternate in structure between 2 types of messages; 1) skills training messages will deliver tips and motivational messages to help their child practice the study's goals and 2) self monitoring messages will ask parents to respond to the message and track health behaviors important to this study. | Behavioural | Health Coaching |
Primary outcome
Change in BMI z Score
Time frame: baseline and one year
Height and weight will be measured by the medical assistants at each site using standard protocols. BMI measures will be obtained from the electronic health record (EHR) as provided through usual care. BMI measures will be converted to z-scores using CDC age and sex-specific normative data for children between 2 and 20 years old. This will allow the research team to combine data across children of different ages.
Change in Quality of Life
Time frame: baseline and one year
The PedsQL is an extensively validated, widely used, 23-item measure of health-related quality of life in children with chronic conditions such as obesity. Parents will be asked to complete 4 subscales: physical health, school, social, and emotional functioning which exists for parental report of children as young as 2 years of age. Items are reverse-scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0), so that higher scores indicate better HRQOL. Scale Scores are computed as the sum of the items divided by the number of items answered (this accounts for missing data). If more than 50% of the items in the scale are missing, the Scale Score is not computed.
Change in Parent Resource Empowerment
Time frame: Baseline to one-year follow-up
The five items in the scale assessed parents' perceived knowledge of resources, ability to access resources, comfort with accessing resources, knowledge of how to find resources, and ability to acquire resources related to child weight management. For each question, parents responded strongly disagree, disagree, agree, or strongly agree, which were worth 1 to 4 points, respectively. Items were averaged to create a summary parental resource empowerment score (range= 1-4), where a higher score indicated greater perceived knowledge and ability to access resources related to weight management. Cronbach's α for this score was 0.87.
5 secondary outcomes
Change in Screen Time
Time frame: baseline and one year
Change in Sleep
Time frame: baseline and 1 year
Change in Physical Activity
Time frame: baseline and 1 year
Change in Fruit and Vegetable Consumption
Time frame: baseline and 1 year
Change in Consumption of Sugar-sweetened Beverages and Juice
Time frame: baseline and 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39218948Simione M, Ferreira P, Luo M, Hoover C, Perkins M, Fiechtner L, Taveras EM. Psychometrics of the modified family-centered care assessment short version for childhood obesity. Health Qual Life Outcomes. 2024 Sep 2;22(1):71. doi: 10.1186/s12955-024-02284-5.
- Derived from this study: PubMed 38798356Simione M, Ferreira P, Luo M, Hoover C, Perkins M, Fiechtner L, Taveras EM. Psychometrics of the modified Family-Centered Care Assessment short version for childhood obesity. Res Sq [Preprint]. 2024 May 15:rs.3.rs-4365570. doi: 10.21203/rs.3.rs-4365570/v1.
- Derived from this study: PubMed 32527270Simione M, Sharifi M, Gerber MW, Marshall R, Avalon E, Fiechtner L, Horan C, Orav EJ, Skelton J, Taveras EM. Family-centeredness of childhood obesity interventions: psychometrics & outcomes of the family-centered care assessment tool. Health Qual Life Outcomes. 2020 Jun 11;18(1):179. doi: 10.1186/s12955-020-01431-y.
- Derived from this study: PubMed 30925139Baskind MJ, Taveras EM, Gerber MW, Fiechtner L, Horan C, Sharifi M. Parent-Perceived Stress and Its Association With Children's Weight and Obesity-Related Behaviors. Prev Chronic Dis. 2019 Mar 28;16:E39. doi: 10.5888/pcd16.180368.
- Derived from this study: PubMed 30894004Bala N, Price SN, Horan CM, Gerber MW, Taveras EM. Use of Telehealth to Enhance Care in a Family-Centered Childhood Obesity Intervention. Clin Pediatr (Phila). 2019 Jun;58(7):789-797. doi: 10.1177/0009922819837371. Epub 2019 Mar 20.
- Derived from this study: PubMed 28682745Fiechtner L, Puente GC, Sharifi M, Block JP, Price S, Marshall R, Blossom J, Gerber MW, Taveras EM. A Community Resource Map to Support Clinical-Community Linkages in a Randomized Controlled Trial of Childhood Obesity, Eastern Massachusetts, 2014-2016. Prev Chronic Dis. 2017 Jul 6;14:E53. doi: 10.5888/pcd14.160577.
- Derived from this study: PubMed 28586856Taveras EM, Marshall R, Sharifi M, Avalon E, Fiechtner L, Horan C, Gerber MW, Orav EJ, Price SN, Sequist T, Slater D. Comparative Effectiveness of Clinical-Community Childhood Obesity Interventions: A Randomized Clinical Trial. JAMA Pediatr. 2017 Aug 7;171(8):e171325. doi: 10.1001/jamapediatrics.2017.1325. Epub 2017 Aug 7.
- Derived from this study: PubMed 26427562Taveras EM, Marshall R, Sharifi M, Avalon E, Fiechtner L, Horan C, Orav J, Price SN, Sequist T, Slater D. Connect for Health: Design of a clinical-community childhood obesity intervention testing best practices of positive outliers. Contemp Clin Trials. 2015 Nov;45(Pt B):287-295. doi: 10.1016/j.cct.2015.09.022. Epub 2015 Sep 30.
Related trials for Overweight
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Elsie M Taveras, MD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Coaching in people with Overweight and Obesity, run by Massachusetts General Hospital 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 5 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 10 Apr 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?
Yes. Results are posted in the registry (first posted 10 Apr 2017). 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 in BMI z Score (time frame: baseline and one year). 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 NCT02124460, which also lists 8 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 10 Apr 2017.