Health BehaviorDNAbleNCT03583983
The DNA-Based Lifestyle Enhancement Trial
A study testing Personalized Health Recommendations and Generic Health Recommendations in people with Health Behavior and Genetic Information, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
Despite the known cardiovascular benefits of regular physical activity and having a balanced diet, it has proven challenging to change health behaviours towards favourable lifestyles. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Genetic Information, Cardiovascular Risk Factor
- What is being tested?
- Personalized Health Recommendations and Generic Health Recommendations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 424 participants
- Where
- 1 siteCanada
- Study dates
- 7 Mar 2018to 3 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hamilton Health Science employees living in Southern Ontario who are capable and willing to follow an exercise and diet program for 3 months as well as fitness and blood assessments
Who cannot join
- Insulin-dependent diabetes
- History of cardiovascular disease (stroke, heart attack, coronary artery bypass graft (CABG) surgery, coronary angioplasty, peripheral artery disease)
- Injury or condition impeding ability to engage in physical activity (e.g. osteoarthritis, COPD)
- Pregnant or breast-feeding or planning to be pregnant
- Anyone on medication that interacts with foods
- Anyone planning to be on vacation for > 2 weeks in the next 3 months.
- Dietary restrictions (e.g. vegetarianism, gluten sensitivity, etc.)
- History of bone marrow transplant
Trial locations and contacts
1 site in 1 country.
Canada1 site
Hamilton Health Sciences (Juravinski Hospital, General Hospital, MUMC)
Hamilton, Ontario, L8L2X2
About this study
Official title: Evaluating the Impact of Personalized Recommendations on Healthy Behaviours and Cardio-metabolic Risk
Despite the known cardiovascular benefits of regular physical activity and having a balanced diet, it has proven challenging to change health behaviours towards favourable lifestyles. The overarching aim of the study is to test the effect of providing personalized genetic information along with diet and exercise plans on adherence to healthy lifestyle habits and cardio-metabolic risk. There is tremendous public interest in genetics and some evidence that providing genetic information can help improve health habits. However, no intervention to date has examined the effect of comprehensive genetic testing using cutting-edge polygenic score (PGS) prediction and an interactive health portal on health behaviours and cardio-metabolic risk. The investigators hypothesize that providing participants with detailed genetic information about genetic determinants of fitness and nutrition traits will help motivate people to adopt healthy lifestyle habits. The primary objective is to test the effect of providing genetic information and interactive recommendations for diet and exercise on adoption of healthy behaviours. The secondary objective is to evaluate the effects of the personalized health recommendations on cardio-metabolic risk markers, such as dyslipidemia, inflammatory markers, and fasting glucose.
Read the detailed description
Cardiovascular disease (CVD) is a leading cause of death and disability worldwide, accounting for 17.9 million deaths and the loss of 348 million disability-adjusted life years in 2015 alone. Diabetes and obesity are very strong risk factors for CVD. Individuals with diabetes and obesity have an 82.75% life-time risk for developing CVD. While treatments do exist for both obesity (e.g. bariatric surgery) and diabetes (e.g. pharmaceutical control of blood sugar levels), these only partially attenuate risk of adverse health outcomes and they do not address prevention and upstream causes of cardiovascular diseases, namely sedentary lifestyle and unhealthy diet. Despite the known cardiovascular benefits of regular physical activity and having a balanced diet, it has proven challenging to change health behaviours towards favourable lifestyles. Indeed, the prevalence of obesity is increasing in Canada as less than 80% of adults follow the current recommendation of 150 minutes of moderate-to-vigorous physical activity per week and approximately less than 60% of adults consume fruits and vegetables 5 or more times a day. The overarching aim of the study is to test the effect of providing personalized genetic information along with diet and exercise plans on adherence to healthy lifestyle habits and cardio-metabolic risk. There is tremendous public interest in genetics and some evidence that providing genetic information can help improve health habits. However, no intervention to date has examined the effect of comprehensive genetic testing using cutting-edge polygenic score (PGS) prediction and an interactive health portal on health behaviours and cardio-metabolic risk.
The investigators hypothesize that providing participants with detailed genetic information about genetic determinants of fitness and nutrition traits will help to motivate people to adopt healthy lifestyle habits. The primary objective is to test the effect of providing genetic information and interactive recommendations for diet and exercise on adoption of healthy behaviours. The secondary objective is to evaluate the effects of the personalized health recommendations on cardio-metabolic risk markers, such as dyslipidemia, inflammatory markers, and fasting glucose.
The investigators propose to conduct a randomized controlled trial investigating whether personalized lifestyle recommendations including genetic information motivates Hamilton Health Sciences employees to adopt healthy lifestyle changes. Study participation will be open to Hamilton Health Sciences employees. Recruitment will begin in March 2017. Eligible and consenting individuals will be enrolled. Enrollment will occur in a staggered fashion. The intervention group will receive (1) a free 3-month GoodLife Fitness gym membership providing access to any Ontario GoodLife Fitness facility, (2) professional trainer-approved workout plans, (3) dietitian-approved meal plans, and (4) genetic information pertaining to their health and fitness. The control group will also receive a GoodLife Fitness membership to ensure that all study participants are granted similar ease-of-access to perform physical activities and generic health recommendations (Canadian Food Guide / Health Canada Physical Activity Recommendations) but will not receive the personalized component of the intervention (workout plans, meal plans or genetic information) until the end of their trial period. Participants will be randomized to treatment or control groups using a minimization scheme for adaptive randomization, which will serve to balance age, gender, and ethnicity across groups as participants are enrolled. Thus, randomization will be performed in a single-blind fashion wherein the study team is unaware of whom is receiving the intervention or control. All study participants will be monitored over the course of 3 months beginning with their baseline assessment and ending with their 3-month follow-up assessment. At these two timepoints, study participants will be assessed for behavioural (physical activity levels and diet healthiness), fitness markers (blood pressure, resting heart rate, body fat %, and other anthropometric measurements) and biological markers (lipids, insulin sensitivity, and inflammation) of cardio-metabolic disease.
- Being tested
- Personalized Health Recommendations, Generic Health Recommendations
- Keywords
- Physical Activity, Dietary Habits, Genetic Scores, Cardiovascular Health
- Medical subject headings
- Health Behavior, Motor Activity, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Health RecommendationsBehavioural
Includes 3-month gym membership, personalized exercise and meal plans, and genetic information related to health and wellness traits. The genetic information provided to study participants will consist of scores ranging from 0 to 100 based on the population percentile of the combined effects of many genetic variants, herein referred to as polygenic scores (PGS). PGS for approximately twenty traits related to health, fitness and nutrition will be provided to study participants. These traits are chosen for their relevance to healthy lifestyle habits (e.g. genetic predisposition to adiposity or muscle strength), entertainment value (e.g. preference for mornings) or both (e.g. bitterness taste perception, which while entertaining can also help guide vegetable choices).
Generic Health RecommendationsBehavioural
Includes 3-month gym membership and generic recommendations (Canada Food Guide / Health Canada Physical Activity guidelines)
| Study group | Role | What they receive |
|---|---|---|
| Personalized Health Recommendations | Other | Not described Receives: Behavioral: Personalized Health Recommendations |
| No Health Recommendations | Other | Not described Receives: Behavioral: Generic Health Recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physical Activity Levels (Strength Training)
Physical activity levels (strength training) will be defined by frequency of strength training per week. Strength training is one of the domains of physical activity recognized by the Canadian Physical Activity Guidelines, which recommend at least two sessions of strength training per week. Accordingly, physical activity levels will be ascertained through the following survey question: "In the last 3 months, how many times per week did you perform strength training?" The minimum value for this outcome would be 0 and there is no theoretical maximum though we expect most values to be below 7 since 7 would represent strength training on a daily basis. Higher values indicate higher levels of physical activity and vice versa.
Measured: Baseline and 3 months follow-up
Change in Physical Activity Levels (Aerobic Exercise)
Physical activity levels (aerobic exercise) will be defined by frequency of aerobic exercise per week. Aerobic exercise is one of the domains of physical activity recognized by the Canadian Physical Activity Guidelines, which recommend at least 150 minutes of moderate to vigorous physical activity per week. Accordingly, physical activity levels will be ascertained through the following survey question: "In the last 3 months, how many times per week did you perform aerobic exercises training?" The minimum value for this outcome would be 0 and there is no theoretical maximum though we expect most values to be below 7 since 7 would represent aerobic exercise on a daily basis. Higher values indicate higher levels of physical activity and vice versa.
Measured: Baseline and 3 months follow-up
Change in Dietary Healthiness
Dietary healthiness will be ascertained using the dietary risk score developed by the INTERHEART study which was found to explain 30% of the population attributable risk for acute myocardial infarction. Briefly, the dietary risk score takes into account consumption of meat, salty snacks, fried foods, fruits and vegetables. The point score ranges from 0 to 6 with higher scores indicating a less healthy diet.
Measured: Baseline and 3 months follow-up
Secondary outcomes (9)
Change in Triglycerides
Serum Triglyceride Levels (mmol/L)
Measured: Baseline and 3 months follow-up
Change in C-Reactive Protein
High Sensitivity Serum C-reactive protein Levels (mg/L)
Measured: Baseline and 3 months follow-up
Change in Fasting Glucose
Serum Fasting Glucose Levels (mmol/L)
Measured: Baseline and 3 months follow-up
Change in Blood Pressure
Blood Pressure (mmHg). Both systolic and diastolic blood pressures will be assessed.
Measured: Baseline and 3 months follow-up
Change in Resting Heart Rate
Resting Heart Rate (Beats / min)
Measured: Baseline and 3 months follow-up
Change in Body Fat %
Body Fat (%)
Measured: Baseline and 3 months follow-up
Change in Circumference of Body Parts
Circumference of thigh, calf, bicep, and shoulder span (millimeters)
Measured: Baseline and 3 months follow-up
Change in Body Mass Index
Body Mass Index - derived from height and weight (weight in kg / height in m ^2)
Measured: Baseline and 3 months follow-up
Change in Cardio-metabolic Risk Score
Cardio-metabolic risk estimated by the validated INTERHEART modified risk score. This score was developed by INTERHEART investigators and developed in the following paper: https://academic.oup.com/eurheartj/article/32/5/581/426790. The score consolidates multiple established risk factors for heart disease in addition to physical activity and diet, including psychosocial stress, lipids, smoking status, diabetes etc. Higher scores indicate greater predicted risk of heart attack and lower scores indicate lower risk of heart attack. The score ranges from 0 to 32. A one point increase in the score is associated with a 12% increased risk of having a heart attack.
Measured: Baseline and 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start7 Mar 2018
- Primary completion30 Dec 2018
- Study completion3 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 424 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- GeneBlueprint Corp, Federal Economic Development Agency for Southern Ontario (FedDev Ontario), GoodLife Fitness, Southlake Health
- Responsible party
- Sponsor
- Investigators
- Guillaume Pare, MSc,MD,FRCPC, Principal investigator, Hamilton Health Sciences, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03583983
- Sponsor's protocol ID
- 20170928
- Acronym
- DNAble
- Status last verified
- Mar 2019
- First submitted
- 13 Jun 2018
- Last updated
- 6 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Personalized Recommendations on Healthy Behaviours and Cardio-metabolic Risk
- ClinicalTrials.gov ID
- NCT03583983
- Acronym / sponsor ID
- DNAble / 20170928
- Keywords
- Physical Activity, Dietary Habits, Genetic Scores, Cardiovascular Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 424 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- GeneBlueprint Corp, Federal Economic Development Agency for Southern Ontario (FedDev Ontario), GoodLife Fitness, Southlake Health
- Study start
- 7 Mar 2018 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 3 Jan 2019 (actual)
- First posted
- 12 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite the known cardiovascular benefits of regular physical activity and having a balanced diet, it has proven challenging to change health behaviours towards favourable lifestyles. The overarching aim of the study is to test the effect of providing personalized genetic information along with diet and exercise plans on adherence to healthy lifestyle habits and cardio-metabolic risk. There is tremendous public interest in genetics and some evidence that providing genetic information can help improve health habits. However, no intervention to date has examined the effect of comprehensive genetic testing using cutting-edge polygenic score (PGS) prediction and an interactive health portal on health behaviours and cardio-metabolic risk. The investigators hypothesize that providing participants with detailed genetic information about genetic determinants of fitness and nutrition traits will help motivate people to adopt healthy lifestyle habits. The primary objective is to test the effect of providing genetic information and interactive recommendations for diet and exercise on adoption of healthy behaviours. The secondary objective is to evaluate the effects of the personalized health recommendations on cardio-metabolic risk markers, such as dyslipidemia, inflammatory markers, and fasting glucose.
Detailed description
Cardiovascular disease (CVD) is a leading cause of death and disability worldwide, accounting for 17.9 million deaths and the loss of 348 million disability-adjusted life years in 2015 alone. Diabetes and obesity are very strong risk factors for CVD. Individuals with diabetes and obesity have an 82.75% life-time risk for developing CVD. While treatments do exist for both obesity (e.g. bariatric surgery) and diabetes (e.g. pharmaceutical control of blood sugar levels), these only partially attenuate risk of adverse health outcomes and they do not address prevention and upstream causes of cardiovascular diseases, namely sedentary lifestyle and unhealthy diet. Despite the known cardiovascular benefits of regular physical activity and having a balanced diet, it has proven challenging to change health behaviours towards favourable lifestyles. Indeed, the prevalence of obesity is increasing in Canada as less than 80% of adults follow the current recommendation of 150 minutes of moderate-to-vigorous physical activity per week and approximately less than 60% of adults consume fruits and vegetables 5 or more times a day. The overarching aim of the study is to test the effect of providing personalized genetic information along with diet and exercise plans on adherence to healthy lifestyle habits and cardio-metabolic risk. There is tremendous public interest in genetics and some evidence that providing genetic information can help improve health habits. However, no intervention to date has examined the effect of comprehensive genetic testing using cutting-edge polygenic score (PGS) prediction and an interactive health portal on health behaviours and cardio-metabolic risk.
The investigators hypothesize that providing participants with detailed genetic information about genetic determinants of fitness and nutrition traits will help to motivate people to adopt healthy lifestyle habits. The primary objective is to test the effect of providing genetic information and interactive recommendations for diet and exercise on adoption of healthy behaviours. The secondary objective is to evaluate the effects of the personalized health recommendations on cardio-metabolic risk markers, such as dyslipidemia, inflammatory markers, and fasting glucose.
The investigators propose to conduct a randomized controlled trial investigating whether personalized lifestyle recommendations including genetic information motivates Hamilton Health Sciences employees to adopt healthy lifestyle changes. Study participation will be open to Hamilton Health Sciences employees. Recruitment will begin in March 2017. Eligible and consenting individuals will be enrolled. Enrollment will occur in a staggered fashion. The intervention group will receive (1) a free 3-month GoodLife Fitness gym membership providing access to any Ontario GoodLife Fitness facility, (2) professional trainer-approved workout plans, (3) dietitian-approved meal plans, and (4) genetic information pertaining to their health and fitness. The control group will also receive a GoodLife Fitness membership to ensure that all study participants are granted similar ease-of-access to perform physical activities and generic health recommendations (Canadian Food Guide / Health Canada Physical Activity Recommendations) but will not receive the personalized component of the intervention (workout plans, meal plans or genetic information) until the end of their trial period. Participants will be randomized to treatment or control groups using a minimization scheme for adaptive randomization, which will serve to balance age, gender, and ethnicity across groups as participants are enrolled. Thus, randomization will be performed in a single-blind fashion wherein the study team is unaware of whom is receiving the intervention or control. All study participants will be monitored over the course of 3 months beginning with their baseline assessment and ending with their 3-month follow-up assessment. At these two timepoints, study participants will be assessed for behavioural (physical activity levels and diet healthiness), fitness markers (blood pressure, resting heart rate, body fat %, and other anthropometric measurements) and biological markers (lipids, insulin sensitivity, and inflammation) of cardio-metabolic disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized Health Recommendations | Other | Behavioral: Personalized Health Recommendations |
| No Health Recommendations | Other | Behavioral: Generic Health Recommendations |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hamilton Health Science employees living in Southern Ontario who are capable and willing to follow an exercise and diet program for 3 months as well as fitness and blood assessments
Key exclusion criteria (8 listed)
- Insulin-dependent diabetes
- History of cardiovascular disease (stroke, heart attack, coronary artery bypass graft (CABG) surgery, coronary angioplasty, peripheral artery disease)
- Injury or condition impeding ability to engage in physical activity (e.g. osteoarthritis, COPD)
- Pregnant or breast-feeding or planning to be pregnant
- Anyone on medication that interacts with foods
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 |
|---|---|---|
| Personalized Health RecommendationsIncludes 3-month gym membership, personalized exercise and meal plans, and genetic information related to health and wellness traits. The genetic information provided to study participants will consist of scores ranging from 0 to 100 based on the population percentile of the combined effects of many genetic variants, herein referred to as polygenic scores (PGS). PGS for approximately twenty traits related to health, fitness and nutrition will be provided to study participants. These traits are chosen for their relevance to healthy lifestyle habits (e.g. genetic predisposition to adiposity or muscle strength), entertainment value (e.g. preference for mornings) or both (e.g. bitterness taste perception, which while entertaining can also help guide vegetable choices). | Behavioural | Personalized Health Recommendations |
| Generic Health RecommendationsIncludes 3-month gym membership and generic recommendations (Canada Food Guide / Health Canada Physical Activity guidelines) | Behavioural | No Health Recommendations |
Primary outcome
Change in Physical Activity Levels (Strength Training)
Time frame: Baseline and 3 months follow-up
Physical activity levels (strength training) will be defined by frequency of strength training per week. Strength training is one of the domains of physical activity recognized by the Canadian Physical Activity Guidelines, which recommend at least two sessions of strength training per week. Accordingly, physical activity levels will be ascertained through the following survey question: "In the last 3 months, how many times per week did you perform strength training?" The minimum value for this outcome would be 0 and there is no theoretical maximum though we expect most values to be below 7 since 7 would represent strength training on a daily basis. Higher values indicate higher levels of physical activity and vice versa.
Change in Physical Activity Levels (Aerobic Exercise)
Time frame: Baseline and 3 months follow-up
Physical activity levels (aerobic exercise) will be defined by frequency of aerobic exercise per week. Aerobic exercise is one of the domains of physical activity recognized by the Canadian Physical Activity Guidelines, which recommend at least 150 minutes of moderate to vigorous physical activity per week. Accordingly, physical activity levels will be ascertained through the following survey question: "In the last 3 months, how many times per week did you perform aerobic exercises training?" The minimum value for this outcome would be 0 and there is no theoretical maximum though we expect most values to be below 7 since 7 would represent aerobic exercise on a daily basis. Higher values indicate higher levels of physical activity and vice versa.
Change in Dietary Healthiness
Time frame: Baseline and 3 months follow-up
Dietary healthiness will be ascertained using the dietary risk score developed by the INTERHEART study which was found to explain 30% of the population attributable risk for acute myocardial infarction. Briefly, the dietary risk score takes into account consumption of meat, salty snacks, fried foods, fruits and vegetables. The point score ranges from 0 to 6 with higher scores indicating a less healthy diet.
9 secondary outcomes
Change in Triglycerides
Time frame: Baseline and 3 months follow-up
Change in C-Reactive Protein
Time frame: Baseline and 3 months follow-up
Change in Fasting Glucose
Time frame: Baseline and 3 months follow-up
Change in Blood Pressure
Time frame: Baseline and 3 months follow-up
Change in Resting Heart Rate
Time frame: Baseline and 3 months follow-up
Change in Body Fat %
Time frame: Baseline and 3 months follow-up
Change in Circumference of Body Parts
Time frame: Baseline and 3 months follow-up
Change in Body Mass Index
Time frame: Baseline and 3 months follow-up
Change in Cardio-metabolic Risk Score
Time frame: Baseline and 3 months follow-up
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 6 Mar 2019.
- 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.
Guillaume Pare, MSc,MD,FRCPC principal investigator
Hamilton Health Sciences, McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Health Recommendations and Generic Health Recommendations in people with Health Behavior and Genetic Information, run by Hamilton Health Sciences Corporation at 1 site in Canada.
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 1 inclusion and 8 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 6 Mar 2019. 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 Canada. 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?
Change in Physical Activity Levels (Strength Training) (time frame: Baseline and 3 months follow-up). 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?
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 6 Mar 2019.