Overweight and ObesityGROWNCT01316653
Growing Right Onto Wellness (GROW): Changing Early Childhood Body Mass Index (BMI) Trajectories
A study testing GROW Healthier and GROW Smarter in people with Overweight and Obesity and Childhood Obesity, run by Vanderbilt University at 1 site in United States.
Trial summary
The purpose of this study is to conduct a randomized controlled trial that examines how a family based, community centered intervention effects early childhood BMI trajectories. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Childhood Obesity
- What is being tested?
- GROW Healthier and GROW Smarter
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 610 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to 6 Jul 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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- English or Spanish speaking
- Address in select zip code regions around participating Metro community centers
- Parental commitment to consistent participation
- Consistent phone access for 3 years
- Child aged 3-5 years old
- Child BMI ≥ 50% and < 95% (no diagnosis of failure to thrive or difficulty with appropriate weight gain)
- Healthy parent and child (without medical conditions necessitating limited physical activity)
- Parent ≥ 18 years of age
Who cannot join
- Non English or Spanish speaking
- Address outside select zip code regions around participating Metro community centers
- Lack of parental commitment to consistent participation
- Lack of consistent phone access
- Child outside specified age range
- Child BMI < 50% or ≥ 95%
- Parents and/or children who are diagnosed with medical illnesses where regular exercise might be contraindicated
- Parent < 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
The purpose of this study is to conduct a randomized controlled trial that examines how a family based, community centered intervention effects early childhood BMI trajectories.
Read the detailed description
Increases in sedentary lifestyle and high calorie food consumption, among other factors, have contributed to epidemic levels of childhood obesity in the US. Children who are overweight during the preschool period are more likely to become overweight adolescents and obese adults. Food preferences and activity habits set in early childhood can profoundly influence lifelong trajectories for Body Mass Index (BMI) and health. Specifically, rapid BMI gain in early childhood has been established to affect adulthood mortality and morbidity. Unfortunately, the longer such unhealthy patterns are in place, the more difficult it can be to reverse them. Therefore, healthy lifestyle interventions targeted at children as early as preschool have enormous potential to affect lifelong health. Furthermore, nutrition and activity patterns are determined not only at the child level, but within the family and the community.
This study will assess the impact of a family-based and community centered multilevel behavioral intervention addressing nutrition and physical activity with high risk parent-preschool children dyads to promote pediatric obesity prevention. The 7 year study will follow 600 parent preschool child dyads, half of whom will be randomized into the intervention condition which will utilize a health literate approach, build new social networks, utilize behavior modification tools including goal setting, self monitoring, and problem solving, and create behavior-environmental synergy with cues to action for use of the built environment for healthy behaviors. Both the intervention and control group (separately) will receive the control condition in which parent-child dyads will receive a literacy promotion/school success curriculum.
The primary outcome of interest will be early childhood BMI trajectories measured at multiple time points over the three year RCT. Additional measures collected throughout the study from children and parents will include: tricep skin fold, waist circumference, actigraphy, 3-day diet recalls, questionnaires, social network data, and saliva to assess a genetics/epigenetics associated with obesity. Consistent with a multilevel systems approach, the investigators will develop and assess built environment changes related to obesity prevention. Moreover, working with the study's community partners, the investigators will evaluate how this approach affects local policy.
- Conditions
- Overweight and Obesity, Childhood Obesity
- Being tested
- GROW Healthier, GROW Smarter
- Medical subject headings
- Overweight, Obesity, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GROW HealthierBehavioural
Group sessions that meet once weekly for 3 months (intensive phase) with choice of phone call session as preferred by participant, phone call coaching monthly for 9 months (maintenance phase), and monthly cues to action to use one's built environment for healthy activities for 24 months (sustainability phase)
GROW SmarterBehavioural
Group sessions that meet six times over the course of three years with quarterly newsletters.
| Study group | Role | What they receive |
|---|---|---|
| GROW Smarter | Active comparator | Library based program to promote early literacy Receives: Behavioral: GROW Smarter |
| GROW Healthier | Experimental | Healthy lifestyle intervention focused on building healthy lifestyle skills for preschool children and participating parents and building new social networks between the intervention group members. Receives: Behavioral: GROW Healthier; Behavioral: GROW Smarter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Childhood BMI Trajectory
Measured: Baseline, 3 months, 9 months, 12 months, 24 months, and 36 months
Secondary outcomes (12)
Average daily energy intake (kcal)
Measured: Baseline, 12 months, 24 months, and 36 months
Percentage of Energy Intake from Fat
Measured: Baseline, 12 months, 24 months, and 36 months
Percentage of Energy Intake from Carbohydrates
Measured: Baseline, 12 months, 24 months, and 36 months
Percentage of Energy Intake from Protein
Measured: Baseline, 12 months, 24 months, and 36 months
Average daily time (minutes) spent in rest and sedentary behavior
Measured: Baseline, 12 months, 24 months, and 36 months
Average daily time (minutes) spent in moderate and vigorous physical activity
Measured: Baseline, 12 months, 24 months, and 36 months
Parent community center use with child
never versus at least once
Measured: Baseline, 12 months, 24 months, and 36 months
Parent BMI
Measured: Baseline, 3 months, 9 months, 12 months, 24 months, and 36 months
Parent Waist Circumference
Measured: Baseline, 12 months, 24 months, and 36 months
Parent Triceps Skinfold
Measured: Baseline, 12 months, 24 months, and 36 months
Child Waist Circumference
Measured: Baseline, 12 months, 24 months, and 36 months
Child Triceps Skinfold
Measured: Baseline, 12 months, 24 months, and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2011 (estimated)
- Study startJun 2011
- Primary completion13 Jun 2017
- Study completion6 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (42)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies 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
- None (open label)
- Enrolment
- 610 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Nashville Metro Parks and Recreation Department, Nashville Public Library Foundation
- Responsible party
- Principal investigator, Shari Barkin, MD, MSHS, Vanderbilt University
- Investigators
- Shari Barkin, MD, MSHS, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01316653
- Sponsor's protocol ID
- 100591
- Other IDs
- 5U01HL103620-03
- Acronym
- GROW
- Status last verified
- Sep 2021
- First submitted
- 3 Mar 2011
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Heerman WJ, Bian A, Shintani A, Barkin SL. Interaction between maternal prepregnancy body mass index and gestational weight gain shapes infant growth. Acad Pediatr. 2014 Sep-Oct;14(5):463-70. doi: 10.1016/j.acap.2014.05.005.
PubMed 25169157Ruiz RM, Tracy D, Sommer EC, Barkin SL. A novel approach to characterize physical activity patterns in preschool-aged children. Obesity (Silver Spring). 2013 Nov;21(11):2197-203. doi: 10.1002/oby.20560. Epub 2013 Oct 17.
PubMed 24136917Gesell SB, Barkin SL, Valente TW. Social network diagnostics: a tool for monitoring group interventions. Implement Sci. 2013 Oct 1;8:116. doi: 10.1186/1748-5908-8-116.
PubMed 24083343Po'e EK, Heerman WJ, Mistry RS, Barkin SL. Growing Right Onto Wellness (GROW): a family-centered, community-based obesity prevention randomized controlled trial for preschool child-parent pairs. Contemp Clin Trials. 2013 Nov;36(2):436-49. doi: 10.1016/j.cct.2013.08.013. Epub 2013 Sep 5.
PubMed 24012890Reinert KR, Po'e EK, Barkin SL. The relationship between executive function and obesity in children and adolescents: a systematic literature review. J Obes. 2013;2013:820956. doi: 10.1155/2013/820956. Epub 2013 Feb 21.
PubMed 23533726White RO, Thompson JR, Rothman RL, McDougald Scott AM, Heerman WJ, Sommer EC, Barkin SL. A health literate approach to the prevention of childhood overweight and obesity. Patient Educ Couns. 2013 Dec;93(3):612-8. doi: 10.1016/j.pec.2013.08.010. Epub 2013 Aug 19.
PubMed 24001660Gesell SB, Barkin SL, Sommer EC, Thompson JR, Valente TW. Increases in Network Ties Are Associated With Increased Cohesion Among Intervention Participants. Health Educ Behav. 2016 Apr;43(2):208-16. doi: 10.1177/1090198115599397. Epub 2015 Aug 17.
PubMed 26286298Heerman WJ, Krishnaswami S, Barkin SL, McPheeters M. Adverse family experiences during childhood and adolescent obesity. Obesity (Silver Spring). 2016 Mar;24(3):696-702. doi: 10.1002/oby.21413. Epub 2016 Feb 8.
PubMed 26853526Hudnut-Beumler J, Po'e E, Barkin S. The Use of Social Media for Health Promotion in Hispanic Populations: A Scoping Systematic Review. JMIR Public Health Surveill. 2016 Jul 11;2(2):e32. doi: 10.2196/publichealth.5579.
PubMed 27400979JaKa MM, Haapala JL, Trapl ES, Kunin-Batson AS, Olson-Bullis BA, Heerman WJ, Berge JM, Moore SM, Matheson D, Sherwood NE. Reporting of treatment fidelity in behavioural paediatric obesity intervention trials: a systematic review. Obes Rev. 2016 Dec;17(12):1287-1300. doi: 10.1111/obr.12464. Epub 2016 Sep 9.
PubMed 27612933Heerman WJ, White RO, Hotop A, Omlung K, Armstrong S, Mathieu I, Sherwood NE, Barkin SL. A Tool Kit to Enhance the Informed Consent Process for Community-Engaged Pediatric Research. IRB. 2016 Sep-Oct;38(5):8-14. No abstract available.
PubMed 29442474Heerman WJ, Berge JM, Barkin SL. Mentoring of Early-Stage Investigators When Funding Is Tight: The Childhood Obesity Prevention and Treatment Research Experience. JAMA Pediatr. 2018 Jan 1;172(1):4-6. doi: 10.1001/jamapediatrics.2017.3396. No abstract available.
PubMed 29181507Heerman WJ, Lounds-Taylor J, Mitchell S, Barkin SL. Validity of the toddler feeding questionnaire for measuring parent authoritative and indulgent feeding practices which are associated with stress and health literacy among Latino parents of preschool children. Nutr Res. 2018 Jan;49:107-112. doi: 10.1016/j.nutres.2017.10.018. Epub 2017 Nov 3.
PubMed 29224793Heerman WJ, JaKa MM, Berge JM, Trapl ES, Sommer EC, Samuels LR, Jackson N, Haapala JL, Kunin-Batson AS, Olson-Bullis BA, Hardin HK, Sherwood NE, Barkin SL. The dose of behavioral interventions to prevent and treat childhood obesity: a systematic review and meta-regression. Int J Behav Nutr Phys Act. 2017 Nov 15;14(1):157. doi: 10.1186/s12966-017-0615-7.
PubMed 29141651Fletcher GE, Teeters L, Schlundt D, Bonnet K, Heerman WJ. Maternal conception of gestational weight gain among Latinas: A qualitative study. Health Psychol. 2018 Feb;37(2):132-138. doi: 10.1037/hea0000555. Epub 2017 Oct 2.
PubMed 28967775
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growing Right Onto Wellness (GROW): Changing Early Childhood Body Mass Index (BMI) Trajectories
- ClinicalTrials.gov ID
- NCT01316653
- Acronym / sponsor ID
- GROW / 100591
- Conditions
- Overweight and Obesity, Childhood Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 610 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Nashville Metro Parks and Recreation Department, Nashville Public Library Foundation
- Study start
- Jun 2011
- Primary completion
- 13 Jun 2017 (actual)
- Study completion
- 6 Jul 2017 (actual)
- First posted
- 16 Mar 2011 (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 purpose of this study is to conduct a randomized controlled trial that examines how a family based, community centered intervention effects early childhood BMI trajectories.
Detailed description
Increases in sedentary lifestyle and high calorie food consumption, among other factors, have contributed to epidemic levels of childhood obesity in the US. Children who are overweight during the preschool period are more likely to become overweight adolescents and obese adults. Food preferences and activity habits set in early childhood can profoundly influence lifelong trajectories for Body Mass Index (BMI) and health. Specifically, rapid BMI gain in early childhood has been established to affect adulthood mortality and morbidity. Unfortunately, the longer such unhealthy patterns are in place, the more difficult it can be to reverse them. Therefore, healthy lifestyle interventions targeted at children as early as preschool have enormous potential to affect lifelong health. Furthermore, nutrition and activity patterns are determined not only at the child level, but within the family and the community.
This study will assess the impact of a family-based and community centered multilevel behavioral intervention addressing nutrition and physical activity with high risk parent-preschool children dyads to promote pediatric obesity prevention. The 7 year study will follow 600 parent preschool child dyads, half of whom will be randomized into the intervention condition which will utilize a health literate approach, build new social networks, utilize behavior modification tools including goal setting, self monitoring, and problem solving, and create behavior-environmental synergy with cues to action for use of the built environment for healthy behaviors. Both the intervention and control group (separately) will receive the control condition in which parent-child dyads will receive a literacy promotion/school success curriculum.
The primary outcome of interest will be early childhood BMI trajectories measured at multiple time points over the three year RCT. Additional measures collected throughout the study from children and parents will include: tricep skin fold, waist circumference, actigraphy, 3-day diet recalls, questionnaires, social network data, and saliva to assess a genetics/epigenetics associated with obesity. Consistent with a multilevel systems approach, the investigators will develop and assess built environment changes related to obesity prevention. Moreover, working with the study's community partners, the investigators will evaluate how this approach affects local policy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROW Smarter | Active comparator | Behavioral: GROW SmarterLibrary based program to promote early literacy |
| GROW Healthier | Experimental | Behavioral: GROW Healthier, Behavioral: GROW SmarterHealthy lifestyle intervention focused on building healthy lifestyle skills for preschool children and participating parents and building new social networks between the intervention group members. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- English or Spanish speaking
- Address in select zip code regions around participating Metro community centers
- Parental commitment to consistent participation
- Consistent phone access for 3 years
- Child aged 3-5 years old
Key exclusion criteria (8 listed)
- Non English or Spanish speaking
- Address outside select zip code regions around participating Metro community centers
- Lack of parental commitment to consistent participation
- Lack of consistent phone access
- Child outside specified age range
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 |
|---|---|---|
| GROW HealthierGroup sessions that meet once weekly for 3 months (intensive phase) with choice of phone call session as preferred by participant, phone call coaching monthly for 9 months (maintenance phase), and monthly cues to action to use one's built environment for healthy activities for 24 months (sustainability phase) | Behavioural | GROW Healthier |
| GROW SmarterGroup sessions that meet six times over the course of three years with quarterly newsletters. | Behavioural | GROW Healthier, GROW Smarter |
Primary outcome
Early Childhood BMI Trajectory
Time frame: Baseline, 3 months, 9 months, 12 months, 24 months, and 36 months
12 secondary outcomes
Average daily energy intake (kcal)
Time frame: Baseline, 12 months, 24 months, and 36 months
Percentage of Energy Intake from Fat
Time frame: Baseline, 12 months, 24 months, and 36 months
Percentage of Energy Intake from Carbohydrates
Time frame: Baseline, 12 months, 24 months, and 36 months
Percentage of Energy Intake from Protein
Time frame: Baseline, 12 months, 24 months, and 36 months
Average daily time (minutes) spent in rest and sedentary behavior
Time frame: Baseline, 12 months, 24 months, and 36 months
Average daily time (minutes) spent in moderate and vigorous physical activity
Time frame: Baseline, 12 months, 24 months, and 36 months
Parent community center use with child
Time frame: Baseline, 12 months, 24 months, and 36 months
Parent BMI
Time frame: Baseline, 3 months, 9 months, 12 months, 24 months, and 36 months
Parent Waist Circumference
Time frame: Baseline, 12 months, 24 months, and 36 months
Parent Triceps Skinfold
Time frame: Baseline, 12 months, 24 months, and 36 months
Child Waist Circumference
Time frame: Baseline, 12 months, 24 months, and 36 months
Child Triceps Skinfold
Time frame: Baseline, 12 months, 24 months, and 36 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 Oct 2021.
- Background: PubMed 25169157Heerman WJ, Bian A, Shintani A, Barkin SL. Interaction between maternal prepregnancy body mass index and gestational weight gain shapes infant growth. Acad Pediatr. 2014 Sep-Oct;14(5):463-70. doi: 10.1016/j.acap.2014.05.005.
- Background: PubMed 24136917Ruiz RM, Tracy D, Sommer EC, Barkin SL. A novel approach to characterize physical activity patterns in preschool-aged children. Obesity (Silver Spring). 2013 Nov;21(11):2197-203. doi: 10.1002/oby.20560. Epub 2013 Oct 17.
- Background: PubMed 24083343Gesell SB, Barkin SL, Valente TW. Social network diagnostics: a tool for monitoring group interventions. Implement Sci. 2013 Oct 1;8:116. doi: 10.1186/1748-5908-8-116.
- Background: PubMed 24012890Po'e EK, Heerman WJ, Mistry RS, Barkin SL. Growing Right Onto Wellness (GROW): a family-centered, community-based obesity prevention randomized controlled trial for preschool child-parent pairs. Contemp Clin Trials. 2013 Nov;36(2):436-49. doi: 10.1016/j.cct.2013.08.013. Epub 2013 Sep 5.
- Background: PubMed 23533726Reinert KR, Po'e EK, Barkin SL. The relationship between executive function and obesity in children and adolescents: a systematic literature review. J Obes. 2013;2013:820956. doi: 10.1155/2013/820956. Epub 2013 Feb 21.
- Background: PubMed 24001660White RO, Thompson JR, Rothman RL, McDougald Scott AM, Heerman WJ, Sommer EC, Barkin SL. A health literate approach to the prevention of childhood overweight and obesity. Patient Educ Couns. 2013 Dec;93(3):612-8. doi: 10.1016/j.pec.2013.08.010. Epub 2013 Aug 19.
- Background: PubMed 26286298Gesell SB, Barkin SL, Sommer EC, Thompson JR, Valente TW. Increases in Network Ties Are Associated With Increased Cohesion Among Intervention Participants. Health Educ Behav. 2016 Apr;43(2):208-16. doi: 10.1177/1090198115599397. Epub 2015 Aug 17.
- Background: PubMed 26853526Heerman WJ, Krishnaswami S, Barkin SL, McPheeters M. Adverse family experiences during childhood and adolescent obesity. Obesity (Silver Spring). 2016 Mar;24(3):696-702. doi: 10.1002/oby.21413. Epub 2016 Feb 8.
- Background: PubMed 27400979Hudnut-Beumler J, Po'e E, Barkin S. The Use of Social Media for Health Promotion in Hispanic Populations: A Scoping Systematic Review. JMIR Public Health Surveill. 2016 Jul 11;2(2):e32. doi: 10.2196/publichealth.5579.
- Background: PubMed 27612933JaKa MM, Haapala JL, Trapl ES, Kunin-Batson AS, Olson-Bullis BA, Heerman WJ, Berge JM, Moore SM, Matheson D, Sherwood NE. Reporting of treatment fidelity in behavioural paediatric obesity intervention trials: a systematic review. Obes Rev. 2016 Dec;17(12):1287-1300. doi: 10.1111/obr.12464. Epub 2016 Sep 9.
- Background: PubMed 29442474Heerman WJ, White RO, Hotop A, Omlung K, Armstrong S, Mathieu I, Sherwood NE, Barkin SL. A Tool Kit to Enhance the Informed Consent Process for Community-Engaged Pediatric Research. IRB. 2016 Sep-Oct;38(5):8-14. No abstract available.
- Background: PubMed 29181507Heerman WJ, Berge JM, Barkin SL. Mentoring of Early-Stage Investigators When Funding Is Tight: The Childhood Obesity Prevention and Treatment Research Experience. JAMA Pediatr. 2018 Jan 1;172(1):4-6. doi: 10.1001/jamapediatrics.2017.3396. No abstract available.
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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.
Shari Barkin, MD, MSHS principal investigator
Vanderbilt University 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 GROW Healthier and GROW Smarter in people with Overweight and Obesity and Childhood Obesity, run by Vanderbilt University 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 8 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 8 Oct 2021. 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?
Early Childhood BMI Trajectory (time frame: Baseline, 3 months, 9 months, 12 months, 24 months, and 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01316653, which also lists 42 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 8 Oct 2021.