Cleft Lip and PalateNCT04384276
Weigh Easy: Simplifying Home Weight Monitoring for Infants
A study testing The Weigh Easy System in people with Cleft Lip and Palate, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
This single-site, experimental, pilot study in infants identified from 0 - 3 months of age who present to the Cleft and Craniofacial Clinic with a cleft lip and/or palate will compare weight outcomes of infants who used the Weigh Easy system to monitor weight and historical infants whose weights were monitored without… Read more about this study
- Who is it for?
- Ages Up to 12 weeksHealthy volunteers can take part
- Conditions the study is for
- Cleft Lip and Palate
- What is being tested?
- The Weigh Easy System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 30 Sep 2022
- 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 Up to 12 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Newborn patient ≤ 12 weeks old
- Referred to Children's Mercy Hospital Multidisciplinary Cleft Team from December 1, 2019 - November 30, 2020
- With a diagnosis of cleft lip and/or cleft palate
- Male or female infant of any ethnic background
- Newborn patient ≤ 12 weeks old
- Referred to Children's Mercy Hospital Multidisciplinary Cleft Team from January 1, 2016 to June 30, 2019
- With a diagnosis of cleft lip and/or cleft palate
- Male or female infant of any ethnic background
Who cannot join
- Infant with secondary major birth defect such as heart or abdominal wall defect in addition to cleft condition
- Infant who is placed in foster care prior to or during the applicable study period
- Patient parents unable to complete an electronic survey.
- Patient parents unable to speak and read Spanish or English.
- Retrospective Group:
- Infant with secondary major birth defect such as heart or abdominal wall defect in addition to cleft condition
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
Official title: Simplifying Home Weight Monitoring for Infants With Cleft Lip and/or Palate Differences to Determine if Use of an In-home Scale Leads to Better Compliance With Weight Monitoring Recommendations
This single-site, experimental, pilot study in infants identified from 0 - 3 months of age who present to the Cleft and Craniofacial Clinic with a cleft lip and/or palate will compare weight outcomes of infants who used the Weigh Easy system to monitor weight and historical infants whose weights were monitored without the Weigh Easy system.
Read the detailed description
Patients will be recruited at the earliest possible visit to the Cleft and Craniofacial Clinic. At this visit, families will complete the consent process. After consent is obtained, the study team will ensure that the family is signed up for the Patient Portal and will provide a demonstration of how to safely obtain a weight using the Weigh Easy scale and the infant's car seat. In addition to the luggage scale, a handout will also be sent home with the family, including instructions and safety tips for weighing their infant and instructions for submitting a weight via the Patient Portal.
Families will be asked to submit a weight, obtained with the Weigh Easy scale, via the Weigh Easy eClipboard message on a weekly basis for 3 months.
Three months after the family is enrolled onto the study, the family will be provided the Parental Satisfaction Survey to complete. This will occur at a clinic visit, in the event that a standard of care visit occurs within the window for the visit. If a clinic visit is unavailable, the surveys will be emailed to the family and three reminders will be sent if the survey is not completed in a timely manner.
- Conditions
- Cleft Lip and Palate
- Being tested
- The Weigh Easy System, Retrospective Control
- Keywords
- Weight Monitoring
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Weigh Easy SystemOther
By use of a small user-friendly luggage scale, the family can easily and safely obtain a weight within the comfort of their own home. Using the Weigh Easy eClipboard, a message will be sent to the family on a weekly basis via Cerner's Message Center that will include a link. The link will be used by parents to enter and submit the patient's current weight. Upon submission, the weight will be transmitted into the patient's EMR after it's reviewed and accepted by a member of the study team. When the weight is received in the system, an alert will be triggered that will notify the study team of its arrival. While the Weigh Easy eClipboard function does qualify as a device, as the investigators will be making clinical decisions based off of the data received through the form, the device is not being used investigationally on this study. The eClipboard function is a standard part of the Cerner framework and has been previously investigated and vetted by for safety and efficacy.
Retrospective ControlOther
No interventions will be administered to the historical control group.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Weigh Easy | Experimental | Patients enrolled onto this arm of the study will use the Weigh Easy system for weight tracking in the first three months of life. Weights will be measured in home using the Weigh Easy scale and transmitted to the study team via the Weigh Easy eClipboard message. A notification scheme will be activated for weights found to have plateaued or decreased to ensure that the infant's standard of care nutritionist and provider are able to follow up and recommend additional interventions to counteract the weight change.
After three months, families will complete a satisfaction survey to determine if the Weigh Easy system was preferable or if there are any improvements that could be made.
All other aspects of the patients' care will follow the standard of care for cleft and craniofacial diagnoses and will be guided by the nutritionists specializing in cleft and craniofacial care. Receives: Other: The Weigh Easy System |
| Retrospective Control Arm | Other | Patients enrolled onto the control arm will have retrospectively presented to the Cleft and Craniofacial Clinic from January 1, 2016 to December 31, 2018 as infants. These patients were treated with the standard of care for cleft and craniofacial diagnoses and were followed by the nutritionists specializing in cleft and craniofacial care. Receives: Other: Retrospective Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight
Weight will be recorded for the duration of the study to identify points of weight destabilization.
Measured: up to 3 months
Change in Nutritional Interventions
Recommended nutritional interventions will be recorded and analyzed against the recorded weights to identify any correlations to improved growth.
Measured: up to 3 months
Change in Admissions
Number of admission due to feeding problems or failure to thrive will be analyzed by comparing the number and frequency of admissions between the retrospective and prospective cohorts.
Measured: up to 3 months
Secondary outcomes (1)
Parental Satisfaction: survey
The Weigh Easy Parental Satisfaction Survey will be used to create a satisfaction score for each family participating. Answers to this survey will be built using a five-point Likert scale. Minimum score: 4, Maximum score: 20, with higher scores indicating lower parental satisfaction. The survey will be administered at a standard of care appointment three months after enrollment (± 1 month) or via email if an appointment is unavailable during this window. This variable will be measured for the prospective cohort only.
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start1 Oct 2020
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Cleft Lip and PalateStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Model description
- A single experimental group will be enrolled prospectively to use the Weigh Easy system. Due to the potential impacts of weight gain within this patient population and the lifelong implications of early malnutrition, we do not feel we can safely randomize a prospective control group. As a result, a retrospective control group will be enrolled to enable a comparison of outcomes between those families using the Weigh Easy system and those who did not. All patients, both retrospective and prospective, will be treated according to the standard cleft lip and/or palate treatment protocols and followed by the registered nutritionists who routinely participate in the Cleft and Craniofacial Clinic
- Masking
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shao Jiang, Children's Mercy Hospital Kansas City
- Investigators
- Shao Jiang, MD, Principal investigator, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04384276
- Sponsor's protocol ID
- STUDY00000822
- Status last verified
- Jan 2023
- First submitted
- 6 Feb 2020
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual patient data only can be shared with other researchers, however the necessary contracting will be needed prior to any data can be shared.
Publications
Avedian LV, Ruberg RL. Impaired weight gain in cleft palate infants. Cleft Palate J. 1980 Jan;17(1):24-6.
PubMed 6928113Barrett, D. E., Radke-Yarrow, M., & Klein, R. E. (1982). Chronic malnutrition and child behavior: Effects of early caloric supplementation on social and emotional functioning at school age. Developmental Psychology, 18(4):541-556. doi:10.1037/0012-1649.18.4.541
Beaumont D. A study into weight gain in infants with cleft lip/palate. Paediatr Nurs. 2008 Jul;20(6):20-3. doi: 10.7748/paed2008.07.20.6.20.c6626.
PubMed 18686410Gregory KE, Radovinsky L. Research strategies that result in optimal data collection from the patient medical record. Appl Nurs Res. 2012 May;25(2):108-16. doi: 10.1016/j.apnr.2010.02.004. Epub 2010 Apr 9.
PubMed 20974093Hartley SL, MacLean WE Jr. A review of the reliability and validity of Likert-type scales for people with intellectual disability. J Intellect Disabil Res. 2006 Nov;50(Pt 11):813-27. doi: 10.1111/j.1365-2788.2006.00844.x.
PubMed 16999781Idohou-Dossou N, Wade S, Guiro AT, Sarr CS, Diaham B, Cisse D, Beau JP, Chappuis P, Hoffman D, Lemonnier D. Nutritional status of preschool Senegalese children: long-term effects of early severe malnutrition. Br J Nutr. 2003 Dec;90(6):1123-32. doi: 10.1079/bjn2003990.
PubMed 14641972Jones WB. Weight gain and feeding in the neonate with cleft: a three-center study. Cleft Palate J. 1988 Oct;25(4):379-84.
PubMed 3060285Kaye A, Thaete K, Snell A, Chesser C, Goldak C, Huff H. Initial Nutritional Assessment of Infants With Cleft Lip and/or Palate: Interventions and Return to Birth Weight. Cleft Palate Craniofac J. 2017 Mar;54(2):127-136. doi: 10.1597/15-163. Epub 2016 Feb 16.
PubMed 26882024Lao LJ, Zhang LY, DU LZ. [Malnutrition in early life and cardiovascular disease in adulthood]. Zhejiang Da Xue Xue Bao Yi Xue Ban. 2015 May;44(3):349-53. doi: 10.3785/j.issn.1008-9292.2015.05.18. Chinese.
PubMed 26350019Marques IL, Nackashi JA, Borgo HC, Martinelli AP, Pegoraro-Krook MI, Williams WN, Dutka JC, Seagle MB, Souza TV, Garla LA, Neto JS, Silva ML, Graciano MI, Moorhead J, Piazentin-Penna SH, Feniman MR, Zimmermann MC, Bento-Goncalves CG, Pimentel MC, Boggs S, Jorge JC, Antonelli PJ, Shuster J. Longitudinal study of growth of children with unilateral cleft-lip palate from birth to two years of age. Cleft Palate Craniofac J. 2009 Nov;46(6):603-9. doi: 10.1597/08-105.1. Epub 2009 May 16.
PubMed 19860503Martin V, Greatrex-White S. An evaluation of factors influencing feeding in babies with a cleft palate with and without a cleft lip. J Child Health Care. 2014 Mar;18(1):72-83. doi: 10.1177/1367493512473853. Epub 2013 Feb 25.
PubMed 23439590Montagnoli LC, Barbieri MA, Bettiol H, Marques IL, de Souza L. Growth impairment of children with different types of lip and palate clefts in the first 2 years of life: a cross-sectional study. J Pediatr (Rio J). 2005 Nov-Dec;81(6):461-5. doi: 10.2223/JPED.1420.
PubMed 16385363Pandya AN, Boorman JG. Failure to thrive in babies with cleft lip and palate. Br J Plast Surg. 2001 Sep;54(6):471-5. doi: 10.1054/bjps.2001.3618.
PubMed 11513506Ranalli DN, Mazaheri M. Height-weight growth of cleft children, birth to six years. Cleft Palate J. 1975 Oct;12:400-4.
PubMed 1058750Sawaya AL, Martins PA, Grillo LP, Florencio TT. Long-term effects of early malnutrition on body weight regulation. Nutr Rev. 2004 Jul;62(7 Pt 2):S127-33. doi: 10.1111/j.1753-4887.2004.tb00082.x.
PubMed 15387478
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simplifying Home Weight Monitoring for Infants With Cleft Lip and/or Palate Differences to Determine if Use of an In-home Scale Leads to Better Compliance With Weight Monitoring Recommendations
- ClinicalTrials.gov ID
- NCT04384276
- Acronym / sponsor ID
- STUDY00000822
- Conditions
- Cleft Lip and Palate
- Keywords
- Weight Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 12 May 2020 (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.
This single-site, experimental, pilot study in infants identified from 0 - 3 months of age who present to the Cleft and Craniofacial Clinic with a cleft lip and/or palate will compare weight outcomes of infants who used the Weigh Easy system to monitor weight and historical infants whose weights were monitored without the Weigh Easy system.
Detailed description
Patients will be recruited at the earliest possible visit to the Cleft and Craniofacial Clinic. At this visit, families will complete the consent process. After consent is obtained, the study team will ensure that the family is signed up for the Patient Portal and will provide a demonstration of how to safely obtain a weight using the Weigh Easy scale and the infant's car seat. In addition to the luggage scale, a handout will also be sent home with the family, including instructions and safety tips for weighing their infant and instructions for submitting a weight via the Patient Portal.
Families will be asked to submit a weight, obtained with the Weigh Easy scale, via the Weigh Easy eClipboard message on a weekly basis for 3 months.
Three months after the family is enrolled onto the study, the family will be provided the Parental Satisfaction Survey to complete. This will occur at a clinic visit, in the event that a standard of care visit occurs within the window for the visit. If a clinic visit is unavailable, the surveys will be emailed to the family and three reminders will be sent if the survey is not completed in a timely manner.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A single experimental group will be enrolled prospectively to use the Weigh Easy system. Due to the potential impacts of weight gain within this patient population and the lifelong implications of early malnutrition, we do not feel we can safely randomize a prospective control group. As a result, a retrospective control group will be enrolled to enable a comparison of outcomes between those families using the Weigh Easy system and those who did not. All patients, both retrospective and prospective, will be treated according to the standard cleft lip and/or palate treatment protocols and followed by the registered nutritionists who routinely participate in the Cleft and Craniofacial Clinic
| Arm | Type | Receives |
|---|---|---|
| Prospective Weigh Easy | Experimental | Other: The Weigh Easy SystemPatients enrolled onto this arm of the study will use the Weigh Easy system for weight tracking in the first three months of life. Weights will be measured in home using the Weigh Easy scale and transmitted to the study team via the Weigh Easy eClipboard message. A notification scheme will be activated for weights found to have plateaued or decreased to ensure that the infant's standard of care nutritionist and provider are able to follow up and recommend additional interventions to counteract the weight change. After three months, families will complete a satisfaction survey to determine if the Weigh Easy system was preferable or if there are any improvements that could be made. All other aspects of the patients' care will follow the standard of care for cleft and craniofacial diagnoses and will be guided by the nutritionists specializing in cleft and craniofacial care. |
| Retrospective Control Arm | Other | Other: Retrospective ControlPatients enrolled onto the control arm will have retrospectively presented to the Cleft and Craniofacial Clinic from January 1, 2016 to December 31, 2018 as infants. These patients were treated with the standard of care for cleft and craniofacial diagnoses and were followed by the nutritionists specializing in cleft and craniofacial care. |
Who may qualify
- Ages
- Up to 12 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Newborn patient ≤ 12 weeks old
- Referred to Children's Mercy Hospital Multidisciplinary Cleft Team from December 1, 2019 - November 30, 2020
- With a diagnosis of cleft lip and/or cleft palate
- Male or female infant of any ethnic background
- Newborn patient ≤ 12 weeks old
Key exclusion criteria (6 listed)
- Infant with secondary major birth defect such as heart or abdominal wall defect in addition to cleft condition
- Infant who is placed in foster care prior to or during the applicable study period
- Patient parents unable to complete an electronic survey.
- Patient parents unable to speak and read Spanish or English.
- Infant with secondary major birth defect such as heart or abdominal wall defect in addition to cleft condition
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 |
|---|---|---|
| The Weigh Easy SystemBy use of a small user-friendly luggage scale, the family can easily and safely obtain a weight within the comfort of their own home. Using the Weigh Easy eClipboard, a message will be sent to the family on a weekly basis via Cerner's Message Center that will include a link. The link will be used by parents to enter and submit the patient's current weight. Upon submission, the weight will be transmitted into the patient's EMR after it's reviewed and accepted by a member of the study team. When the weight is received in the system, an alert will be triggered that will notify the study team of its arrival. While the Weigh Easy eClipboard function does qualify as a device, as the investigators will be making clinical decisions based off of the data received through the form, the device is not being used investigationally on this study. The eClipboard function is a standard part of the Cerner framework and has been previously investigated and vetted by for safety and efficacy. | Other | Prospective Weigh Easy |
| Retrospective ControlNo interventions will be administered to the historical control group. | Other | Retrospective Control Arm |
Primary outcome
Change in Weight
Time frame: up to 3 months
Weight will be recorded for the duration of the study to identify points of weight destabilization.
Change in Nutritional Interventions
Time frame: up to 3 months
Recommended nutritional interventions will be recorded and analyzed against the recorded weights to identify any correlations to improved growth.
Change in Admissions
Time frame: up to 3 months
Number of admission due to feeding problems or failure to thrive will be analyzed by comparing the number and frequency of admissions between the retrospective and prospective cohorts.
1 secondary outcome
Parental Satisfaction: survey
Time frame: Month 3
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 17 Jan 2023.
- Background: PubMed 6928113Avedian LV, Ruberg RL. Impaired weight gain in cleft palate infants. Cleft Palate J. 1980 Jan;17(1):24-6.
- BackgroundBarrett, D. E., Radke-Yarrow, M., & Klein, R. E. (1982). Chronic malnutrition and child behavior: Effects of early caloric supplementation on social and emotional functioning at school age. Developmental Psychology, 18(4):541-556. doi:10.1037/0012-1649.18.4.541
- Background: PubMed 18686410Beaumont D. A study into weight gain in infants with cleft lip/palate. Paediatr Nurs. 2008 Jul;20(6):20-3. doi: 10.7748/paed2008.07.20.6.20.c6626.
- Background: PubMed 20974093Gregory KE, Radovinsky L. Research strategies that result in optimal data collection from the patient medical record. Appl Nurs Res. 2012 May;25(2):108-16. doi: 10.1016/j.apnr.2010.02.004. Epub 2010 Apr 9.
- Background: PubMed 16999781Hartley SL, MacLean WE Jr. A review of the reliability and validity of Likert-type scales for people with intellectual disability. J Intellect Disabil Res. 2006 Nov;50(Pt 11):813-27. doi: 10.1111/j.1365-2788.2006.00844.x.
- Background: PubMed 14641972Idohou-Dossou N, Wade S, Guiro AT, Sarr CS, Diaham B, Cisse D, Beau JP, Chappuis P, Hoffman D, Lemonnier D. Nutritional status of preschool Senegalese children: long-term effects of early severe malnutrition. Br J Nutr. 2003 Dec;90(6):1123-32. doi: 10.1079/bjn2003990.
- Background: PubMed 3060285Jones WB. Weight gain and feeding in the neonate with cleft: a three-center study. Cleft Palate J. 1988 Oct;25(4):379-84.
- Background: PubMed 26882024Kaye A, Thaete K, Snell A, Chesser C, Goldak C, Huff H. Initial Nutritional Assessment of Infants With Cleft Lip and/or Palate: Interventions and Return to Birth Weight. Cleft Palate Craniofac J. 2017 Mar;54(2):127-136. doi: 10.1597/15-163. Epub 2016 Feb 16.
- Background: PubMed 26350019Lao LJ, Zhang LY, DU LZ. [Malnutrition in early life and cardiovascular disease in adulthood]. Zhejiang Da Xue Xue Bao Yi Xue Ban. 2015 May;44(3):349-53. doi: 10.3785/j.issn.1008-9292.2015.05.18. Chinese.
- Background: PubMed 19860503Marques IL, Nackashi JA, Borgo HC, Martinelli AP, Pegoraro-Krook MI, Williams WN, Dutka JC, Seagle MB, Souza TV, Garla LA, Neto JS, Silva ML, Graciano MI, Moorhead J, Piazentin-Penna SH, Feniman MR, Zimmermann MC, Bento-Goncalves CG, Pimentel MC, Boggs S, Jorge JC, Antonelli PJ, Shuster J. Longitudinal study of growth of children with unilateral cleft-lip palate from birth to two years of age. Cleft Palate Craniofac J. 2009 Nov;46(6):603-9. doi: 10.1597/08-105.1. Epub 2009 May 16.
- Background: PubMed 23439590Martin V, Greatrex-White S. An evaluation of factors influencing feeding in babies with a cleft palate with and without a cleft lip. J Child Health Care. 2014 Mar;18(1):72-83. doi: 10.1177/1367493512473853. Epub 2013 Feb 25.
- Background: PubMed 16385363Montagnoli LC, Barbieri MA, Bettiol H, Marques IL, de Souza L. Growth impairment of children with different types of lip and palate clefts in the first 2 years of life: a cross-sectional study. J Pediatr (Rio J). 2005 Nov-Dec;81(6):461-5. doi: 10.2223/JPED.1420.
- Individual participant dataSharing planned: No. De-identified individual patient data only can be shared with other researchers, however the necessary contracting will be needed prior to any data can be shared.
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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.
Shao Jiang, MD principal investigator
Children's Mercy Hospital Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Weigh Easy System in people with Cleft Lip and Palate, run by Children's Mercy Hospital Kansas City 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 6 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 17 Jan 2023. 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?
Change in Weight (time frame: up to 3 months). 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 NCT04384276, which also lists 19 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 17 Jan 2023.