Breastfeeding, ExclusiveNCT04826796
Feasibility and Effectiveness of WhatsApp Online Group on Breastfeeding by Peer Counsellors.
A study testing WhatsApp peer support in people with Breastfeeding, Exclusive and Breastfeeding, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Due the uncertainty of the pandemic wave and government restrictions that may affect health care services and behaviour, alternative mhealth strategies should be explored to identify breastfeeding support or problems early to prevent subsequent cessation that may affect mother and child health. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Exclusive, Breastfeeding
- What is being tested?
- WhatsApp peer support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteHong Kong
- Study dates
- 5 Mar 2021to 31 Dec 2021
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Primiparous
- Intend to breastfeed
- had a singleton pregnancy
- had term infant (37-42 weeks gestation)
- Cantonese speakers
- Hong Kong residents
- had no serious medical or obstetrical complications
Who cannot join
- Infant is <37 weeks gestation
- Infant has an Apgar score <8 at five minutes
- Infant has a birthweight <2500 grams
- Infant has any severe medical conditions or congenital malformations
- Infant is placed in the special care baby unit for more than 48 hours after birth
- Infant is placed in the neonatal intensive care unit at any time after birth
Trial locations and contacts
1 site in 1 country.
About this study
Due the uncertainty of the pandemic wave and government restrictions that may affect health care services and behaviour, alternative mhealth strategies should be explored to identify breastfeeding support or problems early to prevent subsequent cessation that may affect mother and child health. It is also important to understand the feasibility of a WhatsApp online group on breastfeeding by peer counsellors during postnatal period and the acceptability of such intervention. Therefore this study will provide preliminary information necessary for implementation of a full RCT of mhealth intervention in the future. The aim of this study is to examine the feasibility and effectiveness of a WhatsApp online peer support group program in improving breastfeeding practices.
There have been no published studies that have examined the feasibility and acceptability of a Whatsapp online group on breastfeeding for postnatal women in Hong Kong. Given the significant pandemic problem that may affect health services and health behavior of pregnant women, the proposed study will contribute substantial new information about the feasibility and potential implications for future care pathways for postnatal women. Such information will be invaluable to public health professional working to breastfeeding promotion and to health policy makers in setting institutional policies.
Read the detailed description
Mobile health (mhealth) refers to delivering health care and health promotion through mobile devices [1]. Advances of mobile technologies have led to increased use of mhealth interventions for effective healthy infant feeding practices and breastfeeding promotion. A meta-analysis reviewed that mhealth significantly improved exclusive breastfeeding initiation, breastfeeding attitude and knowledge [2]. Whether more interactive and adaptive mHealth platforms, including smartphone apps and social networking tools, could further improve breastfeeding outcomes remains understudied. Smartphones have become new channels and tools for information acquisition and exchange and have been well adopted by the general public. In 2019, the number of smartphone users in Hong Kong was estimated to reach 6.5 million. By the year 2025, it is predicted that 93% of the population in Hong Kong will use a smartphone [3]. Among instant messaging apps for smartphones, WhatsApp is regarded as one of the largest social network platforms used in Hong Kong. WhatsApp is a free all in one communications app widely used for sending text and voice messages, video calls. Online discussion platforms have been used, acceptable, affordable and accessible in previous years for promoting physical activity [4], a healthy diet [5], smoking cessation [6] and reducing alcohol use [7]. Interventions using these communication tools tend to have high uptake due to personalized intervention and instant response without having time and location limitations. Whether WhatsApp can be used as a communication tool to positively change selected behaviours has yet to be assessed its effects on breastfeeding outcomes.
With the current pandemic and social distancing measures, this study offers insight on the practicality and feasibility of supporting Chinese mothers who are housebound due to Chinese traditional cultural "doing the month" in which Chinese mothers are housebound during the first month post-birth. In addition, due to the pandemic, there is limited face to face antenatal and postnatal support from the health services. Unresolved problems and inadequate support with infant feeding may result in a decision to stop exclusively breastfeeding. Our previous qualitative study suggested that WhatsApp messaging might be a viable way of promoting breastfeeding (unpublished data). Therefore, a pilot study is developed to address an important service gap in Hong Kong to promote and sustain exclusive breastfeeding. However, there might be potential barriers to successful implementation and to evaluating the effectiveness of the innovation intervention. This is the first WhatsApp breastfeeding support programme provided by peer supporters in Hong Kong. In Hong Kong, the most recent breastfeeding survey showed that the exclusive breastfeeding rate at 6 months was 26.3% in Hong Kong [8]. Furthermore, more than 88% of mothers initiated breastfeeding but half of breastfeeding mothers never exclusively breastfed their babies [8]. Despite the importance of exclusive breastfeeding for the first 6 months postpartum, the maintenance of exclusive breastfeeding is a major public health issue particularly in Hong Kong where the rate on exclusive breastfeeding duration indicated that it tailed off during the first 2 months [8]. This indicates novel approaches are needed to engage hard to reach mothers who encounter breastfeeding problems or support during the first 6 months.
Existing services mainly target mothers in clinical or primary care settings delivered by health professionals for promoting breastfeeding. Hong Kong has an extensive smartphone penetration rate (78% in 2020). Therefore, before proceeding with a full scale randomized controlled trial (RCT), a feasibility and pilot study is needed to identify if a WhatsApp online group on breastfeeding by peer counsellors, delivered through instant/video messaging support, designed to improve breastfeeding outcomes is feasible and acceptable. The main objective of the study is to determine the feasibility of conducting a WhatsApp online group on breastfeeding by peer counsellors over a six-month period in postpartum Chinese women in Hong Kong.
- Conditions
- Breastfeeding, Exclusive, Breastfeeding
- Being tested
- WhatsApp peer support
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WhatsApp peer supportBehavioural
Trained peer supporters will provide breastfeeding and emotional support for participants in the WhatsApp group.
| Study group | Role | What they receive |
|---|---|---|
| Whatsapp intervention group | Experimental | In addition to standard care, participants will be included into a peer support Whatsapp group on Whatsapp with other participants and trained peer supporters after study entry. Standard weekly prompt text messages will be sent to the group by peer supporters to encourage questions and discussion related to breastfeeding. Peer supporters will provide breastfeeding and emotional support. Intervention will last for 6 months after birth. Receives: Behavioral: WhatsApp peer support |
| Control group | No intervention | Participants in the control group will continue to receive standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in proportion of participants who are exclusively breastfeeding
The number of participants who are exclusively breastfeeding at each time point.
Measured: At 1, 2, 4, and 6 months postpartum
Change in proportion of participants who are any breastfeeding
The number of participants who are any breastfeeding at each time point.
Measured: At 1, 2, 4, and 6 months postpartum
Secondary outcomes (2)
Breastfeeding self-efficacy
Breastfeeding efficacy measured using Breastfeeding Self-Efficacy Scale - Short Form (BSES-SF). BSES-SF is a 14-item scale with total score ranging from 14 to 70. A higher score indicates higher breastfeeding self-efficacy.
Measured: At baseline and 2 month postpartum
Breastfeeding attitude
Attitude towards breastfeeding measured using the Iowa Infant Feeding Attitude Scale (IIFAS). IIFAS is a 17-item scale with total score ranging from 17 to 85. A higher score indicates a more favourable attitude towards breastfeeding.
Measured: At baseline and 2 month postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start5 Mar 2021
- Primary completion30 Apr 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Breastfeeding, ExclusiveStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kris Lok, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826796
- Sponsor's protocol ID
- BFPSW
- Status last verified
- Sep 2022
- First submitted
- 25 Mar 2021
- Last updated
- 21 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Premji S. Mobile health in maternal and newborn care: fuzzy logic. Int J Environ Res Public Health. 2014 Jun;11(6):6494-503. doi: 10.3390/ijerph110606494.
PubMed 25003177Lau Y, Htun TP, Tam WS, Klainin-Yobas P. Efficacy of e-technologies in improving breastfeeding outcomes among perinatal women: a meta-analysis. Matern Child Nutr. 2016 Jul;12(3):381-401. doi: 10.1111/mcn.12202. Epub 2015 Jul 21.
PubMed 26194599Statista. Available from: www.statista.com Access date 20-11-2020
Rovniak LS, Kong L, Hovell MF, Ding D, Sallis JF, Ray CA, Kraschnewski JL, Matthews SA, Kiser E, Chinchilli VM, George DR, Sciamanna CN. Engineering Online and In-Person Social Networks for Physical Activity: A Randomized Trial. Ann Behav Med. 2016 Dec;50(6):885-897. doi: 10.1007/s12160-016-9814-8.
PubMed 27405724Ahmad N, Shariff ZM, Mukhtar F, Lye MS. Family-based intervention using face-to-face sessions and social media to improve Malay primary school children's adiposity: a randomized controlled field trial of the Malaysian REDUCE programme. Nutr J. 2018 Aug 2;17(1):74. doi: 10.1186/s12937-018-0379-1.
PubMed 30071855Cheung YTD, Chan CHH, Ho KS, Fok WP, Conway M, Wong CKH, Li WHC, Wang MP, Lam TH. Effectiveness of WhatsApp online group discussion for smoking relapse prevention: protocol for a pragmatic randomized controlled trial. Addiction. 2020 Sep;115(9):1777-1785. doi: 10.1111/add.15027. Epub 2020 Mar 20.
PubMed 32107817Byrnes HF, Miller BA, Grube JW, Bourdeau B, Buller DB, Wang-Schweig M, Woodall WG. Prevention of alcohol use in older teens: A randomized trial of an online family prevention program. Psychol Addict Behav. 2019 Feb;33(1):1-14. doi: 10.1037/adb0000442. Epub 2019 Jan 14.
PubMed 30640504Department of Health. Breastfeeding Survey 2019. Available from: https://www.fhs.gov.hk/english/archive/files/reports/BF_survey_2019.pdf.
Fan HSL, Ho MY, Ko RWT, Kwok JYY, Chau PH, Wong JYH, Wang MP, Lok KYW. Feasibility and effectiveness of WhatsApp online group on breastfeeding by peer counsellors: a single-blinded, open-label pilot randomized controlled study. Int Breastfeed J. 2022 Dec 22;17(1):91. doi: 10.1186/s13006-022-00535-z.
PubMed 36544208Lok KY, Ko RW, Fan HS, Chau PH, Wong JY, Wang MP, Tsang V. Feasibility and Acceptability of an Online WhatsApp Support Group on Breastfeeding: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Mar 9;11(3):e32338. doi: 10.2196/32338.
PubMed 35262504
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Effectiveness of WhatsApp Online Group on Breastfeeding by Peer Counsellors.
- ClinicalTrials.gov ID
- NCT04826796
- Acronym / sponsor ID
- BFPSW
- Conditions
- Breastfeeding, Exclusive, Breastfeeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 1 Apr 2021 (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.
Due the uncertainty of the pandemic wave and government restrictions that may affect health care services and behaviour, alternative mhealth strategies should be explored to identify breastfeeding support or problems early to prevent subsequent cessation that may affect mother and child health. It is also important to understand the feasibility of a WhatsApp online group on breastfeeding by peer counsellors during postnatal period and the acceptability of such intervention. Therefore this study will provide preliminary information necessary for implementation of a full RCT of mhealth intervention in the future. The aim of this study is to examine the feasibility and effectiveness of a WhatsApp online peer support group program in improving breastfeeding practices.
There have been no published studies that have examined the feasibility and acceptability of a Whatsapp online group on breastfeeding for postnatal women in Hong Kong. Given the significant pandemic problem that may affect health services and health behavior of pregnant women, the proposed study will contribute substantial new information about the feasibility and potential implications for future care pathways for postnatal women. Such information will be invaluable to public health professional working to breastfeeding promotion and to health policy makers in setting institutional policies.
Detailed description
Mobile health (mhealth) refers to delivering health care and health promotion through mobile devices [1]. Advances of mobile technologies have led to increased use of mhealth interventions for effective healthy infant feeding practices and breastfeeding promotion. A meta-analysis reviewed that mhealth significantly improved exclusive breastfeeding initiation, breastfeeding attitude and knowledge [2]. Whether more interactive and adaptive mHealth platforms, including smartphone apps and social networking tools, could further improve breastfeeding outcomes remains understudied. Smartphones have become new channels and tools for information acquisition and exchange and have been well adopted by the general public. In 2019, the number of smartphone users in Hong Kong was estimated to reach 6.5 million. By the year 2025, it is predicted that 93% of the population in Hong Kong will use a smartphone [3]. Among instant messaging apps for smartphones, WhatsApp is regarded as one of the largest social network platforms used in Hong Kong. WhatsApp is a free all in one communications app widely used for sending text and voice messages, video calls. Online discussion platforms have been used, acceptable, affordable and accessible in previous years for promoting physical activity [4], a healthy diet [5], smoking cessation [6] and reducing alcohol use [7]. Interventions using these communication tools tend to have high uptake due to personalized intervention and instant response without having time and location limitations. Whether WhatsApp can be used as a communication tool to positively change selected behaviours has yet to be assessed its effects on breastfeeding outcomes.
With the current pandemic and social distancing measures, this study offers insight on the practicality and feasibility of supporting Chinese mothers who are housebound due to Chinese traditional cultural "doing the month" in which Chinese mothers are housebound during the first month post-birth. In addition, due to the pandemic, there is limited face to face antenatal and postnatal support from the health services. Unresolved problems and inadequate support with infant feeding may result in a decision to stop exclusively breastfeeding. Our previous qualitative study suggested that WhatsApp messaging might be a viable way of promoting breastfeeding (unpublished data). Therefore, a pilot study is developed to address an important service gap in Hong Kong to promote and sustain exclusive breastfeeding. However, there might be potential barriers to successful implementation and to evaluating the effectiveness of the innovation intervention. This is the first WhatsApp breastfeeding support programme provided by peer supporters in Hong Kong. In Hong Kong, the most recent breastfeeding survey showed that the exclusive breastfeeding rate at 6 months was 26.3% in Hong Kong [8]. Furthermore, more than 88% of mothers initiated breastfeeding but half of breastfeeding mothers never exclusively breastfed their babies [8]. Despite the importance of exclusive breastfeeding for the first 6 months postpartum, the maintenance of exclusive breastfeeding is a major public health issue particularly in Hong Kong where the rate on exclusive breastfeeding duration indicated that it tailed off during the first 2 months [8]. This indicates novel approaches are needed to engage hard to reach mothers who encounter breastfeeding problems or support during the first 6 months.
Existing services mainly target mothers in clinical or primary care settings delivered by health professionals for promoting breastfeeding. Hong Kong has an extensive smartphone penetration rate (78% in 2020). Therefore, before proceeding with a full scale randomized controlled trial (RCT), a feasibility and pilot study is needed to identify if a WhatsApp online group on breastfeeding by peer counsellors, delivered through instant/video messaging support, designed to improve breastfeeding outcomes is feasible and acceptable. The main objective of the study is to determine the feasibility of conducting a WhatsApp online group on breastfeeding by peer counsellors over a six-month period in postpartum Chinese women in Hong Kong.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whatsapp intervention group | Experimental | Behavioral: WhatsApp peer supportIn addition to standard care, participants will be included into a peer support Whatsapp group on Whatsapp with other participants and trained peer supporters after study entry. Standard weekly prompt text messages will be sent to the group by peer supporters to encourage questions and discussion related to breastfeeding. Peer supporters will provide breastfeeding and emotional support. Intervention will last for 6 months after birth. |
| Control group | No intervention | –Participants in the control group will continue to receive standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years of age or older
- Primiparous
- Intend to breastfeed
- had a singleton pregnancy
- had term infant (37-42 weeks gestation)
Key exclusion criteria (6 listed)
- Infant is <37 weeks gestation
- Infant has an Apgar score <8 at five minutes
- Infant has a birthweight <2500 grams
- Infant has any severe medical conditions or congenital malformations
- Infant is placed in the special care baby unit for more than 48 hours after birth
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 |
|---|---|---|
| WhatsApp peer supportTrained peer supporters will provide breastfeeding and emotional support for participants in the WhatsApp group. | Behavioural | Whatsapp intervention group |
Primary outcome
Change in proportion of participants who are exclusively breastfeeding
Time frame: At 1, 2, 4, and 6 months postpartum
The number of participants who are exclusively breastfeeding at each time point.
Change in proportion of participants who are any breastfeeding
Time frame: At 1, 2, 4, and 6 months postpartum
The number of participants who are any breastfeeding at each time point.
2 secondary outcomes
Breastfeeding self-efficacy
Time frame: At baseline and 2 month postpartum
Breastfeeding attitude
Time frame: At baseline and 2 month postpartum
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 21 Sep 2022.
- Background: PubMed 25003177Premji S. Mobile health in maternal and newborn care: fuzzy logic. Int J Environ Res Public Health. 2014 Jun;11(6):6494-503. doi: 10.3390/ijerph110606494.
- Background: PubMed 26194599Lau Y, Htun TP, Tam WS, Klainin-Yobas P. Efficacy of e-technologies in improving breastfeeding outcomes among perinatal women: a meta-analysis. Matern Child Nutr. 2016 Jul;12(3):381-401. doi: 10.1111/mcn.12202. Epub 2015 Jul 21.
- BackgroundStatista. Available from: www.statista.com Access date 20-11-2020
- Background: PubMed 27405724Rovniak LS, Kong L, Hovell MF, Ding D, Sallis JF, Ray CA, Kraschnewski JL, Matthews SA, Kiser E, Chinchilli VM, George DR, Sciamanna CN. Engineering Online and In-Person Social Networks for Physical Activity: A Randomized Trial. Ann Behav Med. 2016 Dec;50(6):885-897. doi: 10.1007/s12160-016-9814-8.
- Background: PubMed 30071855Ahmad N, Shariff ZM, Mukhtar F, Lye MS. Family-based intervention using face-to-face sessions and social media to improve Malay primary school children's adiposity: a randomized controlled field trial of the Malaysian REDUCE programme. Nutr J. 2018 Aug 2;17(1):74. doi: 10.1186/s12937-018-0379-1.
- Background: PubMed 32107817Cheung YTD, Chan CHH, Ho KS, Fok WP, Conway M, Wong CKH, Li WHC, Wang MP, Lam TH. Effectiveness of WhatsApp online group discussion for smoking relapse prevention: protocol for a pragmatic randomized controlled trial. Addiction. 2020 Sep;115(9):1777-1785. doi: 10.1111/add.15027. Epub 2020 Mar 20.
- Background: PubMed 30640504Byrnes HF, Miller BA, Grube JW, Bourdeau B, Buller DB, Wang-Schweig M, Woodall WG. Prevention of alcohol use in older teens: A randomized trial of an online family prevention program. Psychol Addict Behav. 2019 Feb;33(1):1-14. doi: 10.1037/adb0000442. Epub 2019 Jan 14.
- BackgroundDepartment of Health. Breastfeeding Survey 2019. Available from: https://www.fhs.gov.hk/english/archive/files/reports/BF_survey_2019.pdf.
- Derived from this study: PubMed 36544208Fan HSL, Ho MY, Ko RWT, Kwok JYY, Chau PH, Wong JYH, Wang MP, Lok KYW. Feasibility and effectiveness of WhatsApp online group on breastfeeding by peer counsellors: a single-blinded, open-label pilot randomized controlled study. Int Breastfeed J. 2022 Dec 22;17(1):91. doi: 10.1186/s13006-022-00535-z.
- Derived from this study: PubMed 35262504Lok KY, Ko RW, Fan HS, Chau PH, Wong JY, Wang MP, Tsang V. Feasibility and Acceptability of an Online WhatsApp Support Group on Breastfeeding: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Mar 9;11(3):e32338. doi: 10.2196/32338.
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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.
Kris Lok, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WhatsApp peer support in people with Breastfeeding, Exclusive and Breastfeeding, run by The University of Hong Kong at 1 site in Hong Kong.
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 21 Sep 2022. 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 Hong Kong. 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 proportion of participants who are exclusively breastfeeding (time frame: At 1, 2, 4, and 6 months postpartum). The study lists 2 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 NCT04826796, which also lists 10 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 21 Sep 2022.