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Confidentiality {27} | infection, fainting, bruising, pain | INFECTION | All participants will go through an informed consent process. The study staff will provide information for those who are interested in being tested but not interested in study participation. All potential clients will read or have read to them the consent form. The consent form will be available in both the local langu... | PMC9842495 |
Plans for collection, laboratory evaluation, and storage of biological specimens for genetic or molecular analysis in this trial/future use {33} | To ensure the confidentiality of participants, all data will be coded by subject number. Data recorded on paper will be kept in locked cabinets with access only by members of the research team. There will be strict limited access to electronically stored data as well, using password protection. Research records will be... | PMC9842495 | ||
Statistical methods | PMC9842495 | |||
Statistical methods for primary and secondary outcomes {20a} | Statistical analysis is summarized below. Additional details will be provided in a statistical analysis plan (SAP) prior to the analysis of the trial data. | PMC9842495 | ||
Primary outcome | viral suppression | REGRESSION | We will assess the contribution of lottery incentives to the primary outcome of viral suppression after 18 months by comparing outcomes for individuals in two of the embedded adaptive interventions—(i) start with best clinic practices and continue for 18 months and (ii) start with best clinic practices plus lottery inc... | PMC9842495 |
Secondary outcomes | viral suppression | REGRESSION, SECONDARY | The same analyses as outlined for the primary outcome of viral suppression will be repeated for the secondary outcomes of retention in care (defined as the proportion of clinical visits and medication refills missed over the last 12 months of the intervention) and time to ART initiation, where logistic regression will ... | PMC9842495 |
Testing for non-inferiority in addition to superiority | HIV viral suppression | SECONDARY | We hypothesize that community-based/home ART initiation will be acceptable and have a higher or comparable impact on the clinical outcome of HIV viral suppression compared to the standard clinic ART delivery model. For primary and secondary outcomes, we will first test for superiority. If the intervention is superior, ... | PMC9842495 |
Interim analyses {21b} | ADVERSE EVENTS | Interim analyses will include summaries of demographic data and whether participants were living with HIV who have a detectable viral load at enrollment or were not engaged in care at baseline. We will also summarize the numbers of adverse events and individuals lost to follow-up. All summaries will be conducted overal... | PMC9842495 | |
Methods for additional analyses (e.g., subgroup analyses) {20b} | viral suppression | REGRESSION, SECONDARY | We will conduct subgroup analyses for the primary and secondary outcomes where we separate individuals living with HIV who have a detectable viral load at enrollment and individuals not engaged in care at enrollment. We will conduct further subgroup analyses for all primary and secondary outcomes restricted to male/fem... | PMC9842495 |
Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c} | The primary analysis will be modified intent-to-treat (mITT) restricted to participants who are not lost to follow-up and have complete endpoint data at the 18-month follow-up (inclusion in the mITT analysis will be determined separately for each outcome). As a sensitivity study, we will repeat all analyses as intent-t... | PMC9842495 | ||
Plans to give access to the full protocol, participant-level data, and statistical code {31c} | Using a data sharing platform, a complete dataset with patient identifies removed that is sufficient to reproduce the study findings will be made available approximately 1 year after completion of the trial. To gain access, a concept sheet summarizing the analyses to be done will first need to be submitted to the princ... | PMC9842495 | ||
Oversight and monitoring | PMC9842495 | |||
Composition of the coordinating center and trial steering committee {5d} | The SMART ART study will be jointly led by Harvard University and the Center for Community Based Research, Human Sciences Research Council of South Africa. | PMC9842495 | ||
Composition of the data monitoring committee, its role, and reporting structure {21a} | viral suppression | ADVERSE EVENTS | We will constitute a Data Safety and Monitoring Board (DSMB) who will meet every 6 months to review the available study data. The analysis will evaluate participant safety (SAEs and social harms) and available endpoint data and review the operational factors, specifically participant enrollment and follow-up, to assess... | PMC9842495 |
Adverse event reporting and harms {22} | nausea and vomiting, tuberculosis, gastrointestinal disturbance | OPPORTUNISTIC INFECTIONS, ADVERSE EVENTS, TUBERCULOSIS, STIS, ADVERSE EFFECTS, ADVERSE EVENT, EVENTS | All participants who experience adverse events will receive follow-up until the adverse event is resolved. The SMART ART study clinical monitor, based at the University of Washington Coordinating Center, will review all severe (grade 3/4) and serious adverse events to ensure follow-up and reporting. Serious adverse eve... | PMC9842495 |
Frequency and plans for auditing trial conduct {23} | RECRUITMENT | The project management group will meet weekly to review key metrics including balanced randomization, screen to enrollment rate, weekly recruitment, and retention rates. This team will be supported by a Data Safety and Monitoring Board (DSMB) and Institutional Review Board (IRB). The DSMB will meet annually for about 2... | PMC9842495 | |
Plans for communicating important protocol amendments to relevant parties (e.g., trial participants, ethical committees) {25} | RECRUITMENT | Modifications to study protocol, informed consent forms, and recruitment materials will all be submitted for review to both the HSRC and Harvard IRBs. The study will be reviewed annually by both IRBs when relevant information about recruitment, enrolment, follow-up, AEs and SAEs, and protocol deviations and violations ... | PMC9842495 | |
Dissemination plans {31a} | TRANSMISSION | Our team of investigators is fully committed to rapid and multi-pronged dissemination of study results, regardless of the results. Through our previous HIV prevention trials (HPTN 039, Partners in Prevention HSV/HIV Transmission Study, and Partners PrEP Study), we have found that community and stakeholder consultations... | PMC9842495 | |
Discussion | death, DSD, viral suppression | DISEASE | Globally, more than half of the world’s 37 million people living with HIV are on antiretroviral therapy (ART) representing immense and encouraging success with access to HIV care. ART prevents disease, death, and HIV transmission and HIV-positive persons can expect to live as long as their HIV-negative peers when their... | PMC9842495 |
Trial status | RECRUITMENT | This protocol references version 1.2 from July 9, 2021. The first participant was screened on November 3, 2021. The first participant was enrolled on November 10, 2021. The study is expected to conclude recruitment on April 24, 2023, with all enrolled participants followed quarterly for 18 months thereafter. | PMC9842495 | |
Acknowledgements | This study would not be possible without the participants who agree to take part in this SMART trial, the hard work of the SMART ART study team (Xolani Ntinga—study coordinator; Thulani Ngubane—community programs and stakeholder manager; Phil Joseph—operations manager; Bomikazi Mthembu—data collector; Sive Sikhakhane—d... | PMC9842495 | ||
Authors’ contributions {31b} | ZE, AVH | RB and AVH conceived the study, led the proposal, and contributed to the protocol development. HVR, CC, and ZE contributed to the study design and development of the proposal. XN contributed to the development of protocol operation procedures. AS was the lead trial methodologist. The authors read and approved the final... | PMC9842495 | |
Funding {4} | Funding for this study was obtained from the US National Institutes of Health (R01MH124465T). | PMC9842495 | ||
Availability of data and materials {29} | Listed investigators have full access to the final dataset. The final dataset will be curated and made available on request. | PMC9842495 | ||
Declarations | PMC9842495 | |||
Ethics approval and consent to participate {24} | Ethics approval was received from all relevant authorities in South Africa including the Human Sciences Research Councils Research Ethics Committee (REC 6/19/05/21) and the Department of Health (KZ_202108_020). In the USA, IRB approval was obtained (STUDY00013492). Written informed consents to screen and enrol will be ... | PMC9842495 | ||
Consent for publication {32} | Not applicable—no identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results. Informed consent materials are from the corresponding author on request. | PMC9842495 | ||
Competing interests {28} | The authors declare that they have no competing interests | PMC9842495 | ||
References | PMC9842495 | |||
Abstract | PMC10028033 | |||
Background | cancer, depression, anxiety | CANCER | Parents of children treated for cancer may experience mental health difficulties, such as depression and anxiety. There is a lack of evidence‐based psychological interventions for parents, with psychological support needs unmet. An internet‐administered, guided, low‐intensity cognitive behavioral therapy‐based (LICBT) ... | PMC10028033 |
Methods | RECRUITMENT | The feasibility and acceptability of such an intervention was examined using a single‐arm feasibility trial (ENGAGE). Primary objectives examined: (1) estimates of recruitment and retention rates; (2) feasibility and acceptability of data collection instruments and procedures; and (3) intervention feasibility and accep... | PMC10028033 | |
Results | The following progression criteria were met: sample size was exceeded within 5 months, with 11.0% enrolled of total population invited, study dropout rate was 24.0%, intervention dropout was 23.6%, missing data remained at ≤10% per measure, and no substantial negative consequences related to participation were reported... | PMC10028033 | ||
Conclusion | cancer | CANCER, MINOR, RECRUITMENT, CHILDHOOD CANCER | Findings suggest an internet‐administered, guided, LICBT self‐help intervention may represent a feasible and acceptable solution for parents of children treated for cancer. With minor study protocol and intervention modifications, progression to a pilot randomized controlled trial (RCT) and subsequent superiority RCT i... | PMC10028033 |
INTRODUCTION | cancer | CANCER, CHILDHOOD CANCER | Advances in cancer treatment have resulted in increased childhood cancer survival rates worldwide.Solutions to increase access to psychological interventions are being implemented globally,A program of phase I (development) research, following the Medical Research Council complex interventions framework | PMC10028033 |
MATERIALS AND METHODS | The study protocol is published | PMC10028033 | ||
Study design | EJDeR | A single‐arm feasibility trial of a guided, internet‐administered LICBT‐based intervention (EJDeR), with data collected at baseline, post‐treatment (12 weeks), and follow‐up (6 months) with an embedded mixed‐methods process evaluation. EJDeR is delivered via the U‐CARE‐portal (Portal), a web‐based platform, designed to... | PMC10028033 | |
Participants | CHILDHOOD CANCER | Eligible participants were: (1) parent of a child diagnosed with childhood cancer (0–18 years) who completed treatment 3 months to 5 years previously (timespan informed by our previous longitudinal research that has identified this as a time period of vulnerability for parents) | PMC10028033 | |
Recruitment | PMC10028033 | |||
Postal study invitations | CHILDHOOD CANCER, RECRUITMENT | Personal identification numbers of children who had completed treatment 3 months to 5 years previously were provided by the Swedish Childhood Cancer Registry (CCR), and linked to parents' names and addresses via NAVET, a population registry from the Swedish Tax Agency. The first recruitment block was pre‐selected with ... | PMC10028033 | |
Online advertisements | cancer | CANCER | Advertisements were placed on social media sites, websites, and newsletters of 12 cancer organizations and interest groups. | PMC10028033 |
Opt‐out and reminders | Parents invited via the post could opt‐out of ENGAGE via the Portal, post, telephone, or e‐mail. Up to five reminder telephone contact attempts were made if parents did not respond within 4 weeks of invitation. Telephone numbers were identified using internet search engines. Contact attempts were documented in paper‐ba... | PMC10028033 | ||
Reasons for non‐participation | Parents opting out of ENGAGE were asked to complete a reason for non‐participation questionnaire including a closed, multiple choice question and an open question for other reason(s). | PMC10028033 | ||
Consent, eligibility, and baseline | PTSS, Anxiety, psychiatric, Stress Disorder, Depression, Fatigue | DISORDER, RECURRENCE, DISORDERS | Parents provided consent via the Portal. Parents who registered interest in participation but did not provide consent, or opt out, within 2 weeks, were contacted to confirm interest in participation (maximum five reminders via telephone, SMS or e‐mail).Parents providing consent were contacted to organize a telephone el... | PMC10028033 |
Intervention | depression, anxiety disorder, EJDeR | The EJDeR protocol is published following the Template for Intervention Description and Replication (TIDieR) checklist.EJDeR is a guided internet‐administered LICBT intervention delivered over 12 weeks on the Portal and includes text, illustrations, film, audio files, in‐module exercises, and homework exercises. EJDeR ... | PMC10028033 | |
Outcomes | semi‐structured, suicidality, Semi‐structured, psychiatric disorders | Feasibility outcomes are informed by the CONSORT 2010 statement extension for randomized pilot and feasibility trials,Overview of feasibility outcomes, methods of evaluation, and progression criteriaPercentage completing assessmentsM.I.N.I. (eligibility interview, post‐treatment, and follow‐up)Semi‐structured interview... | PMC10028033 | |
Sample size | Following recommendations for feasibility trial sample sizes the target sample size was 50. | PMC10028033 | ||
Double data entry | Paper‐based CRFs were used for data collected outside the Portal, with data independently entered onto a Microsoft® Access database by two research assistants, exported into Microsoft® Excel spreadsheets, with accuracy checked using Microsoft® Spreadsheet. | PMC10028033 | ||
Reminders | A prompt (SMS and/or e‐mail) was sent when it was time to complete Portal assessments with automatic reminders (SMS and/or e‐mail) sent if not completed within 1 week. Participants who did not complete Portal assessments within 2 weeks, were offered to complete over the telephone, with up to six reminder attempts made ... | PMC10028033 | ||
Participant adherence | The minimum treatment dose (MTD) (i.e., full intervention adherence) was defined as: (1) attendance of the initial assessment session; (2) completion of the introduction and psychoeducation module; (3) completion of one LICBT module (BA or WM); and (4) attendance of the mid‐intervention booster session. | PMC10028033 | ||
E‐therapist adherence | A 15% random sample of initial assessment and mid‐intervention booster sessions and written messages via the Portal from e‐therapists were marked for adherence, with each item within the structured support protocols marked as absent/present. | PMC10028033 | ||
Statistical methods | RECRUITMENT | Feasibility outcomes relating to recruitment and eligibility, data collection, attrition, resources needed to complete the study and the intervention, participants' adherence to the intervention, participants' use of the intervention, e‐therapists' adherence to the intervention, and participants' sociodemographic chara... | PMC10028033 | |
Risk and safety procedures | depression | Participants scoring >0 on PHQ‐9 (depression) question 9 (suicidal ideation), or a total score >20 (severe depression) were risk assessed by a licensed psychologist within one working day. If needed, participants were directed to appropriate support and excluded. | PMC10028033 | |
Public involvement | cancer | CANCER | A Parent Research Partner (PRP) group was established consisting of four parents with lived experience of being a parent of a child treated for cancer (two fathers and two mothers, aged between 45 and 54 years of age). The PRP group was involved in optimizing the acceptability of EJDeR e.g., relevancy, ease of understa... | PMC10028033 |
RESULTS | RECRUITMENT | Data supporting feasibility objectives pertaining to recruitment and eligibility, data collection, attrition, and resources needed to complete the study and intervention are available in Zenodo. | PMC10028033 | |
Recruitment and eligibility | PTSD | DISORDER, REMISSION | Participant flow is summarized in an adapted CONSORT diagram (Figure Study flow of participants in the ENGAGE feasibility trial. Solid black lines denote participant flow through the study, including study drop outs i.e., those who discontinued the study. Dashed gray lines represent participants that were lost to follo... | PMC10028033 |
Sociodemographic and clinical characteristics | Baseline sociodemographic and clinical characteristics for participants (Baseline sociodemographic and clinical self‐report characteristics for participants (
Multiple responses possible.Participants' internet usage is reported in Table | PMC10028033 | ||
Data collection | Data collection (baseline, post‐treatment, and follow‐up) took place between 24‐07‐2020 and 04‐10‐2021. Percentage completing assessments at each time‐point are reported in Table Number and percentages of participants completing assessments of the total study sample (Total sample defined as all participants enrolled in... | PMC10028033 | ||
Attrition | In total, 18/75 (24.0% [95%CI, 14.9–35.3]) of participants enrolled into the study dropped out of the study, bettering progression criteria (≤30%). In total, 17/72 (23.6% [95%CI, 14.4–35.1]) of participants gaining access to EJDeR, dropped out of EJDeR, bettering progression criteria (≤30%). | PMC10028033 | ||
Resources needed to complete the study and the intervention | Length of time for participants to work through EJDeR and complete assessments at each time‐point are provided in Table Seventy‐two participants gained access to EJDeR and 71 were allocated to an e‐therapist (one dropped out before allocation). Psychology program students (Difficulties recruiting research personnel was... | PMC10028033 | ||
Participants' adherence to intervention | Seventy‐two participants gained access to EJDeR. One was excluded shortly after access (severe and enduring mental health difficulty) and 34/71 (47.9%) adhered to the MTD, nearly meeting progression criteria of 50%. The mean number of modules opened was 2.3 (SD 0.9, range, 1–4), parents completed a mean of 1.7 modules ... | PMC10028033 | ||
Participants' use of the intervention | SD | A mean of 20 participant logins were made (SD 14.9, range, 1–72). A mean of 8.5 participant written messages were sent to e‐therapists (SD 7.6, range, 0–33), and a mean of 28.8 e‐therapist written messages (SD 16.3, range, 0–74) were sent to participants. | PMC10028033 | |
E‐therapists' adherence to intervention | Adherence rates were 90.5% for initial assessment sessions, 85.2% for mid‐intervention booster sessions, and 87.5% for written communication between participants and e‐therapists. | PMC10028033 | ||
Participants' acceptability of the intervention and data collection | Reasons for study dropout are reported in Figure | PMC10028033 | ||
Psychological and health economics outcomes | PTSS, Anxiety, Stress Disorder, Depression, Fatigue | DISORDER, RECURRENCE | M.I.N.I. data at baseline, post‐treatment, and follow‐up are provided in Table Treatment outcomes at baseline, post‐treatment, and follow‐up with change scoresAbbreviations: AAQ‐6, Acceptance and Action Questionnaire; BADS, Behavioral Activation for Depression Scale; EQ‐5D, EuroQol 5‐dimension questionnaire; EQ‐5D VAS,... | PMC10028033 |
DISCUSSION | cancer, depression, depressive, anxiety | CANCER | The ENGAGE feasibility trial demonstrated it is possible to recruit and retain parents of children treated for cancer into a single‐arm feasibility trial of an internet administered, guided, LICBT based, self‐help intervention. In summary: (1) 12.0% of invited parents consented and 11.0% of invited parents were enrolle... | PMC10028033 |
Strengths and limitations | cancer, TIDieR | CANCER | To the best of our knowledge, ENGAGE is first trial worldwide designed to test the feasibility of an internet administered, guided, LICBT based, self‐help intervention for parents of children treated for cancer. Robust methods examined a range of feasibility objectives, alongside a priori specified progression criteria... | PMC10028033 |
Interpretation and implications for future research | cancer | CANCER, RECRUITMENT | While we successfully recruited our target sample size with an enrolment rate of 11.0%, confidence intervals ranged from 8.4% to 14.1% and in a future pilot RCT we will continue to identify participants via additional sources such as cancer organizations and interest groups. Further, we targeted parents of children tre... | PMC10028033 |
CONCLUSIONS | RECRUITMENT | Using robust methods, including a priori specified progression criteria, the use of novel recruitment strategies | PMC10028033 | |
AUTHOR CONTRIBUTIONS | PMC10028033 | |||
FUNDING INFORMATION | Cancer | CHILDHOOD CANCER, CANCER | This work is supported by the Swedish Research Council (grant number 521‐2014‐3337/E0333701, 2018‐02578, and 2021‐00868), the Swedish Cancer Society (grant number 15 0673 and 17 0709), the Swedish Childhood Cancer Foundation (grant number PR2017‐0005), and funding via the Swedish Research Council to U‐CARE, a Strategic... | PMC10028033 |
CONFLICTS OF INTEREST | Declaration of interest: none. | PMC10028033 | ||
ETHICS APPROVAL STATEMENT | The ENGAGE feasibility trial was approved by the Regional Ethical Review Board in Uppsala, Sweden (Dnr: 2017/527) and was conducted in accordance with the Helsinki Declaration, ensuring the welfare and rights of all participants, and Good Clinical Practice (GCP) guidelines. Ethical amendment was obtained from Swedish E... | PMC10028033 | ||
PATIENT CONSENT STATEMENT | Not applicable. | PMC10028033 | ||
PERMISSION TO REPRODUCE MATERIAL FROM OTHER SOURCES | Not applicable. | PMC10028033 | ||
TRIAL REGISTRATION | ISRCTN 57233429. | PMC10028033 | ||
Supporting information |
Data S1
Click here for additional data file. | PMC10028033 | ||
ACKNOWLEDGMENTS | We wish to thank Ian Horne (Portal team member) for performing all data extractions on the Portal. We thank data coordinator Agnes von Essen for assistance with data entry, data processing, and data organization. We also thank the e‐therapists and clinical psychologists who facilitated intervention delivery and data co... | PMC10028033 | ||
DATA AVAILABILITY STATEMENT | RECRUITMENT | Data supporting feasibility objectives pertaining to recruitment and eligibility, data collection, attrition, and resources needed to complete the study and intervention are available in Zenodo at | PMC10028033 | |
REFERENCES | PMC10028033 | |||
Abstract | Ruilin Meng and Haofeng Xu are joint first authors. | PMC10076092 | ||
Background | Drowning, death | Drowning is the leading cause of death for children under the age of 15 years in Guangdong Province, China. This serious public health issue also exists in low- and middle-income countries (LMICs), which have few value-integrated intervention programs. The current study presents an integrated intervention project that ... | PMC10076092 | |
Methods | We conducted a cluster randomized controlled trial by comparing the incidence of non-fatal drowning among children in two groups in rural areas of southern China. We recruited the participants in two phases and reached a total of 10 687 students from 23 schools at two towns in Guangdong Province, China. At the first an... | PMC10076092 | ||
Results | The final evaluation questionnaires were collected after 18 months of integrated intervention, where we obtained 9791 data from Grades 3–9. The incidence of non-fatal drowning between the intervention and control groups after intervention did not differ significantly from the baseline according to the total number of s... | PMC10076092 | ||
Conclusions | The integrated intervention exerted a significant impact on the prevention and management of child non-fatal drowning, especially in rural areas. | PMC10076092 | ||
INTRODUCTION | death | DISEASE | The disease burden of child drowning remains at a high level, such that it is among the top 10 leading causes of death among children and young people worldwide [The rates of child drowning exhibited a continuing decline in high-income countries (HICs). Prevention strategies in view of the peculiar characteristics of c... | PMC10076092 |
METHODS | Based on the mortality surveillance data for Guangdong Province, we conducted a study in two rural townships in Qingyuan City, namely, Jintan and Longjing, which feature abundant nature and man-made bodies of water and high mortality rates due to drowning. We used the cluster random sampling strategy to assign the two ... | PMC10076092 | ||
Participant and public involvement | DISEASE | The development of the research questionnaire and outcome measures was informed by a study by Ma, The study recruited 8966 and 1721 students for two phases, respectively, for a total of 10 687. At the second phase of the study, 896 (544 and 352 students from the intervention and control groups, respectively) were exclu... | PMC10076092 | |
Integrated intervention | DISEASE, CROSS | This program was implemented from July 2014 to December 2016. The intervention group received the integrated intervention, which included systematic health education, community actions, policies promotion strategies and environmental improvement (Components of integrated intervention and measurement timesFurthermore, a... | PMC10076092 | |
Data collection and analysis | death, respiratory impairment | RESPIRATORY IMPAIRMENT | The study conducted baseline and final evaluation surveys for both groups. The design of the questionnaire was based on a previous study conducted on child drowning prevention [The study used the same questionnaire with the same definition of drowning for both groups in a double-blind method by investigators. According... | PMC10076092 |
RESULTS | The study obtained a total of 8317 questionnaires from students in Grades 3–8 at baseline; the average ages [standard deviation (SD)] were 12.5 (1.9; Baseline characteristics of students in the two groupsFor the final evaluation survey, the study obtained a total of 9757 responses from students in Grades 3–9 (control g... | PMC10076092 | ||
Incidence of non-fatal drowning | At baseline, the intervention group displayed a higher incidence rate for non-fatal drowning in terms of the total number of students, male students, female students and Grades 3–5 than that of the control group (
The primary outcome at 18-month follow-up of the integrated intervention | PMC10076092 | ||
Changes in awareness and risk behaviours related to non-fatal drowning | By the end of the study, awareness and risk behaviours displayed positive benefits (0.27; 95% CI: [0.21, 0.33]; | PMC10076092 | ||
DISCUSSION | death, drowning | EVENTS, DISEASE | In China, drowning mortality in 2017 was higher than the global average despite the substantial decline in the disease burden of drowning from 1990 to 2015 [Analysis suggested that integrated intervention could reduce the incidence of non-fatal drowning among younger students. Alternatively, the results implied signifi... | PMC10076092 |
CONCLUSION | The program of the integrated intervention for drowning prevention of non-fatal drowning among younger students has increased awareness and reduced risk behaviours associated with child drowning. The study explored an effective pattern for the integrated prevention of child drowning in LMICs. | PMC10076092 | ||
ACKNOWLEDGEMENTS | NON-COMMUNICABLE DISEASE, DISEASE | The project was conducted under the support of the National Centre for Non-communicable Disease Control and Prevention, Qingyuan City Centre for Disease Control and Prevention and Qingxin District Centre for Disease Control and Prevention. The authors would like to acknowledge their field work and contribution. | PMC10076092 | |
AUTHOR CONTRIBUTIONS | Ruilin Meng (Data curation [lead], Investigation [lead], Project administration [lead], Software [equal], Writing—original draft [lead]), Haofeng Xu (Data curation [supporting], Investigation [lead], Project administration [lead]), Mingqu Zhang (Data curation [supporting], Investigation [supporting], Project administra... | PMC10076092 | ||
ETHICS APPROVAL AND CONSENT TO PARTICIPATE | The study was approved by Ethical Review Committee of NCNCD, China CDC. The study is no ethics committee approval ID. Informed consent was obtained from all subjects, if subjects were under 16, from a parent or legal guardian. All methods were carried out in accordance with relevant guidelines and regulation. | PMC10076092 | ||
FUNDING | NON-COMMUNICABLE DISEASE | This project was funded by the National Centre for Chronic Non-communicable Disease Control and Prevention and Health Commission of Guangdong Province. There is no award/grant number for this project. | PMC10076092 | |
DATA AVAILABILITY | The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. | PMC10076092 |
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