Understanding the pubertal, psychosocial, and cognitive developmental trajectories of stunted and non-stunted adolescents: protocol of a multi-site Indonesian cohort study.

Background: The prevalence of stunting among Indonesian children aged 5-12 years decreased from 30.7% in 2013 to 23.6% in 2018 but has remained among the highest rates worldwide. Furthermore, Indonesian children were shorter than the standard reported by the World Health Organization and experienced obesity. The Indonesian government has created many programs to reduce stunting in children under the age of 5 years. An early preventive strategy is necessary because stunting can manifest within the initial 1,000 days of life, including during pregnancy. Therefore, a newer perspective, such as that achieved by addressing stunting in adolescents, has been deemed useful, given that adolescents are in their pubertal stage and are undergoing lifestyle changes. This cohort study was designed to measure these factors comprehensively in stunted and non-stunted children as they pass through adolescence. Methods: For the prospective cohort, 560 individuals will be recruited from DKI Jakarta, DI Yogyakarta, and East Java. The participants will be categorized into stunted and non-stunted groups, then undergo annual examinations in which key objectives, such as weight, height, and body mass index ,will be assessed for the growth profile; waist circumference, middle-upper arm circumference, hand-grip strength, body fat percentage, and food intake will be evaluated in a nutritional assessment; psychosocial and mental issues will be evaluated according to behavioral problems, symptoms of depression, quality of life, sleep patterns, anxiety disorders, and parenting style through the use of specific questionnaires; and pubertal stage will be assessed using a self-report questionnaire. Some cross-sectional data, such as cognitive performance, hair zinc levels, vitamin D levels, bone mineral density, and bone age, will also be included. All the outcomes will be analyzed in accordance with the variable types. Discussion: This study provides a thorough dataset of Indonesian adolescents encompassing several elements, such as growth, nutrition, psychosocial wellbeing, mental health, and pubertal development, for both stunted and non-stunted individuals. The data acquired from this study can be used to formulate policies to prevent stunting through targeted interventions for adolescents. Finally, a better understanding of adolescent health could lead to improved strategies to decrease the number of stunted individuals in the next Indonesian generation.

Validity and reliability test of the Indonesian version of the PedHALshort questionnaire.

INTRODUCTION: The PedHAL questionnaire is employed in measuring the activities of haemophilia children. The PedHALshort was developed in 2022 to determine the most relevant item for the assessment. Haemo-QoL questionnaire assesses the quality of life of haemophilia children. AIM: Determine the validity and reliability of the PedHALshort Indonesia language version compared to the Haemo-QoL in the Indonesian population. METHODS: A cross-sectional study was conducted in Jakarta, Indonesia. The subjects were children (4-16 years old) with moderate or severe haemophilia A or B with repeated joint bleeding. The daily activity was assessed using the PedHALshorts and Haemo-QoL. The validity and reliability were tested. The validity was determined with Pearson correlation test, construct validity was assessed using convergent and discriminant validity. The Spearman correlation was used to determine which domains of Haemo-QoL correlated with PedHALshort. The reliability was analyzed using test-retest reliability. Cronbach's α was used to determined internal consistency. RESULTS: Fifty children were included in the study (78% haemophilia A, 70% severe group). All domains were valid (r > .284). The convergent validity test showed PedHALshort had a moderate negative correlation with physical health and sports school domain of Haemo-QoL (r = -.479, p < .001). The discriminant validity test showed the PedHALshort demonstrated a moderate negative correlation with physical health (r = -.585), view (r = -.590), sport school domain (r = -.430) in severe haemophilia subjects. The internal consistency of the PedHALshort questionnaire was high (Cronbach's α of .85 (.74-.92)). CONCLUSION: The PedHALshort is valid and reliable, hence, it can be used to measure the functional physical activity of children with haemophilia.

Immunogenicity Assessment of the SARS-CoV-2 Protein Subunit Recombinant Vaccine (CoV2-IB 0322) in a Substudy of a Phase 3 Trial in Indonesia.

BACKGROUND: COVID-19 is one of the most devastating pandemics of the 21st century. Vaccination is one of the most effective prevention methods in combating COVID-19, and one type of vaccine being developed was the protein subunit recombinant vaccine. We evaluated the efficacy of the CoV2-IB 0322 vaccine in Depok, Indonesia. METHODS: This study aimed to assess the humoral and cellular immune response of the CoV2-IB 0322 vaccine compared to an active control vaccine (COVOVAX™ Vaccine). A total of 120 subjects were enrolled and randomized into two groups, with 60 subjects in each group. Participants received either two doses of the CoV2-IB 0322 vaccine or two doses of the control vaccine with a 28-day interval between doses. Safety assessments were conducted through onsite monitoring and participant-reported adverse events. Immunogenicity was evaluated by measuring IgG anti-RBD SARS-CoV-2 and IgG-neutralizing antibodies. Cellular immunity was assessed by specific T-cell responses. Whole blood samples were collected at baseline, 14 days, 6 months, and 12 months after the second dose for cellular immunity evaluation. RESULTS: Both vaccines showed high seropositive rates, with neutralizing antibody and IgG titers peaking 14 days after the second dose and declining by 12 months. The seroconversion rate of anti-S IgG was 100% in both groups, but the rate of neutralizing antibody seroconversion was lower in the CoV2-IB 0322 vaccine group at 14 days after the second dose (p = 0.004). The CoV2-IB 0322 vaccine showed higher IgG GMT levels 6 and 12 months after the second dose (p < 0.001 and p = 0.01). T-cell responses, evaluated by IFN-γ, IL-2, and IL-4 production by CD4+ and CD8+ T-cells, showed similar results without significant differences between both groups, except for %IL-2/CD4+ cells 6 months after the second dose (p = 0.038). CONCLUSION: Both vaccines showed comparable B- and T-cell immunological response that diminish over time.

Immunization Simulation Using Actual-Size Infant Manikins for Medical Students in Indonesia: A Quasi-Experimental Study.

INTRODUCTION: Manikins are tools used in simulation training for medical students to develop important skills, one of which is immunization. However, conventional manikins often do not resemble the actual size of an infant's arm or leg. This study aimed to determine the impact of using actual-size manikins on students' knowledge and practical skills, evaluate their confidence in immunization practice, and assess students' responses and feedback regarding the practice using actual-size manikins. METHODS: This was a quasi-experimental study involving medical students at the Faculty of Medicine, Universitas Indonesia, from October 2020 to April 2021. Students in the intervention group used newly developed actual-size infant arm and leg manikins, while the control group used conventional manikins. All students underwent the objective structured clinical examination (OSCE) and the scores were compared between the 2 groups. Within the intervention group, data on pretest and posttest scores, feedback questionnaires, and self-confidence assessments were also obtained and analyzed. RESULTS: A total of 205 students were included. Statistically significant difference was found in the OSCE scores between the intervention and control groups (P < 0.01). Students in the intervention group (n = 108) showed significant improvement in knowledge scores after the workshop (P < 0.01). Most students (81.7%) expressed confidence in administering vaccines to live patients after practicing with manikins. In addition, 98.2% of students (n = 107) acknowledged the benefits of practicing with actual-size manikins in accurately determining the injection sites. CONCLUSIONS: Simulation with the actual-size manikins significantly improved students' knowledge and practical immunization skills, leading to increased confidence and competence in their immunization skills.

Seroconversion among children with HBsAg-positive mothers in Indonesia and factors affecting the anti-HBs titers.

Background and aim: Around 2% of newborns are at risk of hepatitis B virus (HBV) infection from their mothers. To prevent this, infants born to HBsAg-positive mothers are given hepatitis B immune globulin (HBIG) and hepatitis B (HB) vaccine as immunoprophylaxis. This study aims to investigate the efficacy of immunoprophylaxis in infants born to HBsAg-positive mothers and the contributing factors. Methods: The study was conducted on a group of 87 children, ranging from nine months to under 36 months, born to HBsAg-positive mothers and received immunoprophylaxis within 24 h after birth followed by a national immunization schedule at the Community Health Center (CHC) in three administrative cities of DKI Jakarta. We measured the levels of HBsAg and anti-HBs, and utilized ordinal logistic regression models to identify factors that influence the anti-HBs titers after vaccination. Results: Out of 87 children, only one child had positive HBsAg results. The data showed that 88.5% of the children had seroprotection with anti-HBs levels ≥10 mIU/mL. Additionally, 48.3% of the children had a high protective response with anti-HBs levels ≥100 mIU/mL, while 11.5% had a non-protective response. Children under one year of age, with a family history of HBV carriers, and who received five doses of the HB vaccine exhibited higher levels of anti-HBs titer category with adjusted OR 3.9 (95%CI: 1.3-11.6), 5.3 (95%CI: 1.1-27.4), and 8.3 (95%CI: 2-34.8), respectively. Conclusion: The administration of HBIG and HB vaccine successfully prevented vertical transmission, resulting in a high seroprotection rate.

A phase II clinical trial of a Vi-DT typhoid conjugate vaccine in healthy Indonesian adolescents and adults: one-month evaluation of safety and immunogenicity.

BACKGROUND: Typhoid fever is commonly found until today, especially in developing countries. It has fatal complications and measures must be taken to reduce the incidence of typhoid. Vaccinations are a key factor in prevention. This is a phase II randomized observer-blind clinical trial on a novel Vi-DT conjugate vaccine on 200 subjects 12 to 40 years of age. METHODS: Subjects were screened for eligibility after which a blood sample was taken and one dose of vaccine was administered. Investigational vaccine used was Vi-DT and control was Vi-PS. Twenty-eight days after vaccination, subjects visited for providing blood sample to assess immunogenicity and were asked about local and systemic adverse reactions that occurred in the first 28 days. RESULTS: Subjects had minor adverse reactions. Pain was the most common local reaction. Muscle pain was the most common systemic reaction. There were no serious adverse events up to 28 days post vaccination. Seroconversion rates were 100% in the Vi-DT group and 95.96% in the Vi-PS group. Post vaccination GMTs were increased in both groups but it was significantly higher in the Vi-DT group (p < 0.001). CONCLUSIONS: Vi-DT typhoid conjugate vaccine is safe and immunogenic in healthy Indonesian subjects 12 to 40 years. TRIAL REGISTRATION: Approved by ClinicalTrials.gov. CLINICAL TRIAL REGISTRATION NUMBER: NCT03460405. Registered on 09/03/2018. URL: https://clinicaltrials.gov/ct2/show/NCT03460405 .

Safety profile of inactivated COVID-19 in healthy adults aged ≥ 18 years: A passive surveillance in Indonesia.

Coronavirus Disease 2019 (COVID-19) vaccination in Indonesia has shown effectiveness in reducing the morbidity and mortality of Covid-19. The study aims to evaluate the incidence rate and severity of Adverse Events Following Immunization (AEFI) of inactivated SARS-CoV-2 vaccine during the first quarter of 2021 until the second quarter of 2022 in Indonesia. More than two hundred million Sinovac/CoronaVac were given from January 13th, 2021, until June 30th, 2022. Data for this study were collected manually and electronically from the national vaccine safety website managed by the National Committee (NC) of AEFI Indonesia and the Ministry of Health Indonesia. The total number of injections observed in the study was 264,311,992 doses consisting of 142,449,795 (first dose), 121,613,324 (second dose), and 248,873 (booster dose). Of the injections given, 301 subjects with Serious AEFIs (SAE) and 10.261 subjects with non-serious AEFIs (AE) reported, with a majority of SAE and AEs found in the first dose. Most of the SAEs were classified as coincidental events by the NC AEFI (IR 0.8/1 million doses on first dose injection; 0.31 on second dose injection). ISRR (immunization stress-related response) is in the second rank of SAEs reported (0.59 IR/1 million doses on the first dose; 0.14 on the second dose). The incidence rate of SAEs and AEs, both in the variable of age, sex, and symptoms per 1 million dose injections in Indonesia, was very rare according to WHO guidelines. Most SAEs were classified as coincidences or unrelated to the vaccine. The result showed that the Sinovac/CoronaVac in Indonesia is safe.

The efficacy and safety of first-line anti-seizure medications as substitution therapy for children with drug-resistant epilepsy: a randomized controlled trial protocol.

Although many anti-seizure medications (ASMs) are available, treatment failure, known as drug-resistant epilepsy (DRE), still occurs in around 30% of children with epilepsy. Second-line ASMs are usually used as substitution therapy in DRE to control seizures, although international consensus is not available yet. Previous studies focus on comparing the ASMs, whether as add-on or substitution therapy, mainly conducted in newly diagnosed epilepsy. However, the study that investigated first-line ASMs as substitution therapy compared to second-line ones, particularly among DRE children, is still lacking. A randomized controlled trial (RCT) enrolling 102 participants, aged 1-18, at three referral hospitals in Indonesia will be conducted, dividing them into intervention and control groups. The intervention group will be treated with first-line ASMs as the substitution therapy, while the other in the control group will get second-line ASMs. The primary outcome measure is the proportion difference of responders between groups who get first-line and second-line ASMs in 14 weeks of intervention. Clinical trial registration: ClinicalTrials.gov, identifier NCT05697614.

Safety profile of inactivated COVID-19 vaccine in indonesian adults.

Background: Vaccines are urgently needed to handle the morbidity and mortality of the COVID-19 pandemic in Indonesia. The inactivated vaccine is widely used in Indonesia's national immunization program due to its eligibility of stock, easier to transport, and considered to be more established than newer platforms. In this study, we aimed to evaluate the safety profile of the inactivated vaccine and analyze the safety profile between adults and the elderly. Methods: A prospective analytical study was conducted to evaluate the safety profile of inactivated COVID-19 vaccine among healthy adults aged ≥ 18 years from September 2nd to December 28th, 2021, at ten primary health centers from 5 districts in Jakarta, Indonesia. The participants were instructed to record the symptoms after inactivated COVID-19 vaccine injection in the diary card for 28 days. Chi-square tests were carried out to analyze the relationship between the adverse event following immunization (AEFI) in adults and elderly groups. Results: Four of 1113 participants were not included in this study due to the lack of follow-up. Out of 1109 participants, there were 1044 adults (18-59 years) and 65 elderly (>59 years). There were no serious AEFI cases reported. Most AEFI cases were mild to moderate and resolved after several days of injection. Local pain, myalgia and fatigue were the most frequent adverse events reported. We found that there was no correlation between the adults and elderly age group with the incidence of AEFI (p = 0.924) for local reactions (p = 0.181) and most of the systemic reactions (p = 0.629). However, there is an increased risk of fever in the elderly group compared to the adult group (OR 4.046, 95 % CI 1.794-9.124, p = 0.003) following immunization. Conclusions: Our study demonstrated that the inactivated COVID-19 vaccine is safe, considering that all symptoms experienced were mild to moderate and resolved entirely.

Evaluating the Efficacy of a Social Media-Based Intervention (Warna-Warni Waktu) to Improve Body Image Among Young Indonesian Women: Parallel Randomized Controlled Trial.

BACKGROUND: Body dissatisfaction is a global issue, particularly among adolescent girls and young women. Effective body image interventions exist but face barriers to scaling up, particularly in lower- and middle-income countries, such as Indonesia, where a need exists. OBJECTIVE: We aimed to evaluate the acceptability and efficacy of Warna-Warni Waktu, a social media-based, fictional 6-episode video series with self-guided web-based activities for improving body image among young Indonesian adolescent girls and young women. We hypothesized that Warna-Warni Waktu would increase trait body satisfaction and mood and decrease internalization of appearance ideals and skin shade dissatisfaction relative to the waitlist control condition. We also anticipated improvements in state body satisfaction and mood immediately following each video. METHODS: We conducted a web-based, 2-arm randomized controlled trial among 2000 adolescent girls and young women, aged 15 to 19 years, recruited via telephone by an Indonesian research agency. Block randomization (1:1 allocation) was performed. Participants and researchers were not concealed from the randomized arm. Participants completed self-report assessments of trait body satisfaction (primary outcome) and the internalization of appearance ideals, mood, and skin shade dissatisfaction at baseline (before randomization), time 2 (1 day after the intervention [T2]), and time 3 (1 month after the intervention [T3]). Participants also completed state body satisfaction and mood measures immediately before and after each video. Data were evaluated using linear mixed models with an intent-to-treat analysis. Intervention adherence was tracked. Acceptability data were collected. RESULTS: There were 1847 participants. Relative to the control condition (n=923), the intervention group (n=924) showed reduced internalization of appearance ideals at T2 (F1,1758=40.56, P<.001, partial η2=0.022) and T3 (F1,1782=54.03, P<.001, partial η2=0.03) and reduced skin shade dissatisfaction at T2 (F1,1744=8.05, P=.005, partial η2=0.005). Trait body satisfaction improvements occurred in the intervention group at T3 (F1, 1781=9.02, P=.005, partial η2=0.005), which was completely mediated by the internalization change scores between baseline and T2 (indirect effect: ß=.03, 95% CI 0.017-0.041; direct effect: ß=.03, P=.13), consistent with the Tripartite Influence Model of body dissatisfaction. Trait mood showed no significant effects. Dependent sample t tests (2-tailed) found each video improved state body satisfaction and mood. Cumulative analyses found significant and progressive improvements in pre- and poststate body satisfaction and mood. Intervention adherence was good; participants watched an average of 5.2 (SD 1.66) videos. Acceptability scores were high for understandability, enjoyment, age appropriateness, usefulness, and likelihood to recommend. CONCLUSIONS: Warna-Warni Waktu is an effective eHealth intervention to reduce body dissatisfaction among Indonesian adolescent girls and young women. Although the effects were small, Warna-Warni Waktu is a scalable, cost-effective alternative to more intense interventions. Initially, dissemination through paid social media advertising will reach thousands of young Indonesian women. TRIAL REGISTRATION: ClinicalTrials.gov NCT05383807, https://clinicaltrials.gov/ct2/show/NCT05383807 ; ISRCTN Registry ISRCTN35483207, https://www.isrctn.com/ISRCTN35483207. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/33596.

A Qualitative Exploration of Parenting Adolescents in Indonesia.

OBJECTIVE: To explore how parents of Indonesian adolescents conceptualize adolescence and to identify the challenges faced in parenting adolescents, focusing on parents from different sociodemographic backgrounds. METHOD: Focus group discussions (FGD) were undertaken with parents of adolescents aged 10-18 years old from different sociodemographic backgrounds (urban high socioeconomic; urban low socioeconomic; rural low socioeconomic) using a semi-structured interview guide. Content and thematic analysis were assisted by Nvivo version 12.6.0. RESULTS: Forty-three parents participated in four FGD. All parents recognized that adolescence was a distinct developmental stage, reflected in changing behaviors, escalation of peer influences and sexual development. Parents from poor, rural backgrounds had relatively limited understanding of the emerging capabilities of adolescents and had a narrow repertoire of responses to challenging behaviors, with heavy reliance on religious rules and punishment. Parents from higher socioeconomic backgrounds displayed a wider range of warmer, more engaging approaches that they reported using to shape their children's behaviors. CONCLUSION FOR PRACTICE: These findings highlight opportunities to enhance parenting skills, which appear most warranted in parents of adolescents from disadvantaged backgrounds. Embedding basic adolescent parenting information within community programs appears indicated, and enhancing religious leaders' understanding of different approaches to parenting could be helpful in more religious communities.

"What is already known on this subject? Parenting practices play an important role in adolescent health, development, and well-being. Parenting practices are influenced by socio-economic, demographic and cultural determinants. The evidence for how Indonesian parents conceptualize adolescence and how parenting practices might differ across diverse sociodemographic contexts is scarce."What this study adds? While parents from different sociodemographic groups had a common conceptual understanding of some aspects of adolescence, there were substantial differences in their approaches to parenting. There are opportunities to enhance parenting skills, especially in more disadvantaged regions.

Mental Health Awareness and Promotion during the First 1000 Days of Life: An Expert Consensus.

The first 1000 days of life constitute a critical phase that will determine the optimum growth and development of a child. An important factor in this phase of life is the perinatal mental health of mothers and children. Mental health awareness is an important public health issue with significant impacts on mothers, spouses, and families, as well as the long-term emotional and cognitive development of children as well. However, the awareness and promotion of mental health within the realms of reproductive health, maternal health, and infant health, i.e., the first 1000 days of life, do not receive high prioritization in Indonesia. Nonetheless, Indonesia, with its existing primary healthcare system, has the potential to raise awareness of and promote the importance of perinatal mental health for its citizens. This experts' consensus proposes several strategies to maximize the usefulness of primary healthcare facilities in Indonesia, including Community Health Centers and Integrated Healthcare Posts, to support perinatal mental health awareness and promotion during the first 1000 days of life. The success of this program, in return, will improve the health status of women and children in Indonesia.

Health effects of alkaline, oxygenated, and demineralized water compared to mineral water among healthy population: a systematic review.

OBJECTIVES: There are many water types available on the market. They are widely known in public with health claims. The questions are, are those claims are scientifically proven or those are just testimonies from the consumers or overclaimed by the producers. This study aims to systematically review evidences on the health effects of alkaline, oxygenated, and demineralized water in comparison with mineral water among healthy population. CONTENTS: Data were obtained from databases PubMed, Cochrane, Scopus, EBSCO, dan Science Direct since January 2000 until July 2022. There were 10 eligible articles, consisted of two articles on alkaline, four articles on oxygenated, and four articles on demineralized water, that furtherly being analyzed. SUMMARY: Compared to consumption of mineral water, consumption of alkaline and oxygenated water did not show any significant difference on gut microbiota, urine pH, blood parameter, or fitness parameter. While, consumption of demineralized water in the long term resulted in lower quality of certain nutrient intake. OUTLOOK: Recent evidences do not prove any additional health effects of alkaline, oxygenated, or demineralized water compared to mineral water. In contrast, demineralized water consumption in the long run was proven to lead to adverse effect.

Assessment of water consumption during Ramadan intermittent fasting: Result from Indonesian cross-sectional study.

During Ramadan fasting, people are likely to consume water and beverages lower than recommended intake due to the limited time. However, it is necessary to achieve the recommended daily water intake to maintain the hydration status, as well as productivity during fasting. Unfortunately, there is a lack of data on drinking patterns during Ramadan. This study aims to investigate water and beverage intake and drinking patterns to help achieve water requirements during Ramadan among Indonesian adults. This is a cross-sectional study conducted during the Ramadan period from April to May 2021 (Ramadan 1442 Hijri). We used a self-administered questionnaire on drinking habits during Ramadan and utilized a 7-day fluid record (Liq.In 7) to assess water and beverage intake among participants who were managed through online procedure. There were 380 participants from five universities across Indonesia who completed the questionnaire accordingly and then analyzed it. The result shows that total water and beverage intake during Ramadan among participants was below the recommendation [1,670 (1,326-2,034) ml/day]. Among the type of beverages, water is the highest level of consumption [1,262 (983-1,666) ml/day] then followed by sugar-sweetened beverages [200 (91-350) ml/day]. We found a significant difference in water and beverages consumption between time of iftar [474 (375-590) ml/day], nighttime [574 (414-810) ml/day], and suhoor [560 (423-711) ml/day]. From this study, we found that during Ramadan the most common drinking pattern is 2-4-2, but a drinking pattern of 4-2-2 glasses (sequence of four glasses at iftar, two glasses at nighttime, two glasses at suhoor) had a significantly higher chance to adhere with the recommendation of fluid intake compared to other patterns. Therefore, based on this research on water and beverage intake, it is necessary and important to make improvements among Indonesian adults during Ramadan, and the drinking pattern of 4-2-2 glasses may help to achieve the recommended daily water consumption.

Water and Beverages Intake Among Workers Amid the COVID-19 Pandemic in Indonesia.

As the COVID-19 pandemic hit worldwide in the early 2020, people were urged to alter their behavior to prevent disease spread, thus, led to change water intake. This study aimed to analyze water and beverage intake among health workers and general workers during COVID-19 pandemic in Indonesia. This study was a comparative descriptive study where the participants were 20-45-year-old health workers and general workers in Indonesia. Data collected included demographic, water and beverage intake, physical activity, nutrient intake, and body weight and height. All data collection was obtained online using self-reported questionnaire. Water intake data was collected for 7 days consecutively using a 7-day fluid record. There were 246 participants comprised of 102 (41.5%) general workers and 144 (58.5%) health workers who were analyzed in this study. All participants showed barely adequate intake of daily total fluid 1,882 (1,473-2,433) ml/day. Total fluid intake among general workers was 1,759 (1,447-2,396) ml/day, whereas in health workers it was slightly higher 1,939 (1,516-2,446) ml/day (p-value = 0.378). Among health workers who were highly exposed to patients with COVID-19 showed the highest percentage in drinking water adequately (20 participants, 60.6%) compared to health workers who worked under moderate (29 participants, 48.3%) and low (24 participants, 47.2%) level of exposure to patients with COVID-19. In conclusion, workers need to improve their daily fluid intake. This study also showed better behavior of water consumption among health workers compared to general workers despite of their strict personal protection equipment during working hour.

A Novel, Scalable Social Media-Based Intervention ("Warna-Warni Waktu") to Reduce Body Dissatisfaction Among Young Indonesian Women: Protocol for a Parallel Randomized Controlled Trial.

BACKGROUND: Despite the prevalence of body dissatisfaction among young Indonesian women and its consequential negative impacts, there are currently no evidence-based, culturally appropriate interventions to tackle this issue. Therefore, there is a need to develop scalable, cost-effective, and accessible interventions to improve body image among this population. OBJECTIVE: This paper describes the study protocol of a parallel randomized controlled trial to evaluate the effectiveness of Warna-Warni Waktu, a social media-based intervention that aims to reduce state and trait body dissatisfaction and improve mood among young Indonesian women aged 15-19 years. METHODS: The trial will take place online. Approximately 1800 young women from 10 cities in Indonesia, evenly split across the ages of 15-19 years, will be recruited via a local research agency's established research panel. Participants will be randomly allocated to the intervention condition or a waitlist control condition. The intervention consists of six 5-minute videos, with each video supplemented with up to five brief interactive activities. The videos (and associated activities) will be delivered at a rate of one per day across 6 days. All participants will complete three self-report assessments: at baseline (Day 1), 1 day following the intervention (Day 9), and 1 month following the intervention (Day 36). The primary outcome will be change in trait body dissatisfaction. Secondary outcomes include change in internalization of appearance ideals, trait mood, and skin shade satisfaction. Intervention effectiveness on these outcomes will be analyzed using linear mixed models by a statistician blinded to the randomized condition. Intervention participants will also complete state measures of body satisfaction and mood before and after watching each video to assess the immediate impact of each video. This secondary analysis of state measures will be conducted at the within-group level. RESULTS: Recruitment began in October 2021, with baseline assessments underway shortly thereafter. The results of the study will be submitted for publication in 2022. CONCLUSIONS: This is the first study to evaluate an eHealth intervention aimed at reducing body dissatisfaction among young Indonesian women. If effective, the intervention will be disseminated to over half a million young women in Indonesia via Facebook, Instagram, and YouTube. TRIAL REGISTRATION: ClinicalTrials.gov NCT05023213; https://clinicaltrials.gov/ct2/show/NCT05023213. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/33596.

A novel Vi-diphtheria toxoid typhoid conjugate vaccine is safe and can induce immunogenicity in healthy Indonesian children 2-11 years: a phase II preliminary report.

BACKGROUND: Typhoid fever caused by Salmonella enteric serovar Typhi (S. Typhi) is a common cause of morbidity in the world. In 2017, 14.3 million cases of Typhoid and paratyphoid fever occurred globally. School age children between 3 to 19 years old are the most affected. Poor sanitation and multi drug resistance have increased the need for vaccines to reduce the global burden of disease. Based on previous trials, typhoid conjugate vaccines have longer- lasting protection, higher efficacy, require fewer doses and are suitable from infancy that allows them to be incorporated into the routine immunization program. Our previous phase I trial proved that a novel Vi-DT typhoid conjugate vaccine is safe and immunogenic in subjects 2-5 and 18-40 years. Our phase II trial consisted of subjects 6 months to 40 years. Our previously published paper on subjects 6 to < 24 months proved that this vaccine is safe and immunogenic for this age group. Therefore, with this paper we aimed to evaluate the safety and immunogenicity in children 2-11 years. METHODS: A randomized, observer-blind, superiority design of Vi-DT Typhoid conjugate vaccine compared to Vi-polysaccharide vaccine (Vi-PS) phase II study was conducted from October 2018 to December 2018 where 200 subjects aged 2-11 years were recruited. A blood sample prior to vaccination was taken, followed by administration of a single dose of either test vaccine (Vi-DT) or control vaccine (Vi-PS) and then a second blood sample was collected 28 days post vaccination. Adverse reactions were assessed and antibody increment was evaluated at 28 days post vaccination through collected serum sample. RESULTS: Pain was the most common local reaction. Fever and muscle pain were the most common systemic reactions. Both Vi-DT and Vi-PS groups had roughly the same number of adverse reactions. At 28 days post vaccination, 100% of subjects in the Vi-DT group and 93% of subjects in the Vi-PS group produced antibody increment ≥4 times. The Vi-DT group produced a higher GMT as compared to Vi-PS. CONCLUSION: Vi-DT vaccine is safe and immunogenic in children 2-11 years old. TRIAL REGISTRATION: Trial registration number: NCT03460405 .

Understanding mental health and its determinants from the perspective of adolescents: A qualitative study across diverse social settings in Indonesia.

Poor mental health is a leading contributor to the burden of disease experienced by adolescents, including in resource constrained settings. However, little is known about how adolescents in these countries conceptualise mental health and its determinants which is essential to informing effective responses. This study aimed to explore how adolescents in Indonesia (a populous and rapidly developing country) conceptualise mental health and what they identify as important determinants. Eight focus group discussions (FGDs) were conducted with 86 Indonesian adolescents (aged 16-18 years), sampled from schools and community settings from Jakarta and South Sulawesi. FGDs were recorded, transcribed, translated and thematically analysed. Mental health was recognised as a significant concern by adolescents in Indonesia. Good mental health was conceptualised as emotional wellbeing and happiness. By contrast, poor mental health was predominantly described in terms of substantial mental illness manifesting as behavioural and physical disturbance. Further, poor mental health only happened to 'other' people, with stigmatising views prevalent. Absent from the discussions were common symptoms of poor mental health (stress, loneliness, poor sleep) and common mental disorders (e.g. depression, anxiety) or a conceptualisation that reflected poor mental health to be a normal human experience. Discussions around determinants of poor mental health suggested that family connections (particularly with parents), school pressures, and adverse exposures on social media were important drivers of poor mental health, with religion also surfacing as an important determinant. In highlighting mental health as an important issue for Indonesian adolescents, this study provides a foundation for targeted responses.

One-month follow up of a randomized clinical trial-phase II study in 6 to <24 months old Indonesian subjects: Safety and immunogenicity of Vi-DT Typhoid Conjugate Vaccine.

INTRODUCTION: World Health Organization estimates the annual global incidence of typhoid fever at 11-21 million cases and approximately 128 000 to 161 000 deaths. The currently used Vi-polysaccharides (Vi-PS) vaccines have been proven to be safe and efficacious in children 2 years and above. However, poor immunogenicity of Vi-PS was observed in children below 2 years of age. This Phase II study is the continuation of the previously published Phase I study that aims to evaluate the safety and immunogenicity of a novel Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in subjects 6 to <24 months. METHODS: An interventional, blinded, comparative, randomized phase II study was conducted from July 2018 until January 2019. There were 200 healthy subjects divided into two groups: trial and control groups. Inactivated poliovirus vaccine was given to control group. Immediate and delayed local and systemic reactions up to 28 days post vaccination were recorded. Antibody titers were measured prior to vaccination (V1) and 28 days post vaccination (V2). RESULT: The study showed that the seroconversion of Vi-DT vaccine 98.99%. One dose of Vi-DT vaccine induced higher geometric mean titers (GMT) in all subjects compared to that of baseline. Pain was the most common immediate and delayed local reaction. Immediate and delayed systemic reactions that mostly occurred was fever. There were no serious adverse events reported within 28 days post vaccination. CONCLUSION: The novel typhoid Vi-DT conjugate vaccine is safe and immunogenic in children 6 to <24 months. TRIAL REGISTRATION NUMBER: NCT03460405.

Six-month follow up of a randomized clinical trial-phase I study in Indonesian adults and children: Safety and immunogenicity of Salmonella typhi polysaccharide-diphtheria toxoid (Vi-DT) conjugate vaccine.

INTRODUCTION: There is a high global incidence of typhoid fever, with an annual mortality rate of 200,000 deaths. Typhoid fever also affects younger children, particularly in resource-limited settings in endemic countries. Typhoid vaccination is an important prevention tool against typhoid fever. However, the available polysaccharide typhoid vaccines are not recommended for children under 2 years of age. A new typhoid conjugate Vi-diphtheria toxoid (Vi-DT) vaccine has been developed for infant immunization. We aimed to define the safety and immunogenicity of the Vi-DT vaccine among adults and children in Indonesia. METHODS: An observational, blinded, comparative, randomized, phase I safety study in two age de-escalating cohorts was conducted in East Jakarta, Indonesia, from April 2017 to February 2018. We enrolled 100 healthy subjects in 2 age groups: adults and children (18-40 and 2-5 years old). These groups were randomized into study groups (Vi-DT vaccine), and comparator groups (Vi-polysaccharide (Vi-PS) vaccine and another additional vaccine) which was administered in 4 weeks apart. Subjects were followed up to six months. RESULT: One hundred healthy adults and children subjects completed the study. The Vi-DT and Vi-PS vaccines showed no difference in terms of intensity of any immediate local and systemic events within 30 minutes post-vaccination. Overall, pain was the most common local reaction, and muscle pain was the most common systemic reaction in the first 72 hours. No serious adverse events were deemed related to vaccine administration. The first and second doses of the Vi-DT vaccine induced seroconversion and higher geometric mean titers (GMT) in all subjects compared to that of baseline. However, in terms of GMT, the second dose of Vi-DT did not induce a booster response. CONCLUSION: The Vi-DT vaccine is safe and immunogenic in adults and children older than two years. A single dose of the vaccine is able to produce seroconversion and high GMT in all individuals.