South East Asian Nutrition Surveys (SEANUTS) II - a multi-country evaluation of nutrition and lifestyle indicators in children aged 12 years and below: rationale and design.

OBJECTIVE: To assess the nutritional status, growth parameters and lifestyle behaviours of children between 0·5 and 12 years in nationally representative samples in Malaysia, Indonesia, Thailand and Vietnam. DESIGN: A cross-sectional study was conducted in the four countries, between May 2019 and April 2021. Data collected can be categorised into four categories: (1) Growth - anthropometry, body composition, development disorder, (2) nutrient intake and dietary habits - 24-h dietary recall, child food habits, breast-feeding and complementary feeding, (3) socio-economic status - food insecurity and child health status/environmental and (4) lifestyle behaviours - physical activity patterns, fitness, sunlight exposure, sleep patterns, body image and behavioural problems. Blood samples were also collected for biochemical and metabolomic analyses. With the pandemic emerging during the study, a COVID-19 questionnaire was developed and implemented. SETTING: Both rural and urban areas in Malaysia, Indonesia, Thailand and Vietnam. PARTICIPANTS: Children who were well, with no physical disability or serious infections/injuries and between the age of 0·5 and 12 years old, were recruited. RESULTS: The South East Asian Nutrition Surveys II recruited 13 933 children. Depending on the country, data collection from children was conducted in schools and commune health centres, or temples, or sub-district administrative organisations. CONCLUSIONS: The results will provide up-to-date insights into nutritional status and lifestyle behaviours of children in the four countries. Subsequently, these data will facilitate exploration of potential gaps in dietary intake among Southeast Asian children and enable local authorities to plan future nutrition and lifestyle intervention strategies.

Cooking behavior among mothers of children aged 2-5 years old in Kendari, Southeast Sulawesi, Indonesia.

BACKGROUND: Cooking at home was associated with parental feeding practices. This study aimed to explore the interplay of components in cooking behavior of mothers with young children aged 2-5 years old in Kendari city of Southeast Sulawesi, Indonesia. METHODS: This qualitative study involved 33 mothers from Kendari city, which was represented by each two sub-districts in coastal and mainland areas that were randomlyselected. Six focus group discussions (FGDs) were carried out using 20-item guide questions. The guide questions were developed following the Model of Goal-Directed Behavior (MGDB) theory approach exploring the components of cooking behavior i.e., skill, intention, desire, confidence, and attitude in cooking. Data analysis was performed in the field to assist decision on data saturation, followed by data analysis at desk through multilevel coding from the verbatim transcripts using NVivo R1 software. The data was analyzed thematically using pre-determined themes according to the MGDB theory. Emerging topics on enabling factors and constraints were captured to enhance our understanding of the complexity of cooking behavior. RESULTS: The mothers' mean age was about 30 years old with a comparable representation of younger and older mothers. Most mothers were housewives and accomplished secondary school level. The mothers' intention was shown as they frequently cooked at home and allocated time for cooking. The enabling factors included their knowledge about food and nutrition, food source availability, their confidence in cooking meals and following recipes, and their motivation to keep their children healthy representing some intrinsic factors. The main constraint was the lack of skill to make snacks. The other extrinsic barriers were dependence on mobile food sellers and the availability of food kiosks that facilitated children's snack preferences. CONCLUSION: The study obtained some insights that mothers had favorable cooking intention and desire, were supported with a confidence in some basic cooking skills. However, the existing constraints that encouraged the development of unfavorable children's snacking habit were beyond the mothers' control. A cookbook specifically for snack recipes that utilizes local ingredients may assist mother in preparing more healthier options for the children.

Development and validation of the adolescent behavioural change Counselling Assessment Tool in Indonesia.

BACKGROUND: Primary care provides an important context to engage adolescents and their families in healthy lifestyles with the goal of reducing future behaviour-related health problems. Developing a valid tool to assess health professionals' skills in behavioural change counselling is integral to improving the quality of clinical care provided to adolescents in Indonesia. METHODS: This work was nested within a project to develop a training program to enhance the behaviour-change counselling of adolescents and their parents by Indonesian primary care professionals. Initial item development was based on the content of the training module and the domain structure of the Behavioral Change Counselling Index (BECCI), a commonly used tool to assess counselling quality in healthcare settings. Expert panels were used to test content validity, while face validity was assessed by a group of trained psychologists. Inter-rater agreement was calculated prior to tests of construct validity and reliability, which involved psychologists rating 125 audio-taped counselling sessions between the health professional and adolescent patients, together with a parent. RESULTS: An initial 13-item tool was developed using a 1-5 Likert scale. Validity and reliability testing resulted in the decision to use a 14-item tool with a 0-3 Likert scale. The scale was found to have a Cronbach's α coefficient of 0.839 (internal consistency), and there was strong inter-rater agreement (0.931). CONCLUSION: The assessment tool known as the Adolescent Behavioural Change Counselling Assessment Tool, is a valid and reliable instrument to measure Indonesian health professionals' behavioural-change counselling skills with adolescent patients. The tool provides an evaluation framework for future interventions that aim to improve health professionals' skills in addressing adolescent behaviour-related health problems.

The barriers of home environments for obesity prevention in Indonesian adolescents.

BACKGROUND: Obesity and its related cardiovascular-metabolic diseases are growing public health concerns. Despite global attention to obesity, its prevalence is steeply increasing in developing countries, especially in children and adolescents. Eating behaviours and physical activity are modifiable risk factors for obesity that can variably be shaped by families. Eating behaviours and physical activity are especially important during adolescence, given its significance as a foundational period for developing healthy lifestyles. This qualitative study aimed to explore barriers and opportunities around creating healthy lifestyles among adolescents in Indonesia, focussing on family environments from diverse socio-demographic backgrounds. METHOD: In-depth interviews using a semi-structured guide were undertaken with consecutively recruited 10-18-year-old adolescents with overweight or obesity, and their parents, from three different sites: urban (Jakarta, the capital city of Indonesia), peri-urban (West Java Province) and rural (Banten Province). Thematic analysis was used to identify patterns of meaning. RESULTS: Nineteen dyads were interviewed. Thematic analysis revealed four themes: limited knowledge of healthy lifestyles; healthy lifestyles not a concern of daily life; limited parenting skills, including inequity around gender roles; and aspects of availability and accessibility. These interconnected barriers influenced lifestyle practices at home within the context of daily preferences and decisions around food and activities. Gender role inequity and healthy food accessibility were more prominent in rural families than in those from urban or peri-urban settings. CONCLUSIONS: Healthy lifestyles in adolescence may be supported by strategies to enhance parenting skills, build individual motivation, and support the development of more enabling environments.

Animal source foods, rich in essential amino acids, are important for linear growth and development of young children in low- and middle-income countries.

Growth faltering under 5 years of age is unacceptably high worldwide, and even more children, while not stunted, fail to reach their growth potential. The time between conception and 2 years of age is critical for development. The period from 6 to 23 months, when complementary foods are introduced, coincides with a time when growth faltering and delayed neurocognitive developments are most common. Fortunately, this is also the period when diet exercises its greatest influence. Growing up in an adverse environment, with a deficient diet, as typically seen in low- and middle-income countries (LMICs), hampers growth and development of children and prevents them from realising their full developmental and economic future potential. Sufficient nutrient availability and utilisation are paramount to a child's growth and development trajectory, especially in the period after breastfeeding. This review highlights the importance of essential amino acids (EAAs) in early life for linear growth and, likely, neurocognitive development. The paper further discusses signalling through mammalian target of rapamycin complex 1 (mTORC1) as one of the main amino acid (AA)-sensing hubs and the master regulator of both growth and neurocognitive development. Children in LMICs, despite consuming sufficient total protein, do not meet their EAA requirements due to poor diet diversity and low-quality dietary protein. AA deficiencies in early life can cause reductions in linear growth and cognition. Ensuring AA adequacy in diets, particularly through inclusion of nutrient-dense animal source foods from 6 to 23 months, is strongly encouraged in LMICs in order to compensate for less than optimal growth during complementary feeding.

Validity of Telemedicine for Diagnosing Autism Spectrum Disorder: Protocol-Guided Video Recording Evaluation.

Background: Delayed diagnosis of autism spectrum disorder (ASD) remains a persistent pediatric health problem, due to limited access to competent diagnosticians and tertiary health care. A telemedicine method using a store-and-forward approach presents an opportunity to facilitate early identification and referral for intervention. This study aimed to evaluate the validity of protocol-guided video recording compared with direct assessment (DA) for diagnosing ASD. Materials and Methods: Children aged 18-30 months with chief complaints of delayed speech or social indifference, and Modified Checklist for Autism in Toddlers, Revised (M-CHAT-R) score of more than two were included. Parents were instructed to video record certain scenarios, which were assessed by an experienced professional based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) checklist for ASD. DAs using DSM-5 criteria were considered to be the gold standard of diagnosis. Diagnostic agreement, sensitivity, specificity, predictive values, and likelihood ratios were calculated to measure diagnostic validity. Results: The diagnostic agreement between the two methods was 82.5%. The sensitivity of video recording for diagnosing ASD was 91.3% (95% confidence interval [CI] [79.7%-100%]), while the specificity was 70.6% (95% CI [48.9%-92.2%]). The positive predictive value was 80.7% (95% CI [65.6%-95.9%]), while the negative predictive value was 85.7% (95% CI [67.4%-100%]). The positive likelihood ratio was 3.1 (95% CI [1.47-6.5]), while the negative likelihood ratio was 0.16 (95% CI [0.03-0.47]). Conclusions: A telemedicine approach using protocol-guided video recording evaluation has substantial validity compared with DA for diagnosing ASD.

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OBJECTIVES: To study the association between milk consumption and lactose malabsorption in Indonesian children aged 3-12 years. METHODS: This cross sectional study was conducted in randomly selected presumed healthy children with good nutritional status aged 3-12 years in Central Jakarta, Indonesia (n=174), including 72 children aged 3-5 years and 102 children aged 6-12 years. RESULTS: The prevalence of lactose malabsorption in children aged 3-5 years and children aged 6-12 years was 20.8% (15/72) and 35.3% (36/102), respectively. There was no association between milk or milk product consumption and lactose malabsorption (P>0.05). In the 51 children with lactose malabsorption, the predominant clinical symptoms were diarrhea (62%), abdominal pain (52%), and nausea (5%) during the hydrogen breath test. CONCLUSIONS: There is no association between milk consumption and lactose malabsorption in Indonesian children aged 3-12 years, suggesting that genetic predisposition may be more important than adaptive mechanisms to lactose consumption.

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 .

An evening milk drink can affect word recall in Indonesian children with decreased sleep efficiency: A randomized controlled trial.

STUDY OBJECTIVES: Sleep is important for memory consolidation in children. This study intended to find out whether an evening milk-based drink could influence sleep efficiency and memory recall in a group of Indonesian children (5-6 years old) with sleep deprivation. METHODS: Children were randomly allocated to one of three interventions: Reference product, satiety-stimulating product, and a relaxing product. The intervention lasted for 6 weeks and children consumed two servings per day of each 200 ml, the serving in the morning being the same for all children. All measurements took place at baseline and at the end of the intervention. Sleep parameters were studied using actigraphy and a sleep diary during three consecutive days. Memory consolidation was tested using a 20 word-pair list, which was memorized the evening before being recalled the next morning at home-base. Anthropometry was measured using standard equipment. RESULTS: The Satiety group showed a significant decrease in word recall, and a significant increase in nocturnal awakenings that was inversely associated with sleep efficiency at the end of the intervention. Sleep efficiency did not differ between the three groups being 75.5 ± 8.6% and 75.7 ± 6.3% at baseline and end of the intervention, respectively. Despite the lower energy intake in the Standard (reference) group, this condition showed the highest increase in weight. DISCUSSION: Evening growing-up milks can affect memory recall, sleep characteristics, and growth. However, to correct sleep efficiency and sleep duration, improvement of parental behavior may be the most important factor with nutrition providing a supplementary effect.

DTwP-HB-Hib: antibody persistence after a primary series, immune response and safety after a booster dose in children 18-24 months old.

BACKGROUND: The new combination of DTwP-HB-Hib vaccines has been developed in Indonesia following World Health Organization (WHO) recommendation and integrated into national immunization program. The aims of the study were to measure 1) antibody persistence 12-18 months after a primary series, 2) immune response and safety after a booster dose of DTwP-HB-Hib. METHODS: This was a multi-center, open-labeled, prospective, interventional study. Subjects who had received complete primary dose of DTwP-HB-Hib vaccine from the previous phase III trial were recruited in this trial. Subjects were given one dose of DTwP-HB-Hib (Pentabio®) booster at age 18-24 months old. Diphtheria, tetanus, pertussis, hepatitis B, Hemophilus influenza type B antibodies were measured before and after booster to determine antibody persistence and immune response. Vaccine adverse events were assessed immediately and monitored until 28 days after the booster recorded with parent's diary cards. RESULTS: There were 396 subjects who completed the study. Increased proportion of seroprotected subjects from pre-booster to post-booster were noted in all vaccine antigens: 74.5 to 99.7% for diphtheria; 100 to 100% for tetanus; 40.4 to 95.5% for pertussis; 90.2 to 99.5% for hepatitis B; and 97.7 to 100% for Hib. Common systemic adverse events (AEs) were irritability (23.7-25%) and fever (39.9-45.2%). Local AEs such as redness, swelling, and induration were significantly less common in the thigh group (7.7, 11.3, and 7.1%) than in the deltoid group (28.9, 30.7, and 25%) (P < 0.001). Most AEs were mild and resolved spontaneously within three-day follow-up period. CONCLUSIONS: Booster of DTwP-HB-Hib vaccine at age 18-24 months is required to achieve and maintain optimal protective antibody. The vaccine is safe and immunogenic to be used for booster vaccination. TRIAL REGISTRATION: NCT02095314 (retrospectively registered, March 24, 2014).

The immunogenicity, safety, and consistency of an Indonesia combined DTP-HB-Hib vaccine in expanded program on immunization schedule.

BACKGROUND: WHO recommended incorporation of Haemophilus influenzae type b (Hib) vaccination into immunization program. Indonesia would adopt Hib as a National Immunization Program in 2013. We aimed at analyzing immunogenicity, safety, and consistency of a new combined DTP-HB-Hib (diphtheria-tetanus-pertussis-Hepatitis B-Haemophilus influenza B) vaccine. METHODS: A prospective, randomized, double blind, multicenter, phase III study of Bio Farma DTP-HB-Hib vaccine conducted in Jakarta and Bandung, August 2012 - January 2013. Subjects were divided into three groups with different batch number. Healthy infants 6-11 weeks of age at enrollment were immunized with 3 doses of DTP-HB-Hib vaccine with interval of 4 weeks, after birth dose of hepatitis B vaccine. Blood samples obtained prior to vaccination and 28 days after the third dose. Safety measures recorded until 28 days after each dose. RESULTS: Of 600 subjects, 575 (96 %) completed study protocol. After 3 doses, 100.0 and 96.0 % had anti-PRP concentration ≥0.15 and ≥1.0 µg/ml. Anti-diphtheria and anti-tetanus concentration ≥0.01 IU/ml detected in 99.7 and 100.0 %; while concentration ≥0.1 IU/ml achieved in 84.0 and 97.4 %. Protective anti-HBs found in 99.3 %. The pertussis vaccine response rate was 84.9 %. None Serious Adverse events (SAEs) considered related to study vaccine or procedure. CONCLUSIONS: The 3-dose of DTP-HB-Hib was immunogenic, well tolerated and suitable for replacement of licensed-equivalent vaccines based on immunologic and safety profiles. TRIAL REGISTRATION: NCT01986335 - October 30(th) 2013.

Primary School-Aged Children's Physical Activity Level, Eating Habit, and Sleeping Pattern Changes During the COVID-19 Pandemic in Indonesia.

Background and objective This study aims to explore the effect of physical distancing on physical activity, eating habits, and sleeping patterns among Indonesian primary schoolchildren during the COVID-19 pandemic. Methodology This cross-sectional study was conducted from October to December 2020, involving 489 primary schoolchildren. Parents/caregivers were queried about changes in their children's physical activity (utilizing the Physical Activity Questionnaire for Older Children - PAQ-C), eating habits (via a questionnaire modified from Southeast Asian Nutrition Surveys - SEANUTS), and sleeping patterns (assessed using the Children's Sleep Habits Questionnaire - CSHQ) both before and during the pandemic. Various sociodemographic characteristics and income status were also obtained. Paired univariate and multivariate analyses were conducted where applicable. Results In comparison to the period before the pandemic, both the PAQ-C score and active proportion significantly decreased during the pandemic (P = 0.000). Children consumed more snacks (322, 65.8%) but less canned and processed foods (180, 36.8%, and 128, 26.2%, respectively). Sleep duration and sufficiency increased significantly, with a CSHQ score mean of 48.62 ± 9.88 (P = 0.000, P = 0.004), and sleep disturbance was observed in 391 (79.96%) subjects. Conclusions Children were physically less active during the COVID-19 pandemic. They also experienced variable changes in eating habits based on parental employment, family income and expenses, and the presence of governmental support. While more children had longer sleep duration and more achieved the recommended sleep time, sleep disturbance happened in most subjects.

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.

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 .

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.

Immunogenicity and safety of SARS-CoV-2 recombinant protein subunit vaccine (IndoVac) adjuvanted with alum and CpG 1018 in Indonesian adults: A phase 3, randomized, active-controlled, multicenter trial.

BACKGROUND: Bio Farma has developed a recombinant protein subunit vaccine (IndoVac) that is indicated for active immunization in population of all ages. This article reported the results of the phase 3 immunogenicity and safety study in Indonesian adults aged 18 years and above. METHODS: We conducted a randomized, active-controlled, multicenter, prospective intervention study to evaluate the immunogenicity and safety of IndoVac in adults aged 18 years and above. Participants who were SARS-CoV-2 vaccine-naïve received two doses of either IndoVac or control (Covovax) with 28 days interval between doses and were followed up until 12 months after complete vaccination. RESULTS: A total of 4050 participants were enrolled from June to August 2022 and received at least one dose of vaccine. The geometric mean ratio (GMR) of neutralizing antibody at 14 days after the second dose was 1.01 (95 % confidence interval (CI) 0.89-1.16), which met the WHO non-inferiority criteria for immunobridging (95 % CI lower bound > 0.67). The antibody levels were maintained through 12 months after the second dose. The incidence rate of adverse events (AEs) were 27.95 % in IndoVac group and 32.15 % in Covovax group with mostly mild intensity (27.70 %). The most reported solicited AEs were pain (14.69 %) followed by myalgia (7.48 %) and fatigue (6.77 %). Unsolicited AEs varied, with each of the incidence rate under 5 %. There were no serious AEs assessed as possibly, probably, or likely related to vaccine. CONCLUSIONS: IndoVac in adults showed favourable safety profile and elicited non-inferior immune response to Covovax. (ClinicalTrials.gov: NCT05433285, Indonesian Clinical Research Registry: INA-R5752S9).

The effect of lactose-isomaltulose-containing growing-up milks on cognitive performance of Indonesian children: a cross-over study.

Glycaemic response to dietary carbohydrates might have an impact on cognitive performance. The present study investigated the effects of growing-up milks (GUM) with isomaltulose and extra minerals and vitamins or lower protein content on cognitive parameters in children aged 5­6 years. In a blinded, partly randomised, controlled, cross-over study, four GUM were provided, each taken over 14 d (2 × 200 ml/d): standard (Std) GUM; Std GUM+5 g isomaltulose (Iso-5 GUM); Iso-5 GUM with 26 % less protein (Iso-5 LP GUM); Std GUM with 2·5 g isomaltulose and extra Mg, Zn, Se, D3, B1, B2, B12, folic acid and choline (Iso-2·5 GUM). At test days, when GUM replaced breakfast, repeated (0, 60, 120 and 180 min post-dose) cognitive tasks were performed (picture presentation, simple reaction time, digit vigilance, choice reaction time, spatial and numeric working memory and picture recognition). Task performance of all subjects (n 50) worsened over the morning. Best performance was seen on isomaltulose GUM, most notably at 180 min. Iso-2·5 GUM showed best performance on several parameters of attention and memory, Iso-5 GUM performed best on parameters of memory and Iso-5 LP GUM was positively associated with parameters of attention but less with memory. Std GUM showed only a benefit on one attention and one memory task. Thus, isomaltulose-enriched GUM positively affected parameters of attention and memory at 180 min post-dose when compared with Std GUM. Extra minerals and vitamins seem beneficial, whereas lowering protein content might improve attention in particular.

Development of an internet-based intervention to improve health professionals' counseling skills around adolescent weight management in Indonesia.

BACKGROUND: Obesity is a growing public health and clinical concern, worldwide. In many countries, including Indonesia, health professionals lack the capacity to promote behavior change around obesity prevention and management, especially with adolescents for whom a wider set of communication skills are required. This study describes the theoretical basis, approach to development of content, use and satisfaction of an internet-based educational intervention designed to improve the quality of health professional weight management counseling with adolescents in Indonesia. METHODS: This study is part of an exploratory sequential mixed methods design which was undertaken from 2020 to 2022. Following a needs analysis, an internet-based training resource was developed, informed by constructive alignment theory and active learning principles. Using both synchronous and asynchronous approaches over a four-week pilot study, a weekly interactive session was held online, using multifaceted training materials housed on a website (https://ramahremaja.id). The training resource was then tested in a two-arm study involving health professionals from 17 of 34 provinces across Indonesia. RESULTS: Sixty-four primary health professionals were recruited for the two-arm study. The completion rate for reviewing all materials and assignments on the website was 72% and the online meeting participation rate was 78%. Participants were highly positive about the clarity of the training material and the appropriateness of the delivery methods. The main challenges related to poor internet literacy and interrupted internet connectivity. CONCLUSION: Designed to support weight management in adolescents, this internet-based training program shows potential for enhancing Indonesian health professional behavior-change counseling skills.

The effectiveness of self-empowerment-based patient-centered care for obese students in primary services: A randomized controlled trial.

BACKGROUND: Self-empowerment-based patient-centered services with a coaching approach are imperative in the management of students with obesity. This study evaluated the applicability and effectiveness of self-empowerment-based patient-centered coaching for the weight loss program model for obese students. MATERIALS AND METHODS: This randomized control trial recruited 60 obese students aged 17-22 years in Universitas Indonesia from August to December 2021. Intervention group subjects were coached by a health coach. Each health coach assisted four subjects with SMART model coaching in six meetings every 2 weeks through a zoom platform. Both groups had instructions on obesity, nutrition, and physical activity from specialist doctors online. Paired t-test or Mann-Whitney test, as appropriate, to compare the measurements of anthropometry, body composition (bioelectrical impedance analysis), food intake (food record form), physical activity (physical activity form), subjective well-being (subjective well-being questionnaire), and healthy behavior habits (satisfaction scale) between the two groups before and after the intervention. RESULTS: A total of 41 obese students completed the study, 23 from intervention group and 18 from the control group. The change in total body fat (-0.9 [-12.9, 0.70] vs. 0.0 [-6.9, 3.50], P = 0.02) and healthy behavior habit (13.5 ± 11.85 vs. 7.5 ± 8.08, P = 0.04) in the intervention group was significantly greater than in the control group. The change in satisfaction scale of hobby/passion (2 [-4.6] vs. 1 [-2.2], P = 0.02), movement exercise (2.3 ± 2.11 vs. 1.2 ± 1.93, P = 0.03), sleep rest (2 [-6.5] vs. 1 [-3.2], P = 0.01), and spiritual (1 [0.6] vs. 0 [-1.3], P = 0.00) was significantly higher in the coached group. CONCLUSION: A weight loss program for obese students was tested through self-empowerment-based patient-centered care with a coaching approach and has proven to effect changes in anthropometric indicators, body composition, self-empowerment, food intake, and physical activity.

Effect of current breastfeeding on sleep patterns in infants from Asia-Pacific region.

AIM: The aim of this study was to assess the relationship between breastfeeding and sleep patterns in infants from Asia-Pacific region. METHODS: Parents of 10 321 infants (0-11 months) from Australia, China, Hong Kong, India, Indonesia, Korea, Japan, Malaysia, New Zealand, the Philippines, Singapore, Taiwan, Thailand and Vietnam completed an expanded version of the Brief Infant Sleep Questionnaire. RESULTS: Overall, 4714 (45.72%) were currently being breastfed; 61.3% of those between 0 and 5 months and 36.6% of those between 6 and 11 months. Currently breastfed infants, when compared with not currently breastfed infants, had a significant increase in the number and duration of night-time wakings and less consolidated sleep. Interestingly, currently breastfed infants less than 6 months also showed longer duration of daytime sleep and obtained more sleep overall. Of note, of those who were currently breastfed, those infants who were nursed back to sleep during night, woke up more often at night (2.41 vs. 1.67 times) and had shorter continuous night-time sleep period (5.58 vs. 6.88 h; P < 0.001). There was no significant difference between breastfeeding and non-breastfeeding infants in the number of night wakings, when the nursing to sleep variable was controlled for in the analysis of variance. CONCLUSION: Breastfeeding is associated with reduced sleep consolidation in infants. This relationship, however, may be moderated by parenting practices of nursing to sleep and back to sleep during the night. Thus, parents of infants with night waking problems should be encouraged to limit the association between nursing and falling to sleep, to improve sleep while maintaining breastfeeding.