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Children discharged from hospital following management of complicated severe acute malnutrition (SAM) have a high risk of mortality, readmission and failed nutritional recovery. Current management approaches fail to sufficiently promote convalescence after inpatient nutritional rehabilitation. Novel interventions during the post-discharge period could enhance convalescence to help children survive and thrive.
The Co-SAM trial is an adaptive, multicountry, phase III, individually randomised clinical trial, based on the principles that (i) interacting biological and social factors drive multimorbidity in children with SAM, and (ii) both medical and psychosocial interventions may therefore ameliorate underlying causal pathways to reduce morbidity and mortality and improve recovery. Children aged 6–59 months with complicated SAM, who have stabilised and started the transition to ready-to-use therapeutic food (RUTF), will be enrolled and randomised to one of five trial arms (standard-of-care alone; antimicrobials; reformulated RUTF; psychosocial support; or a combination of all strategies). Standard-of-care, which is provided in all trial arms, includes RUTF until nutritional recovery (defined as weight-for-height Z-score >–2, mid-upper arm circumference >12.5 cm and oedema-free since the last study visit), and other management recommended in WHO guidelines. The 12-week antimicrobial package provides daily co-formulated rifampicin and isoniazid (with pyridoxine) and 3 days of azithromycin monthly. The reformulated RUTF, which incorporates medium-chain triglycerides and hydrolysed protein to increase nutrient bioavailability and reduce metabolic stress, is provided at the same dose and duration as standard RUTF. The 12-week psychosocial package includes caregiver problem-solving therapy, educational modules, peer support groups and child play. The combined arm includes all interventions. Children start their intervention package prior to hospital discharge, with follow-up data collection in study clinics at 2, 4, 6, 8, 12 and 24 weeks. The primary composite outcome is death, hospitalisation or failed nutritional recovery within 24 weeks post-randomisation. An interim analysis will allow unpromising arms to be dropped, while the final analysis will be conducted when 1266 children have completed the study. Embedded process evaluation and laboratory substudies will explore the mechanisms of action of the interventions.
The trial has been approved by ethics committees in Zimbabwe, Zambia, Kenya and UK. Dissemination will be via community advisory boards in each country; Ministries of Health; and dialogue with policymakers including UNICEF.
Clinicaltrials.gov: NCT05994742; Pan African Clinical Trials Registry: PACTR202311478928378.
by Wiriya Mahikul, Wisut Lamlertthon, Kanchana Ngaosuwan, Pawaree Nonthasaen, Napat Srisermphoak, Wares Chancharoen, Saimai Chatree, Arpaporn Arnamwong, Pisinee Narayam, Chatchamon Wandeecharassri, Pakin Wongpanawiroj
BackgroundDepression has a growing trend in the population worldwide. In this cross-sectional study, we investigated the prevalence and associated factors of depression among individuals residing in rural (Ban Luang district, Nan Province) and urban (Lak Si, Bangkok) areas of Thailand. Understanding the differences in depression between these two settings can provide insights for specific targeted interventions and mental health policies.
MethodsThe multistage stratified random sampling was applied to select the study participants. We recruited participants from rural and urban communities in Thailand using a structured survey questionnaire through either face-to-face interviews or in paper or electronic form. We collected data on depression using the Patient Health Questionnaire-9 (PHQ-9) tool and sociodemographic characteristics and conducted descriptive statistics and logistic regression analysis.
ResultsOf 867 survey participants, 420 were from rural areas (Nan) and 447 were from urban areas (Bangkok). Participants’ mean age was 55.9±9.5 years in rural areas and 56.0±12.0 years in urban areas. Most participants in urban areas were women, married, and had lower education levels (71.1%, 50.3%, 58.8%, respectively). The overall prevalence of depression across both settings was 18.6%. We found a higher prevalence of depression in the urban (31.8%) than the rural (4.5%) setting. In multiple logistic regression analysis, urban residence was significantly associated with higher rates of depression compared with rural residence (adjusted odds ratio [AOR] 9.43, 95% confidence interval [CI] 5.08–17.52). Nuclear family and using social media were associated with lower levels of depression in urban areas (AOR 0.50 and 0.43, 95% CI 0.27–0.93 and 0.22–0.84, respectively). Higher education level was significantly associated with higher levels of depression in rural areas (AOR 3.84, 95% CI 1.19–12.42).
ConclusionThis study emphasized the difference in depression and related factors between rural and urban areas of Thailand, highlighting a greater prevalence in urban areas. To help prevent depression, it is important to address specific challenges in each setting, such as those faced by highly educated individuals living in rural areas with high depression rates, exploring social media use patterns in urban populations, and understanding dynamics of the nuclear family. Our findings can inform the development of public health policies aimed at effectively mitigating the burden of depression and improving overall mental well-being in specific settings.
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