scholarly journals An Intervention Package Including Egg and Milk-Based Snack Improved Growth and Development of U-2 Children in Bangladesh: A Community-Based Randomized Controlled Trial

2021 ◽  
Vol 5 (Supplement_2) ◽  
pp. 99-99
Author(s):  
Gulshan Ara ◽  
Kazi Istiaque Sanin ◽  
Mansura Khanam ◽  
Md. Shafiqul Alam Sarker ◽  
Fahmida Tofail ◽  
...  
Keyword(s):  
Growth And Development ◽  
Health Messages ◽  
Fine Motor ◽  
Control Group ◽  
Intervention Package ◽  
Community Based ◽  
Randomized Controlled ◽  
Micronutrient Powder ◽  
Intervention Cost ◽  
Comprehensive Intervention

Abstract Objectives We aimed to compare the effect of a comprehensive intervention package focusing on the animal-source protein (egg and milk)-based snack in conjunction with feeding counseling, water sanitation and hygiene, and supplementation with multiple micronutrient powder on linear growth and development of 6‒12-month old children in rural Bangladesh. Primary and secondary outcomes were differences in length-for-age Z score and cognitive development. Methods A community-based cluster randomized controlled longitudinal trial included 412 mother-infant pairs from 13 unions (small-administrative-unit) of Harirampur sub-district, allocating to receive treatment (n = 206) or regular health messages (n = 206) as control. The treatment group received monthly food vouchers (30 eggs, 12 L milk, 500 g semolina, 500 mL oil, 500 g sugar) to prepare nutritious children's snacks, micronutrient powder, child feeding and handwashing counseling for 12 months. The Control group received routine health messages from the government. Anthropometry, feeding and morbidity data were collected at baseline, monthly and endpoint. Children's development was assessed only once at an endpoint using Extended Ages and Stages Questionnaire (EASQ), Bayley III and Wolke's behavior rating scales. We used generalized linear regression modelling to conduct intention to treat analysis. Results Children's mean weight and length were similar between groups at baseline. At endpoint, compared to the control, treatment children had higher mean length (83.52 and 80.89 cm; difference: 2.62, P < 0.001); higher LAZ score (β: 0.38, CI: 0.24, 0.51); 61% lower rate of stunting (IRR: 0.39, CI: 0.22, 0.67); higher cognitive (β: 4.01, CI: 2.08, 5.94), language (β: 2.94, CI: 0.94, 4.94) and motor (β: 4.53, CI: 1.87, 7.20) scores, all being statistically significant. The intervention also improved developmental EASQ outcomes of the treatment children (gross and fine motor, problem-solving, and socio-emotional scores). Conclusions A comprehensive intervention package focusing on egg and milk-based snacks improved child growth and development in poor households in Bangladesh. Reducing the intervention cost and scale-up to larger communities in resource-poor settings merit further research. Funding Sources Children Investment Fund Foundation funded the trial.

Structured Counselling and Regular Telephonic Follow Up among Diabetic Retinopathy Patients to improve Timely Referral Flow and Compliance from peripheral eye care centre to tertiary centre in Nepal: A Randomised Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Binita Bhattarai ◽  
Saraswati Khadka, Thapa ◽  
Hari Bahadur Thapa ◽  
Sandip Bashyal ◽  
Bhesh Bikram Thapa, Chhetri ◽  
...  
Keyword(s):  
Diabetic Retinopathy ◽  
Controlled Trial ◽  
Treatment Options ◽  
Control Group ◽  
Intervention Package ◽  
Referral Centre ◽  
Randomized Controlled ◽  
Referral Compliance ◽  
Timely Referral

BACKGROUND Diabetic Retinopathy (DR) is an emerging public health issue. DR may lead to severe visual impairment or blindness. Referral communication and tracking system is helpful to monitor patients flow, timeliness and compliance; ensures a close relationship across health facilities and improves patient’s satisfaction. The aim of the study is to improve timely referral flow and compliance of patients diagnosed with DR. OBJECTIVE Primary objective: To assess the effect of intervention on timely referral compliance Secondary objectives: To assess the determinants and cost effectiveness of the intervention for timely referral compliance. METHODS This is an operational research study using cluster randomized controlled health facility-based trial. A situational analysis was conducted and problem tree was developed to identify different barriers to referral compliance (long waiting time, lack of knowledge about diabetic retinopathy, its impact on vision and different treatment options).Appropriate solutions were identified through comprehensive literature review and addressing individual barriers to improve poor referral and compliance of patients diagnosed with DR from peripheral centres (referring centre). These solutions were systemically arranged in the form of an intervention package, which will be tested using a cluster-based randomized controlled trial. Ten eligible peripheral hospitals out of 19will be randomly selected and allocated (lottery method); five each in intervention and control groups. Structured counselling and referral communication linkage will be implemented to the intervention group. Structured counselling, health educational material, and telephonic follow-up will be provided by a trained counsellor at the referring centre; patients will be told in detail about DR, its impact on eyes and vision, treatment options available and the treatment cost for different procedures. They will be explained process at LEIRC (referral centre) and a contact person shall facilitate their treatment at the referral centre. Patients in Control group will receive ongoing routine counselling and health education material. We collected data on referral and compliance, and their determinants using referral-and DR-registers, and structured questionnaires for 1.demographic and socioeconomic profile of patients, 2.telephonicfollow-up with noncompliant patients,3.Feedback of those referred, and 4.Performa for clinical information. Compliance is considered when the referred participant reports at referral centre within one month of counselling. Referral compliance between the two groups will be compared using appropriate statistical tests. Adjusted analysis will be conducted. RESULTS Due to COVID-19 pandemic the inflow of patients is reduced, thus the duration of the data collection will be increased. In the first 6 months of pilot data collection73 in intervention and 34 in control group were screened for referral; 12(21.82%) and 15(27,2%) already had severe NPDR or PDR at the time of screening. CONCLUSIONS Early stage of DR is asymptomatic and can go unnoticed until it affects vision leading to visual impairment and blindness. This study will assess the feasibility and effectiveness of a referral intervention package for improving early diagnosis and treatment with preservation of vision among DR patients. CLINICALTRIAL Clinicaltrials.gov NCT 04834648

scholarly journals A community-based comprehensive intervention to reduce syphilis infection among low-fee female sex workers in China: a matched-pair, community-based randomized study

2019 ◽  
Vol 8 (1) ◽  
Author(s):  
Wei Dong ◽  
Chu Zhou ◽  
Ke-Ming Rou ◽  
Zun-You Wu ◽  
Jun Chen ◽  
...  
Keyword(s):  
Sex Workers ◽  
Standard Of Care ◽  
Matched Pair ◽  
Intervention Package ◽  
Current Standard ◽  
Community Based ◽  
Syphilis Infection ◽  
Intervention Measures ◽  
Comprehensive Intervention

Abstract Background Low-fee female sex workers (FSWs) are at high risk of acquiring and spreading human immunodeficiency virus (HIV)/sexually transmitted diseases (STDs) in China. There is an urgent need to develop comprehensive intervention measures targeted towards low-fee FSWs to reduce HIV/STD infections. Thus, this study aimed to reduce HIV/STD infections among low-fee FSW through a matched-pair, community-based randomized intervention trial carried out in 12 cities in three provinces in China. Methods Four cities from Guangxi Zhuang Autonomous Region, four from Yunnan Province, and four from Hunan Province were paired and participants received either the intervention package (including condom promotion, HIV and syphilis testing, reimbursement for syphilis treatment costs, and free anti-retroviral therapy or the current standard of care. Venue-based, convenience sampling was used to recruit FSWs. A face-to-face interview and HIV and syphilis blood testing was conducted at baseline and follow-up intervals of 24 months. Generalized linear mixed models (GLMM) were used to evaluate the effect of the intervention package on reducing HIV/STD infection in the FSWs. Results A total of 1024 eligible FSWs were enrolled in the baseline survey and 843 in the follow-up. GLMM results showed that syphilis infection was reduced by 49% in the intervention group compared to the current standard of care group (P = 0.0378, OR = 0.51, 95% CI: 0.27–0.96). FSWs aged 35 years or older were 2.38 times more likely to get syphilis infection compared to those younger than 35 years old (P <  0.0001, OR = 2.38, 95% CI: 1.55–3.65). The risk of syphilis infection among more educated FSWs was 0.43 times less than those with lower levels of education (P <  0.05, OR = 0.43, 95% CI: 0.63–0.93). Conclusions This study demonstrates that comprehensive interventions can lead to significant declines in syphilis infection amongst low-tier FSWs. Integrating both behavioral and biomedical intervention measures should be considered when developing programs for low-fee FSWs. Trial registration CHiCTR-TRC-12002655.

scholarly journals Challenges and Innovations in a Community-Based Participatory Randomized Controlled Trial

2016 ◽  
Vol 44 (1) ◽  
pp. 123-130 ◽  
Author(s):  
Jessica R. Goodkind ◽  
Suha Amer ◽  
Charlisa Christian ◽  
Julia Meredith Hess ◽  
Deborah Bybee ◽  
...  
Keyword(s):  
Mental Health ◽  
Controlled Trial ◽  
Control Group ◽  
Ethical Challenges ◽  
Community Based ◽  
Support Intervention ◽  
Randomized Controlled ◽  
Research Interviews ◽  
Important Design

Randomized controlled trials (RCTs) are a long-standing and important design for conducting rigorous tests of the effectiveness of health interventions. However, many questions have been raised about the external validity of RCTs, their utility in explicating mechanisms of intervention and participants’ intervention experiences, and their feasibility and acceptability. In the current mixed-methods study, academic and community partners developed and implemented an RCT to test the effectiveness of a collaboratively developed community-based advocacy, learning, and social support intervention. The goals of the intervention were to address social determinants of health and build trust and connections with other mental health services in order to reduce mental health disparities among Afghan, Great Lakes Region African, and Iraqi refugee adults and to engage and retain refugees in trauma-focused treatment, if needed. Two cohorts completed the intervention between 2013 and 2015. Ninety-three adult refugees were randomly assigned to intervention or control group and completed four research interviews (pre-, mid-, and postintervention, and follow-up). Several challenges to conducting a community-based RCT emerged, including issues related to interviewer intervention to assist participants in the control group, diffusion of intervention resources throughout the small refugee communities, and staff and community concerns about the RCT design and what evidence is meaningful to demonstrate intervention effectiveness. These findings highlight important epistemological, methodological, and ethical challenges that should be considered when conducting community-based RCTs and interpreting results from them. In addition, several innovations were developed to address these challenges, which may be useful for other community–academic partnerships engaged in RCTs.

scholarly journals Role of Topiramete in Moderate to Severe Perinatal Asphyxia - A Randomized Controlled Clinical Trial

2020 ◽  
Vol 35 (2) ◽  
pp. 135-140
Author(s):  
Naznin Akther ◽  
M Monir Hossain ◽  
Ahmed Ferdous Jahangir ◽  
Shayla Imam Kanta ◽  
Sayeeda Mehnaz Masud
Keyword(s):  
Perinatal Asphyxia ◽  
Tertiary Care ◽  
Mode Of Delivery ◽  
Intervention Group ◽  
Treatment Protocol ◽  
Fine Motor ◽  
Control Group ◽  
Neurodevelopmental Outcomes ◽  
Randomized Controlled ◽  
And Control

Background: Topiramate is an anticonvulsant drugs that has multiple mode of mechanism of action. Topiramate appears to be effective as both an anti-seizure and neuroprotective agent in animal models of newborn brain injury. Objectives: To determine the neurological outcome of oral topiramate with moderate to severe hypoxic ischemic encephalopathy. Methods: This one year randomized controlled trial was carried out in the Neonatal ward and ICU of a tertiary care specialized hospital. A total of 64 neonate were enrolled in this study and were randomly assigned intervention group (Group-A, n=32) and control group (Group B=32). In case group oral topiramate 10mg/kg was given for 3 consecutive days along with standard treatment protocol. And control was given only standard protocol. Finally outcomes are compared. Results: Baseline clinical characteristics, age, sex, mode of delivery, arterial pH, residence, basic status of HIE cases were matched in both groups. This study has shown significant reduction of neurological impairment in all domain (gross motor, fine motor, vision hearing, speech) at 1 and 3 months in case than control. There is also early seizure control, early initiation of feeding, short duration of hospital stay in case (treatment) than control without any side effects. Conclusion: Early administration of topiramate to infants with moderate and severe HIE in perinatal asphyxia was very effective in controlling seizures, improving USG findings, and producing favorable neurodevelopmental outcomes at1 and 3 months of age. DS (Child) H J 2019; 35(2) : 135-140

scholarly journals Peer Counseling Promotes Appropriate Infant Feeding Practices and Improves Infant Growth and Development in an Urban Slum in Bangladesh: A Community-Based Cluster Randomized Controlled Trial

2019 ◽  
Vol 3 (7) ◽  
Author(s):  
Gulshan Ara ◽  
Mansura Khanam ◽  
Nowshin Papri ◽  
Baitun Nahar ◽  
Iqbal Kabir ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Growth And Development ◽  
Controlled Trial ◽  
Feeding Practices ◽  
Peer Counseling ◽  
Infant Feeding Practices ◽  
Community Based ◽  
Randomized Controlled ◽  
Psychosocial Stimulation ◽  
Cluster Randomized

ABSTRACT Background Undernutrition and poor cognitive development affect many children in developing countries. Good nutrition and health care are essential for optimal child development and growth. Objectives We assessed the impact of peer counseling combined with psychosocial stimulation on feeding practices and child growth and development in slums in Bangladesh. Methods We performed a community-based cluster randomized controlled trial in selected slums; 350 mother–infant pairs were allocated to receive peer counseling on feeding practices plus psychosocial stimulation (PC + PCS; n = 175) or usual health messages (control; n = 175) using restricted randomization. Data were collected at enrollment and 1, 3, 5, 7, 9, and 12 mo after delivery. We collected data on infant and young child feeding practices and anthropometric measurements from birth until 12 mo to assess the main outcomes, including feeding practices and growth. We used the Bayley Scale III at 12 mo to assess child development. The effects of the PC + PCS intervention were assessed by using regression models. Results More mothers in the PC + PCS group than in the control group reported early initiation of breastfeeding (in the first hour: 89% compared with 78%, respectively; P < 0.05) and exclusive breastfeeding at 5 mo (73% compared with 27%, respectively; P < 0.001). Peer counseling had positively impacted infant length gain at 12 mo (P < 0.005). Children in the PC + PCS group were found to be more socially and emotionally active compared with controls at 12 mo (standardized score: 0.165 compared with −0.219, respectively; P < 0.05). Conclusion Combining peer counseling with psychosocial stimulation had positive effects on infant feeding practices and growth at 12 mo and on the social–emotional development of young children. This trial was registered at clinicaltrial.gov as NCT03040375.

scholarly journals Treatment outcomes of a community-Based Addiction Rehabilitation Electronic System in Drug Abusers: A Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Haifeng Jiang ◽  
Xiaomin Xu ◽  
Shujuan Chen ◽  
Junning Chen ◽  
Zhikang Chen ◽  
...  
Keyword(s):  
Social Workers ◽  
Drug Users ◽  
Controlled Trial ◽  
Intervention Group ◽  
Electronic System ◽  
Control Group ◽  
Community Based ◽  
Randomized Controlled ◽  
Community Based Rehabilitation ◽  
The Social

BACKGROUND Drug abuse has high potential to relapse and imposes an enormous burden on public health in China. Since the promulgation of the “Anti-drug law” in 2008, the community-based rehabilitation has become the primary approach to treat drug addiction. However, multi-faceted problems occurred in the implementation process, leading to low detoxification rate in the community. Mobile health (mHealth) serves as a promising tool to improve the effectiveness and efficiency of the community-based rehabilitation. Community-based addiction rehabilitation electronic system (CAREs) is an interactive system for drug users and their corresponding social workers. OBJECTIVE The study aimed to examine the feasibility and efficacy of integrated rehabilitation based on CAREs compared with the standard community-based rehabilitation from both the drug users and social workers perspective in Shanghai, China. METHODS In this pilot randomized controlled trial, 40 participants were recruited from the community in Shanghai from January to May 2019. Participants randomized to the intervention group (n=20) received integrated community rehabilitation based on CAREs, while participants in control group (n=20) received community-based rehabilitation alone for 6 months. Corresponding social workers provided service and monitored their drug use behavior as usual. The primary outcome was percentage of drug-positive samples which was submitted regularly once a week during the study course. The secondary outcome was longest period of abstinence and the change of Addiction Severity Index (ASI) from baseline in the 6th month. Usage of CAREs feature was also calculated. RESULTS After 6-month intervention, 3.3% samples in the intervention group and 7.5% in the control group were drug-positive (F = 4.358, P= .04). No significant differences between the control and intervention group in terms of longest duration of abstinence and ASI composite scores. Among the multiple features of CAREs, participants in intervention group accessed assessment and education features more frequently, while their corresponding social workers favored urine results record and viewing assessments results most. By using the CARES system, the patient's behavior and emotional state can be obtained by the social worker in a timely manner and get a timely response from the social worker. CONCLUSIONS The study preliminarily demonstrated that the feasibility and effectiveness of integrated community rehabilitation based on CAREs. CLINICALTRIAL ClinicalTrials.gov number: NCT03451344; https://clinicaltrials.gov/ct2/show/ NCT03451344 (Archived by WebCite at https://clinicaltrials.gov/ct2/show/ NCT03451344)

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