Low cost local food supplements could improve maternal and birth outcomes: a pilot randomized controlled trial

Objectives. Maternal nutrition plays a crucial role in influencing fetal growth and birth outcomes. The government of Indonesia has provided a manufactured fortified food supplementation program for undernourished pregnant mothers. We hypothesized a low-cost local food supplementation (LFS) would improve maternal and birth outcomes compared with government food supplementation (GFS). Methods. We conducted a randomized control trial. We enrolled 54 pregnant mothers with MUAC<23.5cm who were assigned into two groups. The intervention group received LFS and multiple micronutrient supplements (MMS). The control group received the GFS and iron and folic acid supplements (IFA). LFS was a balanced energy protein food supplement made from nuts and fish. LFS and GFS contained approximately 500kcal energy and 10grams protein. We compared the effectiveness of these two interventions using logistic and linear regression. Results. At the baseline, the two groups had similar characteristics. After 60 days of treatment, mothers in the LFS group were 2.28 folds more likely to increase MUAC (RR 2.28; 95%CI 1.58,3.27, p<0.001) and 4.73 folds to increase gestational weight (RR 4.73; 95%CI 1.37,16.3, p=0.015) than were mothers in the GFS group. For birth outcomes, in the LFS group had reduction of birthweight <3000grams (RR 0.15; 95%CI 0.023,0.98; p=0.048), short birth length (RR 0.068; 95%CI 0.005,0.93; p=0.044), and cesarean delivery (RR 0.11; 95%CI 0.022,0.61, p=011) as compared to the GFS group. Conclusions for Practice. Local foods and MMS supplementation can improve maternal and birth outcomes. Therefore, local food supplements can be considered for food supplementation programs to undernourished pregnant mothers.

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Low‐cost local food supplements could improve maternal and birth outcomes in Indonesia: A pilot randomised controlled trial

Nutrition Bulletin ◽

10.1111/nbu.12519 ◽

2021 ◽

Vol 46 (3) ◽

pp. 321-331

Author(s):

Kun A. Susiloretni ◽

Dyah Nur Subandriani ◽

Elisa Ulfiana ◽

Sunarto Sunarto ◽

Trina Astuti ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Birth Outcomes ◽

Local Food ◽

Low Cost ◽

Controlled Trial ◽

Food Supplements ◽

Pilot Randomised Controlled Trial ◽

Randomised Controlled

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Does Postural Feedback Reduce Musculoskeletal Risk?: A Randomized Controlled Trial

Sustainability ◽

10.3390/su14010583 ◽

2022 ◽

Vol 14 (1) ◽

pp. 583

Author(s):

Coral Oliver Hernández ◽

Shimeng Li ◽

María Dolores Merino Rivera ◽

Inmaculada Mateo Rodríguez

Keyword(s):

Low Cost ◽

Controlled Trial ◽

Intervention Group ◽

Hospital Setting ◽

Assessment Method ◽

Nursing Assistants ◽

Healthcare Sector ◽

Control Group ◽

Practical Training ◽

Entire Body

Background: There is a high prevalence of musculoskeletal disorders among personnel working in the healthcare sector, mainly among nursing assistants and orderlies. Objective: The objective is to analyze the effectiveness of a multi-component intervention that included postural feedback in reducing musculoskeletal risk. Method: A total of 24 nursing assistants and orderlies in a hospital setting were randomly assigned to an intervention group or a control group. After collecting sociodemographic information, a selection of tasks was made and assessed using the REBA (rapid entire body assessment) method. A multi-component intervention was designed combining theoretical and practical training, including feedback on the postures performed by the professionals involved, especially those involving high musculoskeletal risk. This program was applied only to participants in the intervention group. Subsequently, eight months after the first assessment and intervention, the second assessment was carried out using the same method and process as in the first evaluation. Results: The results indicate that the musculoskeletal risk in the second assessment in the intervention group was significantly reduced. However, no significant changes were observed in the control group. Conclusion: The multi-component intervention applied can significantly reduce the musculoskeletal risk of nursing assistants and orderlies. In addition, it is a low-cost intervention with great applicability.

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Promoting the Community's Ability to Detect and Respond to Suicide Risk Through an Online Bystander Intervention Model-Informed Tool

Crisis ◽

10.1027/0227-5910/a000708 ◽

2020 ◽

pp. 1-7

Author(s):

Karien Hill ◽

Shawn Somerset ◽

Ralf Schwarzer ◽

Carina Chan

Keyword(s):

Suicide Prevention ◽

Suicide Risk ◽

Controlled Trial ◽

Intervention Group ◽

Bystander Intervention ◽

Self Report ◽

Innovative Technology ◽

Control Group ◽

Intervention Model ◽

Standard Material

Abstract. Background: The public health sector has advocated for more innovative, technology-based, suicide prevention education for the community, to improve their ability to detect and respond to suicide risk. Emerging evidence suggests addressing the bystander effect through the Bystander Intervention Model (BIM) in education material may have potential for suicide prevention. Aims: The current study aimed to assess whether BIM-informed tools can lead to improved readiness, confidence and intent in the community to detect and respond to suicide risk in others. Method: A sample of 281 adults recruited from the community participated in a randomized controlled trial comprising a factsheet designed according to the BIM (intervention group) and a standard factsheet about suicide and mental health (control group). Participants' self-reported detecting and responding to suicide risk readiness, confidence, and intent when presented with a suicidal peer was tested pre- and postintervention and compared across time and between groups. Results: The intervention group had significantly higher levels of detecting and responding to suicide risk readiness, confidence, and intent than the control group at postintervention (all p < .001) with moderate-to-large effect sizes. Limitations: The study was limited by a homogenous sample, too low numbers at follow-up to report, and self-report data only. Conclusion: This study demonstrates BIM-informed suicide prevention training may enhance the community's intervention readiness, confidence, and intent better than current standard material. Further testing in this area is recommended. While results were statistically significant, clinical significance requires further exploration.

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Breastfeeding Training through Role-Play and Effects on Mother-infant Attachment Behaviours: A Randomised Controlled Trial

Africa Journal of Nursing and Midwifery ◽

10.25159/2520-5293/6232 ◽

2020 ◽

Vol 22 (1) ◽

Author(s):

Farokh Saljughi ◽

Mitra Savabi-Esfahani ◽

Shahnaz Kohan ◽

Soheila Ehsanpour

Keyword(s):

Pregnant Women ◽

Maternal Employment ◽

Controlled Trial ◽

Role Play ◽

Intervention Group ◽

Control Group ◽

Maternal Behaviour ◽

Infant Attachment ◽

Significant Difference ◽

History Of

Mother-infant attachment is an intimate, lasting and satisfying relationship that leads to better cognitive, emotional and social growth of the infant. The aim of this study was to determine the effects of breastfeeding training by role-play on mother-infant attachment behaviours. This research was a randomised clinical trial (parallel design). Inclusion criteria were: no history of mental disorders; ability to read and write the Persian language to complete the questionnaire; no history of drug and tobacco intake in primigravida women. The sample comprised 100 pregnant women (in 2 groups), selected through simple random sampling at healthcare centres. The researcher reviewed prenatal care registries of selected healthcare centres and extracted the names of pregnant women in their early third trimester. The data were imported into randomisation software. The control group received routine breastfeeding training, while the intervention group received routine training together with training through role-play. The data collection tool was the Maternal Behaviour Inventory Questionnaire. Consequently 75 samples were analysed in SPSS16. Independent t-tests and chi-square tests were used to examine the difference between the two groups. Results showed that the mean score of mother-infant attachment one week after delivery was significantly higher in the intervention group in comparison to that in the control group (p<0.001). No significant difference was observed between the two groups in maternal age, age of marriage, neonatal gender, maternal employment and education, number of parity, and number of abortions (P>0.05). Since breastfeeding training through role-play could affect mother-infant attachment, it is suggested that this type of training should be provided for pregnant women to promote mother-infant attachment and exclusive breastfeeding.

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The Effect of Reflexology on Labor Pain and Length Among Primiparous Women: A Randomized Controlled Trial

International Electronic Journal of Medicine ◽

10.31661/iejm805 ◽

2018 ◽

Vol 7 ◽

Author(s):

Azita Kamjoo

Keyword(s):

Controlled Trial ◽

Intervention Group ◽

Active Phase ◽

Labor Pain ◽

Control Group ◽

Singleton Pregnancy ◽

Group Data ◽

Significant Difference ◽

Labor Length ◽

Primiparous Women

Background: Pain control is considered as the key issue in modern midwifery. Along with medical painkillers, reflexology is viewed as a non-medical and noninvasive method. Hence, we aimed to investigate the effect of reflexology on the intensity of pain and length of labor. Materials and Methods: In this clinical trial, participants included 240 Iranian primiparous women with term and singleton pregnancy. Having a 3-4 cm cervical dilatation once they visited the hospital. Through a convenient sampling method, they were selected and then randomly divided into two groups. In the intervention group, reflexology was performed, and the intensity of pain during the active phase of labor along with the length of labor in the active phase was measured by visual analog scale (VAS) and compared with the control group. Data were analyzed using descriptive statistics, t-test, and Mann-Whitney U-test. Result: Data analysis showed a statistically significant difference between the intensity of pain in the 5-7 and 8-10 cm dilatation in the two groups (P=0.01). Moreover, the labor length in the active phase was found to be significantly shorter in the intervention group (P<0.001). Conclusion: It appears that reflexology can lead to a reduction in the pain and length of labor. Therefore, through instructing this technique, a goal of midwifery, which is reducing labor pain and its length can be achieved. Keywords: Reflexology, Labor Pain, Labor Length, Primiparous Women

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Effectiveness of an Educational Intervention in Reducing New International Postgraduates’ Acculturative Stress in Malaysian Public Universities: Protocol for a Cluster Randomized Controlled Trial (Preprint)

10.2196/preprints.12950 ◽

2018 ◽

Author(s):

Musheer Abdulwahid Al-Jaberi ◽

Muhamad Hanafiah Juni ◽

Hayati Kadir Shahar ◽

Siti Irma Fadhilah Ismail ◽

Murad Abdu Saeed ◽

...

Keyword(s):

International Students ◽

Acculturative Stress ◽

Educational Program ◽

Public Universities ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Policy Makers ◽

Randomized Controlled ◽

Cluster Randomized

BACKGROUND Universities around the world, including Malaysia, have attracted many international students from different countries. Research has reported that acculturative stress resulting from international students’ attempts to adjust to the cultures of host countries is one of the most challenging issues that affects their lives in general and academic lives in particular. OBJECTIVE This study aims to examine the effectiveness of an educational intervention on acculturative stress among new postgraduate international students joining Malaysian public universities. METHODS A cluster randomized controlled trial design with Malaysian public universities as the unit of randomization will be used in this study. Public universities will be randomized in a 1:1 ratio to be either in the intervention (educational program) or control group (waiting list). Participants in the intervention group will receive 7 sessions in 9 hours delivered by an expert in psychology and the researcher. The control group will receive the intervention once the 3-month follow-up evaluation is completed. RESULTS The data will be analyzed using the generalized estimation equation with a confidence interval value of 95%; significant differences between and within groups are determined as <i>P</i><.05. The results of the study underlie the effectiveness of educational program in decreasing acculturative stress of new international students and enabling them to cope with a new environment. The results of this study will contribute to previous knowledge of acculturative stress, acculturation, and adjustment of international students. Furthermore, such results are expected to play a role in raising university policy makers’ awareness of their postgraduate international students’ acculturative stress issues and how they can help them avoid such stress and perform well in their academic life. CONCLUSIONS We expect that the intervention group will score significantly lower than the wait-list group on the immediate and 3-month postintervention evaluation of acculturative stress and achieve a higher level of adjustment. Results will have implications for international students, policy makers at universities, the Malaysian Ministry of Higher Education, and future research. CLINICALTRIAL Clinical Trials Registry India CTRI/2018/01/011223; http://ctri.nic.in/Clinicaltrials/showallp.php?mid1= 21978&amp;EncHid=&amp;userName=Muhamad%20Hanafiah%20Juni INTERNATIONAL REGISTERED REPORT PRR1-10.2196/12950

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Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

10.2196/preprints.16141 ◽

2019 ◽

Author(s):

Jan van Lieshout ◽

Joyca Lacroix ◽

Aart van Halteren ◽

Martina Teichert

Keyword(s):

Randomized Controlled Trial ◽

Medication Adherence ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Community Pharmacies ◽

Web Based ◽

Randomized Controlled ◽

Tailored Interventions ◽

Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

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A patient-centered mobile intervention to promote self-management and improve patient outcomes in chronic heart failure: The ManageHF4Life trial (Preprint)

10.2196/preprints.26185 ◽

2020 ◽

Author(s):

Michael P. Dorsch ◽

Karen B. Farris ◽

Brigid E. Rowell ◽

Scott L. Hummel ◽

Todd M. Koelling

Keyword(s):

Heart Failure ◽

Mobile Application ◽

Controlled Trial ◽

Intervention Group ◽

Self Care ◽

Self Management ◽

Control Group ◽

Patient Centered ◽

Self Monitoring ◽

Heart Failure Questionnaire

BACKGROUND Successful management of heart failure (HF) involves guideline based medical therapy as well as self-care behavior. As a result, the management of HF is moving toward a proactive real-time technological model of assisting patients with monitoring and self-management. OBJECTIVE Evaluate the effectiveness of a mobile application intervention that enhances self-monitoring on health-related quality of life, self-management, and reduces HF readmissions. METHODS A single-center randomized controlled trial was performed. Patients greater than 45 years of age and admitted for acute decompensated HF or recently discharged in the past 4 weeks were included. The intervention group used a mobile application (App). The intervention prompted daily self-monitoring and promoted self-management. The control group (No App) received usual care. The primary outcome was the change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) from baseline to 6 and 12 weeks. Secondary outcomes were the Self-Care Heart Failure Index (SCHFI) questionnaire and recurrent HF admissions. RESULTS Eighty-three patients were enrolled and completed all baseline assessments. Baseline characteristics were similar between groups with the exception of HF etiology. The App group had a reduced MLHFQ at 6 weeks (37.5 ± 3.5 vs. 48.2 ± 3.7, P=0.039) but not at 12 weeks (44.2 ± 4 vs. 45.9 ± 4, P=0.778) compared to No App. There was no effect of the App on the SCHFI at 6 or 12 weeks. The time to first HF admission was not statistically different between the App versus No App groups (HR 0.89, 95% CI 0.39-2.02, P=0.781) over 12 weeks. CONCLUSIONS The mobile application intervention improved MLHFQ at 6 weeks, but did not sustain its effects at 12 weeks. No effect was seen on HF self-care. Further research is needed to enhance engagement in the application for a longer period of time and to determine if the application can reduce HF admissions in a larger study. CLINICALTRIAL NCT03149510

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Effect of leg wrapping technique on prevention of spinal induced hypotension and fetal acidosis during cesarean section: Randomized controlled trial

Journal of Nursing Education and Practice ◽

10.5430/jnep.v10n2p70 ◽

2019 ◽

Vol 10 (2) ◽

pp. 70

Author(s):

Samah Nasser Abd El-Aziz El-Shora ◽

Amina Mohamed Rashad El-Nemer

Keyword(s):

Randomized Controlled Trial ◽

Cesarean Section ◽

Controlled Trial ◽

Intervention Group ◽

Cost Effective ◽

Control Group ◽

Induced Hypotension ◽

Randomized Controlled ◽

Significant Difference ◽

Wrapping Technique

Background and aim: Hypotension during cesarean section (CS) under spinal anesthesia has been a subject of scientific study for more than 50 years and the search for the most effective strategy to achieve hemodynamic stability remains challenging. Aim: The study was carried out to apply leg wrapping technique for the prevention of spinal-induced hypotension (SIH) during CS.Methods: Randomized Controlled Trial design was utilized at cesarean delivery operating room Mansoura General Hospital in El-Mansoura City during the period from May 2018 to November 2018. A purposive sample of 88 pregnant women, assigned randomly to an intervention group (n = 44) in which their legs wrapped with elastic crepe bandage and control group (n = 44) in which no wrapping was done. Data collected for maternal, neonatal hemodynamic and signs of hypotension, the feasibility of application and cost analysis.Results: There was a statistically significant difference in the incidence of SIH and Ephedrine use among both groups (18.20% in leg wrapping group whereas 75% in control group). In addition, neonatal acidosis and NICU admission were less among leg wrapping group (11.40%, 9.10% respectively). Economically, leg wrapping technique was cost effective compared to the cost of the hospital regimen for treating SIH and admission to (NICU).Conclusion and recommendations: Leg wrapping technique was cost effective and an efficient method for decreasing SIH, neonatal acidosis and Ephedrine administration. It is recommended to apply leg wrapping technique in maternal hospitals' protocol of care for decreasing SIH during CS.

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Pediatric Residents and Interns in an Italian Hospital Perform Improved Bibliographic Searches when Assisted by a Biomedical Librarian

Evidence Based Library and Information Practice ◽

10.18438/b88321 ◽

2013 ◽

Vol 8 (1) ◽

pp. 76

Author(s):

Mathew Stone

Keyword(s):

Teaching Hospital ◽

Assessment Tool ◽

Controlled Trial ◽

Intervention Group ◽

Real Life ◽

Boolean Logic ◽

Bibliographic Databases ◽

Control Group ◽

Pediatric Residents ◽

Clinical Scenarios

A Review of: Gardois, P., Calabrese, R., Colombi, N., Lingua, C., Longo, F., Villanacci, M., Miniero, R., & Piga, A. (2011). Effectiveness of bibliographic searches performed by paediatric residents and interns assisted by librarian. A randomised controlled trial. Health Information and Libraries Journal, 28(4), 273-284. doi: 10.1111/j.1471-1842.2011.00957.x Objective – To establish whether the assistance of an experienced biomedical librarian delivers an improvement in the searching of bibliographic databases as performed by medical residents and interns. Design – Randomized controlled trial. Setting – The pediatrics department of a large Italian teaching hospital. Subjects – 18 pediatric residents and interns. Methods – 23 residents and interns from the pediatrics department of a large Italian teaching hospital were invited to participate in this study, of which 18 agreed. Subjects were then randomized into two groups and asked to spend between 30 and 90 minutes searching bibliographic databases for evidence to answer a real-life clinical question which was randomly allocated to them. Each member of the intervention group was provided with an experienced biomedical librarian to provide assistance throughout the search session. The control group received no assistance. The outcome of the search was then measured using an assessment tool adapted for the purpose of this study from the Fresno test of competence in evidence based medicine. This adapted assessment tool rated the “global success” of the search and included criteria such as appropriate question formulation, number of PICO terms translated into search terms, use of Boolean logic, use of subject headings, use of filters, use of limits, and the percentage of citations retrieved that matched a gold standard set of citations found in a prior search by two librarians (who were not involved in assisting the subjects) together with an expert clinician. Main Results – The intervention group scored a median average of 73.6 points out of a possible 100, compared with the control group which scored 50.4. The difference of 23.2 points in favour of the librarian assisted group was a statistically significant result (p value = 0.013) with a 95% confidence interval of between 4.8 and 33.2. Conclusion – This study presents credible evidence that assistance provided by an experienced biomedical librarian improves the quality of the bibliographic database searches performed by residents and interns using real-life clinical scenarios.

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