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Evaluation of the impact of breastfeeding support groups in primary health CENTRES in Andalusia, Spain: a study protocol for a cluster randomized controlled trial (GALMA project).

ABSTRACT: BACKGROUND:In 2003, the World Health Organization recommended exclusive breastfeeding (EB) during the newborn's first 6?months of life and, if possible, during the first 2?years. However, EB rates resist these recommendations. In developed countries, only 1 out of 3 babies is breastfed during its first 6?months of life, and great differences between areas and countries can be observed. Only 35% of the newborns receive breastfeeding at 3-4?months of age. There are diverse strategies described in the literature that have proven their efficiency in improving breastfeeding rates. It has also been proven that professional support is an effective tool to extend any kind of breastfeeding; besides, it has been observed that mother-to-mother support also increases breastfeeding initiation, sustainment, and exclusive duration. The overall aim of the study is to assess the impact of the support groups on the sustainment of exclusive breastfeeding until 6?months after birth. METHODS/DESIGN:This study is a cluster-random multicentric clinical trial with a control group and an intervention group, without blinding because it is impossible to mask the intervention. A randomization by centres of primary health (clusters) will be carried out. The women allocated to the intervention or control group will be randomized with a simple randomization sampling. The participants' breastfeeding rate will be followed up at the first 10?days, and at 2, 4, and 6?months of their newborn's life. DISCUSSION:There is a need to assess the impact of mother support groups on exclusive breastfeeding. This study aims to analyse the outcomes related to the support received and to identify what should the structure of these groups be; in other words, to describe factors related to a better breastfeeding experience in order to help women increase breastfeeding rates. TRIAL REGISTRATION:The trial is prospectively recorded at the ISRCTN registry (Trial ID: ISRCTN17263529 ). Date recorded: 17/06/2020.

SUBMITTER: Rodriguez-Gallego I

PROVIDER: S-EPMC7368689 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Evaluation of the impact of breastfeeding support groups in primary health CENTRES in Andalusia, Spain: a study protocol for a cluster randomized controlled trial (GALMA project).

Rodríguez-Gallego Isabel I Leon-Larios Fatima F Ruiz-Ferrón Cecilia C Lomas-Campos Maria-de-Las-Mercedes MD

BMC public health 20200718 1

<h4>Background</h4>In 2003, the World Health Organization recommended exclusive breastfeeding (EB) during the newborn's first 6 months of life and, if possible, during the first 2 years. However, EB rates resist these recommendations. In developed countries, only 1 out of 3 babies is breastfed during its first 6 months of life, and great differences between areas and countries can be observed. Only 35% of the newborns receive breastfeeding at 3-4 months of age. There are diverse strategies descr ...[more]

PMID: 32682408

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Project description:BackgroundThe prevalence of early initiation of breastfeeding and exclusive breastfeeding (EBF) at 6 months remain low in the Philippines. To help meet the 90% early initiation of breastfeeding target and to improve infant and young child feeding practices in the Philippines, the Millennium Development Goals - Fund 2030 Joint Programme (JP) on Ensuring Food Security and Nutrition for Children 0-24 months old was implemented. We aimed to determine the effectiveness of visits by peer counselors during pregnancy and after delivery, and membership in breastfeeding support groups in promoting these optimal breastfeeding practices.MethodsWe used data from the Endline Survey of the JP to study the effects of prenatal and postnatal peer counselor visits, and membership in breastfeeding support groups, and their possible interactions with initiation of breastfeeding within 1 hour of birth among children aged 0 to 24 months and EBF at 6 months among children aged 6 to 24 months, while adjusting for confounding. We used logistic regression methods for survey data to assess these associations.ResultsOf the 2343 mother-infant pairs, only 1500 (63.1%) practiced early initiation of breastfeeding. Of the 1865 children aged 6 months or older, only 621 (34.7%) were exclusively breastfed at 6 months. After adjusting for confounding variables, there was no strong evidence that peer counselor visits were associated with early initiation or EBF at 6 months. However, members of breastfeeding support groups had 1.49 times higher odds of early initiation of breastfeeding (95% CI [Confidence Interval] 1.12, 1.98) and 1.65 times higher odds of EBF (95% CI 1.20, 2.24) compared to those who were not members of breastfeeding support groups. There was no interaction between the different exposure variables and early initiation and EBF at 6 months.ConclusionsOur findings suggest breastfeeding support groups may be institutionalized to promote both early initiation of breastfeeding and EBF in the Philippines, while the role of peer counselors in promoting optimal breastfeeding behaviors should be further reviewed. Our suggestion to integrate non-healthcare professionals to promote early initiation of breastfeeding and EBF could be tested in future intervention studies.

Project description:BACKGROUND:Infant mortality rates are still high in Ethiopia. Breastfeeding is regarded as the simplest and least expensive strategy for reduction of infant mortality rates. Community-based educational and support interventions provided prenatally and postnatally are effective in increasing breastfeeding rates. However, such interventions are not widely implemented in Ethiopia. This study aims to assess the effect of breastfeeding education and support on timely initiation and duration of exclusive breastfeeding. METHODS:A cluster-randomized controlled trial at the community level will be conducted to compare the effect of breastfeeding education and support versus routine care. The intervention will be provided by Women Development Army leaders who are already in the country's health system using a 40-h WHO breastfeeding counseling course, "Infant and Young Child Feeding Counseling: an integrated course" and the "Training of Trainers Manual for Counseling on Maternal, Infant and Young Child Nutrition" in the local language. Culturally appropriate operational packages of information will be developed for them. Using preset criteria at least 432 pregnant women in their third trimester will be recruited from 36 zones. Visits in the intervention arm include two prenatal visits and 8 postnatal visits. Supervisory visits will be conducted monthly to each intervention zone. Data will be entered into Epi-data version 3.1 and analyzed using STATA version 13.0. All analysis will be done by intention to treat analysis. We will fit mixed-effects linear regression models for the continuous outcomes and mixed-effects linear probability models for the binary outcomes with study zone as random intercept to estimate study arm difference (intervention vs. routine education) adjusted for baseline value of the outcome and additional relevant covariates. The protocol was developed in collaboration with the Jimma Zone and Mana district Health office. Ethical clearance was obtained from the Institutional Review Board of University of Oslo and Jimma University. This study is partly funded by NORAD's NORHED programme. DISCUSSION:We expect that the trial will generate findings that can inform breastfeeding policies and practices in Ethiopia. TRIAL REGISTRATION:ClinicalTrials.gov NCT 03030651 January 25, 2017 version 3 dated 16 July 2018.

Project description:BackgroundMany women stop breastfeeding before they intend to as they cannot overcome breastfeeding difficulties. Breastfeeding support, as an evidence-based intervention by trained lay or professional breastfeeding support providers, can prevent early unintended cessation. Yet some women report dissatisfaction with support and reluctantly stop breastfeeding despite receiving this intervention. Understanding the experiences which shape how support is provided can inform effective implementation of breastfeeding support interventions. This review aims to synthesise experiences of trained breastfeeding support providers in high income settings and how these may influence their breastfeeding support practices.MethodsA qualitative systematic review of trained breastfeeding supporters' experiences of supporting women to breastfeed, as part of a generic healthcare role or focused breastfeeding support role, will be conducted. A systematic search will be performed of the databases: Cumulative Index to Nursing and Allied Health Literature (CINAHL +), MEDLINE ALL, Maternity and Infant Care, EMBASE, APA PsycINFO, Web of Science and Scopus. Title and abstract screening using eligibility criteria will be conducted using Covidence software. Eligible papers will be agreed by the review team following full text screening and reported using PRISMA guidelines. CASP and COREQ tools will assess study methodological quality and quality of reporting. Data will be extracted using a bespoke form and coded, using Excel software for data management. Analysis will involve the three stages of thematic synthesis: initial free coding, development of descriptive and subsequent analytical themes. Confidence in findings will be assessed using the CERQual framework.DiscussionThis review is the first to date to synthesise qualitative evidence on experiences which influence how trained lay and professional providers support women with breastfeeding. Findings will enable deeper understanding of the underpinning mechanisms of breastfeeding support provision and inform the development of tailored interventions to improve breastfeeding rates.Systematic review registrationPROSPERO registration number: CRD42020207380.

Project description:BackgroundThe onset of puberty and menarche is a specifically vulnerable time for girls, during which they begin to show interest in the opposite sex, while becoming exposed to a myriad of external pressures, including sexual coercion or harassment from boys and men, expectations to marry from their families, and the need to perform well in primary school in order to qualify for secondary school. According to several qualitative studies in Africa, such pressures are exacerbated by girls' lack of knowledge of their bodies, their rights, and the implications of their decisions, and by their inability to manage puberty and adolescence safely and comfortably with appropriate menstrual health and hygiene management (MHM) products. The evaluation of the Nia Project is one of the first to analyze the individual and combined contributions of sanitary pads and provision of comprehensive reproductive health education on girls' education and reproductive health outcomes.MethodsThe design for the evaluation of the Nia Project is a longitudinal, cluster-randomized controlled trial consisting of a baseline survey with a cohort of Class 7 girls, a school quality survey, qualitative data collection, school attendance tracking, and an endline survey at the completion of the 18-month intervention period with the same cohort. The study involves 140 public primary schools in three rural sub-counties (Magarini, Kaloleni and Ganze) of Kilifi County in the Coastal area of Kenya. The research sample includes 3489 girls, with about 25 girls per school on average. Before program implementation, the schools were stratified by sub-county and randomized to one of four study arms (35 schools per arm): 1) control, 2) disposable sanitary pads distribution, 2) reproductive health education, and 4) sanitary pad distribution and reproductive health education.DiscussionThe evidence provided will inform program investment and design, and contribute to the literature on the effect of menstrual health-based interventions on girls' agency, safety and life outcomes.Trial registrationISRCTN10894523 . Trial Registration Date: August 22, 2017.

Project description:BackgroundIn 2021, more than two-thirds of the world's children lived in a conflict-affected country. In 2022, 13 million Ukrainians were forced to flee their homes after Russia's full-scale invasion. Hope Groups are a 12-session psychosocial, mental health, and parenting support intervention designed to strengthen parents, caregivers, and children affected by war and crisis. The primary objective of this study is to evaluate the effectiveness of Hope Groups among Ukrainians affected by war, compared to a wait-list control group. This protocol describes a promising decentralized intervention delivery model and an innovative research design, which estimates the causal effect of Hope Groups while prioritizing prompt delivery of beneficial services to war-affected participants.MethodsThis protocol describes a pragmatic cluster randomized controlled trial (RCT) among Ukrainians externally displaced, internally displaced within Ukraine, and living at home in war-affected areas. This study consists of 90 clusters with 4-7 participants per cluster, totaling approximately n = 450 participants. Intervention clusters will receive 12-session Hope Groups led by peer facilitators, and control clusters will be wait-listed to receive the intervention after the RCT concludes. Clusters will be matched on the facilitator performing recruitment and intervention delivery. Primary outcomes are caregiver mental health, violence against children, and positive parenting practices. Secondary outcomes include prevention of violence against women and caregiver and child well-being. Outcomes will be based on caregiver report and collected at baseline and endline (1-week post-intervention). Follow-up data will be collected among the intervention group at 6-8 weeks post-intervention, with aims for quasi-experimental follow-ups after 6 and 12 months, pending war circumstances and funding. Analyses will utilize matching techniques, Bayesian interim analyses, and multi-level modeling to estimate the causal effect of Hope Groups in comparison to wait-list controls.DiscussionThis study is the first known randomized trial of a psychosocial, mental health, and parenting intervention among Ukrainians affected by war. If results demonstrate effectiveness, Hope Groups hold the potential to be adapted and scaled to other populations affected by war and crisis worldwide. Additionally, methodologies described in this protocol could be utilized in crisis-setting research to simultaneously prioritize the estimation of causal effects and prompt delivery of beneficial interventions to crisis-affected populations.Trial registrationThis trial was registered on Open Science Framework on November 9, 2023.RegistrationOSF.IO/UVJ67 .

Dataset Information

Evaluation of the impact of breastfeeding support groups in primary health CENTRES in Andalusia, Spain: a study protocol for a cluster randomized controlled trial (GALMA project).

Publications

Evaluation of the impact of breastfeeding support groups in primary health CENTRES in Andalusia, Spain: a study protocol for a cluster randomized controlled trial (GALMA project).

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