scholarly journals Impact of a demand-side integrated WASH and nutrition community-based care group intervention on behavioural change: a randomised controlled trial in western Kenya

2020 ◽  
Vol 5 (11) ◽  
pp. e002806
Author(s):  
Matthew C Freeman ◽  
Anna S Ellis ◽  
Emily Awino Ogutu ◽  
Bethany A Caruso ◽  
Molly Linabarger ◽  
...  
Keyword(s):  
Low Income ◽  
Controlled Trial ◽  
Behavioural Change ◽  
Randomised Trial ◽  
Nutrition Intervention ◽  
Double Difference ◽  
Cluster Randomised Trial ◽  
Care Group ◽  
Western Kenya ◽  
The Impact

IntroductionGrowth shortfalls and diarrhoeal diseases remain a major cause of morbidity and mortality in low-income settings. Due to the multifaceted causes of undernutrition and the identified limitations of siloed nutrition programmes, improving the delivery of integrated water, sanitation, hygiene (WASH) and nutrition programming could improve child health.MethodsWe conducted a cluster randomised trial in western Kenya to assess the impact on household behaviours of a novel, theory-informed and integrated WASH and nutrition intervention delivered through care groups as compared with the standard care group approach. We developed an intervention targeting practices relating to food hygiene, mealtime and feeding, and compound cleanliness, each using various behavioural change techniques to influence the uptake of targeted behaviours. Prespecified behavioural outcomes were verified through direct observation, 24 hours recall, and self-reported picture-based methods.ResultsCompared with control households, a greater proportion of intervention households had a hygienic food preparation area (Risk double difference (RDD) 0.81, 95% CI 0.68 to 0.96), had stored food hygienically (RDD 0.76, 95% CI 0.58 to 1.00), had a functional handwashing station (RDD 0.64, 95% CI 0.56 to 0.74), provided a safe space for their child to play (RDD 0.73, 95% CI 0.56 to 0.96), and who fed their children thickened porridge (RDD 0.56, 95% CI 0.51 to 0.63) at endline. The proportion of children 6–24 months in intervention households consuming a sufficient diversity of foods (RDD 0.81, 95% CI 0.64 to 1.04) was higher than in control households; however, there was a non-significant increase in the percentage of pregnant and lactating women receiving an adequate diversity of foods in their diets (RDD 0.86, 95% CI 0.70 to 1.05) among intervention compared with control households at endline.ConclusionOur integrated WASH and nutrition intervention resulted in important changes in behaviours. This theory-informed intervention could be added to existing care group programmes to considerable advantage.

scholarly journals Effectiveness of conditional cash transfers (Afya credits incentive) to retain women in the continuum of care during pregnancy, birth and the postnatal period in Kenya: a cluster-randomised trial

BMJ Open ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. e055921
Author(s):  
Fedra Vanhuyse ◽  
Oliver Stirrup ◽  
Aloyce Odhiambo ◽  
Tom Palmer ◽  
Sarah Dickin ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Randomised Trial ◽  
Electronic System ◽  
Continuum Of Care ◽  
Cash Transfers ◽  
Conditional Cash Transfers ◽  
Cluster Randomised Trial ◽  
Cluster Randomised ◽  
The Impact ◽  
The Continuum

ObjectivesGiven high maternal and child mortality rates, we assessed the impact of conditional cash transfers (CCTs) to retain women in the continuum of care (antenatal care (ANC), delivery at facility, postnatal care (PNC) and child immunisation).DesignWe conducted an unblinded 1:1 cluster-randomised controlled trial.Setting48 health facilities in Siaya County, Kenya were randomised. The trial ran from May 2017 to December 2019.Participants2922 women were recruited to the control and 2522 to the intervention arm.InterventionsAn electronic system recorded attendance and triggered payments to the participant’s mobile for the intervention arm (US$4.5), and phone credit for the control arm (US$0.5). Eligibility criteria were resident in the catchment area and access to a mobile phone.Primary outcomesPrimary outcomes were any ANC, delivery, any PNC between 4 and 12 months after delivery, childhood immunisation and referral attendance to other facilities for ANC or PNC. Given problems with the electronic system, primary outcomes were obtained from maternal clinic books if participants brought them to data extraction meetings (1257 (50%) of intervention and 1053 (36%) control arm participants). Attendance at referrals to other facilities is not reported because of limited data.ResultsWe found a significantly higher proportion of appointments attended for ANC (67% vs 60%, adjusted OR (aOR) 1.90; 95% CI 1.36 to 2.66) and child immunisation (88% vs 85%; aOR 1.74; 95% CI 1.10 to 2.77) in intervention than control arm. No intervention effect was seen considering delivery at the facility (90% vs 92%; aOR 0.58; 95% CI 0.25 to 1.33) and any PNC attendance (82% vs 81%; aOR 1.25; 95% CI 0.74 to 2.10) separately. The pooled OR across all attendance types was 1.64 (1.28 to 2.10).ConclusionsDemand-side financing incentives, such as CCTs, can improve attendance for appointments. However, attention needs to be paid to the technology, the barriers that remain for delivery at facility and PNC visits and encouraging women to attend ANC visits within the recommended WHO timeframe.Trial registrationNCT03021070.

scholarly journals Food and Agricultural Approaches to Reducing Malnutrition (FAARM): protocol for a cluster-randomised controlled trial to evaluate the impact of a Homestead Food Production programme on undernutrition in rural Bangladesh

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e031037 ◽  
Author(s):  
Amanda S Wendt ◽  
Thalia M Sparling ◽  
Jillian L Waid ◽  
Anna A Mueller ◽  
Sabine Gabrysch
Keyword(s):  
Food Production ◽  
Dietary Diversity ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Child Growth ◽  
Cluster Randomised Trial ◽  
Hygiene Practices ◽  
Cluster Randomised ◽  
Home Gardening ◽  
The Impact

IntroductionChronic undernutrition affects over 150 million children worldwide and has serious consequences. The causes are complex and include insufficient dietary diversity and poor hygiene practices. Systematic reviews of nutrition-sensitive agricultural interventions concluded that while these hold promise, there is insufficient evidence for their impact on child growth. The Food and Agricultural Approaches to Reducing Malnutrition (FAARM) project is a 1:1 cluster-randomised trial aiming to evaluate the impact of a Homestead Food Production (HFP) programme implemented by Helen Keller International on women’s and children’s undernutrition.Methods and analysisThe HFP intervention comprises training of women’s groups and asset distribution to support year-round home gardening, poultry rearing and improved nutrition and hygiene practices. Formal trainings are supplemented by behaviour change communication during household visits, and facilitated links between producer groups and market actors. The FAARM trial will examine if and how this complex intervention reduces undernutrition. In 2015, FAARM enrolled married women and their children (0–3 years) in 96 rural settlements of Habiganj district in Sylhet division, Bangladesh. Covariate-constrained randomisation was used to assign 48 settlements to receive a 3-year HFP intervention, with the other 48 acting as controls, targeting over 2700 women. To study impact pathways, a surveillance system collects data on all participants every 2 months. In late 2019, children 0–3 years of age (born during the intervention period) will be surveyed, thus capturing impact during the critical first 1000 days of life. Children’s length/height-for-age z-scores will be compared between intervention and control arms using mixed-effects linear regression. Secondary outcomes include women’s and children’s micronutrient status, dietary intake, dietary diversity and other indicators of child growth, development and morbidity.Ethics and disseminationEthical approval was received in Bangladesh and Germany. Results will be disseminated through peer-reviewed publications and presentations in Bangladesh and internationally.Trial registration numberNCT02505711; Pre-results.

scholarly journals The RATIONS (Reducing Activation of Tuberculosis by Improvement of Nutritional Status) study: a cluster randomised trial of nutritional support (food rations) to reduce TB incidence in household contacts of patients with microbiologically confirmed pulmonary tuberculosis in communities with a high prevalence of undernutrition, Jharkhand, India

BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e047210
Author(s):  
Anurag Bhargava ◽  
Madhavi Bhargava ◽  
Banurekha Velayutham ◽  
Kannan Thiruvengadam ◽  
Basilea Watson ◽  
...  
Keyword(s):  
Risk Factor ◽  
Nutritional Status ◽  
G Proteins ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Household Contacts ◽  
Cluster Randomised ◽  
High Prevalence ◽  
Secondary Outcomes ◽  
The Impact

IntroductionIndia has the largest burden of cases and deaths related to tuberculosis (TB). Undernutrition is the leading risk factor accounting for TB incidence, while severe undernutrition is a common risk factor for mortality in patients with TB in India. The impact of nutritional supplementation on TB incidence is unknown, while few underpowered studies have assessed its impact on TB mortality. We designed an open-label, field-based cluster randomised trial to assess the impact of nutritional supplementation (with food rations) on TB incidence in a group at higher risk of TB infection and disease, viz household contacts (HHC) of patients with microbiologically confirmed pulmonary TB (PTB) in Jharkhand, a state with a high prevalence of undernutrition.Methods and analysisWe shall enrol 2800 adult patients with PTB of the national TB programme, across 28 treatment units in 4 districts, and their approximately 11 200 eligible contacts. The sample size has 80% power to detect the primary outcome of 50% reduction in incidence of active TB in HHC over 2 years of follow-up. Patients and HHC in both the arms will undergo nutritional assessment and counselling. Patients will receive monthly food rations (supplying 1200 kcal and 52 g proteins/day) and multivitamins along with antitubercular treatment. The HHC in the intervention arm will receive food rations (supplying 750 kcal and 23 g proteins/day) and multivitamins while HHC in control arm will be on usual diet. The secondary outcomes in HHC will include effects on nutritional status, non-TB infections. Secondary outcomes in patients are effects on TB mortality, adherence, adverse effects, nutritional and performance status. Substudies will examine micronutrient status and effects on dietary intake, body composition, muscle strength and immune function.Ethics and disseminationThe institutional ethics committee of ICMR-NIRT, Chennai, approved the study (289/NIRT-IEC/2018). The results will be disseminated in publications and presentations.Trial registration numberClinical Trial Registry of India: CTRI/2019/08/020490.

Cluster randomised trial of the impact of biosecurity measures on poultry health in backyard flocks

2013 ◽  
Vol 198 (3) ◽  
pp. 649-655 ◽  
Author(s):  
Anne Conan ◽  
Flavie Luce Goutard ◽  
Davun Holl ◽  
Sok Ra ◽  
Aurélia Ponsich ◽  
...  
Keyword(s):  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Cluster Randomised ◽  
Backyard Flocks ◽  
The Impact

scholarly journals Bypassing nearest hospital for more distant neuroscience care in head-injured adults with suspected traumatic brain injury: findings of the head injury transportation straight to neurosurgery (HITS-NS) pilot cluster randomised trial

BMJ Open ◽  
2017 ◽  
Vol 7 (10) ◽  
pp. e016355 ◽  
Author(s):  
Fiona Elizabeth Lecky ◽  
Wanda Russell ◽  
Graham McClelland ◽  
Elspeth Pennington ◽  
Gordon Fuller ◽  
...  
Keyword(s):  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Injury Severity ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Measurable Effect ◽  
Cluster Randomised ◽  
Head Injured ◽  
Secondary Transfer

ObjectiveReconfiguration of trauma services, with direct transport of patients with traumatic brain injury (TBI) to specialist neuroscience centres (SNCs)—bypassing non-specialist acute hospitals (NSAHs), could improve outcomes. However, delays in stabilisation of airway, breathing and circulation (ABC) may worsen outcomes when compared with selective secondary transfer from nearest NSAH to SNC. We conducted a pilot cluster randomised controlled trial to determine the feasibility and plausibility of bypassing suspected patients with TBI —directly into SNCs—producing a measurable effect.SettingTwo English Ambulance Services.Participants74 clusters (ambulance stations) were randomised within pairs after matching for important characteristics. Clusters enrolled head-injured adults—injured nearest to an NSAH—with internationally accepted TBI risk factors and stable ABC. We excluded participants attended by Helicopter Emergency Medical Services or who were injured more than 1 hour by road from nearest SNC.InterventionsIntervention cluster participants were transported directly to an SNC bypassing nearest NSAH; control cluster participants were transported to nearest NSAH with selective secondary transfer to SNC.OutcomesTrial recruitment rate (target n=700 per annum) and percentage with TBI on CT scan (target 80%) were the primary feasibility outcomes. 30-day mortality, 6-month Extended Glasgow Outcome Scale and quality of life were secondary outcomes.Results56 ambulance station clusters recruited 293 patients in 12 months. The trial arms were similar in terms of age, conscious level and injury severity. Less than 25% of recruited patients had TBI on CT (n=70) with 7% (n=20) requiring neurosurgery. Complete case analysis showed similar 30-day mortality in the two trial arms (control=8.8 (2.7–14.0)% vs intervention=9.4(2.3–14.0)%).ConclusionBypassing patients with suspected TBI to SNCs gives an overtriage (false positive) ratio of 13:1 for neurosurgical intervention and 4:1 for TBI. A measurable effect from a full trial of early neuroscience care following bypass is therefore unlikely.Trial registration numberISRCTN68087745.

scholarly journals Broader impacts of an intervention to transform school environments on student behaviour and school functioning: post hoc analyses from the INCLUSIVE cluster randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e031589
Author(s):  
Christopher Bonell ◽  
Matthew Dodd ◽  
Elizabeth Allen ◽  
Leonardo Bevilacqua ◽  
Jennifer McGowan ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Cigarette Use ◽  
School Environments ◽  
Broader Impacts ◽  
Cluster Randomised ◽  
Disciplinary Procedures ◽  
Aggressive Behaviours ◽  
Post Hoc

BackgroundWe have previously reported benefits for reduced bullying, smoking, alcohol and other drug use and mental health from a trial of ‘Learning Together’, an intervention that aimed to modify school environments and implement restorative practice and a social and emotional skill curriculum.ObjectivesTo conduct post hoc theory-driven analyses of broader impacts.DesignCluster randomised trial.Settings40 state secondary schools in southern England.ParticipantsStudents aged 11/12 years at baseline.OutcomesStudent self-reported measures at 24 and 36 months of: cyberbullying victimisation and perpetration; observations of other students perpetrating aggressive behaviours at school; own perpetration of aggressive behaviours in and outside school; perceived lack of safety at school; participation in school disciplinary procedures; truancy and e-cigarette use.ResultsWe found evidence of multiple impacts on other health (reduced e-cigarette use, cyberbullying perpetration, perpetration of aggressive behaviours) and educational (reduced participation in school disciplinary procedures and truancy) outcomes.ConclusionThese analyses suggested that the intervention was effective in bringing about a broader range of beneficial outcomes, adding to the evidence that the intervention is a promising approach to promote adolescent health via an intervention that is attractive to schools.Trial registration numberISRCTN10751359.

scholarly journals We Can Quit2 (WCQ2): a community-based intervention on smoking cessation for women living in disadvantaged areas of Ireland—study protocol for a pilot cluster randomised controlled trial

2019 ◽  
Vol 5 (1) ◽  
Author(s):  
Catherine Hayes ◽  
Aurelia Ciblis ◽  
Catherine Darker ◽  
Nadine Dougall ◽  
Joanne Vance ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Health Service ◽  
Sample Size ◽  
Quantitative Methods ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Pilot Trial ◽  
Cluster Randomised Trial ◽  
Community Based ◽  
Cluster Randomised

Abstract Background Tobacco use is the leading cause of preventable death in Ireland with almost 6000 smokers dying each year from smoking-related diseases. The ‘We Can Quit2’ (WCQ2) study is a pilot pragmatic two-arm, parallel-group, cluster randomised trial that aims to explore the feasibility and acceptability of trial processes including recruitment and to estimate parameters to inform sample size estimates needed for an effectiveness trial. This future trial will assess the effectiveness of a community-based smoking cessation intervention for women living in disadvantaged areas on short- and medium-term cessation rates. Methods/design Four matched pairs of districts (eight clusters) selected by area level of deprivation, geographical proximity, and eligibility for free medical services will be randomised to receive either WCQ (behavioural support + access to Nicotine Replacement Therapy (NRT)) delivered over 12 weeks by trained Community Facilitators (CFs) or to a form of usual care, a one-to-one smoking cessation service delivered by Smoking Cessation Officers from Ireland’s national health service, the Health Service Executive (HSE). Within each cluster, 24–25 women will be recruited (97 per arm; 194 in total) in 4 phases with consent obtained prior to cluster randomisation. The outcome measures will assess feasibility and acceptability of trial processes, including randomisation. Outcome data for a future definitive intervention (biochemically validated smoking abstinence) will be collected at end of programme (12 weeks) and at 6 months. WCQ2 has an embedded process evaluation using both qualitative and quantitative methods. This will be conducted (semi-structured client and CF interviews, intervention delivery checklist, and diary) to explore acceptability of trial processes, intervention fidelity, trial context, and implementation. Trial processes will be assessed against domains of the PRECIS-2 wheel to inform a future definitive trial design. Discussion Data from this pilot trial will inform the design and sample size for a full cluster randomised trial to determine the effectiveness of an intervention tailored to disadvantaged women in improving smoking cessation rates. It will provide transferable learning on the systems and implementation strategies needed to support effective design of future pragmatic community-based trials which address health promotion interventions for women in disadvantaged communities. Trial registration Concurrent to publication. Controlled trials ISRCTN74721694.

scholarly journals Implementation, mechanisms of impact and key contextual factors involved in outcomes of the Modification of Diet, Exercise and Lifestyle (MODEL) randomised controlled trial in Australian adults: protocol for a mixed-method process evaluation

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e036395
Author(s):  
Reindolf Anokye ◽  
Simone Radavelli-Bagatini ◽  
Catherine P Bondonno ◽  
Marc Sim ◽  
Lauren C Blekkenhorst ◽  
...  
Keyword(s):  
Process Evaluation ◽  
Mixed Method ◽  
Controlled Trial ◽  
Behavioural Change ◽  
Implementation Strategies ◽  
Pictorial Representation ◽  
Model Study ◽  
Study Results ◽  
Qualitative Component ◽  
The Impact

IntroductionThe Modification of Diet, Exercise and Lifestyle (MODEL) study aims to examine the impact of providing visualisation and pictorial representation of advanced structural vascular disease (abdominal aortic calcification), on ‘healthful’ improvements to diet and lifestyle. This paper reports the protocol for the process evaluation for the MODEL study.Methods and analysisThe overall aim of the process evaluation is to understand the processes that took place during participation in the MODEL study trial and which elements were effective or ineffective for influencing ‘healthful’ behavioural change, and possible ways of improvement to inform wider implementation strategies. A mixed-method approach will be employed with the use of structured questionnaires and semistructured in-depth interviews. All 200 participants enrolled in the trial will undertake the quantitative component of the study and maximum variation sampling will be used to select a subsample for the qualitative component. The sample size for the qualitative component will be determined based on analytical saturation. Interviews will be digitally recorded and transcribed verbatim. Qualitative data will be analysed thematically and reported according to the Consolidated Criteria for Reporting Qualitative Research (COREQ) guidelines.Ethics and disseminationThe MODEL study process evaluation has received approval from Edith Cowan University Human Research Ethics Committee (Project Number: 20513 HODGSON). Written informed consent will be obtained from all participants before they are included in the study. The study results will be shared with the individuals and institutions associated with this study as well as academic audiences through peer-reviewed publication and probable presentation at conferences.Trial registration numberACTRN12618001087246.

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