Dataset Information

Protocol for the cost-consequence and equity impact analyses of a cluster randomised controlled trial comparing three variants of a nutrition-sensitive agricultural extension intervention to improve maternal and child dietary diversity and nutritional status in rural Odisha, India (UPAVAN trial).

ABSTRACT:

Background

Undernutrition causes around 3.1 million child deaths annually, around 45% of all child deaths. India has one of the highest proportions of maternal and child undernutrition globally. To accelerate reductions in undernutrition, nutrition-specific interventions need to be coupled with nutrition-sensitive programmes that tackle the underlying causes of undernutrition. This paper describes the planned economic evaluation of the UPAVAN trial, a four-arm, cluster randomised controlled trial that tests the nutritional and agricultural impacts of an innovative agriculture extension platform of women's groups viewing videos on nutrition-sensitive agriculture practices, coupled with a nutrition-specific behaviour-change intervention of videos on nutrition, and a participatory learning and action approach.

Methods

The economic evaluation of the UPAVAN interventions will be conducted from a societal perspective, taking into account all costs incurred by the implementing agency (programme costs), community and health care providers, and participants and their households, and all measurable outcomes associated with the interventions. All direct and indirect costs, including time costs and donated goods, will be estimated. The economic evaluation will take the form of a cost-consequence analysis, comparing incremental costs and incremental changes in the outcomes of the interventions, compared with the status quo. Robustness of the results will be assessed through a series of sensitivity analyses. In addition, an analysis of the equity impact of the interventions will be conducted.

Discussion

Evidence on the cost and cost-effectiveness of nutrition-sensitive agriculture interventions is scarce. This limits understanding of the costs of rolling out or scaling up programs. The findings of this economic evaluation will provide useful information for different multisectoral stakeholders involved in the planning and implementation of nutrition-sensitive agriculture programmes.

Trial registration

ISRCTN65922679 . Registered on 21 December 2016.

SUBMITTER: Haghparast-Bidgoli H

PROVIDER: S-EPMC6537168 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Publications

Protocol for the cost-consequence and equity impact analyses of a cluster randomised controlled trial comparing three variants of a nutrition-sensitive agricultural extension intervention to improve maternal and child dietary diversity and nutritional status in rural Odisha, India (UPAVAN trial).

Haghparast-Bidgoli Hassan H Skordis Jolene J Harris-Fry Helen H Krishnan Sneha S O'Hearn Meghan M Kumar Abhinav A Pradhan Ronali R Mishra Naba Kishore NK Upadhyay Avinash A Pradhan Shibananth S Ojha Amit Kumar AK Cunningham Sarah S Rath Shibanand S Palmer Tom T Koniz-Booher Peggy P Kadiyala Suneetha S

Trials 20190527 1

<h4>Background</h4>Undernutrition causes around 3.1 million child deaths annually, around 45% of all child deaths. India has one of the highest proportions of maternal and child undernutrition globally. To accelerate reductions in undernutrition, nutrition-specific interventions need to be coupled with nutrition-sensitive programmes that tackle the underlying causes of undernutrition. This paper describes the planned economic evaluation of the UPAVAN trial, a four-arm, cluster randomised control ...[more]

PMID: 31133067

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Project description:BACKGROUND:Maternal and child undernutrition have adverse consequences for pregnancy outcomes and child morbidity and mortality, and they are associated with low educational attainment, economic productivity as an adult, and human wellbeing. 'Nutrition-sensitive' agriculture programs could tackle the underlying causes of undernutrition. METHODS/DESIGN:This study is a four-arm cluster randomised controlled trial in Odisha, India. Interventions are as follows: (1) an agricultural extension platform of women's groups viewing and discussing videos on nutrition-sensitive agriculture (NSA) practices, and follow-up visits to women at home to encourage the adoption of new practices shown in the videos; (2) women's groups viewing and discussing videos on NSA and nutrition-specific practices, with follow-up visits; and (3) women's groups viewing and discussing videos on NSA and nutrition-specific practices combined with a cycle of Participatory Learning and Action meetings, with follow-up visits. All arms, including the control, receive basic nutrition training from government community frontline workers. Primary outcomes, assessed at baseline and 32 months after the start of the interventions, are (1) percentage of children aged 6-23 months consuming ??4 out of 7 food groups per day and (2) mean body mass index (BMI) (kg/m2) of non-pregnant, non-postpartum (gave birth >?42 days ago) mothers or female primary caregivers of children aged 0-23 months. Secondary outcomes are percentage of mothers consuming ??5 out of 10 food groups per day and percentage of children's weight-for-height z-score <?-2 standard deviations (SD). The unit of randomisation is a cluster, defined as one or more villages with a combined minimum population of 800 residents. There are 37 clusters per arm, and outcomes will be assessed in an average of 32 eligible households per cluster. For randomisation, clusters are stratified by distance to nearest town (<?10 km or ??10 km), and low (<?30%), medium (30-70%), or high (>?70%) proportion of Scheduled Tribe or Scheduled Caste (disadvantaged) households. A process evaluation will assess the quality of implementation and mechanisms behind the intervention effects. A cost-consequence analysis will compare incremental costs and outcomes of the interventions. DISCUSSION:This trial will contribute evidence on the impacts of NSA extension through participatory, low-cost, video-based approaches on maternal and child nutrition and on whether integration with nutrition-specific goals and enhanced participatory approaches can increase these impacts. TRIAL REGISTRATION:ISRCTN , ISRCTN65922679 . Registered on 21 December 2016.

Project description:BackgroundEconomic evaluations of nutrition-sensitive agriculture (NSA) interventions are scarce, limiting assessment of their potential affordability and scalability.ObjectivesWe conducted cost-consequence analyses of 3 participatory video-based interventions of fortnightly women's group meetings using the following platforms: 1) NSA videos; 2) NSA and nutrition-specific videos; or 3) NSA videos with a nutrition-specific participatory learning and action (PLA) cycle.MethodsInterventions were tested in a 32-mo, 4-arm cluster-randomized controlled trial, Upscaling Participatory Action and Videos for Agriculture and Nutrition (UPAVAN) in the Keonjhar district, Odisha, India. Impacts were evaluated in children aged 0-23 mo and their mothers. We estimated program costs using data collected prospectively from expenditure records of implementing and technical partners and societal costs using expenditure assessment data collected from households with a child aged 0-23 mo and key informant interviews. Costs were adjusted for inflation, discounted, and converted to 2019 US$.ResultsTotal program costs of each intervention ranged from US$272,121 to US$386,907. Program costs per pregnant woman or mother of a child aged 0-23 mo were US$62 for NSA videos, US$84 for NSA and nutrition-specific videos, and US$78 for NSA videos with PLA (societal costs: US$125, US$143, and US$122, respectively). Substantial shares of total costs were attributable to development and delivery of the videos and PLA (52-69%) and quality assurance (25-41%). Relative to control, minimum dietary diversity was higher in the children who underwent the interventions incorporating nutrition-specific videos and PLA (adjusted RRs: 1.19 and 1.27; 95% CIs: 1.03-1.37 and 1.11, 1.46, respectively). Relative to control, minimum dietary diversity in mothers was higher in those who underwent NSA video (1.21 [1.01, 1.45]) and NSA with PLA (1.30 [1.10, 1.53]) interventions.ConclusionNSA videos with PLA can increase both maternal and child dietary diversity and have the lowest cost per unit increase in diet diversity. Building on investments made in developing UPAVAN, cost-efficiency at scale could be increased with less intensive monitoring, reduced startup costs, and integration within existing government programs. This trial was registered at clinicaltrials.gov as ISRCTN65922679.

Project description:BackgroundAlmost a quarter of the world's undernourished people live in India. We tested the effects of three nutrition-sensitive agriculture (NSA) interventions on maternal and child nutrition in India.MethodsWe did a parallel, four-arm, observer-blind, cluster-randomised trial in Keonjhar district, Odisha, India. A cluster was one or more villages with a combined minimum population of 800 residents. The clusters were allocated 1:1:1:1 to a control group or an intervention group of fortnightly women's groups meetings and household visits over 32 months using: NSA videos (AGRI group); NSA and nutrition-specific videos (AGRI-NUT group); or NSA videos and a nutrition-specific participatory learning and action (PLA) cycle meetings and videos (AGRI-NUT+PLA group). Primary outcomes were the proportion of children aged 6-23 months consuming at least four of seven food groups the previous day and mean maternal body-mass index (BMI). Secondary outcomes were proportion of mothers consuming at least five of ten food groups and child wasting (proportion of children with weight-for-height Z score SD <-2). Outcomes were assessed in children and mothers through cross-sectional surveys at baseline and at endline, 36 months later. Analyses were by intention to treat. Participants and intervention facilitators were not blinded to allocation; the research team were. This trial is registered at ISRCTN, ISRCTN65922679.Findings148 of 162 clusters assessed for eligibility were enrolled and randomly allocated to trial groups (37 clusters per group). Baseline surveys took place from Nov 24, 2016, to Jan 24, 2017; clusters were randomised from December, 2016, to January, 2017; and interventions were implemented from March 20, 2017, to Oct 31, 2019, and endline surveys done from Nov 19, 2019, to Jan 12, 2020, in an average of 32 households per cluster. All clusters were included in the analyses. There was an increase in the proportion of children consuming at least four of seven food groups in the AGRI-NUT (adjusted relative risk [RR] 1·19, 95% CI 1·03 to 1·37, p=0·02) and AGRI-NUT+PLA (1·27, 1·11 to 1·46, p=0·001) groups, but not AGRI (1·06, 0·91 to 1·23, p=0·44), compared with the control group. We found no effects on mean maternal BMI (adjusted mean differences vs control, AGRI -0·05, -0·34 to 0·24; AGRI-NUT 0·04, -0·26 to 0·33; AGRI-NUT+PLA -0·03, -0·3 to 0·23). An increase in the proportion of mothers consuming at least five of ten food groups was seen in the AGRI (adjusted RR 1·21, 1·01 to 1·45) and AGRI-NUT+PLA (1·30, 1·10 to 1·53) groups compared with the control group, but not in AGRI-NUT (1·16, 0·98 to 1·38). We found no effects on child wasting (adjusted RR vs control, AGRI 0·95, 0·73 to 1·24; AGRI-NUT 0·96, 0·72 to 1·29; AGRI-NUT+PLA 0·96, 0·73 to 1·26).InterpretationWomen's groups using combinations of NSA videos, nutrition-specific videos, and PLA cycle meetings improved maternal and child diet quality in rural Odisha, India. These components have been implemented separately in several low-income settings; effects could be increased by scaling up together.FundingBill & Melinda Gates Foundation, UK AID from the UK Government, and US Agency for International Development.

Project description:Successful integration of nutrition interventions into large-scale development programmes from nutrition-relevant sectors, such as agriculture, can address critical underlying determinants of undernutrition and enhance the coverage and effectiveness of on-going nutrition-specific activities. However, evidence on how this can be done is limited. This study examines the feasibility of delivering maternal, infant, and young child nutrition behaviour change communication through an innovative agricultural extension programme serving nutritionally vulnerable groups in rural India. The existing agriculture programme involves participatory production of low-cost videos promoting best practices and broad dissemination through village-level women's self-help groups. For the nutrition intervention, 10 videos promoting specific maternal, infant, and young child nutrition practices were produced and disseminated in 30 villages. A range of methods was used to collect data, including in-depth interviews with project staff, frontline health workers, and self-help group members and their families; structured observations of mediated video dissemination sessions; nutrition knowledge tests with project staff and self-help group members; and a social network questionnaire to assess diffusion of promoted nutrition messages. We found the nutrition intervention to be well-received by rural communities and viewed as complementary to existing frontline health services. However, compared to agriculture, nutrition content required more time, creativity, and technical support to develop and deliver. Experimentation with promoted nutrition behaviours was high, but sharing of information from the videos with non-viewers was limited. Key lessons learned include the benefits of and need for collaboration with existing health services; continued technical support for implementing partners; engagement with local cultural norms and beliefs; empowerment of women's group members to champion nutrition; and enhancement of message diffusion mechanisms to reach pregnant women and mothers of young children at scale. Understanding the experience of developing and delivering this intervention will benefit the design of new nutrition interventions which seek to leverage agriculture platforms.

Project description:ObjectiveTo determine whether Rojiroti microfinance, for poor Indian women, improves child nutrition.DesignCluster randomised trial.SettingTolas (village communities) in Bihar State.ParticipantsWomen and children under 5 years.InterventionsWith Rojiroti microfinance, women form self-help groups and save their money to provide loans to group members. After 6 months, they receive larger external loans. Tolas were randomised to receive Rojiroti immediately or after 18 months.Outcome measuresThe primary analysis compared the mean weight for height Z score (WHZ) of children under 5 years in the intervention versus control tolas who attended for weight and height measurement 18 months after randomisation. Secondary outcomes were weight for age Z score (WAZ), height for age Z score, mid-upper arm circumference (MUAC), wasting, underweight and stunting.ResultsWe randomised 28 tolas to each arm and collected data from 2469 children (1560 mothers) at baseline and 2064 children (1326 mothers) at follow-up. WHZ was calculated for 1718 children at baseline and 1377 (674 intervention and 703 control) at follow-up. At 18 months, mean WHZ was significantly higher for intervention (-1.02) versus controls (-1.37; regression coefficient adjusted for clustering β=0.38, 95% CI 0.16 to 0.61, p=0.001). Significantly fewer children were wasted in the intervention group (122, 18%) versus control (200, 29%; OR=0.46, 95% CI 0.28 to 0.74, p=0.002). Mean WAZ was better in the intervention group (-2.13 vs -2.37; β=0.27, 95% CI 0.11 to 0.43, p=0.001) as was MUAC (13.6 cm vs 13.4 cm; β=0.22, 95% CI 0.03 to 0.40, p=0.02). In an analysis adjusting for baseline nutritional measures (259 intervention children and 300 control), only WAZ and % underweight showed significant differences in favour of the intervention.ConclusionIn marginalised communities in rural India, child nutrition was better in those who received Rojiroti microfinance, compared with controls.Trial registration numberNCT01845545.

Project description:IntroductionEffective preparation of children for hospital procedures, including non-sedated medical imaging, is an important clinical issue. This study aimed to assess the costs and consequences (effects) of preparing pediatric patients using two methods of delivering preparation for a scheduled magnetic resonance image (MRI)-virtual reality (VR-MRI) and a certified Child Life Program (CLP).MethodsA cost-consequence analysis (CCA) was performed using a societal perspective in Canada. The CCA catalogs a wide range of costs and consequences of VR-MRI compared with a CLP. The evaluation uses data from a prior randomized clinical trial evaluating VR and a CLP in a simulated trial. The economic evaluation encompassed health-related effects, including anxiety, safety and adverse events, and non-health effects, including preparation time, displaced time from usual activities, workload capacity, patient-specific adaptation, administrative burden, and user-experience metrics. The costs have been categorized into hospital operational costs, travel costs, other patient costs, and societal costs.ResultsVR-MRI has similar benefits to the CLP in managing anxiety, safety and adverse events, as well as converting patients to non-sedated medical imaging. Preparation time and patient-specific adaptation are in favor of the CLP, while displaced time from usual activities, potential workload capacity, and administrative burden are in favor of VR-MRI. Both programs rank favorably in terms of user experience. The hospital operational costs ranged in Canadian dollars (CAN$) from CAN$32.07 for the CLP to between CAN$107.37 and CAN$129.73 for VR-MRI. Travel costs ranged from CAN$50.58 to CAN$2365.18 depending on travel distance for the CLP, and CAN$0 for VR-MRI. Other patient costs involved caregiver time off, and ranged from CAN$190.69 to CAN$$1144.16 for the CLP and CAN$47.67 for VR-MRI. The total cost for the CLP ranged from CAN$315.16 (CAN$277.91-$426.64) to CAN$3843.41 (CAN$3196.59-$4849.91) per patient depending on travel distance and amount of administrative support required, while VR-MRI preparation ranged from CAN$178.30 (CAN$178.20-$188.76) to CAN$283.85 (CAN$283.71-$298.40) per patient. For every instance where patient travel to visit a Certified Child Life Specialist (CCLS) onsite was replaced with VR-MRI, between CAN$119.01 and CAN$3364.62 total costs could be saved per patient.ConclusionsWhile it is neither feasible nor appropriate to replace all preparation with VR, using VR to reach children who cannot otherwise visit the CLP onsite could increase access to quality preparation, and using VR in place of the CLP where clinically indicated could reduce the overall costs for patients, the hospital, and society. Our CCA gives decision makers a cost analysis and the relevant effects of each preparation program so they can value the VR and CLP programs more broadly within the potential health and non-health outcomes of pediatric patients scheduled for MRI at their facilities.

Dataset Information

Protocol for the cost-consequence and equity impact analyses of a cluster randomised controlled trial comparing three variants of a nutrition-sensitive agricultural extension intervention to improve maternal and child dietary diversity and nutritional status in rural Odisha, India (UPAVAN trial).

Background

Methods

Discussion

Trial registration

Publications

Protocol for the cost-consequence and equity impact analyses of a cluster randomised controlled trial comparing three variants of a nutrition-sensitive agricultural extension intervention to improve maternal and child dietary diversity and nutritional status in rural Odisha, India (UPAVAN trial).

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