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"Child Nutrition Disorders - economics"
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The \ComPAS Trial\ combined treatment model for acute malnutrition: study protocol for the economic evaluation
Background
Acute malnutrition is currently divided into severe (SAM) and moderate (MAM) based on level of wasting. SAM and MAM currently have separate treatment protocols and products, managed by separate international agencies. For SAM, the dose of treatment is allocated by the child’s weight. A combined and simplified protocol for SAM and MAM, with a standardised dose of ready-to-use therapeutic food (RUTF), is being trialled for non-inferior recovery rates and may be more cost-effective than the current standard protocols for treating SAM and MAM.
Method
This is the protocol for the economic evaluation of the ComPAS trial, a cluster-randomised controlled, non-inferiority trial that compares a novel combined protocol for treating uncomplicated acute malnutrition compared to the current standard protocol in South Sudan and Kenya. We will calculate the total economic costs of both protocols from a societal perspective, using accounting data, interviews and survey questionnaires. The incremental cost of implementing the combined protocol will be estimated, and all costs and outcomes will be presented as a cost-consequence analysis. Incremental cost-effectiveness ratio will be calculated for primary and secondary outcome, if statistically significant.
Discussion
We hypothesise that implementing the combined protocol will be cost-effective due to streamlined logistics at clinic level, reduced length of treatment, especially for MAM, and reduced dosages of RUTF. The findings of this economic evaluation will be important for policymakers, especially given the hypothesised non-inferiority of the main health outcomes. The publication of this protocol aims to improve rigour of conduct and transparency of data collection and analysis. It is also intended to promote inclusion of economic evaluation in other nutrition intervention studies, especially for MAM, and improve comparability with other studies.
Trial Registration
ISRCTN
30393230
, date: 16/03/2017.
Journal Article
Rojiroti microfinance and child nutrition: a cluster randomised trial
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 number NCT01845545.
Journal Article
Effects of unconditional cash transfers on the outcome of treatment for severe acute malnutrition (SAM): a cluster-randomised trial in the Democratic Republic of the Congo
Background
Cash transfer programs (CTPs) aim to strengthen financial security for vulnerable households. This potentially enables improvements in diet, hygiene, health service access and investment in food production or income generation. The effect of CTPs on the outcome of children already severely malnourished is not well delineated. The objective of this study was to test whether CTPs will improve the outcome of children treated for severe acute malnutrition (SAM) in the Democratic Republic of the Congo over 6 months.
Methods
We conducted a cluster-randomised controlled trial in children with uncomplicated SAM who received treatment according to the national protocol and counselling with or without a cash supplement of US$40 monthly for 6 months. Analyses were by intention to treat.
Results
The hazard ratio of reaching full recovery from SAM was 35% higher in the intervention group than the control group (adjusted hazard ratio, 1.35, 95% confidence interval (CI) = 1.10 to 1.69,
P
= 0.007). The adjusted hazard ratios in the intervention group for relapse to moderate acute malnutrition (MAM) and SAM were 0.21 (95% CI = 0.11 to 0.41,
P
= 0.001) and 0.30 (95% CI = 0.16 to 0.58,
P
= 0.001) respectively. Non-response and defaulting were lower when the households received cash. All the nutritional outcomes in the intervention group were significantly better than those in the control group. After 6 months, 80% of cash-intervened children had re-gained their mid-upper arm circumference measurements and weight-for-height/length Z-scores and showed evidence of catch-up. Less than 40% of the control group had a fully successful outcome, with many deteriorating after discharge. There was a significant increase in diet diversity and food consumption scores for both groups from baseline; the increase was significantly greater in the intervention group than the control group.
Conclusions
CTPs can increase recovery from SAM and decrease default, non-response and relapse rates during and following treatment. Household developmental support is critical in food insecure areas to maximise the efficiency of SAM treatment programs.
Trial registration
ClinicalTrials.gov,
NCT02460848
. Registered on 27 May 2015.
Journal Article
Integrated and simplified approaches to community management of acute malnutrition in rural Kenya: a cluster randomized trial protocol
Background
In many low income countries, the majority of acutely malnourished children are either brought to the health facility late or never at all due to reasons related to distance and associated costs. Integrated community case management (iCCM) is an integrated approach addressing disease and malnutrition through use of community health volunteers (CHVs) in children under-5 years. Evidence on the potential impact and practical experiences on integrating community-based management of acute malnutrition as part of an iCCM package is not well documented. In this study, we aim to investigate the effectiveness and cost effectiveness of integrating management of acute malnutrition into iCCM.
Methods
This is a two arm parallel groups, non-inferiority cluster randomized community trial (CRT) employing mixed methods approach (both qualitative and quantitative approaches). Baseline and end line data will be collected from eligible (malnourished) mother/caregiver-child dyads. Ten community units (CUs) with a cluster size of 24 study subjects will be randomized to either an intervention (5 CUs) and a control arm (5 CUs). CHV in the control arm, will only screening and refer MAM/SAM cases to the nearby health facility for treatment by healthcare professionals. In the intervention arm, however; CHVs will be trained both to screen/diagnose and also treat moderate acute malnutrition (MAM) and severe acute malnutrition (SAM) without complication. A paired-matching design where each control group will be matched with intervention group with similar characteristics will be matched to ensure balance between the two groups with respect to baseline characteristics. Qualitative data will be collected using key informant and in-depth interviews (KIIs) and focused group discussions (FGDs) to capture the views and experiences of stakeholders.
Discussion
Our proposed intervention is based on an innovative approach of integrating and simplifying SAM and MAM management through CHWs bring the services closer to the community. The trial has received ethical approval from the Ethics Committee of AMREF Health Africa - Ethical and Scientific Review Committee (AMREF- ESRC), Nairobi, Kenya. The results will be disseminated through workshops, policy briefs, peer-reviewed publications, and presented to local and international conferences.
Trial registration
PACTR201811870943127
; Pre-results. 26 November 2018.
Journal Article
The REFANI Pakistan study—a cluster randomised controlled trial of the effectiveness and cost-effectiveness of cash-based transfer programmes on child nutrition status: study protocol
Background
Cash-based transfer programmes are an emerging strategy in the prevention of wasting in children, especially targeted at vulnerable households during periods of food insecurity or during emergencies. However, the evidence surrounding the use of either cash or voucher transfer programmes in the humanitarian context and on nutritional outcomes is elusive. More evidence is needed not only to inform the global community of practice on best practices in humanitarian settings, but also to help strengthen national mitigation responses.
Methods/Design
The Research for Food Assistance on Nutrition Impact Pakistan study (REFANI-P) sets out to evaluate the impact of three cash-based interventions on nutritional outcomes in children aged less than five years from poor and very poor households in Dadu District. This four-arm parallel cluster randomised controlled trial is set among Action Against Hunger (ACF) programme villages in Dadu District, Sindh Province. Mothers are the target recipients of either seasonal unconditional cash transfers or fresh food vouchers. A comparison group receives ‘standard care’ provided by the ACF programme to which all groups have the same access. The primary outcomes are prevalence of wasting and mean weight-for-height Z-score (WHZ) in children. Impact will be assessed at 6 months and at 1 year from baseline. Using a theory-based approach we will determine ‘how’ the different interventions work by looking at the processes involved and the impact pathways following the theory of change developed for this context. Quantitative and qualitative data are collected on morbidity, health seeking, hygiene and nutrition behaviours, dietary diversity, haemoglobin concentration, women’s empowerment, household food security and expenditures and social capital. The direct and indirect costs of each intervention borne by the implementing organisation and their partners as well as by beneficiaries and their communities are also assessed.
Discussion
The results of this trial will provide robust evidence to help increase knowledge about the predictability of how different modalities of cash-based transfer work best to reduce the risk of child wasting during a season where food insecurity is at its highest. Evidence on costing and cost-effectiveness will further aid decisions on choice of modality in terms of effectiveness and sustainability.
Trial registration
Current Controlled Trials
ISRCTN10761532
. Registered 26 March 2015.
Journal Article
Feasibility and pilot study of the effects of microfinance on mortality and nutrition in children under five amongst the very poor in India: study protocol for a cluster randomized controlled trial
Background
The United Nations Millennium Development Goals include targets for the health of children under five years old. Poor health is linked to poverty and microfinance initiatives are economic interventions that may improve health by breaking the cycle of poverty. However, there is a lack of reliable evidence to support this. In addition, microfinance schemes may have adverse effects on health, for example due to increased indebtedness. Rojiroti UK and the Centre for Promoting Sustainable Livelihood run an innovative microfinance scheme that provides microcredit via women’s self-help groups (SHGs). This pilot study, conducted in rural Bihar (India), will establish whether it is feasible to collect anthropometric and mortality data on children under five years old and to conduct a limited cluster randomized trial of the Rojiroti intervention.
Methods/Design
We have designed a cluster randomized trial in which participating tolas (small communities within villages) will be randomized to either receive early (SHGs and microfinance at baseline) or late intervention (SHGs and microfinance after 18 months). Using predesigned questionnaires, demographic, and mortality data for the last year and information about participating mothers and their children will be collected and the weight, height, and mid upper arm circumference (MUAC) of children will be measured at baseline and at 18 months. The late intervention group will establish SHGs and microfinance support at this point and data collection will be repeated at 36 months.
The primary outcome measure will be the mean weight for height z-score of children under five years old in the early and late intervention tolas at 18 months. Secondary outcome measures will be the mortality rate, mean weight for age, height for age, prevalence of underweight, stunting, and wasting among children under five years of age.
Discussion
Despite economic progress, marked inequalities in child health persist in India and Bihar is one of the worst affected states. There is a need to evaluate programs that may alleviate poverty and improve health. This study will help to inform the design of a definitive trial to determine if the Rojiroti scheme can improve the nutrition and survival of children under five years of age in deprived rural communities.
Trial registration
Clinicaltrials.gov (study ID:
NCT01845545
). Registered on 24 April 2013.
Journal Article
Drivers of Under-Five Stunting Trend in 14 Low- and Middle-Income Countries since the Turn of the Millennium: A Multilevel Pooled Analysis of 50 Demographic and Health Surveys
Background: Understanding the drivers contributing to the decreasing trend in stunting is paramount to meeting the World Health Assembly’s global target of 40% stunting reduction by 2025. Methods: We pooled data from 50 Demographic and Health Surveys since 2000 in 14 countries to examine the relationships between the stunting trend and potential factors at distal, intermediate, and proximal levels. A multilevel pooled trend analysis was used to estimate the association between the change in potential drivers at a country level and stunting probability for an individual child while adjusting for time trends and child-level covariates. A four-level mixed-effects linear probability regression model was fitted, accounting for the clustering of data by sampling clusters, survey-rounds, and countries. Results: Stunting followed a decreasing trend in all countries at an average annual rate of 1.04 percentage points. Among the distal factors assessed, a decrease in the Gini coefficient, an improvement in women’s decision-making, and an increase in urbanization were significantly associated with a lower probability of stunting within a country. Improvements in households’ access to improved sanitation facilities and drinking water sources, and children’s access to basic vaccinations were the important intermediate service-related drivers, whereas improvements in early initiation of breastfeeding and a decrease in the prevalence of low birthweight were the important proximal drivers. Conclusions: The results reinforce the need for a combination of nutrition-sensitive and -specific interventions to tackle the problem of stunting. The identified drivers help to guide global efforts to further accelerate stunting reduction and monitor progress against chronic childhood undernutrition.
Journal Article
Effect of a conditional cash transfer programme on childhood mortality: a nationwide analysis of Brazilian municipalities
In the past 15 years, Brazil has undergone notable social and public health changes, including a large reduction in child mortality. The Bolsa Familia Programme (BFP) is a widespread conditional cash transfer programme, launched in 2003, which transfers cash to poor households (maximum income US$70 per person a month) when they comply with conditions related to health and education. Transfers range from $18 to $175 per month, depending on the income and composition of the family. We aimed to assess the effect of the BFP on deaths of children younger than 5 years (under-5), overall and resulting from specific causes associated with poverty: malnutrition, diarrhoea, and lower respiratory infections.
The study had a mixed ecological design. It covered the period from 2004–09 and included 2853 (of 5565) municipalities with death and livebirth statistics of adequate quality. We used government sources to calculate all-cause under-5 mortality rates and under-5 mortality rates for selected causes. BFP coverage was classified as low (0·0–17·1%), intermediate (17·2–32·0%), high (>32·0%), or consolidated (>32·0% and target population coverage ≥100% for at least 4 years). We did multivariable regression analyses of panel data with fixed-effects negative binomial models, adjusted for relevant social and economic covariates, and for the effect of the largest primary health-care scheme in the country (Family Health Programme).
Under-5 mortality rate, overall and resulting from poverty-related causes, decreased as BFP coverage increased. The rate ratios (RR) for the effect of the BFP on overall under-5 mortality rate were 0·94 (95% CI 0·92–0·96) for intermediate coverage, 0·88 (0·85–0·91) for high coverage, and 0·83 (0·79–0·88) for consolidated coverage. The effect of consolidated BFP coverage was highest on under-5 mortality resulting from malnutrition (RR 0·35; 95% CI 0·24–0·50) and diarrhoea (0·47; 0·37–0·61).
A conditional cash transfer programme can greatly contribute to a decrease in childhood mortality overall, and in particular for deaths attributable to poverty-related causes such as malnutrition and diarrhoea, in a large middle-income country such as Brazil.
National Institutes of Science and Technology Programme, Ministry of Science and Technology, and Council for Scientific and Technological Development Programme (CNPq), Brazil.
Journal Article
Malnutrition among under-five children in amhara and oromia regions, Ethiopia: Continuous time markov multi-state modeling
Ethiopia faces a high burden of undernutrition prevalence, ranking among the 15 worst-affected nations globally. So, this study aimed to find out how often and how long under-five children (U5C) in Ethiopia's Amhara and Oromia regions move between different states of Composite Index Anthropometry Failure (CIAF) as well as what factors influence these changes.
The data used for this study was extracted from the International Food Policy Research Institute. The institute conducted a follow-up survey in three consecutive rounds: February 8, 2018-April 25, 2018; July 25, 2019-October 23, 2019; and February 8, 2021-April 25, 2021, respectively. The inclusion criteria were households that had children between the ages of 0 and 35 months, were participants in the safety net program, and had the mother or primary female caregiver during the baseline survey. A total of 3,044 households having children with at least two complete anthropometric measurements were included. A continuous-time multi-state Markov model was used to estimate transitions and their probability between CIAF's states.
Nourished children had a 71% probability of becoming undernourished. Time taken to recover from undernourished state for U5C was 41 months on average. 75% of the U5C's life is spent in the undernourished state. Girls had a 1.824 times higher likelihood of recovering from an overnourished state and were less likely to transit from a nourished state to an undernourished state compared to boys (HR: 0.8013). Children older than two years were more likely to recover from undernourished and overnourished states respectively (HR: 1.013 & 1.036), to a nourished state and less likely to transit back to the malnutrition states (HR: 0.9693 & 0.9662). Children of educated mothers and residents in the Oromia region had lower risk of transition from a healthy to an undernourished state respectively (HR: 0.8171& 0.8074).
Undernutrition will affect most U5Cs. Children whose mothers had no education and live in the Amhara region are more susceptible to undernutrition. The Ministry of Health and other relevant stakeholders should develop a practical intervention to enhance adult and maternal education programs.
Journal Article