Dataset Information

Acceptability of locally-produced Ready-to-Use Supplementary Food (RUSF) for children under two years in Cambodia: A cluster randomised trial.

ABSTRACT: In Cambodia, existing food products for treating or preventing undernutrition have met with limited success. Therefore, in 2014, alternative ready-to-use foods were developed. This trial aimed to assess the acceptability of the novel ready-to-use supplementary food (RUSF) as a snack or mixed with borbor (white rice porridge), compared with corn-soy blend plus plus (CSB++) and borbor fortified with micronutrient powder (MNP). The nonblinded, randomised 4 × 4 crossover trial recruited 95 children aged 9-23 months from communities in peri-urban Phnom Penh. Small quantities (100 g for porridges, 42 g for snack) of each food were offered for three consecutive days at testing sites (homes of health volunteers). Main outcomes were children's consumption, caregivers' assessment of children's preferences, and caregivers' ranking of the foods. Median percentage consumed of the test food servings ranged from 21 to 50% (p = 0.003). The odds of children consuming over 50% were greatest for borbor fortified with MNP versus RUSF snack (unadjusted OR = 6.79, CI = 2.80-16.47, p < 0.001). However, the median energy children received when consuming the RUSF with borbor (57 kcals) or as a snack (48 kcals) was greater than with CSB++ (15 kcals) or borbor fortified with MNP (18 kcals; p < 0.001). Therefore, although children ate less RUSF, it provided approximately three times more kilocalories. Caregivers reported that their children had the highest preference for borbor fortified with MNP. Caregivers themselves ranked the novel RUSF snack highest. Thus, the innovative RUSF was considered sufficiently acceptable to proceed to an effectiveness trial.

SUBMITTER: Borg B

PROVIDER: S-EPMC7198957 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Acceptability of locally-produced Ready-to-Use Supplementary Food (RUSF) for children under two years in Cambodia: A cluster randomised trial.

Borg Bindi B Mihrshahi Seema S Griffin Mark M Sok Daream D Chhoun Chamnan C Laillou Arnaud A Wieringa Frank T FT

Maternal & child nutrition 20190220 3

In Cambodia, existing food products for treating or preventing undernutrition have met with limited success. Therefore, in 2014, alternative ready-to-use foods were developed. This trial aimed to assess the acceptability of the novel ready-to-use supplementary food (RUSF) as a snack or mixed with borbor (white rice porridge), compared with corn-soy blend plus plus (CSB++) and borbor fortified with micronutrient powder (MNP). The nonblinded, randomised 4 × 4 crossover trial recruited 95 children ...[more]

PMID: 30690869

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Project description:BACKGROUND:Existing ready-to-use supplementary and therapeutic foods (RUSFs and RUTFs) have had limited acceptance and effectiveness in Cambodia. This has hampered the treatment and prevention of child malnutrition. An innovative, locally produced, multiple micronutrient fortified lipid-based nutrient supplement (LNS) has been developed for use as an RUSF. Unlike most RUSFs, which contain milk, this product contains fish as the animal protein. Few RUSFs have been formulated using non-milk animal-source foods and they have not been widely tested. An acceptability trial that was conducted on this novel RUSF in June 2015 demonstrated that children will eat the RUSF and that caregivers will feed it to their children. The current trial aims to evaluate the effectiveness of the RUSF in preventing growth faltering and improving micronutrient status in Cambodian children. METHODS AND ANALYSIS:This trial is a six-month, prospective, cluster randomised, non-blinded controlled trial among infants in peri-urban Phnom Penh. The trial aims to establish the superiority of the novel RUSF, compared to three alternatives (Corn-Soy Blend Plus Plus (CSB++) and Sprinkles micronutrient powders as active comparators, and the unimproved diet as a control). The allocation ratio is 1:1. Healthy children (N?=?540) aged six to eleven months will be recruited. Data will be collected at baseline, and monthly thereafter for a period of six months. Participants will be provided with a monthly supply of the food to which their village has been allocated. DISCUSSION:There is an urgent need to develop locally produced and culturally acceptable RUSFs, and to compare these with existing options in terms of their potential for preventing malnutrition, in Cambodia and elsewhere. This trial will contribute much-needed data on the effectiveness of supplementary foods with an animal-source food other than milk, by comparing a novel RUSF based on fish to one that uses milk (CSB++). Moreover, it will deepen the understanding of the impact of multiple micronutrients provided with or without macronutrients, by comparing the novel RUSF and CSB++, which combine macronutrients with multiple micronutrients, to Sprinkles, which contains no macronutrients. In addition, it will augment the body of evidence from Asia. TRIAL REGISTRATION:ClinicalTrials.gov, Identifier: LNS-CAMB-INFANTS-EFF; NCT02257762 .

Project description:Inadequate energy and micronutrient intake during childhood is a major public health problem in developing countries. Ready-to-use supplementary food (RUSF) made of locally available food ingredients can improve micronutrient status and growth of children. The objective of this study was to develop RUSF using locally available food ingredients and test their acceptability.A checklist was prepared of food ingredients available and commonly consumed in Bangladesh that have the potential of being used for preparing RUSF. Linear programming was used to determine possible combinations of ingredients and micronutrient premix. To test the acceptability of the RUSF compared to Pushti packet (a cereal based food-supplement) in terms of amount taken by children, a clinical trial was conducted among 90 children aged 6-18 months in a slum of Dhaka city. The mothers were also asked to rate the color, flavor, mouth-feel, and overall liking of the RUSF by using a 7-point Hedonic Scale (1?=?dislike extremely, 7?=?like extremely).Two RUSFs were developed, one based on rice-lentil and the other on chickpea. The total energy obtained from 50 g of rice-lentil, chickpea-based RUSF and Pushti packet were 264, 267 and 188 kcal respectively. Children were offered 50 g of RUSF and they consumed (mean?±?SD) 23.8?±?14 g rice-lentil RUSF, 28.4?±?15 g chickpea based RUSF. Pushti packet was also offered 50 g but mothers were allowed to add water, and children consumed 17.1?±?14 g. Mean feeding time for two RUSFs and Pushti packet was 20.9 minutes. Although the two RUSFs did not differ in the amount consumed, there was a significant difference in consumption between chickpea-based RUSF and Pushti packet (p?=?0.012). Using the Hedonic Scale the two RUSFs were more liked by mothers compared to Pushti packet.Recipes of RUSF were developed using locally available food ingredients. The study results suggest that rice-lentil and chickpea-based RUSF are well accepted by children.ClinicalTrials.gov NCT01553877. Registered 24 January 2012.

Project description:Recently, operational organizations active in child nutrition in developing countries have suggested that blanket feeding strategies be adopted to enable the prevention of child wasting. A new range of nutritional supplements is now available, with claims that they can prevent wasting in populations at risk of periodic food shortages. Evidence is lacking as to the effectiveness of such preventive interventions. This study examined the effect of a ready-to-use supplementary food (RUSF) on the prevention of wasting in 6- to 36-mo-old children within the framework of a general food distribution program.We conducted a two-arm cluster-randomized controlled pragmatic intervention study in a sample of 1,038 children aged 6 to 36 mo in the city of Abeche, Chad. Both arms were included in a general food distribution program providing staple foods. The intervention group was given a daily 46 g of RUSF for 4 mo. Anthropometric measurements and morbidity were recorded monthly. Adding RUSF to a package of monthly household food rations for households containing a child assigned to the intervention group did not result in a reduction in cumulative incidence of wasting (incidence risk ratio: 0.86; 95% CI: 0.67, 1.11; p?=?0.25). However, the intervention group had a modestly higher gain in height-for-age (+0.03 Z-score/mo; 95% CI: 0.01, 0.04; p<0.001). In addition, children in the intervention group had a significantly higher hemoglobin concentration at the end of the study than children in the control group (+3.8 g/l; 95% CI: 0.6, 7.0; p?=?0.02), thereby reducing the odds of anemia (odds ratio: 0.52; 95% CI: 0.34, 0.82; p?=?0.004). Adding RUSF also resulted in a significantly lower risk of self-reported diarrhea (-29.3%; 95% CI: 20.5, 37.2; p<0.001) and fever episodes (-22.5%; 95% CI: 14.0, 30.2; p<0.001). Limitations of this study include that the projected sample size was not fully attained and that significantly fewer children from the control group were present at follow-up sessions.Providing RUSF as part of a general food distribution resulted in improvements in hemoglobin status and small improvements in linear growth, accompanied by an apparent reduction in morbidity.ClinicalTrials.gov NCT01154595 Please see later in the article for the Editors' Summary.

Project description:BackgroundIn sub-Saharan Africa, severely immunocompromised HIV-infected individuals have a high risk of mortality during the first few months after starting antiretroviral therapy (ART). We hypothesise that universally providing ready-to-use supplementary food (RUSF) would increase early weight gain, thereby reducing early mortality compared with current guidelines recommending ready-to-use therapeutic food (RUTF) for severely malnourished individuals only.MethodsWe did a 2 × 2 × 2 factorial, open-label, parallel-group trial at inpatient and outpatient facilities in eight urban or periurban regional hospitals in Kenya, Malawi, Uganda, and Zimbabwe. Eligible participants were ART-naive adults and children aged at least 5 years with confirmed HIV infection and a CD4 cell count of fewer than 100 cells per μL, who were initiating ART at the facilities. We randomly assigned participants (1:1) to initiate ART either with (RUSF) or without (no-RUSF) 12 weeks' of peanut-based RUSF containing 1000 kcal per day and micronutrients, given as two 92 g packets per day for adults and one packet (500 kcal per day) for children aged 5-12 years, regardless of nutritional status. In both groups, individuals received supplementation with RUTF only when severely malnourished (ie, body-mass index [BMI] <16-18 kg/m2 or BMI-for-age Z scores <-3 for children). We did the randomisation with computer-generated, sequentially numbered tables with different block sizes incorporated within an online database. Randomisation was stratified by centre, age, and two other factorial randomisations, to 12 week adjunctive raltegravir and enhanced anti-infection prophylaxis (reported elsewhere). Clinic visits were scheduled at weeks 2, 4, 8, 12, 18, 24, 36, and 48, and included nurse assessment of vital status and symptoms and dispensing of all medication including ART and RUSF. The primary outcome was mortality at week 24, analysed by intention to treat. Secondary outcomes included absolute changes in weight, BMI, and mid-upper-arm circumference (MUAC). Safety was analysed in all randomly assigned participants. Follow-up was 48 weeks. This trial is registered with ClinicalTrials.gov (NCT01825031) and the ISRCTN registry (43622374).FindingsBetween June 18, 2013, and April 10, 2015, we randomly assigned 1805 participants to treatment: 897 to RUSF and 908 to no-RUSF. 56 (3%) were lost-to-follow-up. 96 (10·9%, 95% CI 9·0-13·1) participants allocated to RUSF and 92 (10·3%, 8·5-12·5) to no-RUSF died within 24 weeks (hazard ratio 1·05, 95% CI 0·79-1·40; log-rank p=0·75), with no evidence of interaction with the other randomisations (both p>0·7). Through 48 weeks, adults and adolescents aged 13 years and older in the RUSF group had significantly greater gains in weight, BMI, and MUAC than the no-RUSF group (p=0·004, 0·004, and 0·03, respectively). The most common type of serious adverse event was specific infections, occurring in 90 (10%) of 897 participants assigned RUSF and 87 (10%) of 908 assigned no-RUSF. By week 48, 205 participants had serious adverse events in both groups (p=0·81), and 181 had grade 4 adverse events in the RUSF group compared with 172 in the non-RUSF group (p=0·45).InterpretationIn severely immunocompromised HIV-infected individuals, providing RUSF universally at ART initiation, compared with providing RUTF to severely malnourished individuals only, improved short-term weight gain but not mortality. A change in policy to provide nutritional supplementation to all severely immunocompromised HIV-infected individuals starting ART is therefore not warranted at present.FundingJoint Global Health Trials Scheme (UK Medical Research Council, UK Department for International Development, and Wellcome Trust).

Project description:Facemasks have been employed to mitigate the spread of SARS-CoV-2. The community effect of providing cloth facemasks on COVID-19 morbidity and mortality is unknown. In a cluster randomised trial in urban Bissau, Guinea-Bissau, clusters (geographical areas with an average of 19 houses), were randomised to an intervention or control arm using computer-generated random numbers. Between 20 July 2020 and 22 January 2021, trial participants (aged 10+ years) living in intervention clusters (n = 90) received two 2-layer cloth facemasks, while facemasks were only distributed later in control clusters (n = 91). All participants received information on COVID-19 prevention. Trial participants were followed through a telephone interview for COVID-19-like illness (3+ symptoms), care seeking, and mortality for 4 months. End-of-study home visits ensured full mortality information and distribution of facemasks to the control group. Individual level information on outcomes by trial arm was compared in logistic regression models with generalised estimating equation-based correction for cluster. Facemasks use was mandated. Facemask use in public areas was assessed by direct observation. We enrolled 39,574 trial participants among whom 95% reported exposure to groups of >20 persons and 99% reported facemasks use, with no difference between trial arms. Observed use was substantially lower (~40%) with a 3%, 95%CI: 0-6% absolute difference between control and intervention clusters. Half of those wearing a facemask wore it correctly. Few participants (532, 1.6%) reported COVID-19-like illness; proportions did not differ by trial arm: Odds Ratio (OR) = 0.81, 95%CI: 0.57-1.15. 177 (0.6%) participants reported consultations and COVID-19-like illness (OR = 0.83, 95%CI: 0.56-1.24); 89 participants (0.2%) died (OR = 1.34, 95%CI: 0.89-2.02). Hence, though trial participants were exposed to many people, facemasks were mostly not worn or not worn correctly. Providing facemasks and messages about correct use did not substantially increase their use and had limited impact on morbidity and mortality. Trial registration: clinicaltrials.gov: NCT04471766.

Dataset Information

Acceptability of locally-produced Ready-to-Use Supplementary Food (RUSF) for children under two years in Cambodia: A cluster randomised trial.

Publications

Acceptability of locally-produced Ready-to-Use Supplementary Food (RUSF) for children under two years in Cambodia: A cluster randomised trial.

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