Efficacy of three feeding regimens for home-based management of children with uncomplicated severe acute malnutrition

Location: India

What we know: In India an estimated eight million children under five years old are severely malnourished. Acceptance of ready-to-use therapeutic food (RUTF) for SAM treatment is limited by lack of context-specific evidence.

What this article adds: A randomised trial to compare the efficacy of centrally produced RUTF (RUTF-C) and locally prepared RUTF (RUTF-L) for home-based management of children with uncomplicated SAM compared with a micronutrient-enriched, energy-dense home-prepared foods (A-HPF) was conducted (2012-15) in three diverse settings in India. Primary outcome was recovery by 16 weeks after enrolment, with follow-up for 16 weeks post treatment. The intervention included free RUTF/food provision, weekly house visits to log intake and daily peer support. Recovery rates with RUTF-L, RUTF-C and A-HPF were 56.9%, 47.5% and 42.8%, respectively (all below Sphere standard). Time to recovery was shorter in both RUTF groups. Peer support improved recovery rates. Relapse rate was high. Home-based management of children with uncomplicated SAM is effective and feasible. RUTF-L results in higher recovery rates than home food options. Additional nutritional support post-discharge is critical to sustain recovery.

An estimated 0.5 to 2.0 million global deaths are attributed to Severe Acute Malnutrition (SAM) each year (Olofin et al, 2013). Of the 20 million children with SAM worldwide, over eight million are from India, where around 5% of children under five years old suffer from SAM (Ahmed, 2014; MOWCD, 2015; WHO, 2014). The World Health Organisation (WHO) recommends ready-to-use therapeutic food (RUTF) for home-based management of uncomplicated SAM (WHO, 2007). However, acceptance of this recommendation has been limited in India. This is in part due to a lack of evidence from controlled trials of the efficacy of RUTF compared with other treatment options, as well as the use of ‘standardised’ diets in existing studies. Experts argue that the comparison group should be given locally produced foods high in energy and proteins with adequate micronutrients. In addition, there are questions in India about the use of commercially produced RUTF over locally produced products or augmented home foods, given that locally produced RUTF using indigenous foods may be less expensive and more sustainable if its efficacy could be proved.

Well designed, adequately powered, pragmatic randomised trials have been recommended to compare treatment options for home-based management of uncomplicated SAM (Kapil, 2009; Schoonees et al, 2013). In response, the authors of this study conducted a randomised trial to compare the efficacy of centrally produced RUTF (RUTF-C) and locally prepared RUTF (RUTF-L) for home-based management of children with uncomplicated SAM, compared with micronutrient-enriched, energy-dense, home-prepared foods (A-HPF).

Method

The study was conducted among low-income households in three diverse geographical settings in India; Rajasthan, Tamil Nadu and Delhi. Screening using mid-upper-arm circumference (MUAC) was conducted at household level. Children aged 6-59 months with MUAC < 130mm were referred to clinic for weight-for-height z score (WHZ) assessment. Children with WHZ<−3 SD or oedema of feet or both were identified as SAM.

Children aged 6 to 59 months with uncomplicated SAM and parental consent were enrolled in the study. Enrolment began in October 2012; follow-up was completed in April 2015. Children were randomised into one of the three groups: RUTF-C, RUTF-L and A-HPF. The primary outcome was recovery by 16 weeks after enrolment (defined as WHZ≥−2 SD of the WHO standards and absence of oedema of feet). Secondary outcomes included weight gain, time to recovery, prevalence of diarrhoea, acute lower respiratory tract infection (ALRI) and fever, mortality and hospitalisations during the treatment phase (until recovery or 16 weeks after enrolment, whichever was earlier). Another secondary outcome was the proportion of children with WHZ≥−2 SD at the end of the sustenance phase (16 weeks after completion of the treatment phase. Co-interventions (medical treatment) was the same across all three groups.

Foods were delivered free of cost in the three study groups, with the aim of ensuring an intake of at least 175 kcal/kg body weight/day. The composition of RUTF-C, packaged in 92g sachets (Compact India, Gurgaon, India), conformed to WHO recommendations. Each site team was trained in the preparation of RUTF-L and the preparation was carried out under stringent conditions, with microbiological testing every three months. Families of children in the comparison group (A-HPF) were given raw ingredients to prepare foods at home, including locally available and acceptable cereals and pulses, sugar, oil, milk and eggs. Recipes for making energy-rich and nutrient-rich foods for children were promoted and a micronutrient preparation was given to caregivers to add to the cooked meal prior to feeding. In the A-HPF group, food ingredients were given in excess of requirements for the child, given the expectation of some sharing within the family.

Weekly household visits were carried out by a study worker (government Accredited Social Health Activist) during the treatment phase to counsel, resolve caregivers’ queries and difficulties, replenish supplies and collect empty RUTF-L jars and wrappers of RUTF-C packets to calculate consumption. Information on intake of RUTF-L and RUTF-C was recorded and the amounts of ingredients used weekly were documented for the A-HPF group. Consumption data for the comparison group was not collected, given the greater difficulty in capturing valid information. Site-specific counselling cards made in the local language were used. Neighbourhood peer support workers visited homes several times a day to help caregivers feed their children in all three groups. Data from all sites were pooled and analysed using Stata software (V.12.0).

After completion of the treatment phase, the study team facilitated linkages between the families and the government-run anganwadi centres, where supplementary food is provided under the Integrated Child Development Services (ICDS) scheme. This was carried out over the next 16 weeks (sustenance phase).

Results

Results show that recovery rates with RUTF-L, RUTF-C and A-HPF were 56.9%, 47.5% and 42.8%, respectively. The adjusted OR was 1.71 (95% CI 1.20 to 2.43; p=0.003) for RUTF-L and 1.28 (95% CI 0.90 to 1.82; p=0.164) for RUTF-C compared with A-HPF. Weight gain in the RUTF-L group was higher than in the A-HPF group (adjusted difference 0.90 g/kg/day, 95% CI 0.30 to 1.50; p=0.003). Time to recovery was shorter in both RUTF groups. In-depth interviews with caregivers revealed little evidence of food sharing. Morbidity was high and similar across groups.

The proportion of children with WHZ >−2 was similar (adjusted OR 1.12, 95% CI 0.74 to 1.95; p=0.464) in the RUTF-L and A-HPF groups. However, the proportion was higher for moderate malnutrition (WHZ <-2 and ≥-3) (adjusted OR 1.46, 95% CI 1.02 to 2.08; p=0.039), and lower for those with SAM (adjusted OR 0.58, 95% CI 0.40 to 0.85; p=0.005) in the RUTF-L group, compared to the A-HPF group. The overall recovery rates in children whose families were offered peer support were substantially higher than in those who did not receive this support (55% vs 42%, p<0.001).

During the sustenance phase, 838 children (92.5%) were available for follow-up. Of these, 123 (14.7%) met the definition of recovery; 402 (48.0%) met the definition of moderate acute malnutrition (WHZ<−2 and ≥−3); and 313 children (37.4%) had SAM.

Discussion

The authors discuss the fact that recovery rates are lower in this study than those observed in Africa, despite a longer duration of treatment and support to families for feeding. One reason for this may be that all children in the study had marasmus, whereas in similar studies in Africa the majority of children had kwashiorkor, and it is these children who had higher recovery rates (Oakley et al, 2010; Linneman et al, 2007). Evidence suggests that children with kwashiorkor tend to have higher weight-for-age than those with marasmus and may need to gain less weight to recover once they no longer have oedema. An additional explanation is that African studies used height at enrolment to calculate WHZ during follow-up. In this study, subsequent height was used, measured concurrently with weight every week during follow-up. Using height at enrolment increases the proportion of children who reach the cut-off for recovery.

The authors consider the most valuable lesson of the study implementation is the need for extra support for feeding to ensure weight gain and recovery. Help from local, experienced women seemed to improve food intake. Also important is the finding that many children remain or slide back into moderate or severe malnutrition as early as within 16 weeks after the end of treatment. While linkages between families and the government anganwadi centres were established, the findings suggest additional measures may be needed to sustain recovery. These may include close monitoring, improved counselling, support to caregivers, provision of additional food supplements (including prolonged use of RUTF) and prompt treatment of illness.

The authors conclude that home-based management of children with uncomplicated SAM is an effective and feasible option and that use of an RUTF-L results in higher recovery rates than feeding nutrient-dense and calorie-dense home foods. The gains observed in the initial 16 weeks, however, decline after treatment. Other approaches need to be considered to improve long-term outcomes, including prolonged use of RUTF-L.

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