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Effect of Fortified Complementary Food Supplementation on Child Growth in Rural Bangladesh: a Cluster-randomized Trial

Parul Christian*
Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA,

Saijuddin Shaikh
Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA,

Abu Ahmed Shamim
JiVitA Project, Gaibandha, Bangladesh

Sucheta Mehra
Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA,

Lee Wu
Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA,

Maithilee Mitra
Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA,

Hasmot Ali
Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA,

Rebecca D Merrill
Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA,

Nuzhat Choudhury
Centre for Nutrition and Food Security, International Centre for Diarrhoeal Disease Research, Bangladesh, Mohakhali, Dhaka, Bangladesh

Monira Parveen
United Nations World Food Programme, IDB Bhaban, Dhaka, Bangladesh

Rachel D Fuli
United Nations World Food Programme, IDB Bhaban, Dhaka, Bangladesh

Md Iqbal Hossain
Centre for Nutrition and Food Security, International Centre for Diarrhoeal Disease Research, Bangladesh, Mohakhali, Dhaka, Bangladesh

Md Munirul Islam
Centre for Nutrition and Food Security, International Centre for Diarrhoeal Disease Research, Bangladesh, Mohakhali, Dhaka, Bangladesh

Rolf Klemm
Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA,

Kerry Schulze
Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA,

Alain Labrique
Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA,

Saskia de Pee
Office of Nutrition Advisor, United Nations World Food Programme, Rome, Italy

Tahmeed Ahmed
Centre for Nutrition and Food Security, International Centre for Diarrhoeal Disease Research, Bangladesh, Mohakhali, Dhaka, Bangladesh

Keith P West Jr
Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA,

Abstract/ Executive Summary:

Background: Growth faltering in the first 2 years of life is high in South Asia where the prevalence of stunting is estimated at 40–50%. Although nutrition counselling has shown modest benefits, few intervention trials of food supplementation exist showing improvements in growth and prevention of stunting. Methods: A cluster-randomized controlled trial was conducted in rural Bangladesh to test the effect of two local, ready-to-use foods (chickpea and rice-lentil based) and a fortified blended food (wheat-soy-blendþþ, WSBþþ) compared with Plumpy’doz, all with nutrition counselling vs nutrition counselling alone (control) on outcomes of linear growth (length and length-for-age z-score, LAZ), stunting (LAZ < 2), weight-for-length z-score (WLZ) and wasting (WLZ < 2) in children 6–18 months of age. Children (n = 5536) were enrolled at 6 months of age and, in the food groups, provided with one of the allocated supplements daily for a year. Results: Growth deceleration occurred from 6 to 18 months of age but a deceleration in LAZ was lower (by 0.02–0.04/month) in the Plumpy’doz (P = 0.02), rice-lentil (< 0.01), and chickpea (< 0.01) groups relative to control, whereas WLZ decline was lower only in Plumpy’doz and chickpea groups. WSBþþ did not impact on these outcomes. The prevalence of stunting was 44% at 18 months in the control group, but lower by 5–6% (P 0.01) in those receiving Plumpy’doz and chickpea. Mean length and LAZ at 18 months

Keywords: Complementary food, Stunting, growth, Micronutrients, Supplementation, Bangladesh

Location: 18 Unions of the Gaibandha and one Union of the Rangpur district

Start Date: 00-09-2012

End Date: 00-05-2014

Program Area: Food Safety and Security

Commodity: Fortified food

Objectives:

We designed a study to fill this gap by simultaneously testing in a cluster-randomized, controlled trial the effect of two innovative and well-designed, locally developed and produced products, and an enhanced fortified blended food, in promoting linear growth and reducing stunting and wasting in a typical poor rural area of northern Bangladesh.

Methodology:

Study area and population The study was conducted in the rural north-western study site that our research group established in 1999, located in 18 Unions of the Gaibandha and one Union of the Rangpur district, under the ‘JiVitA Project’ of the Johns Hopkins University in Bangladesh non-governmental organization. The 435 km2 study area has been divided into 596 clusters of communities (sectors) and is home to about 650 000 people. The population is majority Muslim with a poor, agrarian semi-subsistence economy; rice, pulses, vegetables, fisheries and homestead food production are the main sources of income generation.

Study design, hypothesis and sample size The field study was designed as an unblinded, randomized, controlled, community-based trial in which infants were enrolled at 6 months of age into five different study groups from September 2012 until May 2014. The trial evaluated three specially formulated complementary food supplements (CFSs) and an international product (Plumpy’doz) compared with a control (no food supplement), in addition to nutrition counselling provided to all. The main outcomes were LAZ change between 6 and 18 months and LAZ, length and stunting (LAZ< 2) at 18 months as well as WLZ and wasting (WLZ< 2) at 18 months. We hypothesized that compared with nutrition counselling alone (as control), each of the four CFS products given daily for 12 months in addition to nutrition counselling would increase LAZ and WLZ by> 0.2 z-scores, improve linear growth and reduce the prevalence rates of stunting (by 10% in absolute terms) and wasting at 18 months. We further hypothesized that each of the three CFS products would perform as well as an international ‘standard’ lipid-based Plumpy’doz in impacting on growth, defining an inferiority margin for an end-of-trial status at 18 months of age of 0.2 z-scores.

Interventions The nutrition counselling provided to all study participants consisted of home-based, age-specific messages on infant and young child feeding, health and hygiene provided by extensively trained counsellors using the Alive and Thrive (www.aliveandthrive.org) modules. Two lipid-based ready-to-use foods (RUFS, rice-lentil and chickpea-based) were locally developed at the International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b, Dhaka, Bangladesh), and tested for acceptability18 before their use in the trial. Based on the recipe that was developed and tested, a local company (Olympic Industries Ltd, Dhaka, Bangladesh) was contracted to manufacture the supplements for the study.

Randomization Cluster-randomization of the 596 predefined communities in JiVitA, called ‘sectors’, was done by blocks of 19 (total 32 blocks, last block had 7 sectors). A random-number seed was selected by a statistician not involved in the study, using a random number generator, and a random number between 0 and 1 drawn from a uniform distribution was assigned to each sector. Additionally, a block number was assigned to each sector in groups of 19. For blocks 1–31, the first five sectors by sort order were assigned to treatment group 1, the next five to treatment group 2, and so on. For block 32, the two larger controls were assigned two sectors and the intervention groups 1 sector each. This resulted in 157 assigned to each of the control groups and 94 sectors assigned to each of the intervention groups, yielding a ratio of 5:3 (or 1.7) required for the multiple comparison correction factor.

Data collection and procedures Enumeration and enrolment procedures Before study start-up, the JiVitA study area maintained a pregnancy surveillance in a cohort of women of reproductive age enumerated throughout the study area to identify new pregnancies, using urine-based testing as part of a previous trial which ended in May 2011. The identified pregnancies were tracked and live births recorded until April 2012. In February and March of 2012, we also conducted a vital status and household and address update of all previous JiVitA study participants (women and children), at which time we identified women who became pregnant after our pregnancy surveillance was completed and tracked live births in this group. Finally, we also conducted an area-wide enumeration of all 0–3 month old children about 3 months before starting the enrolment, to identify surviving children eligible to be enrolled in the study when they completed 6 months of age. From these three sources, a list of eligible children was generated. These were visited when they were 5 months of age to obtain informed consent from the parents before enrolment in the study at 6 months of age.

Supplementation and nutrition counseling One field distributor (FD) was assigned to each of the study areas’ 596 sectors and was responsible for visiting the homes of enrolled children to provide the foods and to assess daily morbidity. Based on the findings of formative research,24 in the first week of enrolment in the WSBþþ arm, FDs visited the mothers daily for the first 2–3 days to teach them the standard recipe (amount of water and cooking time) for cooking this fortified blended food. Mothers were informed that the food being provided was a snack and breastfeeding and other foods should be given as usual.

Source of Information: International Journal of Epidemiology, 2015, 1862–1876

Article Link (Online Journal): doi: 10.1093/ije/dyv155

Funding Source:

Budget:

Total Budget (Tk.) :

Achievement/Findings:

Among populations living with food insecurity, nutrition counselling alone may not be able to reduce the pervasive levels of stunting. Locally developed and produced ready-touse complementary food supplements that were previously shown to be acceptable were tested in our trial, and may fill an important gap. These foods were culturally appropriate and acceptable and provide essential nutrients in a concentrated form. Fortified blended food, such as WSBþþ, on the other hand are commonly used in national programmes, unlike the lipid-based products that are generally provided in small quantities to complement the daily diet. As yet there is no one fix or magic bullet to reducing stunting, and other causes including environmental enteropathy among others may be important. Other considerations are the affordability of these foods not addressed in our study, especially for the most marginalized populations, and ensuring daily intakes, which would need to be replicated under programmatic and less controlled situations. Use and promotion of these foods may be important in concert with nutrition counselling and other strategies, including improving adolescent and maternal nutrition to address the huge burden of stunting in South Asia.

Knowledge Management: Journal