Needs Statement

Follows is a needs statement excerpt from an academic research proposal that I wrote for a Research Methods graduate course.


The Safe Infant Formula Education Project (SIFEP)

Research Proposal Excerpt


Orphans and other vulnerable children (OVC) in India are at high risk for malnutrition, infectious disease, and early death. According to UNICEF’s latest country data, India has an alarming under five years of age mortality rate of 53 out of 1,000 children born; 44 out of 1,000 for infants under the age of one (2015). Approximately 28% of Indian children are born at low birthweight (UNICEF). As they grow, 48% of Indian children are considered moderately to severely stunted, and 19.8% are deemed moderate to severely wasted (UNICEF, 2012).

In addition to malnutrition, poor sanitation also contributes to poor health outcomes in Indian children. Roughly half of the Indian population defecates out of doors (Heidi Worley PBR, 2014). Relatedly, half of the country regularly drinks potentially contaminated water sources (NYT, 2014). One common bacterial infection spread by fecal matter in the water supply is enterotoxigenic E. coli (ETEC) which is a frequent cause of diarrhea (CDC, 2005). According to authors Taneja et al. “the burden of infection due to ETEC has been correlated with low socioeconomic status, improper hygienic practices and contaminated sources of food and water with a seasonal increase during the summer” (2000, pg 196). While diarrhea may be relatively harmless for healthy adults, it can be fatal in young children. In India, diarrheal disease caused 22.8% of deaths of those aged 1-59 months (UNICEF, 2015).

Contaminated water supply is particularly dangerous to babies subsisting on powdered infant formula (PIF). Infants are at higher risk for foodborne illness because their immune system is still developing (Turck, 2012). While the World Health Organization (WHO) recommends exclusive breastfeeding for infants until the age of six months, access to safe infant formula is essential for OVC in care-taking settings (2015). WHO suggests that Sterile liquid infant formula can be used as safe alternative to breastmilk; however, these products may not always be available in a resource-constrained location such as an adoption agency. In these caretaking settings, PIF is a less-expensive and therefore more commonly used.

PIF is not a sterile product and can be dangerous for infants if not handled properly. While much attention has been paid in the literature to quality control on the part of food manufacturers, consumer practices of handling PIF are less well studied (Redmond & Griffith, 2009). According to Safe Preparation, Storage and Handling of Powdered Infant Formula Guidelines the “correct preparation and handling of PIF reduces the risk of illness” (WHO, 2007). Proper bottle decontamination is crucial (Redmond & Griffith, 2009). Also, ensuring caretakers wash hands, pay attention to temperatures, and discard all formula after two hours are all critical to preventing foodborne illness (Wolfe, Fein & Shealy, 2013).

In 2008, three researchers discovered that unsafe infant feeding practices were common among caretakers in the United States. The authors of the 2005-2007 Infant Feeding Practices Study II found that 77% of mothers who formula-fed had never received instruction from a healthcare professional (Labiner-Wolfe, Fein & Shealy, 2008). Additionally, 55% of participants did not wash their hands with soap before preparing PIF. Another 30% of participants had never read the directions on the packaging, and 32% did not wash their rubber teats in between feedings (Labiner-Wolfe, Fein & Shealy, 2008).

Unsafe handling of PIF, coupled with a contaminated water supply, is a major hazard for infants living in orphanages and adoption agencies in India, especially as infections may spread quickly in a healthcare setting (Taneja et al. 2000). For example, at a Chandigarh hospital in 2000, a four-day ETEC outbreak occurred. Traces of ETEC were found on hand swabs, utensils, milk feed and in the PIF. Thankfully, this outbreak was quickly contained through antibiotic treatment regimens in addition to “feedback on hand hygiene, proper disinfection of utensils used to prepare the formula feeds, appropriate boiling of milk feeds and general cleanliness of the kitchen area and food handlers” (Taneja et al. pg 196). Other outbreaks such as one of salmonella in a Canadian newborn nursery in 1993 have demonstrated that the introduction of an infection may spread like wildfire in a childcare setting (Lalonde). Clearly, strong preventive measures are needed to avoid these types of occurrences in childcare facilities in the future.

Currently, the researchers cannot find evidence of published food safety education (FSE) studies that focused on PIF safety practices in adoption agencies or similar care-taking settings making this topic a potential gap in the literature. However, a 2004 study in Gujarat, India found that a multi-material FSE targeted at mothers of impoverished children successfully reduced the incidence of childhood diarrhea by 52% (Sheth & Obrah). In Vietnam, a longitudinal educational intervention of hygiene and food safety behaviors aimed at caregivers resulted in a significant reduction of childhood diarrhea from 21.6% at baseline to 5.9% during the second evaluation after two years (Takanashi et al., 2013). Together, this evidence suggests that a targeted educational intervention may be a potentially viable method of improving food safety and health-related outcomes.

Research Question:

The Safe Infant Formula Education Project (SIFEP) pilot presumes that an early prevention of diarrheal disease in caretaking settings with vulnerable infants can save lives in the short term and promote improvement in long-term growth. The research question of this study is as follows: will the provision of caretaker-focused nutrition education and passive education materials be associated with improved infant food-handling practices within orphanages and adoption agencies in Chennai, India six months after the intervention? 


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Central Adoption Resource Agency. (2015). Ministry of Women & Child Development. List of Recognised Indian Placement Agencies: Tamil Nadu. Retrieved from:

Center for Disease Control. (October 2005). Enterotoxigenic Escherichia coli (ETEC). Retrieved from:

Dupont WD, Plummer WD. (1990). “Power and Sample Size Calculations: A Review and Computer Program.” Controlled Clinical Trials; 11:116-28.

Harris, G. (July 13, 2014). “Poor Sanitation in India May Afflict Well-Fed Children With Malnutrition.” New York Times. Retrieved from:

Labiner-Wolfe, J.; Fein, S.; Shealy, K. (2008). “Infant Formula-Handling Education and Safety.” Pediatrics, 122. S85 – S90.

Lalonde, R. (1993). “Salmonella thomson outbreak in a Canadian newborn nursery.” Canadian Journal of Infectious Diseases. 4 (4), p. 209 – 212

Ljung, K.; Palm, B.; Grander, M.; Vahter, M. (2011). “High Concentrations of Essential and Toxic Elements in Infant Formula and Infant Foods – A Matter of Concern.” Food Chemistry. 127. 943-951.

Population Reference Bureau. (2014). Water, Sanitation, Hygiene, and Malnutrition in India. Retrieved from:

Redmond, E.; Griffith, C. (2009.) “Contamination of bottles used for feeding reconstituted powdered infant formula and implications for public health.” Perspectives in Public Health. p. 85 – 94.

Redmond, E.; Griffith, C. (2009.) “The importance of hygiene in the domestic kitchen: Implications for preparation and storage of food and infant formula.” Perspectives in Public Health. p. 69 – 76

Sheth, M.; Obrah, M. (October 1, 2004). “Diarrhea prevention through food safety education.” Indian Journal of Pediatrics. 71 (10), p. 879 – 882.

Steele, C.; Short, R. (October 2008). “Centralized Infant Formula Preparation Room in the Neonatal Intensive Care Unit Reduces Incidence of Microbial Contamination.” Journal of the American Dietetic Association. 108 (10), p. 1700 – 1703.

Takanashi et al. (2013). “Long-Term Impact of Community-Based Information, Education and Communication Activities on Food Hygiene and Food Safety Behaviors in Vietnam: A Longitudinal Study.” PloS One.8 (8), e70654.

Taneja, N. et al. (March 2003). “Nosocomial outbreak of diarrhoea by enterotoxigenic Escherichia coli among preterm neonates in a tertiary care hospital in India: pitfalls in healthcare.” The Journal of Hospital Infection. 53 (3), p. 193 – 197.

Turck, D. (2012) “Safety Aspects in Preparation and Handling of Infant Food.” Annals of Nutrition and Metabolism. 60 (3), p. 211 – 214.

UNICEF. (2015). India: Key Demographic Indicators. Retrieved from:

UNICEF. (2005 – 2006). India: Nutrition. Retrieved from:

UNICEF. (December 2013.) India: Statistics. Retrieved from:

Viswanathan, G.; Gopalakrishnan, S. ; Siva Ilango, S. (December 2010) “Assessment of water contribution on total fluoride intake of various age groups of people in fluoride endemic and non-endemic areas of Dindigul District, Tamil Nadu, South India.” Water Research. 44 (20), p. 6186 – 6200.

World Health Organization. (February 2007). How to Prepare Bottle-Feeding at Home. Retrieved from:

World Health Organization. (February 2014). Infant and young child feeding. Retrieved from:

World Health Organization. (2007). Safe Preparation, Storage and Handling of Powdered Infant Formula Guidelines. Retrieved from: