Effects of an energy and micronutrient supplement on growth and development in undernourished children in Indonesia: methods.

Abstract

To describe the methodologies of a clinical trial on the effects of an energy and micronutrient supplement on the growth and development of undernourished children. This trial included two cohorts of children classified as nutritionally-at-risk who were randomly assigned to three treatments (condensed milk + micronutrients (E); skimmed milk + micronutrients (M); skimmed milk (S)). Supplements were given for a period up to 12 months. Six tea plantations in Pangalengan, West Java were the site for this study. A 12-month-old (N=53) and an 18-month-old (N=83) cohort were recruited from 24 day-care-centers (DCC). Twenty children that received the S supplement were part of the 12- and 18 month-old cohort. Criteria for case inclusion were absence of chronic disease; length-for-age < or = -1 standard deviation (s.d.) and weight-for-length between -1 and -2 s.d. of the median of the reference of the World Health Organization. Social variables included assessment of health facilities, childcare, housing, income and parental education. Nutrition and growth variables included dietary intake measured over a 24 hr period every 2 months; hemoglobin and three iron indicators measured at baseline, 6 and 12 months; anthropometry measured every 2 months and skeletal maturation measured every 6 months. Cognition and behavior included the assessment of mental and motor development and the behavior of the child under natural conditions. An ANOVA was the statistic most frequently used to test inter-group differences and structural equation modeling was used to test the internal validity of the conceptual model of the study.