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

Objectives: To describe the methodologies of a clinical trial on the effect s of an energy and micronutrient supplement on the growth and development o f undernourished children. Design: This trial included two cohorts of children classified as nutrition ally-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. Setting: Six tea plantations in Pangalengan. West Java were the site for th is study. Subjects: 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 ca se inclusion were absence of chronic disease; length-for-age less than or e qual to -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. Variables: Social variables included assessment of health facilities, child care, housing, income and parental education. Nutrition and growth variable s included dietary intake measured over a 24 hr period every 2 months; hemo globin and three iron indicators measured at baseline, 6 and 12 months: ant hropometry 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. Data analysis: An ANOVA was the statistic most frequently used to test inte r-group differences and structural equation modeling was used to test the i nternal validity of the conceptual model of the study.