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

Abstract

Objectives: 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.

Design: 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.

Setting: Six tea plantations in Pangalengan, West Java were the site for this 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 case inclusion were absence of chronic disease; length-for-age≤−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, 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.

Data analysis: 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.

Sponsorship: Nestlé Foundation.

European Journal of Clinical Nutrition (2000) 54, Suppl 2, S16–S20