Stunting Clinical Trial
Official title:
The Effect of Higher Nutrient-Dense Complementary Foods on Catch-up Growth and Nutritional Status of Stunting Children in Dompu District, Indonesia
The purpose of this study is to determine and compare the effect of higher nutrient-dense complementary foods and standard nutrient dense complementary foods on the catch-up growth and nutritional status of stunting children aged 12-23 months old in Indonesia.
This is an intervention, double blind study. Investigators want to study the effect of
higher nutrient density complementary foods (which consists of optimizing children diet by
practicing Optimized Complementary Feeding Recommendation/CFRs and consume special designed
fortified biscuit) on catch-up growth and nutritional status of stunting children aged 12 -
23 mos old.
There are two phases in this study.
Phase I: Development of CFRs and fortified biscuit
1. Food consumption survey (n=100) to gather information on foods typically consumed by the
stunting children, food patterns, serving sizes, food price.
Methods: 24-hr dietary recall, food weighed dietary records (WDR) and 5-days food tally for
each child.
Data from food consumption survey will be use to develop optimized CFRs by using Linear
Programming (LP) approach with software Optifood v 2.0.
Data from LP analysis such as nutrient gaps will be use to formulate fortified biscuit (3
type of nutrient dense). Biscuit ingredients will use local foods. Acceptability trials will
be conducted to see the acceptance of the biscuit in the community settings (color, smell,
taste and portion).
Phase II: Intervention Screening: Anthropometry measurements (body weight and length) to
screen stunting and non stunting children; and child with hemoglobine level < 7 g/dL was
referred to sub-district health center.
Baseline survey: anthropometry measurements (body weight and length), biochemical
assessments (3 mL of blood obtain from the antecunital vein for serum zinc, ferritin,
transferin receptor, CRP, AGP and RBP), dietary assessment (repeated 24-h recall),
socio-demography, food security, health seeking practices questionnaires.
Intervention -- optimized CFRs + Biscuits (3 groups) Biscuits will be distributed for 6 days
consumption per week (12 months). The waste of the biscuits will be weighted to get actual
biscuit consumptions. Mothers/caregivers will be encouraged to practice CFRs to improve
child's nutritional adequacy. Monthly body weight and length/height measurement. Nutrition
education for mothers/caregivers by field staff.
Endline survey: anthropometry measurements (body weight and length), biochemical assessments
(3 mL of blood obtain from the antecunital vein for serum zinc, ferritin, transferin
receptor, CRP, AGP and RBP), dietary assessment (repeated 24-h recall)
;
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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