Nutrient-Dense Complementary Foods on Catch-up Growth and Nutritional Status of Stunting Children

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

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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) ;

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Growth Disorders
• Stunting

• NCT number: NCT02532816
• Study type: Interventional
• Source: SEAMEO Regional Centre for Food and Nutrition
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2013
• Completion date: July 2016