Clinical Trial: Nutrient-Dense Complementary Foods on Catch-up Growth and Nutritional Status of Stunting Children
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: The Effect of Higher Nutrient-Dense Complementary Foods on Catch-up Growth and Nutritional Status of Stunting Children in Dompu District, Indonesia
Brief 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.
Detailed Summary:
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, transferi
Sponsor: SEAMEO Regional Centre for Food and Nutrition
Current Primary Outcome:
- length gain [ Time Frame: one year ]The increment of body length/height of the subjects, monthly measurement
- linear growth rate [ Time Frame: one year ]growth velocity = (x2-x1)/(t2-t1) where x2 and x1 are values of the measurement on two occacions t2 and t1. in mm/d
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: SEAMEO Regional Centre for Food and Nutrition
Dates:
Date Received: August 20, 2015
Date Started: October 2013
Date Completion: July 2016
Last Updated: August 21, 2015
Last Verified: August 2015
