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

The Effect of Higher Nutrient-Dense Complementary Foods on Catch-up Growth and Nutritional Status of Stunting Children in Dompu District, Indonesia

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02532816
Enrollment
217
Registered
2015-08-26
Start date
2013-10-31
Completion date
2016-07-31
Last updated
2015-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stunting

Keywords

stunting, 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 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)

Interventions

DIETARY_SUPPLEMENTNutrient dense complementary foods

Mothers/caregivers will receive optimized CFRs to improve children diets and fortified biscuits (3 types of biscuit) for 6 days per week (in 12 months). Nutrition eduction for mothers/caregivers. Monthly body weight and length/height measurements

Sponsors

Nestlé Foundation
CollaboratorOTHER
Indonesia University
CollaboratorOTHER
Institut Pertanian Bogor
CollaboratorOTHER
London School of Hygiene and Tropical Medicine
CollaboratorOTHER
SEAMEO Regional Centre for Food and Nutrition
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
12 Months to 23 Months
Healthy volunteers
Yes

Inclusion criteria

* identified as stunting (having HAZ ≤ -2SD of the WHO Growth Standard 2006) * no clinical evidence of any acute infectious disease or other diseases or morbidity condition that could interfere with the intake of study diets * parents and children residence in the study area. * parental concent obtained

Exclusion criteria

* presence of oedema, severe illness warranting hospitalization on the enrolment day such as persistent diarrhea and other disease which may influence feeding practices and nutrient absorption * conncurrent participation in another clinical trial * severe anemia with hemoglobine concentration \< 7.0 g/dL

Design outcomes

Primary

MeasureTime frameDescription
length gainone yearThe increment of body length/height of the subjects, monthly measurement
linear growth rateone yeargrowth velocity = (x2-x1)/(t2-t1) where x2 and x1 are values of the measurement on two occacions t2 and t1. in mm/d

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026