Clinical trial NCT02532816: Nutrient-Dense Complementary Foods on Catch-up Growth and Nutritional Status of Stunting Children
Official title: The Effect of Higher Nutrient-Dense Complementary Foods on Catch-up Growth and Nutritional Status of Stunting Children in Dompu District, Indonesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stunting
Keywords: stunting
indonesia
Lead sponsor: SEAMEO Regional Centre for Food and Nutrition
Sponsor class: OTHER
Collaborators: name: Nestlé Foundation
name: Indonesia University
name: Institut Pertanian Bogor
name: London School of Hygiene and Tropical Medicine
First posted: 2015-08-26
Enrollment: 217
Sex: ALL
Minimum age (years): 12
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: length gain
timeFrame: one year
measure: linear growth rate
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Dompu
country: Indonesia
facility: in the community (Woja,Manggelewa, Kempo subdistrict)
state: West Nusa Tenggara
Study officials:
affiliation: SEAMEO Regional Centre for Food and Nutrition
name: Duma O Fransisca, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: SEAMEO Regional Centre for Food and Nutrition
name: Umi Fahmida, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Golden MH. Proposed recommended nutrient densities for moderately malnourished children. Food Nutr Bull. 2009 Sep;30(3 Suppl):S267-342. doi: 10.1177/15648265090303S302.
citation: Ferguson EL, Darmon N, Briend A, Premachandra IM. Food-based dietary guidelines can be developed and tested using linear programming analysis. J Nutr. 2004 Apr;134(4):951-7. doi: 10.1093/jn/134.4.951.