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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02532816
• Other study ID #: Ind_dompustunting
• Status: Active, not recruiting
• Phase: N/A
• First received: August 20, 2015
• Last updated: August 21, 2015
• Start date: October 2013
• Est. completion date: July 2016

Study information

• Verified date: August 2015
• Source: SEAMEO Regional Centre for Food and Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia: Departement Kesehatan (Department of Health)
• Study type: Interventional

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.

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 217
• Est. completion date: July 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months to 23 Months

Eligibility

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

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

Intervention

Dietary Supplement:
• Nutrient 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

Locations

Country	Name	City	State
Indonesia	in the community (Woja,Manggelewa, Kempo subdistrict)	Dompu	West Nusa Tenggara

Sponsors (5)

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

Country where clinical trial is conducted

Indonesia, 

References & Publications (2)

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. — View Citation

Golden MH. Proposed recommended nutrient densities for moderately malnourished children. Food Nutr Bull. 2009 Sep;30(3 Suppl):S267-342. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	length gain	The increment of body length/height of the subjects, monthly measurement	one year	No
Primary	linear growth rate	growth velocity = (x2-x1)/(t2-t1) where x2 and x1 are values of the measurement on two occacions t2 and t1. in mm/d	one year	No