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

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.

Study Overview

• Status: Unknown
• Conditions: Stunting
• Intervention / Treatment: Dietary supplement: Nutrient dense complementary foods

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)

• Study Type: Interventional
• Enrollment (Actual): 217
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • West Nusa Tenggara
    • Dompu, West Nusa Tenggara, Indonesia
      • in the community (Woja,Manggelewa, Kempo subdistrict)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: HND-CF; subjects will receive nutrient dense complementary foods in optimized CFRs + fortified biscuit (ferrous fumarate 83.5 mg, zinc oxide 50.95 mg, Calcium carbonate 3104.05 mg, Thiamine Mononitrate1.85 mg, Nicotinic Acid 30.45 mg, Pyridoxine Hydrocloride 2.90 mg, Pteroyl monoglutamic acid 764.90 mcg, Cyanocobalamin 0.95 mcg, Retinol Palmitate (dry) 742.50 mcgRE)	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
ACTIVE_COMPARATOR: SND-CF; subjects will receive nutrient dense complementary foods in optimized CFRs + fortified biscuit (ferrous fumarate 32.6 mg, zinc oxide 3.78 mg, Calcium carbonate 874.12 mg, Thiamine Mononitrate1.25 mg, Nicotinic Acid 17.95 mg, Pyridoxine Hydrocloride 1.10 mg, Pteroyl monoglutamic acid 329.90 mcg, Cyanocobalamin 0.55 mcg)	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
PLACEBO_COMPARATOR: NDN-CF; subjects will receive nutrient dense complementary foods in optimized CFRs + non fortified biscuit	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
length gain	The increment of body length/height of the subjects, monthly measurement	one year
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

Collaborators and Investigators

• Sponsor: SEAMEO Regional Centre for Food and Nutrition
• Collaborators: London School of Hygiene and Tropical Medicine; Indonesia University; Nestlé Foundation; Institut Pertanian Bogor
• Investigators: Principal Investigator: Duma O Fransisca, MSc, SEAMEO Regional Centre for Food and Nutrition; Principal Investigator: Umi Fahmida, Dr, SEAMEO Regional Centre for Food and Nutrition

Publications and helpful links

General Publications

• Golden MH. Proposed recommended nutrient densities for moderately malnourished children. Food Nutr Bull. 2009 Sep;30(3 Suppl):S267-342. doi: 10.1177/15648265090303S302.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (ANTICIPATED): April 1, 2016
• Study Completion (ANTICIPATED): July 1, 2016

Study Registration Dates

• First Submitted: August 20, 2015
• First Submitted That Met QC Criteria: August 21, 2015
• First Posted (ESTIMATE): August 26, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): August 26, 2015
• Last Update Submitted That Met QC Criteria: August 21, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: stunting; indonesia
• Additional Relevant MeSH Terms: Pathologic Processes; Growth Disorders
• Other Study ID Numbers: Ind_dompustunting