NCT03509155

Food Supplement Treatment for Wasting Children in Indonesia

A Multicenter Randomized Controlled Trial of Food Supplement Treatment for Wasting Children in Indonesia - Study Protocol

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 720 (actual)
• Sponsor: SEAMEO Regional Centre for Food and Nutrition · Academic / Other
• Sex: All
• Age: 6 Months – 23 Months
• Healthy volunteers: Not accepted

Summary

Assessing program efficacy of under five food supplementation (PMT Biscuits) is needed after the first 6 months of exclusive breastfeeding, children were introduced to liquid and semi-solid food. In this phase of food introduction, children ability to accept food supplementation program was still questionable and the efficacy needs to be assessed. Another aspect that needed to be evaluated is assessing the efficacy of food supplementation to improve the nutritional status of wasting children in multiple cities to describe Indonesian geographical and socio-economic diversity (multi center studies). PMT biscuits supplementation intervention is accompanied by educational modules on Infant and Young Child Feeding (IYCF) in order to improve caregiver's knowledge and skills in providing economically affordable and nutritious food for their children. PMT biscuits supplementation evaluation will be assessed at 9 months observations (3 months intervals). The observation will be conducted every month up until the first 3 months then the observation will be continued in 6th and 9th months of observation.

Conditions

• Wasting
• Nutrition Disorder, Child

Interventions

Type	Name	Description
OTHER	National portion & IYCF counseling	Eight or twelve pieces of Biscuits supplementation per day as serving size recommendation based on the requirement from Ministry of Health, accompanied by IYCF Counseling emphasizing on local food optimization. The difference in serving size recommendation will be evaluated to see the efficacy of Biscuits supplementation on wasting children age 6-23 months of age
OTHER	Adjusted portion & local food counseling	four pieces of Biscuits supplementation per day as serving size recommendation, accompanied by IYCF Counseling. The difference in serving size recommendation will be evaluated to see the efficacy of Biscuits supplementation on wasting children age 6-23 months of age

Timeline

• Start date: 2017-10-01
• Primary completion: 2018-10-31
• Completion: 2018-11-30
• First posted: 2018-04-26
• Last updated: 2018-04-30

Locations

1 site across 1 country: Indonesia