Food Supplement Treatment for Wasting Children in Indonesia

Not Applicable

• Conditions: Wasting; Nutrition Disorder, Child
• Interventions: Other: National portion & IYCF counseling; Other: Adjusted portion & local food counseling

• Registration Number: NCT03509155
• Lead Sponsor: SEAMEO Regional Centre for Food and Nutrition

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-01
• Study First Submitted: 2018-03-12
• Status Verified: 2018-04
• Study First Submitted QC: 2018-04-25
• Study First Posted: 2018-04-26
• Last Update Submitted: 2018-04-26
• Last Update Posted: 2018-04-30
• Primary Completion: 2018-10-31
• Study Completion: 2018-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 720

Inclusion Criteria

• Age 6-17 months (still included in under two years old children during the intervention period)
• Underweight children by weight-per-height less than -2.00
• Not received PMT Biscuits at the time of recruitment
• Parents agree to follow the research

Exclusion Criteria

• Severe wasting (weight for height less than -3 Z-score)
• Severe food insecurity households (Severe Household Food Insecurity)
• Tuberculosis infection based on anamnesis
• The possibility of moving to another city within 6 months of intervention

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
National portion & IYCF counseling	National portion & IYCF counseling	The second arm as the national portion \& IYCF counseling group to get biscuit with standardized portion as recommended by Ministry of Health and also given the IYCF counseling by the cadres and nutritionist.In the second and third arm, treatment was administered for 3 months according to the recommended duration of biscuit delivery by the Ministry of Health, but all respondents from three arms will continue to be followed in third, sixth, and ninth months from the beginning of treatment.
Adjusted portion & local food counseling	Adjusted portion & local food counseling	the third arm as the adjusted portion \& local food counseling group receiving biscuit with adjustment in portion and IYCF Counseling that emphasize the optimization of local food. In the second and third arm, treatment was administered for 3 months according to the recommended duration of biscuit delivery by the Ministry of Health, but all respondents from three arms will continue to be followed in third, sixth, and ninth months from the beginning of treatment.

Primary Outcome Measures

Name	Time	Method
Nutritional status of wasting children	Through study completion, an average of 1 year. Measurement on changes in nutritional status from baseline and at third, sixth, & ninth months	Anthropometry measurement based on weight-for-length indicator (The WHO Child Growth Standards). Weight will be measured in kilograms using an equivalent quality measurement tool using SECA scales. The measuring instrument to be used in measuring the length of the child is a Shorrboard with a unit of cm, precision of 0.1 cm.

Secondary Outcome Measures

Name	Time	Method
PMT biscuits compliance	Through study completion, an average of 1 year. At the first to third months after treatment started, then continued to be observed at the sixth and ninth months from the beginning of treatment.	The caregiver will be asked to fill a form every day noting on how many biscuits the children eat and its remaining stock for that day. The form will be collected by enumerator while doing regular observation.

Trial Locations

Locations (1)

Seameo Regional Center for Food and Nutrition; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia