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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03509155
Enrollment
720
Registered
2018-04-26
Start date
2017-10-01
Completion date
2018-11-30
Last updated
2018-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutrition Disorder, Child, Wasting

Keywords

Infant and Young Child Feeding, Program Evaluation, Food Supplementation, Biscuit, wasting children

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.

Interventions

OTHERNational 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

OTHERAdjusted 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

Sponsors

SEAMEO Regional Centre for Food and Nutrition
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

The intervention is running parallel in three arms. 1. The first arm as a control group obtaining only routine IYCF counseling by the cadre and without the provision of biscuits. If there are respondents at the first three months data collection who experience a decrease in nutritional status, then the respondent will be given biscuits immediately 2. The second arm as the first intervention group to get biscuit with portion as recommended by Ministry of Health and also given the IYCF counseling by the cadres and nutritionist 3. The third arm as the second intervention group receiving biscuit with adjustment in portion and IYCF Counseling that emphasize the optimization of local food In the 2nd and 3rd 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.

Eligibility

Sex/Gender
ALL
Age
6 Months to 23 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Nutritional status of wasting childrenThrough study completion, an average of 1 year. Measurement on changes in nutritional status from baseline and at third, sixth, & ninth monthsAnthropometry 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

MeasureTime frameDescription
PMT biscuits complianceThrough 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.

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026