Food Supplement Treatment for Wasting Children in Indonesia

Study Overview
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Brief Summary
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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.

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

Conditions
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Wasting, Nutrition Disorder, Child

Intervention / Treatment
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* Other: National portion & IYCF counseling
* Other: Adjusted portion & local food counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 23 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The intervention is running parallel in three arms. 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 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 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>The first arm as a control group obtaining only routine IYCF consultation by the posyandu (integrated health service post) cadres and without the provision of biscuits. | |
| Active Comparator: National portion & IYCF counseling<br>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. | Other: National portion & IYCF counseling<br>* 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<br>|
| Experimental: Adjusted portion & local food counseling<br>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. | Other: Adjusted portion & local food counseling<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional status of wasting children | 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. | Through study completion, an average of 1 year. Measurement on changes in nutritional status from baseline and at third, sixth, & ninth months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PMT biscuits compliance | 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infant and Young Child Feeding, Program Evaluation, Food Supplementation, Biscuit, wasting children