Clinical trial NCT03509155: Food Supplement Treatment for Wasting Children in Indonesia
Official title: A Multicenter Randomized Controlled Trial of Food Supplement Treatment for Wasting Children in Indonesia - Study Protocol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Wasting
Nutrition Disorder, Child
Keywords: Infant and Young Child Feeding
Program Evaluation
Food Supplementation
Biscuit
wasting children
Lead sponsor: SEAMEO Regional Centre for Food and Nutrition
Sponsor class: OTHER
First posted: 2018-04-26
Enrollment: 720
Sex: ALL
Minimum age (years): 6
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Nutritional status of wasting children
timeFrame: Through study completion, an average of 1 year. Measurement on changes in nutritional status from baseline and at third, sixth, & ninth months
Secondary outcomes:
measure: PMT biscuits compliance
timeFrame: 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.
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Seameo Regional Center for Food and Nutrition
state: DKI Jakarta
Study officials:
affiliation: Seameo Regional Center For Food And Nutrition
name: Muchtaruddin Mansyur, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Fahmida U, Kolopaking R, Santika O, Sriani S, Umar J, Htet MK, Ferguson E. Effectiveness in improving knowledge, practices, and intakes of "key problem nutrients" of a complementary feeding intervention developed by using linear programming: experience in Lombok, Indonesia. Am J Clin Nutr. 2015 Mar;101(3):455-61. doi: 10.3945/ajcn.114.087775. Epub 2014 Dec 24.
citation: Adu-Afarwuah S, Lartey A, Brown KH, Zlotkin S, Briend A, Dewey KG. Randomized comparison of 3 types of micronutrient supplements for home fortification of complementary foods in Ghana: effects on growth and motor development. Am J Clin Nutr. 2007 Aug;86(2):412-20. doi: 10.1093/ajcn/86.2.412.
citation: Kekalih A, Anak Agung Sagung IO, Fahmida U, Ermayani E, Mansyur M. A multicentre randomized controlled trial of food supplement intervention for wasting children in Indonesia-study protocol. BMC Public Health. 2019 Mar 13;19(1):305. doi: 10.1186/s12889-019-6608-5.