Food Supplement Treatment for Wasting Children in Indonesia
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|ClinicalTrials.gov Identifier: NCT03509155|
Recruitment Status : Active, not recruiting
First Posted : April 26, 2018
Last Update Posted : April 30, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Wasting Nutrition Disorder, Child||Other: National portion & IYCF counseling Other: Adjusted portion & local food counseling||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||720 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
The intervention is running parallel in three arms.
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Randomized Controlled Trial of Food Supplement Treatment for Wasting Children in Indonesia - Study Protocol|
|Actual Study Start Date :||October 1, 2017|
|Estimated Primary Completion Date :||October 31, 2018|
|Estimated Study Completion Date :||November 30, 2018|
No Intervention: Control group
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
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
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
Experimental: 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.
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
- Nutritional status of wasting children [ Time Frame: 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.
- PMT biscuits compliance [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03509155
|Seameo Regional Center for Food and Nutrition|
|Jakarta Pusat, DKI Jakarta, Indonesia, 10430|
|Principal Investigator:||Muchtaruddin Mansyur, PhD||Seameo Regional Center For Food And Nutrition|