Food Supplement Treatment for Wasting Children in Indonesia

Wasting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03509155
• Other study ID #: PMT2017
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: November 30, 2018

Study information

• Verified date: April 2018
• Source: SEAMEO Regional Centre for Food and Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 720
• Est. completion date: November 30, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 23 Months

Eligibility

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

Related Conditions & MeSH terms

• Cachexia
• Child Nutrition Disorders
• Nutrition Disorder, Child
• Nutrition Disorders
• Wasting

Intervention

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
• 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

Locations

Country	Name	City	State
Indonesia	Seameo Regional Center for Food and Nutrition	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
SEAMEO Regional Centre for Food and Nutrition

Country where clinical trial is conducted

Indonesia, 

References & Publications (4)

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. — View Citation

de Onis M, Garza C, Victora CG. The WHO Multicentre Growth Reference Study: strategy for developing a new international growth reference. Forum Nutr. 2003;56:238-40. Review. — View 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. — View Citation

Ferguson EL, Darmon N, Fahmida U, Fitriyanti S, Harper TB, Premachandra IM. Design of optimal food-based complementary feeding recommendations and identification of key "problem nutrients" using goal programming. J Nutr. 2006 Sep;136(9):2399-404. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.