Food Supplement Treatment for Wasting Children in Indonesia

SEAMEO Regional Centre for Food and Nutrition

Status: Unknown

Conditions: Wasting; Nutrition Disorder, Child

Treatments: Other: National portion & IYCF counseling; Other: Adjusted portion & local food counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT03509155

PMT2017

Details and patient eligibility

About

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.

Enrollment: 720 patients

Sex: All

Ages: 6 to 23 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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720 participants in 3 patient groups

Control group

No Intervention group

Description:

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.

National portion & IYCF counseling

Active Comparator group

Description:

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.

Treatment:

Other: National portion & IYCF counseling

Adjusted portion & local food counseling

Experimental group

Description:

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.

Treatment:

Other: Adjusted portion & local food counseling